Robotic Surgery [2 ed.] 3030535932, 9783030535933

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Farid Gharagozloo Vipul R. Patel Pier Cristoforo Giulianotti Robert Poston Rainer Gruessner Mark Meyer Editors

Robotic Surgery Second Edition

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Robotic Surgery

Farid Gharagozloo  •  Vipul R. Patel Pier Cristoforo Giulianotti  •  Robert Poston Rainer Gruessner  •  Mark Meyer Editors

Robotic Surgery Second Edition

Editors Farid Gharagozloo, M.D., FACS, FCCS, FACHE Center for Advanced Thoracic Surgery Global Robotics Institute Advent Health Celebration Celebration, FL USA Pier Cristoforo Giulianotti, M.D., FACS Department of Surgery University of Illinois at Chicago Chicago, IL USA Rainer Gruessner, M.D., FACS Department of Surgery SUNY Downstate Medical Center Brooklyn, NY USA

Vipul R. Patel, M.D. Global Robotics Institute Advent Health Celebration Celebration, FL USA Robert Poston, M.D. Department of Cardiothoracic Surgery Three Crosses Regional Hospital Las Cruces, NM USA Mark Meyer, M.D. Department of Surgery Wellington Regional Medical Center Wellington, FL USA

ISBN 978-3-030-53593-3    ISBN 978-3-030-53594-0 (eBook) https://doi.org/10.1007/978-3-030-53594-0 © Springer Nature Switzerland AG 2021 This work is subject to copyright. All rights are reserved by the Publisher, whether the whole or part of the material is concerned, specifically the rights of translation, reprinting, reuse of illustrations, recitation, broadcasting, reproduction on microfilms or in any other physical way, and transmission or information storage and retrieval, electronic adaptation, computer software, or by similar or dissimilar methodology now known or hereafter developed. The use of general descriptive names, registered names, trademarks, service marks, etc. in this publication does not imply, even in the absence of a specific statement, that such names are exempt from the relevant protective laws and regulations and therefore free for general use. The publisher, the authors, and the editors are safe to assume that the advice and information in this book are believed to be true and accurate at the date of publication. Neither the publisher nor the authors or the editors give a warranty, expressed or implied, with respect to the material contained herein or for any errors or omissions that may have been made. The publisher remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. This Springer imprint is published by the registered company Springer Nature Switzerland AG The registered company address is: Gewerbestrasse 11, 6330 Cham, Switzerland

To the Guiding Light in My Life: My father, who loved Medicine as a science and as a vehicle by which he could serve humankind. Although he was a model of compassion, dedication, and excellence as a father and a man, his soul was that of a physician and a healer. (https://www.youtube.com/watch?v=RFiqa5xxxYU) To My Co-editors: Vipul Patel, who has the distinction of performing the largest number of robotic procedures in the World. Vip’s exceptional talents as a surgeon, innovator, administrator, and businessman have been vital to the development of the field of Robotic Surgery. All robotic surgeons owe a debt of gratitude to this extraordinary pioneer. Pier Cristoforo Giulianotti, a master surgeon and pioneer, who has performed many of the first robotic abdominal and chest procedures in the World. Piero is an artistic virtuoso in Robotic Surgery whose passion and leadership have been the source of great excitement among surgeons. Singlehandedly, and more than any other pioneering robotic surgeon, Piero has been responsible for propagating the field of Robotic Surgery throughout the World. Robert Poston, a pioneer in Robotic Cardiac Surgery and my former Division Chief at the University of Arizona. Rob’s exceptional intellect and extraordinary analytic thinking have been instrumental in defining the organizational requirements for the establishment of successful robotic surgery programs. Rob has defined the importance of “Teams” in robotic surgery and has outlined the programmatic requirements that are necessary to shorten or even erase the “learning” curve in this new field of surgery. Rob’s work has been of existential importance to Robotic Surgery. Indeed, the entire field is indebted to this extraordinary surgeon. Rainer Gruessner, a “Surgeon’s Surgeon,” and my former Chairman at the University of Arizona. The field of Robotic Surgery is indebted to Dr. Gruessner, a world-renowned abdominal transplant surgeon, for his leadership and belief in the promise of robotic surgery. As Chairman of Surgery at the University of Arizona, Dr. Gruessner recruited and nurtured robotic surgeons in all specialties. His unwavering sense of purpose and extraordinary leadership were responsible for the advancement of the careers

of many robotic surgeons who in turn became leaders in the field throughout the world. Dr. Gruessner embodies all that we hold as examples of excellence in surgical leadership. The future of robotics in surgery depends on the enlightened leadership of senior surgeons like Dr. Gruessner. Mark Meyer, who represents the future of Robotic Surgery. I have had the distinct privilege of working with Mark from his first day as an intern in surgery. Watching Mark’s growth as a surgeon has been one of the most rewarding aspects of my surgical career. During this time, I have been humbled and delighted to witness Mark’s drive, conviction, sense of purpose, compassion, decency, and humanity which have culminated in the extraordinary surgeon and leader who is my partner in the editing of this textbook. Mark is a living example of the benevolence of surgeons and surgery. Young surgeons such as Mark will assure a bright future for Robotic Surgery. To the Creators of Surgical Robotics The innumerable engineers, scientists, and visionaries whose tireless quest has resulted in a quantum leap in the advancement of surgery. History will reflect that Robotics is equivalent to such fundamental developments in surgery such as anesthesia and antisepsis. We are indebted to these individuals who have turned science fiction into “Science Fact”. Farid Gharagozloo, MD Celebration, Florida January, 2021

Foreword

Robotic Surgery (and therefore the relevance of this book) is at a critical crossroad. One fork in the road takes a broad look at the tremendous value the robot adds to surgery and sees its flaws as acceptable relative to its benefits. This view is derived by a careful understanding of the well-documented experiences of robotic surgery visionaries, many of whom have made generous contributions to this book. The other fork in the road focuses narrowly on costs and superficially classifies robotics as an unnecessary, and potentially dangerous toy. This path leads to a future of minimally invasive surgery that is limited (likely by federal regulations) to only those procedures that can be done laparoscopically. Most surgeons interested in robotics had no desire to be visionary; they just wanted a tool to do their challenging jobs better and easier. That pragmatism is good for patients, but makes it hard to choose the correct path at a fork in the road. As Lewis Carroll wrote: “If you don’t know where you’re going, any road will get you there.” A small minority of surgeons who felt that they did not have the technical and mental processing skills needed to be safe, appropriately abandoned robotics. More often, surgeons had the skills but stopped robotics too early based largely on the negative influence of experts in their field. Only those with vision can resist that type of peer pressure and choose the only correct path: don’t start robotics in the first place unless you are willing to stick with it and learn from your mistakes. The advice of experts is helpful, but it can have blind spots. The Federal Aviation Administration recognized the downside of having experts when jets began to modernize in the 1960s. They established a mandatory retirement age for commercial pilots out of concern that older pilots would have difficulty learning new skills that require the “unlearning” of previous skills. Unlearning is not easy. It causes pain before things get better—like the alcoholic that stops drinking and goes through withdrawal. It is much easier to minimize pain by allowing old habits to accumulate over time. Those habits are what makes the well-stocked mind of the expert so difficult to change. Some experts deliberately hinder progress to maintain status and power. Hospitals are highly political arenas, so it is realistic for a surgeon to maximize his/her power as a way of getting things done. Power is intractable. As George Orwell wrote: “No one ever seizes power with the intention of relinquishing it.” Planck’s principle describes that a new scientific truth rarely convinces its opponents and makes them see the light; it requires opponents to eventually die so a new generation emerges that is familiar with it. Power also accumulates with age. In the 1800s, an advocate of Darwinism revealed his frustration with how age altered the reception of his ideas by saying “Men of science ought to be strangled on their 60th birthday lest they retard scientific progress in proportion to the influence they had deservedly won.” Before we wait for existing experts to “die or be strangled,” it is reasonable to ask whether robotic experts are the ones failing to accept the truth and cling to the prestige granted by their unique technical skills. There is some truth to the notion that robotics can be dangerous. This is a self-inflicted wound caused by poor training. Peer-reviewed publications, blog posts, Netflix shows, newspaper stories, lawsuits, and many others have documented that robotics training has been woefully inadequate for two decades. Surgeons did not learn in a simulated teaching environment but instead on their unwitting initial clinical cases, which exposed patients and programs to unnecessary risk. The inconsistent results of this approach confound vii

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our understanding about who are the best candidates for robotic procedures, true advantages, and major drawbacks of robotic surgery. However, the fork in the road demands that surgeons tackle a more fundamental question about robotics than what is the optimal training protocol. The answer lies in the story of how our military started using unmanned aerial systems or drones. The controversy surrounding how drones were adopted closely resembles the past two decades of robotic surgery. Drone warfare was enthusiastically hyped by the military in the beginning. Soon, drone pilots complained about not having enough simulators or dedicated time for training. Articles in the press uncovered how pilots counted real missions toward their required initial training requirements. Experts (i.e., pilots of conventional manned aircraft) attacked drone technology by denigrating drone pilots as “video-game warriors in the Chair Force” and “Fobbits” who never leave the safety and comfort of the forward operating base (FOB) like real soldiers. The chief of staff to Colin Powell prevented eligible drone pilots from being awarded medals by arguing that the whole program damaged the “warrior ethos.” Despite the hullabaloo, drone assaults now vastly outnumber those by manned aircraft in all recent military engagements. Drones—a.k.a. flying robots—faced nearly identical trials and tribulations as surgical robots, thus illustrating how much of an existential threat both are to a well-heeled status quo. Since it is impossible to get an expert to change a false belief so deeply tied to their identity, much of their criticism can be discarded as merely “unreasonable doubt.” It is self-evident that the drone is here to stay in the military, which is what makes it such a powerful metaphor for using robots in surgery. Surgeons who struggle to adopt robotics and reach their own fork in the road should consider the value of robots in the air before prejudging those that execute surgery. In the long run, an idea whose time has come will overpower any short-term controversy. The most important aide for making the right decision about robotics is competent and reliable scientific evidence established through methods that are widely accepted by the field. This Second Edition of Robotic Surgery provides a comprehensive resource of exactly that. There is step-by-step coverage of surgical procedures that span the entire surgical spectrum. Each chapter has a focus on how the principles and procedures of robotics lead to improved surgical outcomes. There are insightful sections that examine new frontiers of robotic surgery. Based on the timeliness of its release and vast array of critical information it provides, this book is poised to have a major impact on the path that Robotic Surgery takes in the future. Robert Poston, MD Chairman, Board of Governors Chief of Cardiothoracic Surgery Chief of Robotic Surgery Three Crosses Regional Hospital Las Cruces, NM USA

Preface

…all experience hath shown that mankind are more disposed to suffer, while evils are sufferable than to right themselves by abolishing the forms to which they are accustomed… –Declaration of Independence

In evolution, the crucial axiom for the survival of the “fittest,” and indeed the entire species, is the ability to change. Yet, inexplicably, woven into every cell in the human body, there is a strong instinctive urge to resist change. This is the Paradox of Change. As a society, we applaud progress and believe that change will bring opportunities and improvement in the human condition. Yet, unconsciously, humans perceive that longevity equals goodness. Today is May 15, 2020. As I sit to write the Preface to a book about a new era in surgery, Robotics, which is certain to trigger the Change Paradox in the minds of surgeons, I cannot help but be reminded of an extraordinary event on this very date in 1850. Exactly 170 years ago, on this date, the Hungarian Obstetrician Ignaz Semmelweis stepped onto the exulted podium at a meeting of the Vienna Medical Society. His entire lecture could be summarized in three words: “Wash Your Hands.” Semmelweis’s very simple yet elegant advice was the result of years of investigation into the cause of “childbed” or “puerperal” fever which was killing 1 in 10 patients in the maternity ward of the famed Vienna General Hospital, Allegemeines Krankenhaus. Amazingly, Semmelweis’s advice was rejected as blasphemy by his colleagues. In fact, the Viennese physicians were outraged at the suggestion that they were the cause of their patients’ deaths. Instead of embracing Semmelweis and his important lifesaving discovery about what a century later was found to be the result of the transmission of Hemolytic Streptococcal infection by physicians from the autopsy theaters to their obstetrical patients, the leading physicians of the era chose resistance and criticism. It was not until a quarter of a century later when the practice of antisepsis was acknowledged as a means of preventing infection. Unfortunately, yet understandably, in the history of medicine there have been many instances that illustrate a resistance to change and progress. Late in the nineteenth century, in the face of growing interest in surgical approaches to the heart, in the Handbook of General and Special Surgery, the famous German surgeon Billroth wrote: “The paracentesis of the hydropic pericardium is, in my opinion, an operation approaching rather closely that point which some surgeons call prostitution of the art of surgery, others a surgical frivolity.” In another example of resistance to change, despite the success of esophageal myotomy for Achalasia which was described by Ernst Heller in 1913, the procedure was not accepted by his contemporaries in the German Surgical School who insisted on performing esophagogastrostomies despite the poor results. When it comes to dealing with change, humans experience three primary emotions: cynicism, fear, and acceptance. Why do humans fear change?

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Preface Fear is the main source of superstition, and one of the main sources of cruelty. To conquer fear is the beginning of wisdom.  – Bertrand Russell Fear sees, even when eyes are closed. –Wayne Gerard Trotman

Change is associated with many types of fear: 1. Fear of the Uncertain. The human brain seems to be wired to want to resolve unknowns. When faced with uncertainty, the brain creates certainty by defaulting to the easiest, fastest, and least-painful option. As a result, the brain does not choose the best option, but rather it is programmed to stay in the comfort zone. 2. Fear of Failure. In an environment and society that is based on competition and has a reverence for success, failure is feared. 3. Fear of Being Ridiculed. FEAR is an acronym for False Evidence Appearing Real. Feeling awkward in the face of change and failing to gain the acceptance of others are integral to the human psyche. 4. Fear of Losing Control. Humans have a passion for control. When humans lose the ability to control, they become unhappy, helpless, hopeless, and depressed. 5. Fear of Inadequacy. Facing the unknowns that are brought about by change, questions, and convictions and erodes a perceived sense of clarity. 6. Fear of the Unknown. Uncertainty is one of the most de-motivating emotions in life. Due to the roots in the animal kingdom, humans are programmed to avoid uncertainty at all costs. Therefore, in the face of uncertainty, humans are compelled to do nothing. The Paradox of Change has been an integral part of the human experience in all of history. Undoubtedly, the constant struggle between the need to change and the resistance to change will remain with humanity for eternity. What is certain is that unlike other beings, humans need to force themselves to resist the fear of change, rather than change itself. Humans need to “Manage change.” Change needs to be “managed” through thoughtful discourse and investigation, as opposed to blind acceptance, or instinctive rejection. Therefore, the single answer to overcoming the fear of change is Empathy. This approach to change management requires understanding the emotions and fears that get in the way. Empathy can reduce the overexpressed enthusiasm of those who are introducing a change to the status quo, as well as the overexpressed resistance of those who are comfortable with the status quo. This book represents the work of pioneers in a new era of surgery, Robotics. Robotic Surgery is not about a new surgical instrument, rather Robotic Surgery represents a “Disruptive Vision” which is bringing about a “Fundamental Change” in the culture of surgery. Therefore, as the readers contemplate the adoption of robotics into their respective surgical practices, they must be especially aware of the Paradox of Change. What we should learn from the previous generations of surgeons who have struggled with change in their own time is to resist the blind enthusiasm of the pioneer as well as the blind resistance of the incumbent. I would emphasize that the most important lesson from the history of surgery is that change must be implemented through an active process of scientific investigation with the singular goal of placing the Safety of the Patient First. I would direct every reader to the chapter “The Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hymen R.  Rickover and the

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Nuclear Navy” which outlines the many valuable lessons from the transformative change that was brought about by the introduction of nuclear technology into the conventional navy with Safety as the singular goal of the change process. Robotics represents a monumental triumph of surgical technology. Undoubtedly, the safety of the patient will be the ultimate determinant of its success. Curiosity will conquer fear even more than bravery will. – James Stephens

Farid Gharagozloo Celebration, FL, USA May 15, 2020

Acknowledgement

Medicine has changed significantly over the past several decades. Some may say for the better. Some may say for the worse. There is no doubt that robotic surgical systems have altered the surgical landscape dramatically. We must applaud the pioneers of robotic surgery who have paved the way for us by defining the use of the robot and making these systems more accessible. We must applaud them for sharing their personal techniques. We must applaud them for persevering despite opposition among surgical colleagues. I want to recognize Dr. Farid Gharagozloo, one of the many pioneers in robotic surgery, for his vision in creating this textbook. The book encompasses chapters across all surgical specialties. This cross fertilization of specialties allows for authors to compare differing techniques and approaches that will further enhance the knowledge and development of the robotic surgical systems. The creation of this book would not be possible without the forward, “outside the box” thinking of Dr. Farid Gharagozloo. Where we may have feared the robotic surgical systems in the past; we now fear their absence. Mark Meyer, M.D. Wellington, Florida May, 2020

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Contents

Part I Robotic Surgery: Overview 1 The Journey from Video Laparoscopy to Robotic and Digital Surgery �������������    3 Camran Nezhat, Mailinh Vu, Nataliya Vang, Kavya S. Chavali, and Azadeh Nezhat 2 The Origins of Minimally Invasive and Robotic Surgery and Their Impact on Surgical Practice: A Sociological, Technological History���������������������������������   11 Arnold Byer 3 History of Robotic Surgery �������������������������������������������������������������������������������������   21 Farid Gharagozloo, Barbara Tempesta, Mark Meyer, Duy Nguyen, Stephan Gruessner, and Jay Redan 4 Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rickover and the Nuclear Navy���������������������   31 Farid Gharagozloo, Monica Reed, Mark Meyer, Barbara Tempesta, Hannah Hallman-Quirk, and Stephan Gruessner 5 Validating Robotic Surgery Curricula �������������������������������������������������������������������   55 Edward Lambert, Erika Palagonia, Pawel Wisz, Alexandre Mottrie, and Paolo Dell’Oglio 6 Defining and Validating Non-technical Skills Training in Robotics���������������������   75 Oliver Brunckhorst and Prokar Dasgupta 7 Secrets of the Robotic Dance (The World’s Busiest Surgical Robot)�������������������   83 Jeffrey G. Nalesnik and Shahab P. Hillyer 8 Credentialing and Privileging for Robotic Surgery in the United States �����������   87 Richard H. Feins 9 The Current State of Robotic Education ���������������������������������������������������������������   93 Danielle Julian, Todd Larson, Roger Smith, and J. Scott Magnuson 10 Real Tissue Robotic Simulation: The KindHeart Simulators�������������������������������  105 Richard H. Feins 11 The Institute for Surgical Excellence: Its Role in Standardization of Training and Credentialing in Robotic Surgery �����������������������������������������������  111 Jeffrey S. Levy, Martin A. Martino, Dimitrios Stefanidis, John Porterfield Jr, Justin William Collins, Richard H. Feins, and Ahmed Ghazi 12 Opportunity Cost Analysis of Robotic Surgery�����������������������������������������������������  133 Robert Poston and Safraz Hamid 13 Political Aspects of Robotic Surgery�����������������������������������������������������������������������  141 Robert Poston and Fabrizio Diana xv

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14 Achieving Financial Optimization of a da Vinci Robotic Program While Achieving Best Clinical Outcomes���������������������������������������������������������������  149 Josh Feldstein and Herb Coussons 15 The Senhance® Surgical System �����������������������������������������������������������������������������  159 Mohan Nathan 16 Humanizing the Robot: Medicaroid’s Vision for the Future of Robotic Surgery ���������������������������������������������������������������������������������������������������  165 Leila Bahreinian 17 Mazor Core Robots in Spine Surgery���������������������������������������������������������������������  171 Faissal Zahrawi 18 Intelligence and Autonomy in Future Robotic Surgery�����������������������������������������  183 John Oberlin, Vasiliy E. Buharin, Hossein Dehghani, and Peter C. W. Kim 19 Intellectual Property Considerations and Patent Protection: A Surgical Roadmap�������������������������������������������������������������������������������������������������������������������  197 Babak Tehranchi 20 The Internet of Skills: How 5G-Synchronized Reality Is Transforming Robotic Surgery �������������������������������������������������������������������������������������������������������  207 Mischa Dohler 21 Augmented Surgery: An Inevitable Step in the Progress of Minimally Invasive Surgery�������������������������������������������������������������������������������������������������������  217 Luc Soler, Alexandre Hostettler, Patrick Pessaux, Didier Mutter, and Jacques Marescaux 22 Telementoring for Minimally Invasive Surgery�����������������������������������������������������  227 Justin William Collins, Jian Chen, and Andrew Hung 23 Automation and Autonomy in Robotic Surgery�����������������������������������������������������  237 Paolo Fiorini 24 Will Hydrogel Models Fabricated Using 3D Printing Technology Replace Cadavers as the Ideal Simulation Platform for Robotic Surgery Training?�����������������������������������������������������������������������������������������������������  257 Ahmed Ghazi 25 Robotic Surgery: The Future as I See It�����������������������������������������������������������������  271 Oliver Brunckhorst, Prokar Dasgupta, Kara McDermott, Nicholas Mehan, and Josie Colemeadow Part II Thoracic Section 26 The Basics of Starting a Robotic Thoracic Surgery Program �����������������������������  281 Dana Ferrari-Light and Robert J. Cerfolio 27 Instrumentation, Energy Devices, Staplers �����������������������������������������������������������  285 Tadeusz D. Witek, Matthew S. Vercauteren, and Inderpal S. Sarkaria 28 Robotic Lobectomy���������������������������������������������������������������������������������������������������  291 Farid Gharagozloo, Mark Meyer, Duy Nguyen, Barbara Tempesta, Stephan Gruessner, Hannah Hallman-­Quirk, Fortune Alabi, Fred Umeh, Maximo Lama, Irtza Sharif, and Nelson Medina-Villaneuva 29 Robotic Right Upper Lobectomy with Mediastinal Lymph Node Dissection���������������������������������������������������������������������������������������������������������  345 Richard Lazzaro and Byron Patton

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30 Robotic Right Lower Lobe Lobectomy�������������������������������������������������������������������  351 Travis C. Geraci, Amie J. Kent, Costas Bizekis, and Michael D. Zervos 31 Mediastinal Lymph Node Dissection and Approach to the Fissures �������������������  359 Chigozirim N. Ekeke, Nicholas Baker, Matthew S. Vercauteren, and Inderpal S. Sarkaria 32 Robotic Surgery of the Mediastinum ���������������������������������������������������������������������  367 Farid Gharagozloo, Mark Meyer, Barbara Tempesta, and Stephan Gruessner 33 Robotic Extended Thymectomy�������������������������������������������������������������������������������  387 Feng Li, Mahmoud Ismail, Andreas Meisel, and Jens-C Rueckert 34 The Robotic Approach to Intrathoracic Goiters ���������������������������������������������������  399 Eitan Podgaetz, Gary Schwartz, Leonidas Tapias, and David P. Mason 35 Robotic Anatomic Pulmonary Segmentectomy�����������������������������������������������������  403 Farid Gharagozloo, Duy Nguyen, Barbara Tempesta, Mark Meyer, Hannah Hallman-Quirk, and Stephan Gruessner 36 Robotic Upper Lobe Pulmonary Segmentectomy�������������������������������������������������  453 Kelsey Musgrove, Charlotte Spear, and Ghulam Abbas 37 Robotic Segmentectomy: Lower Lobes�������������������������������������������������������������������  463 Luis J. Herrera and Matthew A. Johnston 38 Hemorrhage Management During Robotic Surgery���������������������������������������������  471 Dana Ferrari-Light and Robert J. Cerfolio 39 Robotic Wedge, Apical Pleural Flap, and Pleurodesis�������������������������������������������  475 Mark Meyer and Farid Gharagozloo 40 Robotic Pulmonary Decortication���������������������������������������������������������������������������  479 Mark Meyer and Farid Gharagozloo 41 Robotic Surgery for Thoracic Outlet Syndrome���������������������������������������������������  481 Farid Gharagozloo, Scott Werden, Mark Meyer, Barbara Tempesta, Amine Bouri, and Stephan Gruessner 42 Robotic Diaphragmatic Plication ���������������������������������������������������������������������������  511 Ankit Dhamija, Brendan Jones, Jeremiah William Awori Hayanga, and Ghulam Abbas 43 Robotic Selective Thoracic Sympathectomy for Hyperhidrosis���������������������������  515 Farid Gharagozloo, Mark Meyer, Barbara Tempesta, Stephan Gruessner, Amine Bouri, Hannah Hallman-Quirk, and Hans Coveliers 44 Pain Control Following Robotic Thoracic Surgery�����������������������������������������������  525 Farid Gharagozloo, Barbara Tempesta, Mark Meyer, and Stephan Gruessner Part III Esophageal and Foregut Section 45 Robotic Laparoscopic Gastroesophageal Valvuloplasty (Modified Belsey Fundoplication) for Gastroesophageal Reflux Disease�����������������������������������������  539 Farid Gharagozloo, Basher Atiquzzaman, Mark Meyer, Robert C. Tolboom, Barbara Tempesta, Amine Bouri, Hannah Hallman-Quirk, and Stephan Gruessner 46 Robotic Nissen Fundoplication �������������������������������������������������������������������������������  571 Kayla Polcari, Kandace Kichler, and Srinivas Kaza

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47 Robotic Gastric Bypass as an Antireflux Procedure���������������������������������������������  579 Michelle H. Scerbo, Melissa M. Felinski, Kulvinder S. Bajwa, Shinil K. Shah, and Erik B. Wilson 48 Robotic Surgery for Reflux Disease �����������������������������������������������������������������������  587 Carlos Eduardo Domene and Paula Volpe 49 Robotic-Assisted Paraesophageal Hernia Repair �������������������������������������������������  609 Carlos A. Galvani, and Mohanad R. Youssef 50 Robotic Anatomic and Physiologic Reconstruction of Paraesophageal Hiatal Hernias: Combining Lessons from a Century of Discovery and Controversy�������������������������������������������������������������������������������������������������������  621 Farid Gharagozloo, Mark Meyer, Basher Atiquzzaman, Khalid Maqsood, Rajab Abukhadrah, Fadi Rahal, Soundarapandian Baskar, Barbara Tempesta, Hannah Hallman-Quirk, Amendha Ware, Fortune Alabi, Fred Umeh, Jay Redan, and Stephan Gruessner 51 Redo Hiatal Hernia Surgery: Robotic Laparoscopic Approach���������������������������  659 Alexander Christiaan Mertens and Ivo A. M. J. Broeders 52 Redo Hiatal Hernia Surgeries: Robotic Thoracoscopic Approach�����������������������  665 Paul J. M. Wijsman, Robert C. Tolboom, Werner Draaisma, and Ivo A. M. J. Broeders 53 Robotic Esophageal Myotomy for Achalasia���������������������������������������������������������  673 Farid Gharagozloo, Amine Bouri, Mark Meyer, Nabiha Atiquzzaman, Stephan Gruessner, and Basher Atiquzzaman 54 Robotic Ivor-Lewis Esophagectomy�����������������������������������������������������������������������  687 Farid Gharagozloo, Mark Meyer, Barbara Tempesta, Jay Redan, Stephan Gruessner, and Basher Atiquzzaman 55 Totally Robotic Ivor Lewis Esophagectomy�����������������������������������������������������������  715 Raghav A. Murthy and Kemp H. Kernstine Sr 56 Robotic Esophagectomy: The European Experience��������������������������������������������  721 Richard van Hillegersberg, Jelle Ruurda, S. van der Horst, Pieter Christiaan van der Sluis, and Peter Philipp Grimminger 57 Robot-Assisted Minimally Invasive Esophagectomy in China�����������������������������  727 Yang Yang, Bin Li, and Zhigang Li Part IV Bariatric Surgery Section 58 Economics of Robotic Bariatric Surgery in Europe ���������������������������������������������  737 Monika E. Hagen and Jonathan Douissard 59 Robotic Roux-En-Y Gastric Bypass (RA-RYGB)�������������������������������������������������  741 Carlos A. Galvani 60 The Learning Curve for Robotic Roux-­en-­Y Gastric Bypass�������������������������������  749 Jonathan Douissard, Monika E. Hagen, and Nicolas C. Buchs 61 Robot-Assisted Biliopancreatic Diversion with Duodenal Switch�����������������������  759 Ranjan Sudan and MacKenzie Landin 62 Robotic Sleeve Gastrectomy�������������������������������������������������������������������������������������  767 Tamara Diaz Vico and Enrique Fernando Elli

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63 Robotic Sleeve Gastrectomy�������������������������������������������������������������������������������������  773 Maxwell J. Presser, Kandace Kichler, and Srinivas Kaza 64 Robotic Revisional Bariatric Surgery���������������������������������������������������������������������  779 Carlos A. Galvani, and Mohanad R. Youssef Part V General Surgery Section 65 Single Site: Historical Perspectives and Current Application �����������������������������  791 Giuseppe Spinoglio, Alfredo Mellano, Domenico Lo Conte, and Dario Ribero 66 Robotic Single-Site Surgery�������������������������������������������������������������������������������������  803 Marinos C. Makris, Panagiotis Athanasopoulos, Fotios Antonakopoulos, Argyrios Ioannidis, Michael Konstantinidis, and Konstantinos M. Konstantinidis 67 Single-Site Systems in General Surgery�����������������������������������������������������������������  821 F. J. Voskens, Richard van Hillegersberg, Ivo A. M. J. Broeders, and Jelle Ruurda 68 The Use of the Robot for Abdominal Oncologic Procedures �������������������������������  829 Franco Roviello and Luigi Marano 69 Robotic Hepatic Lobectomies ���������������������������������������������������������������������������������  849 Eduardo Fernandes, Gabriela Aguiluz, Roberto Bustos, and Pier Cristoforo Giulianotti 70 Robotic Hepatic Segmentectomies and Wedge Resections�����������������������������������  857 Eduardo Fernandes, Roberto Bustos, Gabriela Aguiluz, and Pier Cristoforo Giulianotti 71 Robotic Hepatic Resection���������������������������������������������������������������������������������������  865 Vaishnavi Krishnan and Alvaro Castillo 72 Robotic Hepatectomy�����������������������������������������������������������������������������������������������  871 Essa M. Aleassa, Emin Kose, Amit Khithani, and Eren Berber 73 Robotic Pancreaticoduodenectomy (Whipple)�������������������������������������������������������  877 Francesco Maria Bianco, Valentina Valle, Gabriela Aguiluz, Yevhen Pavelko, and Pier Cristoforo Giulianotti 74 Robotic Distal Pancreatectomy�������������������������������������������������������������������������������  885 Mario Masrur, Roberto Bustos, Gabriela Aguiluz, and Pier Cristoforo Giulianotti 75 Robotic Pancreatectomy�������������������������������������������������������������������������������������������  891 Sarah Hatfield and Alvaro Castillo 76 Robotic Cholecystectomy�����������������������������������������������������������������������������������������  895 Alexandra Hernandez, Kandace Kichler, and Srinivas Kaza 77 Gallbladder Cancer �������������������������������������������������������������������������������������������������  901 Baiyong Shen and Qian Zhan 78 Robotic HPB Surgery in Children���������������������������������������������������������������������������  911 Naved Kamal Alizai, Donatella Di Fabrizio, Michael Dawrant, and Azad S. Najmaldin 79 Robotic Adrenalectomy �������������������������������������������������������������������������������������������  925 Orhan Agcaoglu and Eren Berber

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80 Laparoscopic/Robotic Treatment of the Small Bowel Lesions�����������������������������  931 Antonio Gangemi, Valentina Valle, Mario Masrur, and Pier Cristoforo Giulianotti 81 Robotic Small Bowel Resection�������������������������������������������������������������������������������  937 Carlos Ortiz-Ortiz, Carlos Hartmann, and Carla Herrera 82 Robotic Decompression of Celiac Axis for Median Arcuate Ligament Syndrome�������������������������������������������������������������������������������������������������  943 Samsor Zarak, Kamil Abbas, Neel Sharma, Charlotte Spear, and Ghulam Abbas 83 Robotic Inguinal Hernia Repair �����������������������������������������������������������������������������  947 Francesco Maria Bianco, Valentina Valle, Yevhen Pavelko, and Pier Cristoforo Giulianotti 84 Robotic Ventral Hernia Repair �������������������������������������������������������������������������������  953 Francesco Maria Bianco, Valentina Valle, Yevhen Pavelko, and Pier Cristoforo Giulianotti 85 Robotic TAPP for Inguinal Hernia Simple to Complex ���������������������������������������  961 Sara La Grange, Fahri Gokcal, and Omar Yusef Kudsi 86 Robotic Transabdominal Preperitoneal Ventral Hernia Repair (rTAPP VHR)�����������������������������������������������������������������������������������������������  969 Chris Mellon, Courtney Janowski, Emily Helmick, and Conrad Ballecer 87 Robotic Abdominal Wall Reconstruction: Approaches for Primary Ventral, Incisional, and Recurrent Hernias �������������������������������������������������������������������������  975 Sara La Grange, Fahri Gokcal, and Omar Yusef Kudsi 88 Robotic Transversus Abdominis Release (RoboTAR)�������������������������������������������  981 Conrad Ballecer, Amanda Daoud, and Alexander D. Schroeder 89 Robotic Anterior Component Separation���������������������������������������������������������������  993 Eduardo Parra Davila, Flavio Malcher de Oliveira, and Carlos Hartmann 90 Starting a Robotic Abdominal Wall Surgery Programme in Europe �����������������  999 Jonathan Douissard, Christian Toso, and Monika E. Hagen 91 Complications in Robotic Surgery: How to Prevent and Treat? ������������������������� 1005 Sara La Grange, Fahri Gokcal, and Omar Yusef Kudsi 92 Robotic Transplant Surgery������������������������������������������������������������������������������������� 1009 Ivo G. Tzvetanov, Kiara A. Tulla, and Enrico Benedetti Part VI Urology Section 93 Robot-Assisted Radical Prostatectomy: Keys to Starting and Succeeding��������� 1025 Randy Fagin 94 Surgical Margin in Robot-Assisted Radical Prostatectomy: Does It Matter?��������������������������������������������������������������������������������������������������������� 1037 Stavros I. Tyritzis 95 Management of Positive Surgical Margins After Radical Prostatectomy����������� 1047 Ilter Tufek, Omer Burak Argun, Can Obek, and Ali Riza Kural 96 Key Elements for Approaching Difficult Cases During Urologic Robotic Surgery ������������������������������������������������������������������������������������������������������� 1059 Young Hwii Ko and Jun Cheon

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97 Improving Outcomes for Early Return of Potency����������������������������������������������� 1073 Oscar Schatloff, Alexandre Mottrie, Darian Kameh, and Vipul R. Patel 98 Renal Ischemia and Approach to the Renal Hilum in Robotic Partial Nephrectomy: Tips and Tricks��������������������������������������������������������������������������������� 1081 Craig G. Rogers and Surena F. Matin 99 Robot-Assisted Partial Nephrectomy ��������������������������������������������������������������������� 1091 Juan M. Ochoa-Lopez, Pawel Wisz, Paolo Dell’Oglio, and Alexandre Mottrie 100 Robot-Assisted Pyeloplasty ������������������������������������������������������������������������������������� 1105 Ravi Munver, Jennifer Yates, and David M. Albala 101 Robot-Assisted Ureteral Reimplantation��������������������������������������������������������������� 1117 Pawel Wisz, Peter Penkoff, Erika Palagonia, Alexandre Mottrie, and Paolo Dell’Oglio 102 The Role of Robotics in Adrenal Surgery��������������������������������������������������������������� 1127 Jose Alexandre Pedrosa, Rafael Ferreira Coelho, and Michael William McDonald 103 Step-by-Step Approach to Robotic Cystectomy and Extracorporeal Urinary Diversion ������������������������������������������������������������������������������������������������������������������� 1137 Erik P. Castle, Michael E. Woods, Kassem S. Faraj, and Anojan K. Navaratnam 104 Robotic-Assisted Radical Cystectomy Outcomes��������������������������������������������������� 1149 Angela Smith, Ramgopal Satyanarayana, Murugesan Manoharan, and Raj S. Pruthi 105 Robot-Assisted Radical Cystectomy: The MD Anderson Approach ������������������� 1159 Vikram M. Narayan and Neema Navai 106 Robotic Surgery of the Kidney and Ureter in the Pediatric Population������������� 1165 Thomas S. Lendvay and Micah A. Jacobs 107 Robotic-Assisted Laparoscopic Ileocystoplasty and Mitrofanoff Appendicovesicostomy: Technique and Updated Experience������������������������������� 1175 Pankaj P. Dangle and Mohan Gundeti 108 Preparation of the Operating Room, Back Table, and Surgical Team����������������� 1183 Cathy Jenson Corder, Rafael Ferreira Coelho, and Giuliano Betoni Guglielmetti 109 Enhanced Recovery After Surgery (ERAS) in Urology: Where Do We Go From Here?��������������������������������������������������������������������������������������������������������� 1189 Preston S. Kerr and Stephen B. Williams 110 ERAS Protocol in RARP ����������������������������������������������������������������������������������������� 1201 Joseph Byron John and John Samuel McGrath 111 CUSUM Analysis and the Learning Curve������������������������������������������������������������� 1211 Alexander M. Turner and Ram Subramaniam Part VII Gynecology Section 112 The US Perspective of Benefit of Minimally Invasive Surgery: Why Is This Important Now? ������������������������������������������������������������������������������������������������������� 1217 Gaby N. Moawad, Savannah Smith, and Jordan Klebanoff

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113 Port Placement and Patient Cart Docking for Robot-Assisted Gynecologic Surgery����������������������������������������������������������������������������������������������������������������������� 1223 Erica Schipper and Camran Nezhat 114 Robot-Assisted Laparoscopic Myomectomy���������������������������������������������������������� 1233 Jila Senemar 115 Genital and Extragenital Endometriosis: Video-Laparoscopic with Robotic Assistance������������������������������������������������������������������������������������������������������������������� 1239 Nataliya Vang, Mailinh Vu, Chandhana Paka, M. Ali Parsa, Azadeh Nezhat, Ceana H. Nezhat, and Kavya S. Chavali 116 Robot-Assisted Laparoscopic Hysterectomy ��������������������������������������������������������� 1249 Adi Katz and Ceana H. Nezhat 117 Video Laparoscopic Management of Adnexal Masses With or Without Robotic Assistance������������������������������������������������������������������������������������� 1259 Camran Nezhat, Louise P. King, Jennifer Cho, Mailinh Vu, Nataliya Vang, and Farr Nezhat 118 Robot-Assisted Laparoscopic Microscopic Tubal Anastomosis��������������������������� 1267 Melinda B. Henne 119 Robotic-Assisted Laparoscopic Surgery and Pelvic Floor ����������������������������������� 1275 Nataliya Vang, Mailinh Vu, Chandhana Paka, M. Ali Parsa, and Camran Nezhat 120 Complications in Robotic-Assisted Video Laparoscopic Surgery ����������������������� 1279 Camran Nezhat, Elizabeth Buescher, Mailinh Vu, and Nataliya Vang 121 Robotic Single-Site Gyn Surgery����������������������������������������������������������������������������� 1289 Daniele Geras Fuhrich, Kudrit Riana Kahlon, Jacklyn Locklear, and Aileen Caceres Part VIII Gynecology Oncology Section 122 Robotic Surgery and Physician Wellness in Gynecologic Oncology ������������������� 1301 Martin A. Martino, Andrea Johnson, Joseph E. Patruno, and Pedro F. Escobar 123 Single-Site Robotic Surgery in Gynecology����������������������������������������������������������� 1309 Ricardo Estape 124 Robotic-Assisted Radical Hysterectomy and Trachelectomy������������������������������� 1317 Farr Nezhat, Anthony Marco Corbo, and Nisha A. Lakhi Part IX Cardiovascular Section 125 Robotic CABG via Minithoracotomy: Advantages, Challenges, and Pitfalls����� 1339 Robert Poston 126 Robotically Assisted Hybrid Coronary Intervention��������������������������������������������� 1349 Johannes Bonatti, Ravi Nair, Tomislav Mihaljevic, Eric Lehr, Guy Friedrich, Jeffrey D. Lee, Mark Vesely, and David Zimrin 127 Robotic Mitral Valve Repair ����������������������������������������������������������������������������������� 1357 Raphaelle A. Chemtob, Per Wierup, Daniel J. P. Burns, and A. Marc Gillinov 128 Robot-Assisted Vascular Surgery ��������������������������������������������������������������������������� 1365 Petr Stadler

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Part X Colorectal Section 129 Robotic Colorectal Surgery: General Considerations������������������������������������������� 1385 Eduardo Parra Davila, Carlos Hartmann, Carlos Eduardo Rodríguez, and Aaliya Ali 130 Institutional Economics in Robotic Colorectal Surgery��������������������������������������� 1389 Paolo Pietro Bianchi and Giampaolo Formisano 131 Robotic Colectomy with CME��������������������������������������������������������������������������������� 1395 Giuseppe Spinoglio, Wanda Petz, Emilio Bertani, and Dario Ribero 132 Robotic Left Colectomy with CME������������������������������������������������������������������������� 1403 Paolo Pietro Bianchi, Giuseppe Giuliani, and Giampaolo Formisano 133 Robotic Right Colectomy: The Italian Experience ����������������������������������������������� 1409 Paolo Pietro Bianchi, Adelona Salaj, Giuseppe Giuliani, Dimitri Krizzuk, and Giampaolo Formisano 134 Minimally Invasive Right Colectomy: Extracorporeal Versus Intracorporeal Anastomosis��������������������������������������������������������������������������������������������������������������� 1415 Marcos Gómez Ruiz and Manuel Gómez Fleitas 135 Single-Site Minimally Invasive Colectomy������������������������������������������������������������� 1419 Salini Hota, Ada E. Graham, Salvatore Parascandola, Mayou Martin T. Tampo, and Vincent James Obias 136 The Technique of a Robotic Low Anterior Resection ������������������������������������������� 1425 Patricia Tejedor and Jim S. Khan 137 Robotic Total Mesorectal Excision for Rectal Cancer������������������������������������������� 1433 Slawomir Marecik, Kunal Kochar, and John Park 138 Robotic Transanal Surgery and Navigation for Rectal Neoplasia����������������������� 1445 Sam Atallah and Brenden Berrios 139 Pelvic Nerve Function and Robotic Pelvic Surgery: Is There Any Evidence?����������������������������������������������������������������������������������������������������������� 1455 Trevor M.-Y. Yeung and Jim S. Khan 140 Optimizing Sexual and Urinary Outcomes in Robotic TME������������������������������� 1461 Fabrizio Luca and Maheswari Senthil 141 Robotic Rectal Cancer Surgery: Is There Life After ROLARR?������������������������� 1469 James Toh, Sinan Albayati, Yi Liang, Kevin Phan, Hanumant Chouhan, Satish Kumar Warrier, Thomas Surya Suhardja, Tae Hoon Lee, and Seon-Hahn Kim 142 Robotic Rectal Prolapse Repair������������������������������������������������������������������������������� 1479 Emma M. van der Schans, P. M. Verheijen, Ivo A. M. J. Broeders, and E. C. J. Consten 143 Benign Diseases: Does the Robot Make Sense?����������������������������������������������������� 1489 Giuseppe Spinoglio, Domenico Lo Conte, Alfredo Mellano, and Dario Ribero 144 Future and Other Robotic Platforms ��������������������������������������������������������������������� 1501 Jessie Paull, Salvatore Parascandola, and Vincent James Obias

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Part XI Otolaryngology Section 145 Bilateral Axillo-Breast Approach (BABA) Robotic Thyroidectomy��������������������� 1513 June Young Choi and Kyu Eun Lee 146 Endoscopic and Robotic Thyroidectomy ��������������������������������������������������������������� 1525 Nader Sadeghi and Keith Richardson 147 Management of Sleep Apnea����������������������������������������������������������������������������������� 1535 Claudio Vicini, Filippo Montevecchi, Iacopo Dallan, Giuseppe Meccariello, Giannicola Iannella, and Giovanni Cammaroto 148 Transoral Robotic Surgery for Tonsillar Neoplasms��������������������������������������������� 1547 Eric J. Moore 149 Transoral Robotic Surgery for Supraglottic Neoplasms��������������������������������������� 1557 J. Drew Prosser and C. Arturo Solares 150 Future of Robotics in Otolaryngology–Head and Neck Surgery������������������������� 1561 Kiran Kakarala and Enver Ozer Index����������������������������������������������������������������������������������������������������������������������������������� 1565

Contents

Contributors

Ghulam  Abbas, MD, MHCM, FACS Division of Thoracic Surgery, Department of Cardiovascular & Thoracic Surgery, Ruby Memorial Hospital, West Virginia University Medicine, Morgantown, WV, USA Rajab  Abukhadrah, MD Southlake Gastroenterology, Center for Advanced Thoracic Surgery, Celebration Health, Clermon, FL, USA Orhan  Agcaoglu, MD  Department of General Surgery, Koc University Hospital, Istanbul, Turkey Gabriela Aguiluz, MD  Department of Surgery, Division of General, Minimally Invasive and Robotic Surgery, University of Illinois at Chicago, Chicago, IL, USA Fortune  Alabi, MD, MBA, FCCP, FABSM  University of Central Florida, Department of Pulmonary and Critical Care Medicine, Florida Lung and Asthma Specialists, Advent Health Celebration, Celebration, FL, USA David M. Albala, MD  Department of Urology, Crouse Hospital, Syracuse, NY, USA Sinan Albayati, BSc, MBChB, MS, FRACS  Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia Essa  M.  Aleassa, MD  Digestive Disease and Surgery Institute, Section of Hepatopancreatobiliary Surgery, Department of Surgery, Cleveland Clinic Foundation, Cleveland, OH, USA Department of Surgery, Tawam Medical Campus, College of Medicine and Health Sciences, United Arab Emirates University, Al Ain, United Arab Emirates Aaliya Ali, PAC  Department of General and Colorectal Surgery, Florida Hospital Celebration Health, Celebration, FL, USA Naved Kamal Alizai, MBBS, FRCSI, FRCS (Paeds)  Paediatric Liver Unit, Leeds Children’s Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK Fotios Antonakopoulos, MD  Department of General, Bariatric, Laparoscopic and Robotic Surgery, Athens Medical Center, Athens, Greece Omer Burak Argun, MD  Department of Urology, Acibadem Mehmet Ali Aydınlar University, School of Medicine, Istanbul, Turkey Sam Atallah, MD  Department of Colorectal Surgery, Oviedo Medical Center, Orlando, FL, USA Panagiotis  Athanasopoulos, MD, PhD, FRCS, FACS Department of General, Bariatric, Laparoscopic and Robotic Surgery, Athens Medical Center, Athens, Greece Basher  Atiquzzaman, MD Center for Advanced Thoracic Surgery, Advent Health Celebration, Celebration, FL, USA

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Contributors

Nabiha Atiquzzaman  University of Central Florida, Center for Advanced Thoracic Surgery, Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA Leila Bahreinian, M.A.Sc.  Meditus, Inc., Los Gatos, CA, USA BahrNow Consulting, Los Gatos, CA, USA Formerly, Vice President, Medicaroid, San Jose, CA, USA Kulvinder S. Bajwa, MD  Department of Surgery, McGovern Medical School, UT Health, Houston, TX, USA Nicholas  Baker, MD Department of Thoracic Surgery, UPMC Passavant, Pittsburgh, PA, USA Conrad  Ballecer, MD, MS, BS Department of General Surgery, Abrazo Arrowhead and Banner Thunderbird Medical Center, Peoria, AZ, USA Soundarapandian  Baskar, MD  Center for Advanced Thoracic Surgery, Gastroenterology Associates, Advent Health Celebration, Celebration, FL, USA

Lake

Enrico  Benedetti, MD Department of Surgery, Chairman, Division of Transplantation, University of Illinois at Chicago, Chicago, IL, USA Eren  Berber, MD Department of General and Endocrine Surgery, Cleveland Clinic, Cleveland, OH, USA Brenden Berrios  University of Florida, Gainesville, FL, USA Emilio Bertani, MD  Division of Digestive Surgery, European Institute of Oncology, Milan, Italy Paolo  Pietro  Bianchi, MD Department of General Surgery, Ospedale Misericordia ASL Toscana – Sud-Est, Grosseto, Italy Francesco  Maria  Bianco, MD Department of Surgery, Division of General, Minimally Invasive and Robotic Surgery, University of Illinois at Chicago, Chicago, IL, USA Costas Bizekis, MD  Department of Cardiothoracic Surgery, New York University, Langone Health, New York, NY, USA Johannes Bonatti, MD  Department of Cardiac and Vascular Surgery, Vienna Health Network, Clinic Floridsdorf, Vienna, Austria Amine Bouri, RN, CST  Thoracic Robotics Program, Advent Health Celebration, Celebration, FL, USA Ivo  A.  M.  J.  Broeders, MD, PhD Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands Faculty of Electrical Engineering, Mathematics & Computer Science, Department of Robotics and Mechatronics, University of Twente, Enschede, The Netherlands Oliver Brunckhorst, MBBS, BSc (Hons), MRCS (Eng)  MRC Centre for Transplantation, King’s College London, London, UK Nicolas  C.  Buchs, MD Abdominal Surgery Department, University Hospital of Geneva, Geneva, Switzerland Elizabeth Buescher, MD, M.Ed.  Department of Obstetrics & Gynecology, Good Samaritan Hospital, Los Gatos, CA, USA Vasiliy E. Buharin, PhD  Activ Surgical Inc., Boston, MA, USA Daniel  J.  P.  Burns, MD, MPhil Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, CCF, Cleveland, OH, USA

Contributors

xxvii

Roberto Bustos, MD  Department of Surgery, Division of General, Minimally Invasive and Robotic Surgery, University of Illinois at Chicago, Chicago, IL, USA Arnold Byer, MD, FACS  Rutgers New Jersey Medical School, Newark, NJ, USA Aileen  Caceres, MD, MPH, FACOG, FACS University of Central Florida and Advent Health Celebration, Orlando, FL, USA Giovanni Cammaroto, MD  ENT Department, Morgagni-Pierantoni Hospital, Forlì, Italy Alvaro  Castillo, MD, FACS Department of Surgery, University of Miami JFK Medical Center, Lake Worth, FL, USA Erik P. Castle, MD  Department of Urology, Mayo Clinic Arizona, Phoenix, AZ, USA Robert J. Cerfolio, MD, MBA, FACS, FCCP  Department of Cardiothoracic Surgery, NYU Langone Health, New York, NY, USA Kavya S. Chavali, MD  Camran Nezhat Institute, Center for Special Minimally Invasive and Robotic Surgery, Palo Alto, CA, USA Raphaelle A. Chemtob, MD  Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, CCF, Cleveland, OH, USA Jian Chen, MD  USC Urology, Keck School of Medicine of University of Southern California, Los Angeles, CA, USA Jun Cheon, MD, PhD  Department of Urology, Korea University, College of Medicine, Seoul, Republic of Korea June  Young  Choi, MD, PhD  Department of Surgery, Seoul National University Bundang Hospital, Seongnam-si, Republic of Korea Jennifer Cho, MD  Beth Israel Deaconess Hospital, Boston, MA, USA Hanumant Chouhan, MBBS, FRACS, MPHIL  Department of Colorectal Surgery, Monash Health, Melbourne, VIC, Australia Rafael Ferreira Coelho, MD, PhD  Department of Urology, Instituto do Cancer do Estado de Sao Paulo, University of Sao Paulo School of Medicine, Sao Paulo, Brazil Josie  Colemeadow, MRCS, MBChB, BSc  Department of Urology, Guy’s & St. Thomas’ NHS Trust, London, UK Justin William Collins, MBChB, MD  Department of Urology, University College London Hospital, London, UK E. C. J. Consten, MD, PhD  Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands Academic Medical Center Groningen, Groningen, The Netherlands Domenico  Lo  Conte, MD Program of Hepatobiliary, Pancreatic and Colorectal Surgery, Candiolo Cancer Institute, FPO – IRCCS, Candiolo (TO), Italy Anthony  Marco  Corbo, DO, MS, ME Department of Obstetrics and Gynecology, NYU LISOM, Mineola, NY, USA Cathy Jenson Corder  Global Robotics Institute, Advent Health Celebration, Davenport, FL, USA Herb Coussons, MD  CAVA Robotics International, LLC, Amherst, MA, USA Hans Coveliers, MD, MBA  U-Clinic, Amsterdam, The Netherlands

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Iacopo Dallan, MD  ENT Audiology and Phoniatric Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy Pankaj P. Dangle, MD, MCh  Department of Urology, Children’s of Alabama, University of Alabama at Birmingham, Birmingham, AL, USA Amanda  Daoud, BA Arizona College of Osteopathic Medicine, Midwestern University, Glendale, AZ, USA Prokar Dasgupta, MBBS, MSc, MD, FRCS, FEBU, FLS  MRC Centre for Transplantation, Guy’s Hospital, King’s College London, London, UK Eduardo  Parra  Davila, MD, FACS, FASCRS Department of General and Colorectal Surgery, Good Samaritan Medical Center, West Palm Beach, FL, USA Michael  Dawrant, MBChB, MD, FRCSEd (Paed Surgery)  Paediatric Liver Unit, Leeds Children’s Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK Flavio Malcher de Oliveira, MD, FACS  Department of Surgery, Montefiore Medical Center, The Bronx, NY, USA Hossein Dehghani, PhD  Activ Surgical Inc., Boston, MA, USA Paolo Dell’Oglio, MD  Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium ORSI Academy, Melle, Belgium Department of Urology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy Ankit  Dhamija, MD Department of Cardiovascular & Thoracic Surgery, West Virginia University, Morgantown, WV, USA Fabrizio Diana, ANP  Department of Surgery, SUNY Downstate Medical Center, Brooklyn, NY, USA Mischa Dohler, PhD, MSc, Phd DHC  Department of Engineering, King’s College London, London, UK Carlos  Eduardo  Domene, MD, PhD Department of Surgery, Cimanutro, Professor of University of Sao Paulo Medical School, SOBRACIL (Brazilian Society of Minimally Invasive Surgery and Robotics) PRESIDENT, Sao Paulo, SP, Brazil Jonathan Douissard, MD  Abdominal Surgery Department, University Hospital of Geneva, Geneva, Switzerland Werner  Draaisma, MD, PhD Department of Surgery, Jeroen Bosch Hospital, ‘s Hertogenbosch, The Netherlands Chigozirim N. Ekeke, MD  Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, University of Pittsburgh, Pittsburgh, PA, USA Enrique Fernando Elli, MD, FACS  Department of Surgery, Division of General, Minimally Invasive and Robotic Surgery, Mayo Clinic Florida, Jacksonville, FL, USA Pedro  F.  Escobar, MD, MHL  Department of Gynecologic Surgical Oncology, San Jorge Children and Women’s Hospital, San Juan, Puerto Rico Ricardo  Estape, MD Department of Gynecologic Oncology, HCA East Florida, Kendall Regional Medical Center, Miami, FL, USA Donatella  Di  Fabrizio, MD Department of Paediatric Surgery, Leeds Teaching Hospitals NHS Trust, Leeds, UK Randy Fagin, MD  HCA Healthcare, Nashville, TN, USA Kassem S. Faraj, MD  Department of Urology, Mayo Clinic Arizona, Phoenix, AZ, USA

Contributors

Contributors

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Richard H. Feins, MD  Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA Josh Feldstein, BA  CAVA Robotics International, LLC, Amherst, MA, USA Melissa  M.  Felinski, DO  Department of Surgery, McGovern Medical School, UT Health, Houston, TX, USA Eduardo Fernandes, MD, FRCS  Department of Surgery, Division of General, Minimally Invasive and Robotic Surgery, University of Illinois at Chicago, Chicago, IL, USA Dana  Ferrari-Light, DO, MPH Department of Cardiothoracic Surgery, NYU Langone Health, New York, NY, USA Paolo Fiorini, PhD  Department of Computer Science, University of Verona, Verona, Italy Manuel  Gómez  Fleitas, MD Department of Surgery, Hospital Universitario Marques de Valdecilla, Santander, Spain Giampaolo  Formisano, MD General and Minimally Invasive Surgical Department, Misericordia Hospital, Grosseto, Italy Guy  Friedrich, MD  Department of Cardiology, Medical University Innsbruck, Innsbruck, Austria Daniele Geras Fuhrich, MD  University of Central Florida, Orlando, FL, USA Carlos A. Galvani, MD  Professor and Chief, Division of Minimally Invasive and Bariatric Surgery, Tulane University, School of Medicine, New Orleans, LA, USA Antonio  Gangemi, MD, FACS, FASMBS Division of General, Minimally Invasive and Robotic Surgery, University of Illinois at Chicago, Chicago, IL, USA Travis C. Geraci, MD  Department of Cardiothoracic Surgery, New York University, Langone Health, New York, NY, USA Farid  Gharagozloo, MD, FACS, FCCS, FACHE Professor of Surgery, University of Central Florida, Surgeon-in-Chief, Center for Advanced Thoracic Surgery, Director of Cardiothoracic Surgery, Global Robotics Institute, Director of Cardiothoracic Surgery, Advent Health Celebration, President, Society of Robotic Surgery, Director, International Society of Minimally Invasive Cardiothoracic Surgery, Celebration, FL, USA Ahmed  Ghazi, MD, MHPE, FEBU Department of Urology, University of Rochester, Rochester, NY, USA A. Marc Gillinov, MD  Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic Foundation, CCF, Cleveland, OH, USA Giuseppe  Giuliani, MD, GS General and Minimally Invasive Surgical Department, Misericordia Hospital, Grosseto, Italy Pier Cristoforo Giulianotti, MD, FACS  Professor of Surgery, Lloyd Nyhus Chair in General, Minimally Invasive and Robotic Surgery, University of Illinois at Chicago, Chicago, IL, USA Fahri  Gokcal, MD Department of General Surgery, Good Samaritan Medical Center, Brockton, MA, USA Ada E. Graham, MD  Department of Surgery, George Washington University, Washington, DC, USA Peter Philipp Grimminger, MD  Department of General, Visceral and Transplant Surgery, University Medical Center Mainz, Mainz, Germany

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Stephan Gruessner, MD  Department of Surgery, University of Illinois at Chicago, Chicago, IL, USA Formerly of Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA Giuliano  Betoni  Guglielmetti, MD  Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA Mohan  Gundeti, MD Pediatric Urology (Surgery), MFM (Ob/Gyn) and Pediatrics, The University of Chicago Medicine & Biological Sciences, Chicago, IL, USA Pediatric Urology, Comer Children’s Hospital, Chicago, IL, USA Monika E. Hagen, MD, MBA  Department of Surgery, University Hospital Geneva, Geneva, Switzerland Hannah  Hallman-Quirk, BSN, RN, MS.ED Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA Clinical Coordinator of the Thoracic Surgery Program, Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA Safraz Hamid, BS  Department of Surgery, SUNY Downstate Medical Center, Brooklyn, NY, USA Carlos  Hartmann, MD, FACS Patient Service Representative, Teneth Florida Physician Services, West Palm Beach, FL, USA Department of Surgery, Teneth Health System, West Palm Beach, FL, USA Sarah  Hatfield, BS, BA Department of Undergraduate Medical Education, MD/MPH Program, University of Miami Miller School of Medicine, Miami, FL, USA Jeremiah William Awori Hayanga, MD, MPH, MHL (Cand.)  Department of Cardiovascular & Thoracic Surgery, Heart & Vascular Institute, WVU ECMO Program, West Virginia University School of Medicine, Morgantown, WV, USA Emily  Helmick, DO Department of General Surgery, Creighton University School of Medicine – Phoenix, Phoenix, AZ, USA Melinda  B.  Henne, MD, MS, FACOG Florida Institute for Reproductive Medicine, Jacksonville, FL, USA Alexandra Hernandez, BA  Department of Surgery, University of Miami Miller School of Medicine, Miami, FL, USA Carla  Herrera, MD Department of Surgery, Hospital Clinicas de Caracas and Sociedad Anticancerosa, Caracas, Venezuela Luis J. Herrera, MD  Division of Thoracic Surgery, Department of Surgery, Orlando Health, Orlando, FL, USA Shahab P. Hillyer, MD  Department of Urology, Kern Medical, Bakersfield, CA, USA Alexandre Hostettler, PhD  Department of R&D, IRCAD, Strasbourg, France Salini  Hota, MD Department of Surgery, Eastern Virginia Medical School, Norfolk, VA, USA Andrew  Hung, MD USC Urology, Keck School of Medicine of University of Southern California, Los Angeles, CA, USA Giannicola Iannella, MD  Department of Head-Neck Surgery, Sapienza University of Rome, Rome, Italy Otolaryngology, Head-Neck and Oral Surgery Unit, Morgagni Pierantoni Hospital, Forlì, Italy

Contributors

Contributors

xxxi

Argyrios Ioannidis, MD, PhD (Cand)  Department of General, Bariatric, Laparoscopic and Robotic Surgery, Athens Medical Center, Athens, Greece Mahmoud  Ismail, MD Department of Surgery, Competence Center of Thoracic Surgery, Charité University Hospital Berlin, Berlin, Germany Micah  A.  Jacobs, MD, MPH  Department of Urology, University of Texas, Southwestern Medical Center, Dallas, TX, USA Courtney Janowski, MD  Department of General Surgery, Valleywise Health Medical Center, Phoenix, AZ, USA Joseph Byron John, BSc (Hons, Chemistry), MBBS  Department of Urology, Royal Devon and Exeter NHS Foundation Trust, Exeter, Devon, UK Andrea  Johnson, MD  Obstetrics and Gynecology, University of Minnesota, Minneapolis, MN, USA Matthew A. Johnston, MD  Division of Thoracic Surgery, Department of Thoracic Surgery, Orlando Health, Orlando, FL, USA Brendan Jones, MD  Department of Surgery, West Virginia University Medicine, Morgantown, WV, USA Danielle Julian, BS, MS  Nicholson Center, Advent Health, Celebration, FL, USA Kiran Kakarala, MD  Department of Otolaryngology-Head and Neck Surgery, University of Kansas School of Medicine, Kansas City, KS, USA Darian Scott Kameh, MD  Department of Pathology, AdventHealth Celebration, Celebration, FL, USA Adi  Katz, MD  Department of Obstetrics and Gynecology, Minimally Invasive & Robotic Gynecological Surgery, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, Long Island Jewish Medical Center, New York, NY, USA Srinivas Kaza, MD  Department of Surgery, JFK Medical Center, Atlantis, FL, USA Amie J. Kent, MD  Department of Cardiothoracic Surgery, New York University, Langone Health, New York, NY, USA Kemp  H.  Kernstine Sr, MD, PhD Division of Thoracic Surgery, University of Texas Southwestern Medical Center, Dallas, TX, USA Preston S. Kerr, MD  Department of Surgery, Division of Urology, The University of Texas Medical Branch, Galveston, TX, USA Jim S. Khan, MSc, PhD, FRCS, FCPS, FRCS  Department of Colorectal Surgery, Queen Alexandra Hospital, Portsmouth Hospitals University NHS Trust, Portsmouth, UK Amit Khithani, MD  Department of Surgical Oncology, Kendall Regional Medical Center, Mercy Hospital, Miami, FL, USA Kandace Kichler, MD  Department of Surgery, JFK Medical Center, Atlantis, FL, USA Department of Surgery, University of Miami Miller School of Medicine, Miami, FL, USA Peter C. W. Kim, MD, CM, PhD  Activ Surgical Inc., Boston, MA, USA Department of Bioengineering, Department of Surgery, Brown University, Providence, RI, USA Seon-Hahn Kim, MD, PhD  Colorectal Division, Department of Surgery, Korea University Anam Hospital, Seoul, South Korea Louise P. King, MD, JD  Brigham Women’s Hospital, Boston, MA, USA

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Jordan Klebanoff, MD  Minimally Invasive Gynecologic Surgery, The George Washington University Hospital, Washington, DC, USA Kunal Kochar, MD, FACS, FASCRS  Advocate Lutheran General Hospital, Park Ridge, IL, USA Konstantinos  M.  Konstantinidis, MD, PhD, FACS Department of General, Bariatric, Laparoscopic and Robotic Surgery, Athens Medical Center, Athens, Greece Ohio State University, Columbus, OH, USA Michael  Konstantinidis Department of General, Bariatric, Laparoscopic and Robotic Surgery, Athens Medical Center, Athens, Greece Emin  Kose, MD Department of General Surgery, University of Health Science, Istanbul, Turkey Young  Hwii  Ko, MD, PhD Department of Urology, Yeungnam University, College of Medicine, Daegu, Daegu, South Korea Vaishnavi  Krishnan, BS Department of Undergraduate Medical Education, MD/MPH Program, University of Miami Miller School of Medicine, Miami, FL, USA Dimitri Krizzuk, MD  Department of General and Minimally Invasive Surgery, Misericordia Hospital Grosseto, Grosseto, Italy Kudrit Riana Kahlon, BS  University of Central Florida College of Medicine, Orlando, FL, USA Omar  Yusef  Kudsi, MD, MBA, FACS  Department of General Surgery, Good Samaritan Medical Center, Tufts University School of Medicine, Brockton, MA, USA Ali  Riza  Kural, MD  Department of Urology, Acibadem Mehmet Ali Aydınlar University, School of Medicine, Istanbul, Turkey Sara La Grange, BS, MD  Department of General Surgery, Good Samaritan Medical Center, Brockton, MA, USA Nisha  A.  Lakhi, MD, FACOG  Richmond University Medical Center, New  York Medical College, New York, NY, USA Maximo Lama, MD, FCCP  Department of Pulmonary and Critical Care Medicine, Florida Lung and Asthma Specialists, Advent Health Celebration, Celebration, FL, USA Edward Lambert, MD  Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium MacKenzie Landin, MD  Department of Surgery, Duke University, Durham, NC, USA Todd Larson, RN, BSN, MSIT, CNOR  AdventHealth Nicholson Center, Celebration, FL, USA Richard Lazzaro, MD  Department of Cardiothoracic Surgery, Northwell Health/Lenox Hill Hospital, New York, NY, USA Jeffrey D. Lee, MD, MBA  Department of Surgery, St. Peters Medical Center, Albany, NY, USA Kyu  Eun  Lee, MD, PhD  Department of Surgery, Seoul National University Hospital and College of Medicine, Seoul, Republic of Korea Tae  Hoon  Lee, MD  Colorectal Division, Department of Surgery, Korea University Anam Hospital, Seoul, South Korea Eric Lehr, MD, PhD  Department of Cardiac Surgery, Swedish Heart and Vascular Institute, Seattle, WA, USA

Contributors

Contributors

xxxiii

Thomas  S.  Lendvay, MD Department of Urology, University of Washington, Seattle Children’s Hospital, Seattle, WA, USA Jeffrey S. Levy, MD  Institute of Surgical Excellence, CaseNetwork, Newtown Square, PA, USA Yi  Liang, BSc MBBS  Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia Bin  Li, MD Division of Esophageal Surgery, Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai, China Feng  Li, MD Department of Surgery, Competence Center of Thoracic Surgery, Charité University Hospital Berlin, Berlin, Germany Zhigang  Li, MD, PhD  Division of Esophageal Surgery, Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai, China Jacklyn Locklear, BS  University of Central Florida College of Medicine, Orlando, FL, USA Fabrizio Luca, MD, FACS, FASCRS  Department of Surgery, Loma Linda University Health, Loma Linda, CA, USA J. Scott Magnuson, MD  AdventHealth Nicholson Center, Celebration, FL, USA Marinos C. Makris, MD, MSc, DIG  Department of General, Bariatric, Laparoscopic and Robotic Surgery, Athens Medical Center, Athens, Greece Murugesan  Manoharan, MD, FRCS(Eng), FRACS(Urol) Department of Urologic Oncology, Miami Cancer Institute, Miami, FL, USA Khalid Maqsood, MD  Southlake Gastroenterology, Center for Advanced Thoracic Surgery, Celebration Health, Clermon, FL, USA Luigi  Marano, MD, PhD Department of Medicine, Surgery and Neurosciences, Unit of General Surgery and Surgical Oncology, University of Siena, Siena, Italy Slawomir  Marecik, MD, FACS, FASCRS University of Illinois at Chicago College of Medicine, Chicago, IL, USA Advocate Lutheran General Hospital, Park Ridge, IL, USA Jacques Marescaux, MD  Research Institute against Digestive Cancers (IRCAD), Strasbourg, France Institute of Image-Guided Surgery (IHU Strasbourg), Strasbourg, France Martin A. Martino, MD  Division of Gynecologic Oncology, University of South Florida, Tampa, FL, USA Minimally Invasive Robotic Surgery Program, Lehigh Valley Cancer Institute, Lehigh Valley Health Network, Allentown, PA, USA David P. Mason, MD  Center for Thoracic Surgery, Baylor University Medical Center, Dallas, TX, USA Mario Masrur, MD, FACS  Department of Surgery, Division of General, Minimally Invasive and Robotic Surgery, University of Illinois at Chicago, Chicago, IL, USA Surena F. Matin, MD  Department of Urology, The University of Texas MD Anderson Cancer Center, Houston, TX, USA Kara  McDermott, MBBS, FRACS (Urol)  Department of Urology, Guy’s & St. Thomas’ NHS Trust, London, UK

xxxiv

Michael  William  McDonald, MD Department of Surgery, Advent Health Celebration, University of Central Florida, Orlando, FL, USA John Samuel McGrath, BMedSci, BMBS, FRCS  Department of Urology, Royal Devon and Exeter NHS Foundation Trust, Exeter, Devon, UK Giuseppe  Meccariello, MD Department of Head-Neck Surgery, Morgagni Pierantoni Hospital/Azienda, Forlì, Italy Nelson  Medina-Villaneuva, MD Department of Pulmonary and Critical Care Medicine, Florida Lung and Asthma Specialists, Advent Health Celebration, Celebration, FL, USA Nicholas Mehan, MBBS(Hons)  Department of Urology, Guy’s & St. Thomas’ NHS Trust, London, UK Andreas  Meisel, MD  Department of Neurology, Integrated Center for Myasthenia Gravis, Charité University Hospital Berlin, Berlin, Germany Alfredo  Mellano, MD Program of Hepatobiliary, Pancreatic, and Colorectal Surgery, Candiolo Cancer Institute, FPO – IRCCS, Candiolo (TO), Italy Chris  Mellon, DO Department of General Surgery, Creighton University School of Medicine – Phoenix, Phoenix, AZ, USA Alexander  Christiaan  Mertens, MSc, MD  Department of Robotics and Mechanatronics, University of Twente, Enschede, The Netherlands Mark Meyer, MD  Department of Surgery, Wellington Regional Medical Center, Wellington, FL, USA Tomislav Mihaljevic, MC  Cleveland Clinic, Cleveland, OH, USA Gaby N. Moawad, MD  Department of Obstetrics and Gynecology, The George Washington University School of Medicine and Health Sciences, Washington, DC, USA Filippo Montevecchi, MD  Head & Neck Department, Morgagni Pierantoni Hospital, Forlì, Italy Eric  J.  Moore, MD  Department of Otolaryngology, Head & Neck Surgery, Mayo Clinic, Rochester, MN, USA Alexandre Mottrie, MD, PhD  Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium ORSI Academy, Melle, Belgium Ravi Munver, MD, FACS  Department of Urology, Hackensack University Medical Center, Hackensack, NJ, USA Hackensack Meridian School of Medicine at Seton Hall University, Nutley, NJ, USA Raghav A. Murthy, MD, DABS, FACS  Department of Cardiovascular Surgery, Mount Sinai Hospital, New York, NY, USA Kelsey  Musgrove, MD Department of General Surgery, West Virginia University, Morgantown, WV, USA Didier Mutter, MD, PhD, FACS  Department of Digestive and Endocrine Surgery, University Hospital of Strasbourg, Strasbourg, France Research Institute against Digestive Cancers (IRCAD), Strasbourg, France Institute of Image-Guided Surgery (IHU Strasbourg), Strasbourg, France Ravi Nair, MD  Department of Cardiology, Cleveland Clinic, Cleveland, OH, USA

Contributors

Contributors

xxxv

Azad S. Najmaldin, MB ChB, MS, FRCS (Ed), FRCS  Department of Pediatric Surgery, Leeds Children’s Hospital, Leeds Teaching Hospitals NHS Trust, Leeds, UK Jeffrey G. Nalesnik, MD  Department of Urology, Kern Medical, Bakersfield, CA, USA Vikram M. Narayan, MD  Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA Mohan Nathan, MBA  TransEnterix, Inc., Morrisville, NC, USA Neema Navai, MD  Department of Urology, University of Texas MD Anderson Cancer Center, Houston, TX, USA Anojan  K.  Navaratnam, MBBS  Department of Urology, Mayo Clinic Arizona, Phoenix, AZ, USA Azadeh  Nezhat, MD  Camran Nezhat Institute, Center for Special Minimally Invasive and Robotic Surgery, Palo Alto, CA, USA Camran Nezhat, MD  Camran Nezhat Institute, Center for Special Minimally Invasive and Robotic Surgery, Palo Alto, CA, USA Ceana H. Nezhat, MD  Nezhat Medical Center, Atlanta, GA, USA Farr Nezhat, MD, FACOG, FACS  Nezhat Surgery for Gynecology/Oncology, Valley Stream, NY, USA Weill Cornell Medical College of Cornell University, New York, NY, USA Stony Brook University School of Medicine, Stony Brook, NY, USA Minimally Invasive Gynecologic Surgery and Robotics, NYU Winthrop Hospital, Mineola, NY, USA Duy  Nguyen, MD  Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA Can Obek, MD  Department of Urology, Acibadem Mehmet Ali Aydınlar University, School of Medicine, Istanbul, Turkey John Oberlin, PhD  Activ Surgical Inc., Boston, MA, USA Vincent  James  Obias, MD Department of General Surgery, The George Washington University School of Medicine, Washington, DC, USA Juan M. Ochoa-Lopez, MD  Department of Urology, ORSI Academy, Melle, Belgium Onze Lieve Vrouw Hospital, Aalst, Belgium Carlos Ortiz-Ortiz, MD FACS  Department of General Surgery, Advent Health Celebration Hospital, Celebration, FL, USA Enver  Ozer, MD  Department of Otolaryngology-Head and Neck Surgery, The Ohio State University School of Medicine, Columbus, OH, USA Chandhana Paka, MD  Department of Obstetrics/Gynecology, Kahn School of Medicine at Mt. Sinai, New York, NY, USA Erika  Palagonia, MD, DCH  Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium ORSI Academy, Melle, Belgium Salvatore Parascandola, MD  Department of General Surgery, Walter Reed National Military Medical Center, Washington, DC, USA

xxxvi

John  Park, MD Department of Surgery, Chicago Medical School at Rosalind Franklin University of Medicine and Science, Park Ridge, IL, USA M. Ali Parsa, MD  Department of Obstetrics and Gynecology, Mark Twain Medical Center, Angels Camp, CA, USA Vipul R. Patel, MD  Professor of Surgery, University of Central Florida, Director of Urologic Oncology, Advent Health Celebration, Executive Director, Society of Robotic Surgery, Celebration, FL, USA Joseph  E.  Patruno, MD  Department of Obstetrics and Gynecology, Lehigh Valley Health Network, Allentown, PA, USA Byron  Patton, MD Department of Cardiothoracic Surgery, Northwell Health/Lenox Hill Hospital, New York, NY, USA Jessie  Paull, MD  Department of General Surgery, Walter Reed National Military Medical Center, Bethesda, MD, USA Yevhen Pavelko, MD  Department of Surgery, Division of General, Minimally Invasive and Robotic Surgery, University of Illinois at Chicago, Chicago, IL, USA Jose Alexandre Pedrosa, MD  Department of Surgery, Advent Health Celebration, University of Central Florida, Orlando, FL, USA Peter Penkoff, MD  ORSI Academy, Melle, Belgium Department of Urology, Onze Lieve Vronic Hospital, Aalst, Belgium Patrick  Pessaux, MD, PhD Head of the Hepato-Biliary and Pancreatic Surgical Unit, Department of Digestive and Endocrine Surgery at the University Hospital of Strasbourg, Strasbourg, France University of Medicine of Strasbourg, Strasbourg, France Research Institute against Digestive Cancers (IRCAD), Institute of Image-Guided Surgery (IHU Strasbourg), Strasbourg, France Wanda Petz, MD  Division of Digestive Surgery, European Institute of Oncology, Milan, Italy Kevin  Phan, MD, BSc(Adv), MSc, MPhil Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia Eitan Podgaetz, MD, MPH, FACS  Center for Thoracic Surgery, Baylor University Medical Center, Dallas, TX, USA Kayla Polcari, BS  University of Miami Miller School of Medicine, Miami, FL, USA John Porterfield Jr, MD, MSPH, FACS  Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA Robert Poston, MD  Chairman, Board of Governors, Chief of Cardiothoracic Surgery, Chief of Robotic Surgery, Three Crosses Regional Hospital, Las Cruces, NM, USA Maxwell J. Presser, BA  Department of Surgery, University of Miami, Miami, FL, USA J.  Drew  Prosser, MD  Department of Otolaryngology  – Head and Neck Surgery, Medical College of Georgia at Augusta University, Augusta, GA, USA Raj S. Pruthi, MD, MHA  Department of Urology, University of California – San Francisco, San Francisco, CA, USA Fadi  Rahal, MD Southlake Gastroenterology, Center for Advanced Thoracic Surgery, Celebration Health, Clermon, FL, USA Jay Redan, MD  Advent Health Celebration, Celebration, FL, USA

Contributors

Contributors

xxxvii

Monica Reed, MD  Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA Dario Ribero, MD  Program of Hepatobiliary, Pancreatic and Colorectal Surgery, Candiolo Cancer Institute, FPO – IRCCS, Candiolo (TO), Italy Keith Richardson, MD  Department of Otolaryngology – Head and Neck Surgery, McGill University, Montreal, QC, Canada Carlos Eduardo Rodríguez Rodríguez, MD  Department of Surgery, General and Colorectal Surgery, Hospital Angeles Metropolitano, Mexico City, Ciudad de Mexico, Mexico Craig  G.  Rogers, MD, FACS  Department of Urology, Henry Ford Hospital, Detroit, MI, USA Franco Roviello, MD  Department of Medicine, Surgery and Neurosciences, Unit of General Surgery and Surgical Oncology, Siena, Italy Jens-C Rueckert, MD, PhD  Department of Surgery, Competence Center of Thoracic Surgery, Charité University Hospital Berlin, Berlin, Germany Marcos Gómez Ruiz, MD, PhD  Department of Surgery, Colorectal Surgery Unit, Hospital Universitario Marques de Valdecilla, Santander, Spain Jelle Ruurda, MD, PhD  Department of Surgery, UMC Utrecht, Utrecht, The Netherlands Nader  Sadeghi, MD Department of Otolaryngology  – Head and Neck Surgery, McGill University Health Centre, Montreal, QC, Canada Adelona  Salaj, MD  Department of General and Minimally Invasive Surgery, Misericordia Hospital Grosseto, Grosseto, Italy Inderpal S. Sarkaria, MD  Department of Cardiothoracic Surgery, University of Pittsburgh Medical Center, Pittsburgh, PA, USA Ramgopal  Satyanarayana, MD Department of Urology, University of California, San Francisco, San Francisco, CA, USA Michelle  H.  Scerbo, MD, MS Department of Surgery, McGovern Medical School, UT Health, Houston, TX, USA Oscar Schatloff, MD  Department of Urology, Sudmedica Health, Quillota, Chile Erica Schipper, MD, FACOG  Department of Obstetrics and Gynecology, Sanford Health/ University of South Dakota Sanford School of Medicine, Sioux Falls, SD, USA Alexander  D.  Schroeder, MD Department of Surgery, Creighton University School of Medicine, Omaha, NE, USA Gary Schwartz, MD  Center for Thoracic Surgery, Baylor University Medical Center, Dallas, TX, USA Jila Senemar, MD  FemCare OB GYN, Department of OB GYN, Baptist Hospital of Miami, Miami, FL, USA Maheswari  Senthil, MD, FACS Department of Surgery, Loma Linda University Health, Loma Linda, CA, USA Shinil K. Shah, DO  Department of Surgery, McGovern Medical School, UT Health, Houston, TX, USA Irtza Sharif, MD  Department of Pulmonary and Critical Care Medicine, Florida Lung and Asthma Specialists, Advent Health Celebration, Celebration, FL, USA

xxxviii

Neel  Sharma, MS MD Department of Surgery, WVU JW Ruby Memorial Hospital, Morgantown, WV, USA Baiyong Shen, MD, PhD  Pancreatic Cancer Center, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China Angela Smith, MD  Department of Urology, University of Miami, Miami, FL, USA Roger Smith, PhD, MBA  AdventHealth, Celebration, FL, USA Savannah  Smith, BS The George Washington University School of Medicine & Health Sciences, Washington, DC, USA C.  Arturo  Solares, MD Department of Otolaryngology, Emory University, Atlanta, GA, USA Luc Soler, PhD  Visible Patient, Strasbourg, France Charlotte Spear, MD  Department of General Surgery, Division of Thoracic Surgery, West Virginia University Medicine, Morgantown, WV, USA Giuseppe  Spinoglio, MD Program of Hepatobiliary, Pancreatic and Colorectal Surgery, Candiolo Cancer Institute, FPO – IRCCS, Candiolo (TO), Italy Petr  Stadler, MD, PhD Department of Vascular Surgery, Na Homolce Hospital, Prague, Czech Republic Dimitrios  Stefanidis, MD, PhD Department of Surgery, Indiana University School of Medicine, Indiana University Health, Indianapolis, IN, USA Ram Subramaniam, MBBS, MS, MCh, FRCSI, FRCS  Department of Paediatric Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK Ranjan Sudan, MD  Department of Surgery, Duke University Medical Center, Durham, NC, USA Thomas Surya Suhardja, FRACS, MS, MBBS  Department of Colorectal Surgery, Monash Health, Melbourne, VIC, Australia Mayou  Martin  T.  Tampo, MD Department of Surgery, University of the Philippines, Philippine General Hospital Manila, Metro Manila, Philippines Leonidas Tapias  Center for Thoracic Surgery, Baylor University Medical Center, Dallas, TX, USA Babak Tehranchi, JD, PhD  Perkins Coie LLP, San Diego, CA, USA Patricia  Tejedor, MD Department of Colorectal Surgery, Queen Alexandra Hospital, Portsmouth Hospitals University NHS Trust, Portsmouth, UK Barbara Tempesta, CRNP  Center for Advanced Thoracic Surgery, Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA University of Central Florida, Center for Advanced Thoracic Surgery, Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA James Toh, BSc MBBS FRACS  Department of Surgery, The University of Sydney, Sydney, NSW, Australia Department of Colorectal Surgery, Westmead Hospital, Westmead, NSW, Australia Department of Surgery, UNSW, Sydney, NSW, Australia Robert  C.  Tolboom, MD Department of Surgery, Meander Medical Centre, Amersfoort, The Netherlands

Contributors

Contributors

xxxix

Christian  Toso, MD, PhD Department of Surgery, University Hospital Geneva, Geneva, Switzerland Ilter Tufek, MD  Department of Urology, Acibadem Mehmet Ali Aydınlar University, School of Medicine, Istanbul, Turkey Kiara A. Tulla, MD  Department of Surgery, University of Illinois at Chicago, Chicago, IL, USA Alexander  M.  Turner, BSc, MB, ChB, FRCS, FEAPU, PhD Department of Paediatric Urology, Leeds Teaching Hospitals NHS Trust, Leeds, UK Stavros I. Tyritzis, MD, PhD, FEBU, FACS  4th Department of Urology, HYGEIA Hospital, Athens, Greece Department of Molecular Medicine and Surgery, Section of Urology, Karolinska Institutet, Solna, Sweden Ivo G. Tzvetanov, MD  Department of Surgery, Chief Division of Transplantation, University of Illinois at Chicago, Chicago, IL, USA Fred Umeh, MD  Department of Pulmonary and Critical Care Medicine, Florida Lung and Asthma Specialists, Advent Health Celebration, Celebration, FL, USA Valentina Valle, MD  Department of Surgery, Division of General, Minimally Invasive and Robotic Surgery, University of Illinois at Chicago, Chicago, IL, USA Richard  van Hillegersberg, MD, PhD  Department of Surgery, Cancer Center, University Medical Center Utrecht, Utrecht, The Netherlands S. van der Horst, MD  Department of Surgery, UMC Utrecht, Utrecht, The Netherlands Emma M. van der Schans, MD  Faculty of Electrical Engineering, Mathematics & Computer Science, Department of Robotics and Mechatronics, University of Twente, Enschede, The Netherlands Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands Pieter Christiaan van der Sluis, MD, PhD  Department of Surgery, UMC Utrecht, Utrecht, The Netherlands Nataliya  Vang, MD  Camran Nezhat Institute, Center for Special Minimally Invasive and Robotic Surgery, Palo Alto, CA, USA Matthew  S.  Vercauteren, MPAS Cardiothoracic Department, University of Pittsburgh Medical Center, Pittsburgh, PA, USA P. M. Verheijen, MD, PhD  Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands Mark Vesely, MD  Department of Medicine/Cardiology, University of Maryland School of Medicine, Baltimore, MD, USA Claudio Vicini, MD  Head & Neck Department, Morgagni Pierantoni Hospital, Forlì, Italy Tamara Diaz Vico, MD  Mayo Clinic Florida, Jacksonville, FL, USA Paula Volpe, MD  Department of Surgery, CIMA-Centro Integrado de Medicine Avançada, Sao Paulo, SP, Brazil F.  J.  Voskens, MD  Department of Surgical Oncology, University Medical Center Utrecht, Utrecht, The Netherlands Mailinh Vu, MD  Camran Nezhat Institute, Center for Special Minimally Invasive and Robotic Surgery, Palo Alto, CA, USA

xl

Amendha  Ware, CRNP Center for Advanced Thoracic Surgery, Celebration Health, Celebration, FL, USA Satish  Kumar  Warrier, MBBS, MS, FRACS Colorectal Department, Peter MacCallum Cancer Centre, Melbourne, Melbourne, VIC, Australia Scott  Werden, MD Center for Advanced Thoracic Surgery, Global Robotics Institute, Celebration Health, Celebration, FL, USA Per  Wierup, MD, PhD Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, CCF, Cleveland, OH, USA Paul J. M. Wijsman, MD  Department of Surgery, Meander Medical Centre/Jeroen Bosch Hospital, Amersfoort/’s-Hertogenbosch, The Netherlands Stephen B. Williams, MD  Department of Surgery, Division of Urology, The University of Texas Medical Branch, Galveston, TX, USA Erik  B.  Wilson, MD Department of Surgery, McGovern Medical School, UT Health, Houston, TX, USA Pawel Wisz, MD  Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium ORSI Academy, Melle, Belgium Tadeusz D. Witek, MD  Cardiothoracic Department, University of Pittsburgh Medical Center, Pittsburgh, PA, USA Michael  E.  Woods, MD Department of Urology, Loyola University Medical Center, Maywood, IL, USA Yang Yang, MD  Division of Esophageal Surgery, Department of Thoracic Surgery, Shanghai Chest Hospital, Shanghai, China Jennifer Yates, MD  Department of Urology, University of Massachusetts Medical School, Worcester, MA, USA Trevor  M.-Y.  Yeung, MBBChir, MA, DPhil, FRCS Nuffield Department of Surgical Sciences, University of Oxford, Oxford, UK Mohanad R. Youssef, MD  Research Scientist, Division of Minimally Invasive and Bariatric Surgery, Tulane University, School of Medicine, New Orleans, LA, USA Faissal  Zahrawi, MD, FACS Department of Orthopedics, University of Central Florida, Florida Hospital, Orlando, FL, USA Samsor Zarak, MD  West Virginia University, Morgantown, WV, USA Michael  D.  Zervos, MD Department of Cardiothoracic Surgery, New York University, Langone Health, New York, NY, USA Qian  Zhan, PhD General Surgery Department, Ruijin Hospital Affiliated to Shanghai Jiaotong University School of Medicine, Shanghai, China David  Zimrin, MD Division of Cardiovascular Medicine, Department of Medicine, University of Maryland School of Medicine, Baltimore, MD, USA

Contributors

Part I Robotic Surgery: Overview

1

The Journey from Video Laparoscopy to Robotic and Digital Surgery Camran Nezhat, Mailinh Vu, Nataliya Vang, Kavya S. Chavali, and Azadeh Nezhat

1.1

Visibility and Tangibility

Historically, surgery had long been dominated by laparotomy with large incisions. When conservative options or medical therapies failed, the only way to manage ailments within the human body was to be able to see it firsthand. These large incisions not only allowed surgeons to visualize the problem with the naked eye but they also enabled the disease to become tangible. A clot in a major vessel could be removed to restore normal blood flow. A tumor could be excavated from the patient. A stricture on a major organ could be relieved to resolve a patient’s symptoms. Surgery continued to be a field requiring both visibility and tangibility. The era of laparotomy ruled for countless generations. It was the surgeon’s call to action when an acutely ill or deteriorating patient presented with an unknown condition. The exploratory laparotomy was the path to their answers. Unfortunately, it did not come without a price. The patients may have obtained resolution of the initial complaint or illness that plagued them, but they in turn purchased a new onslaught of problems from their surgical recovery.

1.2

Paradigm Shift

The invention and introduction of video endoscopy by Camran Nezhat M.D. revolutionized the world of surgery. It is considered one of the greatest achievements in modern medical history [1–5]. Instead of large disfiguring incisions, patients could undergo major procedures with small “keyhole” or “Band-Aid” surgery. It became widely known as minimally invasive surgery. The benefit of this shift had a profound impact on patients and their recovery. They no longer endured weeks or even months of post-operative debilitaC. Nezhat (*) · M. Vu · N. Vang · K. S. Chavali · A. Nezhat Camran Nezhat Institute, Center for Special Minimally Invasive and Robotic Surgery, Palo Alto, CA, USA e-mail: [email protected]

tion, increased risks of infection, hemorrhage, cardiopulmonary sequelae, or other morbidities. The influence videoendoscopy had on surgery is considered “revolutionary to this century as the development of anesthesia was to the last.” [6]

1.3

Before Video Endoscopy

Numerous hurdles had to be overcome prior to the widespread acceptance of video endoscopy. Many predecessors had to lay the groundwork for this modern innovation. With a journey that began in the last 200 years, modern endoscopy and minimally invasive surgery is a relatively new field. However, its conceptual origins can be traced back much further. Historical records from Ancient Egypt suggest a philosophy similar to our modern art of triage. Papyrus categorized three levels of ailments, including “treatable, treatable with difficulty, or an ailment not to be treated.” [7] This ideology demonstrates the perception of minimizing medical intervention among Egyptian physicians. This aligns with the Hippocratic oath of “to do no harm” when weighing the benefits of intervention to the costs of increasing morbidity. In Ancient China, with the Confucius school of thought, the acceptance into the afterlife relied on maintaining a body whole without disfigurement. Medical practice during this era focused on delicate instruments with minimal invasiveness, such as acupuncture needles and rudimentary catheters composed of hollow leaves [8]. This model of minimal intervention quietly maintained a presence throughout history. However, it is important to note the two distinct predecessors of video laparoscopy, diagnostic and operative endoscopy. As early as the sixteenth century, a variety of cannulas, specula, or modified tubes were used to peer into different body orifices. Gradually, these evolved over time to include metal reflectors with eyepieces, thus refining the view into body cavities. In 1806, Philip Bozzini developed a relatively sophisticated system which

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_1

3

C. Nezhat et al.

4

was widely regarded as the beginning of the modern-day diagnostic endoscope [9]. Despite the progress made with diagnostic endoscopy, its utility for the abdominal cavity was met with much resistance. With the risk of damage to critical abdominal organs, laparoscopy was not readily adopted. It was not until 1901, when Georg Kelling, a German gastroenterologist, first obtained success viewing the abdomen of an anesthetized dog. He accomplished this by establishing artificial insufflation in the abdomen to avoid injury to vital organs. He then transferred his new minimally invasive diagnostic technique to a small series of human patients [10]. This innovation set the stage for Hans Christian Jacobaeus, a Swedish internist who in 1910 was able to perform the first successful operative laparoscopy with adhesiolysis in the abdominal cavity of 17 patients [11]. It was a new modality that was quickly embraced internationally. It ushered in an era of laparoscopic pioneers who began performing various simple diagnostic and therapeutic procedures. These early achievements did not come without their own difficulties. This new technology was still in its infancy and came with a steep learning curve. Many practitioners struggled to implement its usage safely. Unfortunately, this led to growing concerns among the medical society, with increasing advocacy for its restriction. The rate of serious complications and even death was still too high when compared to the more established exploratory laparotomy. In fact, by this time, most techniques of open abdominal procedures had become more refined and more reliable. With the addition of enhanced antibiotics, anesthetics, and anti-hemorrhagic agents, there was a noted decline in morbidity and mortality from laparotomies. Laparoscopy fell out of favor as quickly as it had risen. By 1972, only 30 Fig. 1.1  Early laparoscopy performed by Dr. Perci with scope adaptation to allow for second observer

centers in the United States were performing any form of laparoscopy [12].

1.4

Gynecologic Surgery

As the exploratory laparotomy continued to reign as the gold standard surgical modality over the next two decades, laparoscopy experienced a modest revival, especially among gynecologists. First introduced in 1936 by the Swiss surgeon, Boesch, the laparoscopic tubal ligation was now perfected and easily performed by many gynecologists. This was evident as 60% of all tubal sterilization was being performed laparoscopically in 1976 compared to 1% in 1971. This was a critical development in re-establishing a role for operative laparoscopy. During the 1970s, laparoscopic training became widely incorporated into gynecologic residency training programs in both Europe and the United States [13]. With more simple operative laparoscopic procedures being introduced into practice, it was quickly realized that there were significant restraints. Its utility for more advanced procedures was stalled by mechanics. With the surgeon hunched over to peer into the aperture of the laparoscope, this cumbersome posture placed the surgeon’s hands at an infeasible location for performing advanced surgery that required more than simple instrument manipulations (Fig. 1.1).

1.5

The Video Revolution

While cinematography and motion pictures continued to grow and gain popularity in the twentieth century, this technology also infiltrated the medical industry. The first live color motion picture bronchoscopy was presented in 1942 by

1  The Journey from Video Laparoscopy to Robotic and Digital Surgery

Americans Frank Dolley and Lyman Brewer [14]. In 1950, the first gastro-camera, measuring the size of a nickel, was developed through the collaboration of Olympus and Japanese pioneers Uji, Fukami, and Suginara [14, 15]. Palmer garnered the world’s attention in 1958 when he was able to capture ovulation in progress using color laparoscopy. These inventions were revolutionizing the future of laparoscopy [16]. From fiber optics to automatic insufflators, and electronically controlled thermo-coagulators, new technologies were being engineered at an astonishing rate. Thus far, these innovations all benefited diagnostic procedures, yet the operative realm remained untapped. These device systems were all designed for the purposes of diagnosis, teaching, and demonstration. They were even known as “teaching attachments” with surgeons still hunched over peering into the laparoscope [17]. The operative laparoscopic procedures performed remained essentially unchanged from the prior 50 years. They were limited to cystic drainage, adhesiolysis, biopsies, cauterization of tumors, and tubal ligations. Anything more complex continued to be relegated to the traditional large incision laparotomy. The main culprit for this hindered progress hinged on the awkward posturing of the surgeon. Forced to contort one’s body to peer into the tiny eyepiece while holding the laparoscope, the surgeon was left with only one free hand to operate and perform whatever procedure was realistically feasible in such a position. This incongruence between technological advancement and surgical progress was simply not acceptable. Camran Nezhat believed that attention needed to be placed on improving the physical constraints of the operating surgeon. The full potential of endoscopy could be reached if the awkward positioning could be circumvented.

1.6

Changing the Perspective

In the 1970’s, Nezhat had a vision to reconcile the inconsistency between the advancing technology and the stagnant role of operative laparoscopy. He tinkered with a variety of video equipment to invent and pioneer a technically feasible configuration that would allow a surgeon to operate while standing upright. This contraption enabled the endoscopic image to be broadcasted to a television monitor. This novel approach changed laparoscopic surgery in significant ways. First, it optimized the surgeon’s stance to an upright position, allowing one to perform more lengthy and complex procedures. Instead of using one hand to hold the endoscope, both hands could be free with full dexterity to operate. Additionally, rather than squinting into a tiny aperture of an eyepiece, both eyes could remain open and in a natural setting thus improving surgical visualization. Furthermore, the laparoscopic

5

image is projected on a monitor and visible to everyone in the room. This transformed the laparoscopic theater from a surgical sonata to a surgical orchestra with the active participation of multiple surgeons [1–5]. This breakthrough of advanced video laparoscopy by Nezhat revolutionized the future landscape of surgery. During his reproductive endocrinology fellowship, he began converting diagnostic laparoscopies into therapeutic ones. Procedures that had previously aimed solely for identifying pathologies became opportunities for him to use his new technique to treat their disorders. In 1980, when he opened the doors of his own private practice, Nezhat saw an influx of patients and infertile couples seeking surgery with his new technique. They saw the potential of these minimally invasive procedures. They desired treatment for their infertility, endometriosis, fibroids, and chronic pelvic pain without the burden of disfiguring surgery and long recovery times. As popular as his new surgical methods were among patients, it unfortunately did not have the same initial reception among the medical societies. Colleagues met him with much skepticism and doubted his methods could improve surgery. Many were apathetic to the benefits of minimally invasive techniques. However, these viewpoints rested primarily from ignorance of what his techniques entailed. Despite conference presentations and academic publications describing his work and experience with this innovative technology, the cynicism abounded. Established medical journals called it experimental or gimmicky [18]. Others doubted that it would improve surgery, medicine, or mankind [19]. Some colleagues were curious nonetheless. They sought him out and observed his surgeries. They saw firsthand the advantages of the surgery and the benefits to the patients. He began to teach courses and share his methods to any who wanted to learn. Soon, the knowledge spread like wildfire. The skeptics became promoters. It was only a matter of time before the medical community accepted and embraced it [20–22]. By the late-1980s, thousands had learned from Nezhat’s methods. Some of these surgeons also became pioneers in the field, moving forward to achieve their own milestones in advancing video endoscopy.

1.7

 he Role of Endometriosis T in Changing Surgery

The transition from open to minimally invasive surgery can be indirectly credited to endometriosis. Plaguing adolescents and adult females for centuries, this enigmatic disease often presented with multi-system symptoms that could not be explained. They were often dismissed as psychiatric with no medical rationalization [23]. In studies from the 1990s, nearly half of all women who sought medi-

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cal consultation for chronic pelvic pain were found to have no known organic cause. It can be assumed that inadequate care was received by many of these patients while they continued to suffer [24]. By using diagnostic laparoscopy and surgical biopsies to confirm endometriosis, patients could be given a tangible etiology for their pain or symptoms. They were finally given an answer to their unsolved mystery, and their pain was validated. This soon followed suit that the gold standard diagnosis for endometriosis was diagnostic laparoscopy with tissue confirmation. Additionally, Nezhat found that increased magnification from video laparoscopy allowed him to consistently visualize atypical endometriotic lesions. These were lesions that would otherwise have been mistaken for normal tissue during open surgery. In fact, he was able to establish an organic cause for chronic pelvic pain in 90% of his patients. This helped to establish laparoscopy as a surgical modality for improving the ability to see pathologies undetected by traditional surgery. He learned that a more thorough treatment of the disease seemed to positively correlate with improved pain relief and fertility rates. Endometriosis was not limited to the pelvis and reproductive organs. With his improved visualization of endometriosis during video laparoscopic surgery, Nezhat began to identify endometriosis everywhere. He found it on the bowels, bladder, and ureters. Being able to see it laparoscopically was one matter, but to thoroughly treat it laparoscopically posed more of a challenge. Thomas Cullen was one of the earliest American surgeons specializing in endometriosis, and he stated that endometriosis-related bowel surgery was known to be “infinitely more difficult than hysterectomies for carcinoma.” [25] To further expand the horizons of video laparoscopic surgery, Nezhat along with colorectal surgeon Earl Pennington, performed the first successful laparoscopic bowel resection and re-anastomosis for deeply infiltrating endometriosis in 1988 [26, 27]. He combined the use of video endoscopy with carbon dioxide laser to create a more controlled and predictable energy source than electrocautery [28, 29]. Using these same delicate techniques and precision surgery, Nezhat began applying these methods to treating bladder and ureteral endometriosis by laparoscopic segmental bladder resection, ureter resection, and reanastomosis [30, 31]. He continued to have unprecedented success and was able to carefully navigate the frozen pelvis of a multitude of patients suffering from extensive disease.

1.8

Laparoscopy Begets Industry

The progress of video laparoscopy was well underway in changing the landscape of surgery in a multitude of ways. Techniques continued to be developed, and surgeons began

to build and hone their skills. However, the speed of growth was still limited by not only technology but also its availability. The unassisted naked eye still had a higher resolution than the 275–450 lines of the surgical video monitors [32]. Enhanced optics and video systems were needed to improve pixelation and resolution for better visualization of the anatomy and pathology. Although the Japanese company Topcon developed beam-­ splitters in 1981 and new high-refractive optics were being introduced on the market, these technologies were not widely available to surgeons [33]. For years, most surgeons continued to use outdated endoscopes and auxiliary equipment, as the financial investments in these more sophisticated tools were not feasible throughout the 1980–1990s. The concept of laparoscopy was well-established, but the industry was still lagging with appropriate equipment. Nezhat began collaborating with engineers to create instruments to support this new surgical modality. Karl Storz and other companies began producing new cameras and light sources specifically for video laparoscopy. Nezhat went so far as to develop some of the instrumentation himself in order to enhance his surgeries, including the suction irrigator with pump system and a special lens and coupler system for laseroscopy [34]. Along with the surgical technology, the surgeon’s senses had to be reinvented. Surgeons could no longer rely on haptic feedback or their tactile senses to estimate physical manipulation of the surgical tissues. Palpation of organs and pathology was essentially eliminated by video laparoscopy. In adapting to the new technology, they had to forgo tactile, spatial, and direct visualization in performing their surgeries. The additional requirement of abdominal insufflation also introduced a new confounding factor. The eventual anesthetic breakthroughs of Fishburne and other innovators improved patient tolerance of insufflation pressures and steep Trendelenberg positions [35].

1.9

Overcoming the Test of Time

Concerns also arose of the long hours needed to perform these laparoscopic procedures. Most surgeons were still becoming accustomed to the technology when it was first available. A steep learning curve was recognized. Those who opposed the technology had concerns regarding the long hours patients were induced under anesthesia and in the operative suite for procedures that only took a fraction of the time when performed by laparotomy. It was given the colloquial term of “forever-scopy.” For instance, laparoscopic ectopic pregnancies could take up to 5 hours compared to the hour-long method by laparotomy [36]. Like all major advances in medical history, the acceptance of video laparoscopic surgery was a slow process. It

1  The Journey from Video Laparoscopy to Robotic and Digital Surgery

was gradually accepted as more became exposed to it, learned about it, and utilized it themselves. After nearly three decades of setbacks and pushbacks, video laparoscopy was finally fully accepted and embraced. In 2004, a New England Journal of Medicine editorial proclaimed, “surgeons must progress beyond the traditional techniques of cutting and sewing to a future in which minimal access to the abdominal cavity is only the beginning.” [37] Video endoscopy transformed the future of surgery. It created a new landscape and ushered a new era with a patient-centered focus. Minimally invasive approaches secured their rightful place as the standard of care for many countless procedures spanning a multitude of disciplines. The broad application of endoscopy continued to grow. From the video laparoscopic truncal vagotomy for peptic ulcer disease by Dallemagne in 1991 followed by the first video laparoscopic nephrectomy by Clayman in 1992, this decade was brimming with surgical firsts. General surgeons had fully adopted the endoscopic technique with major procedures, including a video laparoscopic Billroth II gastrectomy, adrenalectomy, and splenectomy [38]. Gynecologic oncologists such as Farr Nezhat also tapped into the technology’s potential for helping cancer patients, a particularly vulnerable group who had the most to gain from minimally invasive surgery. He revolutionized surgical staging by successfully performing the first video laparoscopic radical hysterectomy with para-aortic and pelvic lymphadenectomy and tumor debulking for advanced cancer [39].

1.10 Introducing the Telepresence Platform During the 1990s and 2000s, technological advances in surgery ran rampant. Video laparoscopy was well entrenched in the medical community, and minimally invasive approaches were becoming the standard of care. The clear advantage of minimally invasive procedures outweighed the many morbidity risks of open surgery. The fabric of surgery had changed, and it spanned multiple surgical specialties. Many saw this modality as the future of surgery. Opportunities were abound with advances in instruments and surgical equipment. The industry continued to grow, and great minds in the field continued to create new methods for advancing the platform. First envisioned by Thring in 1981, telepresence surgery was a concept that a surgeon could control surgical instrumentation over a patient from a remote location [40]. It is commonly known by its more attractive futuristic misnomer, robotic surgery, as it implies autonomous function without human control [41]. Her vision was ultimately realized once the technology caught up to her idea two decades later. It was the dedicated collaboration and innovative efforts of many talented individuals that made this possible.

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Beginning in the early 1990s, a Medical Technology Laboratory (MTL) team at the Stanford Research Institute (SRI) set out to create a system to overcome the challenges and physical shortcomings of laparoscopic surgery. Led by Phil Green and Ajit Shah, this was a team of innovative engineers and scientists who designed an unprecedented surgery system that allowed a surgeon to operate remotely in performing an entire procedure on a patient [42]. Their team appreciated the beneficial role telepresence surgery could play in situations where human proprioception was compromised. The applicability of the system had potential in laparoscopic surgery, endoscopic surgery, and microsurgery. At a time when laparoscopic surgery was fast solidifying its presence in surgery and reshaping the standard of care, the SRI team recognized the highest market opportunity and greatest surgical benefit from this modality. They then designed their system to enhance the technology of laparoscopic surgery. Green and Shah sought out Nezhat and his expertise in developing the video laparoscopic surgery method. As the individual who performed the most laparoscopic surgeries, it seemed only fitting to learn of its shortcomings from him. The SRI team was invited to observe him during surgeries and to witness his operative methods and laparoscopic techniques. He became a core advisor for their telepresence surgical system. Their goal was to create a device that would allow less experienced surgeons to perform laparoscopic surgery with the same ease in which he performed his surgeries [42]. One of the main problems with laparoscopic surgery was the counterintuitive movement of the instruments. Traditional laparoscopic surgery relied on long instruments with a fulcrum point set to the abdominal wall. Thus, hand movements were in the opposite direction of the instruments’ motions. An additional challenge was the visual limitations. The two-­dimensional video display hindered depth perception. Instrumentation was directly over the patient while the surgeon must look up upon a monitor and away from the field of operation. Another significant setback with laparoscopic surgery was the loss of proprioception. Without tactile feedback, surgeons had to rely on only two-dimensional visualization to operate. The collection of these factors made traditional video laparoscopic surgery challenging for many surgeons with limited experience. It required them to abandon their training from open surgery technique and adopt a new style of surgical acumen to be successful. Video laparoscopic surgery continued to gain popularity and expansion in its utility, but the steep learning curve still made it inaccessible to many surgeons. It was an obstacle that the SRI team believed could be resolved with robotic technology. They aimed to mitigate these significant challenges by re-creating the open surgery experience while still

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Fig. 1.2  The daVinci surgeon console and patient cart. Image courtesy of Intuitive Surgical®

performing a closed surgery with laparoscopy. They accomplished this feat with the help of John Hill and Joel Jensen who designed the core technology, laying the groundwork for the daVinci system. The team at SRI had developed the first successful advanced telepresence surgical system. It included master and slave manipulators with four degrees of freedom (DOF), a three-dimensional video display with view direction toward the surgical field, and complete stereophonic sound [43]. They recruited a team of clinical collaborators and used the SRI telepresence system to perform a variety of surgeries on animals, including vascular anastomoses, hysterectomy, cholecystectomy, and splenectomy. As expected, the robotic system resulted in longer surgical durations compared to open surgery, but they demonstrated comparable accuracy and outcomes [44]. The surgeons from the clinical team also remarked on the intuitiveness of the system and commended the great ease in learning and using the robotic device. Surgeons were able to sit comfortably at the console while performing surgery, and thus adding to the potential increased longevity of surgical careers. With such promising surgical outcomes and encouraging feedback from the surgeons, the SRI team knew they had developed a system that would expand the realm of surgery. Once SRI system obtained funding in 1995, it became commercialized by Intuitive Surgical®. In 1999, the first da Vinci system was unveiled and introduced in the market (Fig. 1.2). By the next year in February 2000, they obtained Federal

Drug Administration approval. With the advent of the new millennium was also the dawn of the telepresence surgical age and we were only just beginning to scratch the surface of its potential.

1.11 Conclusion The revolution of modern-day surgery rests on the ingenious minds that acknowledged the need for change, and it began with video laparoscopy. Nezhat recognized the limitations of the current practice of his time and engineered solutions to improve it. He collaborated with others who came from all over the world. They hailed from different backgrounds of medicine, surgical specialties, engineering, or various academic backgrounds. They all shared a common objective in striving to improve the surgical experience and to enhance patient outcomes. The ever-changing landscape and progress of surgery rests on collaboration of individuals, to learn from our historical predecessors as well as our contemporaries. From open surgery to diagnostic endoscopy to video laparoscopy and telepresence surgery, the success of new surgical breakthroughs rests upon the foundation set by previous models. It continues to grow with new ideas envisioned by revolutionary thinkers and are realized by technologies developed by innovative builders. As we continue to grow and expand, the possibilities of surgery are limited only by ourselves.

1  The Journey from Video Laparoscopy to Robotic and Digital Surgery

In order to move toward the future, we must understand our past. In the history of modern surgery, the time between pivotal milestones have decreased. The advancement from open surgery to closed surgery took 200 years to achieve. The adoption of laparoscopy took nearly another century to embrace. The revolution of video laparoscopy required three decades before it became the gold standard. The advent of telepresence and robotic surgery took the world by force within a decade. As we move into the future, surgery will continue to change at a rapid rate. The next frontier of surgery will likely witness an integration of digital surgery, including artificial intelligence, augmented reality, enhanced robotics with automation, and device miniaturization [42, 45].

References 1. Nezhat C, Page B. The advent of advanced operative video-laparoscopy. In: Nezhat’s history of endoscopy. Tuttlingen: Endo Press; 2011. p.159–79. 2. Podratz K.  Degrees of freedom: advances in gynecological and obstetric surgery. remembering milestones and achievements in surgery: inspiring quality for a hundred years 1913–2012. Tampa: Faircount Media Group; 2013. 3. Carter JE.  Biography of Camran Nezhat, MD, FACOG, FACS. JSLS. 2006;10(2):275–80. 4. Kelley WE Jr. The evolution of laparoscopy and the revolution in surgery in the decade of the 1990s. JSLS. 2008;12(4):351–7. 5. Nezhat C, Crowgey SR, Garrison CP. Surgical treatment of endometriosis via laser laparoscopy. Fertil Steril. 1986;45(6):778–83. 6. Schropp K.  History of pediatric laparoscopy and thorascopy. In: Schropp L, editor. Pediatric laparoscopy and thorascopy. Philadelphia: W.B. Saunders Company; 1994. 7. Breasted JH.  New-York historical society. Library. The Edwin Smith surgical papyrus. Chicago, IL: The University of Chicago Press; 1930. 8. Unschuld PU.  Die traditionelle chinesische Medizin im 20. Jahrhundert. Uberlebenskampf und Legitimationsstrategien. Med J. 1985;20(3):263–9. 9. Nezhat C, Page B. Bozzini: The beginning of early modern endoscopy. In: Nezhat’s history of endoscopy. Tuttlingen: Endo Press; 2011. 10. Nezhat C, Page B. Early 20th century. In: Nezhat’s history of endoscopy. Tuttlingen: Endo Press; 2011. 11. Nordentoeft S. Uber Endoskopie Geschlossener Cavitaten mittels eines troKar-endoskops. Verh Dtsch Ges Chir. 1912;41(78):412. 12. Berci G. Present and future developments in endoscopy. Proc R Soc Lond. 1977;195:235–42. 13. Nezhat C, Page B. 1970s. In: History of endoscopy. Tuttlingen: Endo Press; 2011. p. 151–5. 14. Dolley F, Brewer LA. Chest injuries. Ann Surg. 1942;116(5):668–86. 15. Mori T, Mori C, Yamadori F. The original production of the glassfibre hysteroscope and a study on the intrauterine observation of the human fetus, things attached to the fetus and inner side of the uterus wall in late pregnancy and the beginning of delivery by means of hysteroscopy and its recording on the film. J Jpn Obstet Gynecol Soc. 1968;15(2):87–95. 16. Frangenheim H.  Laparoscopy and culdoscopy in gynaecology. London: Butterworth; 1972.

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17. Olsen V, Berci G. Teaching attachments. New York, NY: Appleton-­ Century-­Crofts; 1976. 18. Pitkin RM.  Operative laparoscopy: surgical advance or technical gimmick? Obstet Gynecol. 1992;79(3):441–2. 19. Barham M. Laparoscopic vaginal delivery: report of a case, literature review, and discussion. Obstet Gynecol. 2000;95(1):163–5. 20. Treacy P, Johnson AG. Is the laparoscopic bubble bursting? Lancet. 1995;346:s23. 21. Seidman DS, Nezhat C.  Is the laparoscopic bubble bursting? Lancet. 1996;347(9000):542–3. 22. Pitkin RM, Parker WH. Operative laparoscopy: a second look after 18 years. Obstet Gynecol. 2010;115(5):890–1. 23. McCracken P.  The curse of eve, the wound of the hero: blood, gender, and medieval literature. Philadelphia: University of Pennsylvania Press; 2003. 24. Gomel VTP. Diagnostic and operative gynecologic laparoscopy. St Louis: Mosby; 1995. 25. Cullen T.  The distribution of adenomyomata containing uterine mucosa, vol. 180: American Medical Association Press; 1920. p. 130–8. 26. Nezhat F, Nezhat C, Pennington E, Ambroze W Jr. Laparoscopic segmental resection for infiltrating endometriosis of the rectosigmoid colon: a preliminary report. Surg Laparosc Endosc. 1992;2(3):212–6. 27. Nezhat C, Nezhat F, Pennington E, Nezhat CH, Ambroze W.  Laparoscopic disk excision and primary repair of the anterior rectal wall for the treatment of full-thickness bowel endometriosis. Surg Endosc. 1994;8(6):682–5. 28. Nezhat C, Nezhat F, Pennington E. Laparoscopic treatment of infiltrative rectosigmoid colon and rectovaginal septum endometriosis by the technique of videolaparoscopy and the C02 laser. Br J Obstet Gynaecol. 1992;99(8):664–7. 29. Nezhat CR, Nezhat FR, Silfen SL. Videolaseroscopy. The C02 laser for advanced operative laparoscopy. Obstet Gynecol Clin N Am. 1991;18(3):585–604. 30. Nezhat CR, Nezhat FR. Laparoscopic segmental bladder resection for endometriosis: a report of two cases. Obstet Gynecol. 1993;81(5 (Pt 2)):882–4. 31. Nezhat C, Nezhat F, Green B. Laparoscopic treatment of obstructed ureter due to endometriosis by resection and ureteroureterostomy: a case report. J Urol. 1992;148(3):865–8. 32. Beard RW, Belsey EM, Lieberman BA, Wilkinson JC. Pelvic pain in women. Am J Obstet Gynecol. 1977;128(5):566–70. 33. Amara DP, Nezhat C, Teng NN, Nezhat F, Nezhat C, Rosati M.  Operative laparoscopy in the management of ovarian cancer. Surg Laparosc Endosc. 1996;6(1):38–45. 34. Nezhat CR. My journey with the AAGL. J Minim Invasive Gynecol. 2010;17(3):271–7. 35. Soderstrom RM.  Operative laparoscopy; the master’s techniques. Prinicples and techniques in gynecologic surgery. New York, NY: Raven Press; 1993. 36. Page B. A history of modern video-assisted endoscopy. In: Nezhat C, Nezhat F, Nezhat C, editors. Nezhat’s video-assisted and robotic-assisted laparoscopy and hysteroscopy. 4th ed. New York, NY: Cambridge University Press; 2014. p. 1–17. 37. Pappas TN, Jacobs DO.  Laparoscopic resection for colon cancer—the end of the beginning? N Engl J Med. 2004;350(20): 2091–2. 38. Nezhat C, Page B. Chapter 23: 1990s-2000s. In: Nezhat’s history of endoscopy. Tuttlingen: Endo Press; 2011. p. 193–6. 39. Nezhat FR, Datta MS, Liu C, Chuang L, Zakashansky K. Robotic radical hysterectomy versus total laparoscopic radical hysterectomy with pelvic lymphadenectomy for treatment of early cervical cancer. JSLS. 2008;12(3):227–37.

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40. Thring M.  Robotics and Telchirs: manipulators with memory, 4 3. Shah A, Frazee J. Interactive surgery and telepresence. In: King W, Frazee JG, DeSalles AAF, editors. Endoscopy of the central and remote manipulators, machine limbs for the handicapped. Ultimo: peripheral nervous system. New York: Thieme; 1997. p. 243–62. Halstead Press; 1983. 44. Bowersox JC, Shah A, Jensen J, Hill J, Cordts PR, Green 41. Woo R, Le D, Krummel TM, Albanese C. Robot-assisted pediatric PS. Vascular applications of telepresence surgery: initial feasibility surgery. Am J Surg. 2004;188(4A Suppl):27S–37S. studies in swine. J Vasc Surg. 1996;23(2):281–7. 42. Shah A, Schipper E.  Robot-assisted laparoscopy. In: Nezhat C, 45. Nezhat C, Nezhat FR, Nezhat C. Nezhat’s video-assisted and Nezhat F, Nezhat C, editors. Nezhat’s video-assisted and robotic-­ robotic-assisted laparoscopy and hysteroscopy. Cambridge, UK: assisted laparoscopy and hysteroscopy. Cambridge: Cambridge Cambridge University Press. 2013. University Press; 2013.

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The Origins of Minimally Invasive and Robotic Surgery and Their Impact on Surgical Practice: A Sociological, Technological History Arnold Byer

2.1

Preface

Perhaps it should be a maxim that the number of histories written about any subject is directly proportional to its popular impact. Much has been written about these new technologies. My personal surgical life spans more than a half century. I have seen in that period the origins of every new surgical specialty, operation, and technique arrive, develop, get accepted, and change the lives of surgeons and our patients, and with very few exceptions, always for the better. All, it seemed to me, were either new or improved operations and necessary advanced diagnostic tools. The incisions were large, and Morphine and Demerol were king. It took a long time to get better, but the results were good, and we were able to treat problems that we could not treat before or at least treat what we could do before, better. But then in the late 1980s, something changed. At first there were only whispers about operating without “Can’t see it, can’t do it.” Was that really possible? Probably not, even if the gynecologists had been doing it for years, but all of a sudden laparoscopic surgery for general surgery was here, and forward-looking surgical services like mine were buying different instruments, and I initiated a recruitment for an advanced laparoscopic surgeon to head up a minimally invasive section. The ZEUS and da Vinci Surgical Robots were just around the corner and surgery would become more than just learning a new operation, it would be about relearning how to operate. I had better stop here as this is a chapter, not a personal history. Minimally invasive surgery/robotic surgery evolved so rapidly with many personalities and procedures that historical events often blur. If there are errors or admissions in this work, they are mine alone.

A. Byer (*) Rutgers New Jersey Medical School, Newark, NJ, USA

2.2

Past Is Prologue

Survival of the human race required and still requires work. Improving society’s existence requires work. It has been and continues to be a human desire and in more modern times, often a necessity, to shift the burden to someone else or something else. Life and times became more complex, in order for their work to create something better, more beautiful, more enjoyable, more efficient, and more useful became desirable, as well as inevitable. “I believe man will not only endure; he will prevail” said William Faulkner on accepting his Nobel Prize. That was his assessment for his age. History has, however, shown us that every age develops its own way of prevailing. The way society envisions shifting the burden is sociology. The tools society develops and uses is technology. Even in the beginning, survival meant not only having the bare necessities of life, it also required the most basic healing from injuries and illness with each age providing somewhat improved methods. Invasive and noninvasive remedies were in a very general sense available, and if not were invented, applied, and used probably from prehistory and certainly from recorded history until the present. It would be inevitable then that the development and acquisition of minimally invasive surgery/robotic surgery follow a long, often uninterrupted, historical trek in order to arrive at an easier, better life, and in our surgical world, better patient care, advanced surgeons’ abilities, and considerable societal benefits. What follows will be a voyage of discovery, a realization of our times and a glimpse of the future.

2.3

Pre-history

Anthropology traces the development of early societies and their primitive technology. From a Paleolithic hunter/gatherer/forager, into the Mesolithic toolmakers and more recent Neolithic, where such devices as bows, fishing implements, and canoes, marked a clear, progressive advance in transferring some, if not all the, drudgery necessary to survive and

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_2

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improve society’s existence. Picture a society without agriculture, domestication, or division of labor, which obliged direct procurement of edible plants and animals from the wild [1]. Imagine the achievement involved in the plow, then the harness, for a man to pull the plow and finally the domestication of animals to pull the plow. Thus, an enormous step forward in the development of agricultural societies occurred when horticulture (what is available) became agriculture with farming implements and division of labor. Clearly the plow is not our anthropomorphic idea of a robot although what it does is not so far removed. Perhaps we can avoid confusion if we arrive at an understanding of or define the word robot and what we mean by one now. A prominent Czech Playwright, Karel Capeck’s play “Rossum’s Universal Robots” in 1921 presented a robot in clanking humanoid form [2]. The word robot means compulsory labor or surf labor in Czech, and it was actually his brother Joseph who coined the word. Robot replaced the previously used Automaton. It follows that each age would find its own definition and there would be several. My preference considering where we are now, and as a practical matter, is clearly defined by Steadman’s Medical Dictionary; an electro-­mechanical machine guided by computer or electronic programming [3].

2.4

Antiquity

The ancient’s developed their Automata, which were really toys or puppets meant for amusement. A classic example is the outside is moved from within like a moving figurine, a sigillario or puppet movement [4]. Others with self-moving mechanisms used gravity and shifting sand [5]. There are many records that have documented that human- or animal-­ like statues or statuettes were constructed, but none with an apparent work substitution property. Hero (N) of Alexandria (Egypt), considered the greatest experimenter of antiquity, published a description of a steam powered engine called an Aeolipile, but we do not know how or when, or if, it was constructed or used [6]. It seems reasonable to believe it existed considering the advanced, complex, and still imperfectly understood construction accomplishments of the great civilizations of antiquity. Greece, Rome, Crete, Iraq, China were capable of experimenting and producing automatic or semiautomatic devices. Unfortunately, the ancients left no instructions, so inferring from the end products of their civilizations could be misleading. The next major figure, Al Jazari of Iraq, who we know actually built Automata, did not appear until the twelfth century. Called the engineering genius of the Islamic world, he designed a number of Automata, an interesting one being the first programmable robot, a boat with four musicians playing, which was brought out for drinking parties [7]. No account of premodern

mechanical objects would be complete without reference to Leonardo da Vinci whose name would be adopted for the surgical robot in wide use today. It is known that he invented or designed numerous mechanical devices. His Ornithopter, a wing-flapping machine intended for flight, and a mechanical knight, although designed were probably never built [8]. After the early sixteenth century, there’s not a single reference of a mechanical device seemingly independent until the early 1800s. From the earliest beginnings of civilizations, the need to work continued unabated, albeit with greater efficiency characterized by diverse systems of division of labor. In many societies, labor that did not involve hunting, conflict, or social survival planning was relegated to women. Accepting women’s abilities and equality is an issue that resonates to the present day. It remains one of the greatest human misfortunes and contradictions that the rise of civilizations introduced slavery. The earliest evidence of slavery occurred about 10,000 years ago in Mesopotamia, present-day Iraq. The word derives from Slav as the Germans supplied slave markets with captured Slavs. It is a cruel irony as we discuss robots that Aristotle referred to slaves as human instruments. One wonders if this brutal, inhuman practice was a factor in delaying the Industrial Revolution. For a more detailed account of slavery, the reader is referred to a Brief History of Slavery [9].

2.5

The Industrial Revolution

The Industrial Revolution (1750–1900s) ushered in the age of mechanization in industry. It had, however, relatively little effect on medicine or surgery. True, new treatments, operations, and nursing-care were introduced. In addition, new implements, needles, syringes, and lenses were developed and produced and put in use. There were, however, no significant mechanical devices and no cross-fertilization between industrial mechanization (and later industrial robots) and medicine, particularly surgery. The Civil War similarly contributed little to nil in the way of improved devices. The economic changes, societal attitudes, and especially abolition that were a result of the Civil War did not appear to draw medicine and the Industrial Revolution together. It would be said later that robots replaced slaves in performing repetitive tasks. If the surgeons appeared disinterested and were dismissive of new technologies, it was probably because the mindset and thrust of the Industrial Revolution had so completely bypassed medicine. The inventions of the great minds of the second half of the nineteenth century, like Alexander Graham Bell and Thomas Alva Edison, were directed toward large commercial markets, in fact not so different from the intentions and interests of more recent inventors and entrepreneurs. There is a note-

2  The Origins of Minimally Invasive and Robotic Surgery and Their Impact on Surgical Practice: A Sociological, Technological…

worthy exception, Bell did invent a metal detector that, while functional in the laboratory, did not work when used to locate the bullet lodged in the body of President James Garfield probably, because the President lay on an iron bed. The Industrial Revolution appeared to consist of individual discoveries, not a continuum of cooperative efforts. One technology did not necessarily lead to another and serendipity played its part as it usually does. In actual practice, technologies need to be passed on from one generation (not a human one) to another in order to maximize development. As early as 1750, British engineers had developed a shared vocabulary, an essential tool in order to objectify the physical world [10]. In its final stages, the Industrial Revolution saw not only the emergence of new knowledge but also the ability to better use it. Finally, and of special pertinence to minimally invasive surgery/robotic surgery by the end of the nineteenth century, we begin to see an interest by inventors and engineers in remote control devices. The field of radio dynamics with wireless control of mechanisms, such as the torpedo boats and dogs developed by Nikola Tesla, John Hammond, Jr., and Benjamin Miessner, followed in the footsteps of Marconi and Edison. From this point on, the necessity for, and an interest in, minimally invasive/robotic surgery would unfold rapidly. The Industrial Revolution, up until 1900, and its contribution to the future development of minimally invasive/robotic surgery would be chiefly the province of engineers/inventors with only the occasional physician/inventor. Entering the twentieth century, it would be the courageous pioneer physician/inventors who dominated invention, development, and innovation, and applied them to real patients. We will not encounter the engineers/inventors again until the beginning of the era of surgical robotics.

2.6

The Endoscope as a Basic Tool

In fact, there is nothing new about minimally invasive (surgery) techniques. The Egyptians, in particular, with the exception of skull trephining, were forced into alternative methods because of their medical philosophy. They divided medical care into three categories; credible, treatable with difficulty, not treatable [11]. Later, dynasties discovered simple methods to inspect the natural orifices of the human body. Avicenna (980–1037), the great physician of the Islamic World is credited for his use of reflected light, a basic requirement for peering into dark cavities. In 1806, Philipp Bozzini, a German gynecologist, considered the “father of modern endoscopy” constructed his Lichtleiter (light conductor) and used it on patients. His first example was a device that used existing lens technology and reflected back light from a candle [12]. As has been the fate of many medical pioneers, he was ridiculed when he presented the Lichtleiter and discussed its value to a Vienna

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physician audience. While gas-light was available in the nineteenth century, it was impractical for endoscopic use because it generated heat and soot. Edison’s incandescent light bulb patented in 1880 was constantly improved and modified for various uses. After the turn of the century, the miniaturized mignon lamp was produced, which gave off less heat and, unlike more primitive light sources, was sootless. This was a major advance, as from then on, treatment would be influenced by clear, unobstructed sight, which facilitated inspection of all body cavities, upper and lower. The importance of the cold light source cannot be overemphasized, as it would be an essential tool in the development of minimally invasive surgery. There are two other physician pioneers of the late 1800s that must be introduced because their contributions were crucial elements for laparoendoscopy. The first is Carlo Forlanini who created a Pneumothorax, introducing for the first time the precursor of insufflation techniques. These would be further developed and refined by George Kelling and others. The second is Maximilian Nitze, whose legacies are his contributions to microscopic optics technology, creating the wide-angle lens, which vastly improved the fields of vision of the endoscope [13]. Subsequent advances in fiber optics, photography, and videography would play a major part in surgeons’ acceptance of the less invasive and eventually minimally invasive technologies.

2.7

 he Surgeons Claim Minimally T Invasive Surgery

The engineers/inventors of the past who mainly worked alone gave way in the twentieth century to the clinicians/ innovators, who unburdened by a market mentality, were principally interested in adapting new techniques to patient care, and were communicating their work, results, and problems to their colleagues.

2.8

 he MediCal Meeting and The New T Technology

There is no doubt that with the basic tools available and the state of medicine and surgery in the 1900s the same or similar idea, clinical or experimental approach, would occur to more than one individual at about the same time. I would therefore advise readers not to be too rigid in deciding who was first, because subsequent events and documentation are likely to cause reevaluations of whose operation/contribution influenced the coming revolution most. As promised, I will try to be as faithful to historical chronology and medical hagiology as possible. Dimitri Ott in 1901 was the first to visualize the female pelvic organs with a headlamp and

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s­peculum via culdoscopy [14]. One year later, George Kelling began laparoendoscopy in dogs with the Nitze endoscope. He was curious about the effects of air in a virgin abdomen and named the instrument a Coelioskope. [15] Later he used this technique on live patients in his private practice. It wasn’t until 1911 that the next great pioneer/clinician, Hans Christian Jacobaeus, a Swedish internist, reported in the Munchener Medizinische Wokenschrift performing laparoendoscopy in humans in 1910, albeit limited to the removal of ascites [15]. He coined the term laparoscopy, originally Laparothorakoscopie. American readers will be happy to know that America’s first laparoscopist was not far behind. Bertram M. Bernheim at Johns Hopkins reported his series of laparoscopic operations, coining the term Organoscopy. [16] B. H. Orndoff and O. Steiner and two other Americans became involved in laparoscopic development calling their own scopes with different names. In the current surgical era since the 1990s, we have seen numerous different terms for minimally invasive surgery used interchangeably. The early pioneers named their own operations as follows: • • • • • •

Ott-Ventroscopy, 1901. Kelling-Coelioscopy, 1901. Jacobaeus-Laparoscopy, 1910. Berhneim-Organoscopy, 1911. Orndoff-Peritoneoscopy, 1920. Steiner-Abdominoscopy, 1924.

With the exception of Janos Veress and his spring-loaded insufflation needle (still used today) and Richard Zollikofer’s introduction of C02 instead of filtered air or nitrogen, the intervening years up to the appearance of Kurt Semm, saw no new major clinical developments or indications. Probably the years preceding, during and immediately after World War II, may have delayed the advancement of minimally invasive surgery as medical needs and attention were to be overwhelmed addressing the needs of calamitous world events and their massive numbers of wartime civilian and military casualties.

2.9

The Revolution

The “Magician of Kiel” Kurt Semm, a German gynecologist regularly performed laparoscopic procedures in the 1960s and 1970s. That he did so was not only pioneering, it was also courageous because the German medical establishment had decreed a ban on these “dangerous operations.” It was in great measure his persistent advocacy of the new surgery that ultimately defeated the ban. His troubles however were not ended. When he performed the first laparoscopic appendec-

tomy in 1981, his local colleagues accused him of unethical conduct, and he was threatened with suspension of his hospital privileges. His attempt at publication of this landmark case was rejected as unethical. He was evidently not the one to yield and the case report was finally published in 1983 [17, 18]. In addition to his leading role in laparoscopic surgery, his remarkable contributions innovations and new techniques in the new discipline clearly justify his designation as the father of laparoscopic and advanced laparoscopic surgery. To list even a few citations referencing his work, and him as a surgical figure/teacher, is beyond the scope of this chapter. The interested student of minimally invasive surgery will encounter no difficulty in finding them. The development of fiber optics in the 1950s, new insufflation techniques, and thermo-coagulation devices, influenced more surgeons to consider and then adopt the new surgery. Karl Storz, engineer, entrepreneur, and visionary par excellence was on hand to design and make available to the surgical community the instruments and devices necessary for the minimally invasive surgery revolution that was evolving. Other instrument and device manufacturers would not be far behind. When a group of doctors have something new or old to report, what do they do? First, they have a meeting. In fact, the first International Symposium of Gynecological Endoscopists was held in Palermo, Italy, in 1964. It was well attended, including some of the future leading lights of the minimally invasive surgery movement. The second thing they do is apply it in their practices and academic activities and report it. The third thing they do if so inclined is to write a book. The first text, La Celioscopia in Ginecologia by V. E. Albano and E. Cittadini appeared in 1962 in Italian, followed in 1967 by Laparoscopy in Gynecology in English by PC Steptoe. Considering that laparoscopic cholecystectomy was such a frequently performed operation and today essentially the minimally invasive bread and butter for general surgeons, it should not be surprising that it not only fired up the revolution but sustained it. Eric Muhe, a German surgeon, had been credited with performing the first laparoscopic cholecystectomy in 1985. However, as O. D. Lukichev reported in the Russian literature in 1983, which had very limited circulation, his “First” had not been properly recognized [19]. While it was clear that laparoscopic cholecystectomy could be performed, in order for general acceptance by surgeons and to be really widespread, it had to be proven safe. Documentation of its safety was provided by Raoul Palmer, a French surgeon in 1974 [20]. He also, as early as 1944, stressed monitoring of intra-abdominal pressure and understood the potential of laparoscopy as a diagnostic tool. It is generally believed by surgical historians that it was P. Mouret in 1987 who attributed the worldwide laparoscopic revolution, because he performed cholecystectomy routinely with modern methods and techniques. Although many general surgeons considered 1987 as the cardinal year, it seems

2  The Origins of Minimally Invasive and Robotic Surgery and Their Impact on Surgical Practice: A Sociological, Technological…

equally important to consider that the revolution arrived in America when J. Perisset showed his laparoscopic cholecystectomy video to surgeons at a meeting of the Society of the American Gastrointestinal Endoscopic Surgeons in 1989. In gynecology, the important year was 1981 when J. C. Tarasconi reported his laparoscopic salpingectomy [21]. Despite the acceptance of laparoscopic surgery for general surgery and other broad use by surgeons who were willing to learn new techniques, it was the gynecologist not general surgeons who performed the greater number of minimally invasive surgeries well into the 1990s. Unfortunately, an incomprehensible prejudice by some surgeons, against minimally invasive surgery has, sadly, persisted until the present time. In addition, cost effectiveness, a euphemism for expensive, was and is today an administrative excuse to seek to deny patients the serious advantages of minimally invasive surgery. Ironically, when robotic surgery presented even more advantages, those who sought to deny laparoscopic surgery then, based on cost, now became its advocates and attacked robotic surgery on the same flimsy grounds. We will see more about cost-effectiveness later in the chapter. As we have seen, there have been and are many terms for minimally invasive surgery used interchangeably varying from endoscopy to laparoscopy and combinations of the two, many of which should be self-explanatory. The shorter common term laparoscopy will appear from now on. Give or take a few years, it took a century from the recognizable beginning until minimally invasive surgery became an accepted standard of care worldwide. Until the organization of the major minimally invasive surgical societies, virtually all the important contributions were individual accomplishments. In the next section on robotic surgery, the timeframes were shorter, and the efforts and contributions tended to be more cooperative and complimentary.

2.10 The Quest for a Surgical Robot For robots in surgery, we return to an era dominated by engineer/inventors and begin as one would imagine with inventions for industrial applications. George Devol, Jr., a very prolific inventor, in 1954 applied for a patent of the first digitally operated programmable robotic arm. He called it the Unimate, which became the foundation for the modern robotics industry. In 1961, shortly after the patent was granted, it was put in use on a General Motors assembly line (Wikipedia). John McCarthy, a Dartmouth professor coined the term, “Artificial Intelligence” and after joining the Stanford University faculty was instrumental in forming the Stanford Artificial Intelligence Lab (SAIL), a group that made numerous important contributions to this field. Victor Sheinman, a mechanical engineering student working in SAIL, in 1969 created the Stanford Arm, a pro-

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grammable robotic arm and the first all-electric six-access articulated arm [22]. The use of industrial robots rapidly expanded particularly for repetitive and dangerous tasks and stressed functional, rather than humanoid designs or science fiction, creations. Unquestionably, the concept of function must have had a significant influence on scientists and physicians working at the NASA—Ames Research Center. Their earliest concepts wed virtual reality and telepresence. They took these preliminary ideas to the Stanford Research Institute (SRI) later in the 1980s [23]. Rick Satava played an important role in the complex activities conducted by SRI and DARPA (Defense Advance Research Projects Agency). His article on personal chronicles and its references must be read to fully appreciate that period of discovery so crucial to the development of the surgical robotics we use today [23]. By 1980, DARPA was funding several research sites: SRI, MIT, IBM, JPL, NASA to develop telepresence surgical systems featuring remote articulating arms and stereoscopic imaging, efforts unfortunately not fully developed, but nevertheless of great value to the field of surgical robotics [23]. In 1990, Yulun Wang founded Computer Motion and with DARPA funds developed AESOP (Automated Endoscopic System for Optimal Positioning) in 1993, the first robotic device approved by the FDA for use in humans [24]. AESOP is a voice-activated modified robotic arm holding a laparoscopic camera. In the same year, ZEUS appeared. It is a combination of one AESOP arm and two robotic arms whose manipulations are controlled by a surgeon at a surgical workstation, “a surgical robot.” In 1997, Himpens and Cardiere used ZEUS to perform the first robotic surgical cholecystectomy [25], followed in 1998 by the first robot-assisted CABG by H. Reichenspurner [26]. On September 7, 2001, Marescaux, LeRoy, and Gagner and Associates made history when ZEUS was used for the Lindbergh Operation, the first transatlantic robot-assisted telesurgery, a cholecystectomy performed in New York City on a patient in Strasbourg, France, using a special ATM (Asynchronous Transfer Mode) terrestrial fiber optic cable without significant lag time [27].

2.11 Arrival of Surgical Robots It would not take 100 years for robotic surgery to arrive; in fact, it took about 20. All the required tools and systems were already successfully in wide use. Laparoscopy had its limitations, and there were still ergonomics (work) and other issues that had to be addressed. It became a question of how to transfer the work and complex tasks to a mechanical device. Alert engineering and surgical minds were already working on the answer. ZEUS was here, but was it alone? In 1995, F. Moll, R. Younga, and J. Freund, two physicians and one engineer formed the company and purchased the telepres-

A. Byer

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ence rights from SRI and called their company Intuitive Surgical Incorporated. Their device was the da Vinci Surgical System. In 2000, da Vinci received FDA approval for general surgery, urology, gynecology, and several thoracic interventions. Since then other procedures have been approved so that currently there are virtually no limitations to its application in the surgical specialties. The original da Vinci has undergone several upgrades adding an additional arm and other improvements and recently tying in with a procedure-­ directed simulator. The da Vinci, while functional and in wide use, is not the ultimate surgical robot, which when developed probably will be a complex informatics system capable of performing a wide variety of operations independently and perfectly. In 2003, Intuitive bought Computer Motion and ended the short reign of ZEUS. But why a surgical robot? Traditional surgery benefited but little from the Industrial Revolution. It was anesthesia, pharmacology, and physician intellect and appreciation of industrial robotics that brought us to a point with the devices of industrial mechanics cried out for surgical applications. The first step was laparoscopy, the second AESOP. As the information age exploded, it would only be a question of time for laparoscopy, a two-dimension system, to shift to surgical robotics, a three-dimensional system. Furthermore, the evolution and surgical technology coincided with a time of rapid revolutionary change in which surgeons would need to adapt and learn at a rate previously unseen [28]. Being an agent of change or rapidly adapting to change has become the hallmark of the gifted surgeon [29]. For further insights along these lines, see Robotics in the OR, the History [30].

2.12 The Impact on Surgical Practice The idea that robotic surgery may be a passing fancy has been and continues to be suggested but is no longer valid judging by the overwhelming acceptance by urology and gynecology, as well as having made major inroads in virtually all the other surgical specialties [31]. Within just a short time, the multidisciplinary patterns of practice were evident [32]. The impact of any new (surgical) technology will depend on what it brings to the table, in this case the operating room, in the way of additional, significant benefits. It is necessary that robotic surgery defends its position by comparison with preexisting/companion technologies. The case for or against open surgery at this writing has already been made so the real comparison is with Laparoscopic Surgery. The impact of robotic surgery or any new technology will also need to review: advantages and disadvantages, quality, quantity, education/training, credentialing, and research. The issue of cost effectiveness has never concerned surgeons and administrators to the extent that it does today in a climate of fiscal responsibilities and difficulties. Cost effectiveness, therefore, will be briefly, if not conclusively, examined later on.

2.13 Advantages of the Technology The principal advantages are 3D vision, motion scaling, tremor filtration, micro-articulation motion, and more precise suturing [31–33]. With certain conditions, it may shorten the learning curve for minimally invasive oncology operations [34].

2.14 Advantages to Operator Robotic surgery overcomes the limitations of laparoscopic surgery, decreases the overall invasiveness of operations, gives access to restricted anatomic regions, and may increase minimally invasive surgery among unskilled laparoscopic surgeons [35]. It also has expanded the repertoire of experienced surgeons for advanced, complex difficult access operations [36–38].

2.15 A  dvantages Over Laparoscopic Surgery in General An early and very comprehensive study comparing robotic surgery and laparoscopic surgery for all abdominal surgeries consisted of a systematic review of the literature from four major databases. The results were submitted to meta-­analysis whenever possible. Of the 2869 potential articles published between 2002 and 2009, 164 studies were selected for full text review with 31 that met the six inclusion criteria involving 2166 patients. Of the 31, six were randomized clinical trials and 25 were observational studies comparing nine operations with sample sizes varying from 10 to 37 patients. These advantages remain evident today. The authors express concern that in general the studies included were limited in risk, scope, and not of great quality. This is not a surprising finding for a new technology with very early limited experience studies included. Nevertheless, the authors concluded that the potential advantages of the da Vinci Surgical System over conventional laparoscopic surgery were greater precision, lower error rates, reduced bleeding, shorter hospital stays, more rapid recovery, reduced patient pain, and ergonomic advantages for the surgeon [39].

2.16 Disadvantages The comprehensive study listed above also noted the potential disadvantages of longer operating times and increased cost. Both issues that had preoccupied other observers and will be addressed later in the chapter. The principal disadvantage that has been mentioned over and over again and that affects all the modern minimally invasive operative innova-

2  The Origins of Minimally Invasive and Robotic Surgery and Their Impact on Surgical Practice: A Sociological, Technological…

tions is a loss of haptic (force and tactile) feedback and loss of tridimensional view, which may prove to be of questionable importance. At any rate, although there are many good minds and much research at work on this problem and some device development, there is, at this writing, no clear solution [40].

2.17 Quality Urology The Vattikuti Institute at the Henry Ford Hospital has published the results of their scorecard on robotic radical prostatectomy. In almost 5000 cases compared to open surgery and in six important categories, robotic surgery was determined to be superior. These were cancer removal, continence at 6 months, and potency at 12 months, safety, pain, and blood loss. A perfect score would be 600. Open surgery scored 406 (67%), robotic surgery scored 550 (92%) [41].

2.18 Quality Gynecology Gaia and Associates reviewed eight comparative studies of robotic-assisted hysterectomy for endometrial cancer compared with traditional laparoscopy and laparotomy approaches. The clinical outcomes for laparoscopic and robotic cases were similar; shorter length of stay, less blood loss, and decreased pain scores. The longer operative times of the robotic surgery operations clearly need to be studied and corrected if widespread [42]. Two of the previous studies, one comparing robotic radical hysterectomy and open hysterectomy [43] and the other with laparoscopic hysterectomy [44], report just the opposite that robotic surgery cases take less time. This author’s information obtained in personal communication from experienced, skilled, high-volume gynecologic–oncologic surgeons using robotic surgery is that operative times are either equal or reduced.

2.19 Quantity At the end of 2018, with over 4000 da Vinci’s worldwide, the number of robotic operations increased from 25,000 in 2005 to 3000,000 in 2018, a significant testimonial to its acceptance and utility (the numbers cited were taken from Intuitive Surgical Investors Profile).

2.20 Surgical Education/Training Unlike traditional surgery, which is supervised trial and error on real patients, robotic surgery offers superior methods of training that are currently in use with expanded modalities in

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the works [45, 46]. Chiefly among these are simulation techniques, haptic feedback, virtual reality, image guidance, and training with telepresence and telementoring [47]. These training modalities allow education training programs to finally have an objective assessment of surgical skills, which will ultimately lead to uniformity of results [48]. Paradigms of education/training we have wished for are now available. With the addition of simulators, we can have a structured assessment of technical skills and can accurately measure hand psychomotor skills of residents training on a simulator [49]. It is believed that with these paradigms we will see residents performing better in the OR, take less time operating, and make fewer errors. Other tangible benefits will produce more homogeneous outcomes, less variability of surgeons’ performance, as well as give us an objective demonstration of competence. As early as 2004, it was obvious to many that the practice patterns in the United States and Canada had shifted so that, in urology, the first bastion of robotic surgery, it was included in a large number of education/training programs and that trainees anticipated including robotic surgery in their practices [50]. It would be difficult today to find academic programs in urology or gynecology that were not performing robotic surgery and training residents in robotic surgery. In other surgical disciplines, the presence of robotic surgery may not be as dominant, but it is present particularly in treating cancer and gastroenterology problems. In 2008, the SAGES—MIRA Consensus Group published their Consensus Document (position paper) on robotic surgery recommending protocols and guidelines in four important areas: (1) Training and credentialing (the author was co-chair of this committee), (2) Clinical applications of robots in surgery, (3) Risks of surgery and a Cost—Benefit Analysis, and (4) Research [51]. There is reason to believe they have been helpful (personal experience and information from highly qualified surgeons).

2.21 Cost Surgery today lives in a delicate balance of cost control and expensive new technology from a purely professional point of view. The costs of new treatment over technology are initially more than the traditional methods, it is not a sufficient reason to exclude it, nor, on the other hand, is it realistic not to factor in the real cost and savings. Minimally invasive surgery and robotic surgery in addition to the verified patient and societal benefits may not necessarily involve increased costs. Modern hospital and administration working with a skilled, highly competent, efficient surgical staff can avoid increased costs (author’s considerable experience in just such an environment). An article from the Harvard Medical School published in the New England Journal of Medicine in 2010 reviewed all cost studies on robotic surgery published since 2005 and con-

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cluded that robotic surgery adds a cost of $1600 per case [52]. A critique of the article published later in the same journal argued that the article focused only on added costs and did not discuss the key attributes of robotic surgery. The critics also believed the authors overlooked the great cost savings to society and repeated the assumptions leveled once of laparoscopic surgery or any new technology [53–55]. The author believes it is fair to say that robotic surgery cannot and will not be judged on cost all alone. At this writing, there is no commercial competitor in the market to the da Vinci system.

2.22 Research It would be beyond the scope of this chapter to provide a comprehensive list of the research and surgical robotics underway worldwide. It is pertinent simply to report that it is widespread.

2.23 The Societies A revolution had taken place and following a revolution, society requires a way that allows its members, usually a subgroup of people, to formulate the wishes and needs they cannot fulfill alone. The founders of societies are those with recognized extraordinary abilities and qualities. They are usually in advance of their peers and are individuals, who in the words of Winston Churchill, “Look ahead; it is always wise to look ahead, but difficult to look further than you can see”; sounds clever, but like Isaac Newton who said that he, “Could see further because he stood on the shoulders of giants,” the minimally invasive society’s founders to be mentioned could see further. They saw the need to provide a forum where surgeons might interchange ideas and techniques and find out who is doing what, provide for training, score academic updates, and encourage research. While only a single founder will be listed here, it is important to understand that the cofounders were many and their work and contributions outstanding. They know who they are, and it is sincerely desired that they not be offended, by not having their names mentioned here. Following are the major American and one European minimally invasive surgery and robotic surgery societies. The list is, with respect, limited to societies in the forefront of MIS/RS that have a historical and international significance and are now multidisciplinarian. A list of all the societies is beyond the scope of this chapter and the membership numbers are approximate as exact numbers were not in all cases available to the author. SAGES (Society of American Gastrointestinal and Endoscopic Surgeons) founded 1981 by Gerald Marks and Associates. The initial interest and impetus were to solidify established endoscopy as an essential tool for surgeons. It

quickly became the society for minimally invasive surgery. It is now multidisciplinary encompassing all aspects of minimally invasive surgery and has about 6000 members and its own journal, Surgical Endoscopy. SLS (Society of Laparoscopic Endoscopic Surgeons). Recently renamed, but continues to use this designation, founded in 1991 by Paul Wetter and Associates. Initially aimed mainly at gynecology, it is now multidisciplinary and for the past 12 years has included sessions in robotic surgery. It has about 3000 members and its own journal, Journal of the Society of Laparoendoscopic Surgeons. EAES (European Association for Endoscopic Surgery), founded in 1991 by Hans Troidl and Associates. Mainly general surgeons, but now multidisciplinary, it has about 3000 members and uses Surgical Endoscopy as its journal. MIRA (Minimally Invasive Robotic Association) was conceived in 2004 by Pier Cristoforo Giulianotti and Associates. It was shortly thereafter founded by him and Associates. It has been multidisciplinary since inception and includes non-physicians in fields allied with robotics. It had about 350 members and its own journal: The International Journal of Medical Robotics and Computer-Assisted Surgery. This society fused with the Society of Robotic Surgery in 2012. SRS (Society of Robotic Surgery) was founded in 2006 by Vipul Patel and Associates. It is multidisciplinary, has about 350 members and its own journal, The Journal of Robotic Surgery. CRSA (Clinical Robotic Surgical Association) was founded in 2009 by Pier Cristoforo Giulianotti and Associates. Its main interests are in General Surgery and allied specialties. It has about 350 members. No journal is listed on their website.

2.24 Future There are many attributes that had been suggested to improve surgical robotics that have not already been mentioned in this text. To name just a few, decrease in size, automatic instrument change and supply dispensers, voice-activated or otherwise completely programmable and direct image guided interventions or in any number of ways that appeal to the science fiction in all of us that may not be science fiction at all. The ultimate surgical robot as previously stated will be a complex informatics system capable of performing a wide variety of operations perfectly and independently.

2.25 FINE It is necessary and important that robotic surgery is so widely discussed, compared, diminished, dismissed, advocated, or somewhere in between. There can be little doubt that the da

2  The Origins of Minimally Invasive and Robotic Surgery and Their Impact on Surgical Practice: A Sociological, Technological…

Vinci Surgical System has had a dramatic impact on surgical therapy across disciplines with robotic surgery being performed in continually increasing numbers in virtually all the surgical specialties. With Transoral (TORS) and Single Port Entry (SPE) approaches, new indications are constantly being discovered. The widespread acceptance of robotic surgery by the minimally invasive community and their societies is nearing completion. The wholesale and early conversion of the well-established minimally invasive surgery communities, gynecology and urology, and now the acceptance by specialties who never considered that minimally invasive techniques were applicable to their interventions are certainly a sign of the times. The large number of publications, approximately 15,000 peer reviewed publications, the multiple journals in print, and numerous websites in such a short timeframe and their increasing quality is a testimonial to the acceptance by the clinical and academic communities of a technology that is still developing. Unquestionably, the acceptance and participation by the allied engineering and scientific communities is invaluable and a practical benefit as we anticipate improvements leading to the ultimate surgical robot. The enormous interest of these nonmedical communities represents a unique event in the history of surgery. Hospitals and universities worldwide, notwithstanding financial concerns, have recognized that they need to not only offer robotic surgery to their patients but be actively involved in its teaching, research, and technical evolution. The interest demonstrated by patients is substantial and directly related to the clear patient-care benefits, which were recognized as early as 2004 in the scientific literature [52] and initially in 2011 in the popular press [53]. Additional references are too numerous to mention. Although nothing about societal benefits has been written in the scientific literature, the extrapolation from patient care benefits should not be difficult. While there are already many undeniable facts about the benefits of robotic surgery, it is important to remember that all that has been said or written has been about the da Vinci Surgical System, not future and not the ultimate robot. This short history, I suggest, is but a prologue, not a Finis.

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8. I Roboti di Leonardo (da Vinci’s Robots) Taddei, Mario Pub. 9. A Brief History of Slavery, New Internationalist Issues 337; August 2001. 10. Jacob MC. Scientific culture and the making of the industrial west: Oxford University Press; 1997. 11. Edwin Smith Papyrus (1700—1600 BC Egypt). 12. Sperati G.  Philipp Bozzini and the origin of the endoscope. Acta Otorhinolaringol Ital. 2002 Feb;22(1):42–6. 13. Nezhat C. Nezhat’s history of endoscopy, let there be light: a historical analysis of endoscopy’s ascension since antiquity. Appleton and Lang: Norwalk—Pub; 2005. 14. Ott DO. Ventroscopic illumination of the abdominal cavity in pregnancy. Z Akush Zbenskikl Boleznei. 1901;15:7–8. 15. Litynski GS.  The early attempts spotlighting George Kelling and Hans Christian Jacobaeus. JSLS. 1997;1(1):83–5. 16. Bernheim BH Organoscopy, cystoscopy of the abdominal cavity, Ann Surg 1911 V 53(6); 764—767. 17. Semm K.  Endoscopic appendectomy. Endoscopy. 1983;15(2): 59–64. 18. Litynski GS.  Kurt Semm and the fight against skepticism: endoscopic appendectomy and Semm’s impact on the laparoscopic revolution. JSLS. 1998;2(3):309–13. 19. Lukichev OD, Filimonov MI, Zybin IM. A method of laparoscopic cholecystectomy. Kirurgia (Mosk). 1983;8:125–7. 20. Palmer R. Safety in laparoscopy. J Reprod Med. 1974;13:1): 1–5. 21. Tarasconi JC.  Endoscopic salpingectomy. J Reprod Med. 1981;26(10):541–5. 22. WWW Computer History/Timeline. 23. Satava RM. The early chronicles: a personal historical perspective, E Publication: Web Surg.com. 2006;6(10). 24. Wang Y, Sakier J.  Robotically enhanced surgery from concept to development. Surg Endosc. 1994;8:63–6. 25. Himpins J, Leman J, Cardiere GB. Telesurgical laparoscopic cholecystectomy. Surg Endosc. 1998;12:1091–3. 26. Reichenspurner H, Boehm DH, Gulbins H, et  al. Robotically assisted endoscopic coronary bypass procedures without cardiopulmonary bypass. J Thorax Cardiovasc Surg. 1999;118:960–1. 27. Marescaux J, LeRoy J, Gagner M, et al. Transatlantic robot assisted telesurgery. Nature. 2001;413(6854):379–80. 28. Belsley S, Byer A, Ballantyne GH. MIRA and the future of surgical robotics. Int J Med Rob Comp Assit Surg. 2006;2:98–103. 29. Satava RM. Advanced technologies and the future of medicine and surgery. Yonsei Med J. 2008;59(6):873–8. 30. Ewing DR, Pigazzi A, Wang Y, Ballantyne GH. Robots in the OR; the history, seminars, and laparoscopic. Surg. 2004;11(2):63–71. 31. Warren J, Da Silva M, Caumartin Y, Luk PPW.  Robotic renal surgery; the future or a passing curiosity? Can Yurol Assoc J. 2009;3(3):231–40. 32. Munver R, Jayaratna I, Disick GI, Ballantyne GH, Jabush JH, Byer A, Sawczuk I.  Multidisciplinary Patterns of Robotic Technology; The Hackensack University Medical Center Experience: Abstract and Presentation at Third MIRA International Congress, 2008. 33. Marescaux J, Rubino F.  The ZEUS robotic system: experimental and clinical applications. Surg Clin North Am. 2003;83(6):1305– 15. Vii–Viii. 34. Prasad SM, Prasad SN, Maniar HS, et  al. Surgical robotics: impact of motion scaling on task performance. J Am Coll Surg. 2004;199(6):863–8. 35. Moorthy K, Munzy DAM, et  al. Dexterity enhancement with robotic surgery. Surg Endosc. 2004;18(5):790–5. E Pub 2004 April 6th. 36. Belsley S, Byer A, Ballantyne GH. Oncologic telerobotic surgery. Oncology. 2006;21(4):22–5. 37. Ballantyne GH.  Robotic surgery, telerobotic surgery, telepres ence and telementoring. Review of the early clinical results. Surg Endosc. 2002;16(10):1389–94. E Pub 2002 July 29.

20 38. VanHaasteren G.  Pediatric robotic surgery: early assessment. Pediatric. 2009;124:1642–9. 39. Maeso S, Reza M, Mayal, et al. Efficacy of the da Vinci surgical system in abdominal surgery compared with that of laparoscopy. Ann Surg. 2010;252(2):254–62. 40. Tholey G, Desai JP, Castellanos AE. Force feedback plays a significant role in minimally invasive surgery; results and analysis. Ann Surg. 2005;241:102–9. 41. Mennon M, et  al. Comparing robotic vs. open prostate surgery. Henry Ford Vattikuti Institute Website—7, references—J Urol, J Endourol, BJ Urol. 42. Gaia G, Holloway R, Santoro L, et  al. Robotic assisted hysterectomy for endometrial cancer compared with traditional laparoscopic and laparotomy approaches: systematic review. Obstet Gynecol. 2010;116(6):1422–31. 43. Boggess JF, Gherig PA, Cantrell L, et al. A case controlled study of robot assisted type 3 radical hysterectomy with pelvic node dissection compared with open radical hysterectomy. Am J Obstet Gynecol. 2008;199(4):357–61. 44. Nezhat FR, Datta NS, Liu C, et al. Robotic radical hysterectomy versus laparoscopic hysterectomy with pelvic lymphadenectomy for treatment of early cervical cancer. JSLS. 2008;12(3):227–37. 45. Di Lorenzo N, Koscarella G, Faraci L, et al. Robotic systems and surgical education. SLS. 2005;9(1):3–12. 46. Suzuki S, Suzuki N, Hayashibie N, et  al. Telesurgical simulation system for training in the use of da Vinci surgery. Stud Health Technol/Inform. 2005;111:543–8.

A. Byer 47. Weiss S, Ortmaier P, Maas H, et  al. A virtual reality base haptic surgical training system. Comput Aided Surg. 2003;8(5):269–72. 48. Ro CY, Toumpoulis IK, Aston TC Jr, et al. A novel drill set for the enhancement and assessment of robotic surgical performance. Stud Health Technol/Inform. 2005;111:418–21. 49. Seymour NE, et  al. Objective structured assessment of technical skills. Am Surg. 2002;236:458–64. 50. Wang DS, Winfield HN. Survey of laparoscopic practice patterns in the midwest. J Urol. 2004;172:1431–5. 51. Multi-authored (22). The SAGES—MIRA Consensus Group. A consensus document on robotic surgery. Guidelines for usage of robotic surgery. (1) training/credentialing, (2) clinical applications, (3) risks of surgery and cost benefits analysis, (4) research. Surg Endosc. 2008;22(2):313–25. 52. Gabriel I, Barbash, Glied SA.  New technology and healthcare costs—the case of robotic assisted surgery. NEJM. 2010. Topics of Healthcare. 53. Shukla PI, Schear DS, Milsom JW.  Robot assisted surgery and healthcare costs. NEJM. 2010. Correspondence. 54. Morgan JA, et al. Robotic techniques improve the quality of life in patients undergoing atrial—septal defect repair. Ann Thoracic Surg. 2004;77(4):1328–33. 55. Robotic surgery of ‘tremendous benefit’ to patients. ScienceDaily [Internet]. 2011. Available from: www.sciencedaily.com/ releases/2011/01/110112161000.htm

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History of Robotic Surgery Farid Gharagozloo, Barbara Tempesta, Mark Meyer, Duy Nguyen, Stephan Gruessner, and Jay Redan

3.1

Background

Robots have fascinated and preoccupied human minds for centuries—from ancient tales of “stone golems” to modern science fiction [1]. The concept of autonomously operating machines goes back as early as 1400  BC when Babylonians developed a clock that measured time using the flow of water. This was the first automatic device in history. In 400 BC, Archytas of Tarentum, considered the father of mathematical mechanics, developed a steam-powered autonomous flying machine. [2] The wooden structure was based on the anatomy of a pigeon and contained an airtight boiler for the production of steam. The steam’s pressure would eventually exceed the resistance of the structure, allowing the robotic bird to take flight. F. Gharagozloo (*) Professor of Surgery, University of Central Florida, Surgeon-in-Chief, Center for Advanced Thoracic Surgery, Director of Cardiothoracic Surgery, Global Robotics Institute, Director of Cardiothoracic Surgery, Advent Health Celebration, President, Society of Robotic Surgery, Director, International Society of Minimally Invasive Cardiothoracic Surgery, Celebration, FL, USA e-mail: [email protected] B. Tempesta Center for Advanced Thoracic Surgery, Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA M. Meyer Department of Surgery, Wellington Regional Medical Center, Wellington, FL, USA D. Nguyen Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA S. Gruessner Department of Surgery, University of Illinois at Chicago, Chicago, IL, USA Formerly of Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA J. Redan Advent Health Celebration, Celebration, FL, USA

In 322 BC, the Greek philosopher Aristotle was one of the first great thinkers to consider automated tools and suggested the manner in which these tools would affect society at large. He imagined the great utility of robots, writing, “If every tool, when ordered, or even of its own accord, could do the work that befits it … then there would be no need either of apprentices for the master workers or of slaves for the lords.” In 250 BC, Ctesibius created a clepsydra, or water clock, which included a number of elaborate automatons. Ctesibius’ design allowed for the dropping of pebbles onto a loud gong, effectively making it the first alarm clock as well as an example of early automaton design. During the same period in the third century BC, the Chinese built a singing dancing robot out of wood and leather for the entertainment of King Mu of Zhou [3, 4]. In the eleventh century, during the dark ages in Europe and the Golden Age of Islam, Arab Muslim polymath Badi’al-Zaman Abū al-‘Izz ibn Ismā’īl ibn al-Razāz al-­ Jazari, an engineer and mathematician who is considered by many to be the father of robotics, devised segmental gears [5]. Many of his robotic creations were powered by water and included everything from automatic doors to a humanoid autonomous waitress who could refill drinks. al-Jazari constructed multiple automations including a floating mechanical music-playing band that was programmable using a rotor with moveable peg cams. In 1478, Leonardo DaVinci invented a small carriage which was powered by flexible bows and had pegs that could be inserted into a wheel to create a pre-set steering path. This was the first motorized vehicle, and one of the first programmable devices. DaVinci was influenced by al-Jazari’s work, and later in 1495 went on to invent the first autonomous machine modeled after the human figure (therefore the inspiration for the “da Vinci” robotic surgical system!). With the use of a series of pulleys and gears, Leonardo DaVinci’s metal-plated warrior could mimic human movements of the jaw, arms, and neck [6]. In 1530, the German mathematician Johannes Müller von Königsberg created a mechanical eagle.

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_3

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In 1540, Giannello Torriano designed a female figure which could play the mandolin [7]. Circa 1600, Japanese invented Karakuri Ningyo, a small human-shaped wooden robot which was driven with a series of gears. The seventeenth century saw the invention of “Machine Control” using centrifugal ball governors. Centrifugal governors (ball governor) were used to regulate the speed of grindstones in windmills. This device was later employed in James Watt’s steam engines. The word “governor” is derived from the Ancient Greek κ[kappa]υ[upsilon]β[beta]ε[epsilon] ρ[rho]ν[nu]ή[eta]τ[tau]η[eta]ς[sigma] (kybernētēs), meaning “steersman, pilot, or rudder.” The ball governor is a feedback device; its output is fed back into the device as its input [8]. An additional landmark invention which influenced the design of robots was the “Pendulum Clock” in 1656. It employed the verge escapement mechanism with a foliot or balance wheel timekeeper and a series of gears. It became the standard timekeeping device in the latter half of the seventeenth century. In 1737, Jacques de Vaucanson created a clockwork “Duck” capable of flapping its wings, quacking, and eating food with the illusion of digestion. His other invention was “The Flute Player”—a life-sized humanoid automaton that could play up to 12 different songs on the flute [9]. The automaton used a series of bellows to “breathe” and had a moving mouth and tongue that could vary the airflow, allowing it to play the instrument [9]. In 1769, Hungarian inventor Wolfgang von Kempelen built “The Turk,” a clockwork-filled box with a middle eastern-­looking figure, protruding from the back. The device gained fame as an automaton capable of playing chess against skilled opponents, but in reality, the clockwork was set dressing, and the only functional part was a concealed dwarf chess master turned puppeteer. In 1772, Pierre Jaquet-Droz devised androids, the “automata,” that could write letters, play a musical box, and draw pictures with the use of interchangeable programmable wheels [10, 11]. In 1800, Alessandro Volta invented the first chemical battery. This was significant for the future development of robotics. In 1801, French silk weaver and inventor Joseph Marie Jacquard invented an automated loom controlled by punch cards. In 1835, Joseph Henry invented the electrical relay, by which a current could activate a switch. Originally used for signal amplification on telegraph lines, it was eventually used in machine control systems and logic circuits. In 1846, Austrian mathematician and inventor, Joseph Faber, created Euphonia, a speaking, singing robot [11]. The machine featured a humanoid feminine face connected to a keyboard, where the face’s lips, jaw, and tongue could be

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controlled. A bellows and ivory reed provided the machine’s voice, and pitch and accent could be altered through a screw in the face’s nose. In 1863, the term “android” was first used in U.S. patents in reference to human-like miniature mechanical toys. Later in 1886, “Android” was cited in fiction. “L’Ève future” or “The Future Eve,” was a Symbolist science fiction novel by the French author Auguste Villiers de l’Isle-Adam, featured an artificial woman, created by Thomas Edison that lacked a real woman’s flaws. In 1893, Canadian George Moore built a life-sized steam-­ powered man. It walked at the end of a rotating boom at a speed of around nine miles per hour. In 1907, Tik-Tok, the first true robot in fiction, made its first appearance in Ozma of Oz. In 1912, Leonardo Torres y Quevedo, made “The Chess Player.” The device was capable of playing chess against a human opponent and featured an electrical circuit and a system of magnets which moved the pieces. It debuted at the 1914 World’s Fair in Paris to great excitement and acclaim. The term robot was introduced in the play Rossumovi Univerzální Roboti (R.U.R) by the Czech playwright Karel Čapek in 1923 [12]. The Czech word “robata” means “drudgery.” In the play, robots—mechanical objects designed for drudgery—take over the human race. In 1926, Film director Fritz Lang released Metropolis, a silent film set in a futuristic urban dystopia. It featured a female robot—the first to appear on the silver screen—that took the shape of a human woman in order to destroy a labor movement. In 1928, British engineer, Alan Reffell, and World War I veteran Captain William Richards created “Eric.” “Eric,” which was operated by two people, could move its head and arms, and could speak via a live radio signal. Eric’s movements were controlled by a series of gears, ropes, and pulleys and the robot reportedly spat sparks from its mouth. As an homage to the Čapek’s 1921 play R.U.R, Eric had the letters R.U.R. engraved into its chest. In 1929, Japanese biologist Makoto Nishimura made the robot Gakutensoku. It was over seven feet tall, could change its facial expressions through the movement of gears and springs in its head and could write Chinese characters. In 1942, Issac Asimov first used the term “robotics” in his books Runaround and outlined the three laws of robotics: that robots must not harm humans, that they must obey orders from humans, and that they must protect themselves from threats provided their self-preservation doesn’t break either of the first two laws [13, 14]. In 1947, the science of Cybernetics emerged. A congress on harmonic analysis was held in Nancy, France, and was attended by Mathematician Norbert Wiener, who would be inspired to write the 1948 book Cybernetics, or Control and Communication in the Animal and Machine. This new sci-

3  History of Robotic Surgery

ence was concerned with feedback control systems in machines and nature. The word “cybernetics” is derived from the Ancient Greek κ[kappa]υ[upsilon]β[beta]ε[epsilon] ρ[rho]ν[nu]ή[eta]τ[tau]η[eta]ς[sigma] (kybernētēs), meaning “steersman, pilot, or rudder.” The ball governor, invented in the seventh century, is recognized as a cybernetic device for its use of feedback in control of machinery. During the remaining decades of the twentieth century, the notion of robots was an enormously popular theme for works of science fiction. In films, plays, literature, and television; robots range from friendly companions, to vicious predators which were manipulated by villains, to autonomously functioning machines rising against humanity. In 1961, the first industrial robot, the Unimate, was developed by Unimation Inc. The Unimate robotic arm was first installed at the General Motors assembly line in Ewing, New Jersey, and was capable of transporting die-cast parts and welding them into place. This device would soon change the face of the manufacturing industry forever. In 1968, MIT’s Marvin Minsky created the “tentacle arm”—a robotic 12-jointed arm that was powered by hydraulics and could be controlled via a joystick. In 1969, Victor Scheinman created the Stanford Arm, a robotic arm that is considered to be one of the first robots to be controlled exclusively from a computer. The early 1970s saw the unveiling of the world’s first full-­ scale anthropomorphic robot—the WABOT-1 which was created by Ichiro Kato in Tokyo’s Waseda University. The 1970s also saw the progression of industrial robotics when, in 1973, German company KUKA released the FAMULUS—the first industrial robot with six electromechanically driven axes. In 1976, two robots, Viking 1 and Viking 2, that were powered by radioisotope thermoelectric generators landed on Mars. In reality and in practical daily life, robots have revolutionized industrial production from automobiles to computer chip production to pharmaceutical manufacturing. Industrial robots are used to accomplish repetitive tasks precisely without fatigue. Unlike robots of science fiction, these robots are driven by computers that are in turn programed for specific tasks. Consequently, to the lay public robots are either a science fiction curiosity or mechanical machines that are driven by digital systems without human intervention. When referring to surgical robots, the popular notion of robots can be a cause for great fear. It is therefore somewhat unfortunate that surgical instruments that are manipulated from a remote console and represent extensions of the surgeon’s mind and hands are referred to as “robots.” Consequently, it is crucial to alleviate any misgivings in the patient population about the nature of surgical robots. In the future, surgical robots may be directed from vastly remote locations and may even have computer-controlled or

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autonomous function. However, presently, surgical robots are mere instruments that are remotely manipulated by a surgeon using an electromechanical interface. Present-day surgical robots are not autonomous nor are they driven by preprogrammed computers.

3.1.1 Video-Endoscopic Surgery Video surgery came about as a direct result of development of the cystoscope. In 1806, Philip Bozzini of Frankfurt Germany developed the first known endoscopic instrument the “Lichtleiter.” [15] It had an eyepiece and a speculum which was introduced into the body cavity. Illumination was provided by a candle which was placed in a container located between the eyepiece and the speculum. As the candle was interposed between the observer’s eye and the body cavity, all that the observer saw was the light of the candle! The instrument was used to examine the vulva, the rectum, urethra, and upper respiratory passages. However, as it illuminated a small area and resulted in considerable pain, the instrument was denounced by the Faculty of Medicine in Vienna, Austria [16]. In 1827, Pierre Segala of France devised a similar instrument that used mirrors to deflect the candle light from the observer’s eye [17]. In 1828, John Dix Fisher of Boston described a similar endoscope in the United States [18]. In 1853, Antoin Desormeaux, considered by some as the “father of endoscopy,” devised brighter illumination by the use of alcohol and turpentine and a Plano convective focusing lens [19]. In 1877, Max Nitze incorporated the revolutionary concept of distal illumination using a heated platinum filament and devised the forerunner of the modern cystoscope [20]. In 1883, David Newman of Glasgow, UK, incorporated an incandescent lamp into the cystoscope [21]. Soon thereafter, Charles Preston of Rochester, New  York, developed a “cold” low amperage lamp that did not require a cooling system and interestingly was used in endoscopes for over 100 years until the advent of Fiberoptics [22]. Early in the twentieth century, gynecologists and surgeons began to evaluate the abdominal and thoracic cavities using endoscopes. The invention of the automatic insufflator gave rise to the era of laparoscopic surgery. In 1966, Kurt Semm was the first to perform laparoscopic gynecologic procedures [23]. During the 1970s and 1980s, laparoscopy was applied to the diagnosis and staging of pathologic processes in the abdomen. The German surgeon Erich Muhe, in 1985, the French surgeon Philippe Mouret, in 1987, and Americans McKernan and Saye, in 1988, independently performed the first laparoscopic cholecystectomy procedures [24]. Interestingly, by 1990, laparoscopic cholecystectomy had become the standard of care [25]. Following the advances in the use of minimally invasive surgery in the abdomen in the

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1980s, video-assisted thoracic surgery (VATS) was born in 3.2.2 PROBOT the 1990s. Although presently video-assisted techniques occupy a In the late 1980s, PROBOT robotic system was designed at significant role in the armamentarium of virtually all surgical Imperial College London in order to assist in transurethral subspecialties, the advanced videoendoscopic procedures prostatectomy [27]. PROBOT had four axes of movement, a have not been readily embraced. Most advanced videoendo- 40,000-rpm rotating blade for resection, and a compact size. scopic techniques require precise dissection, manipulation of Using a computer-generated 3D model of the prostate, the delicate structures, endoscopic suturing, and three-­ surgeon could outline a specific area for resection. In turn, dimensional visualization. The current video endoscopic PROBOT calculated the trajectories of excision, and the protechnology has the following limitations: cedure was executed by using a computer-generated 3D model of the prostate. • The 2D camera system causes impaired visualization. Furthermore, video cameras are manipulated by an assistant and not the surgeon. As a result, the rapid adjustment 3.2.3 ROBODOC of the visual field, which is necessary for complex surgical procedures, is not possible. The first computer-enhanced surgical instrument was the • Instruments are very long and operate on a fixed fulcrum ROBODOC (Integrated Surgical Systems, Sacramento, CA, at the point of entry of the trocar. This results in limited USA). range of motion, diminished tactile feel, and exaggeration IBM’s Thomas J. Watson Research Center and researchof the surgeon’s natural tremor. As a direct result of pivot- ers at the University of California, Davis, began collaboraing far away from the operative site, the conventional tive development of an innovative system for Total Hip endoscopic instruments have restricted access to non-­ Arthroplasty (THA). Their goal was to create a robotic surgicontiguous structures and reverse or counterintuitive cal system that would redefine precision in joint replacement response at the instrument tip in relation to the move- procedures. ROBODOC enabled precise drilling of the shaft ments of the surgeon’s hands. Suturing and not tying is of the femur by orthopedic surgeons. ROBODOC was first difficult. Appropriate attention is difficult to achieve when used clinically in 1992 [28, 29]. Endo corporeal knots are tied by instruments that have a fulcrum point at the trocar site rather than the target tissue. Furthermore, long length of the instruments compro- 3.2.4 Aesop mises ergonomics and thereby contributes significantly to surgeon fatigue and longer learning curves. Aesop (automated endoscopic system for operative positioning) (Computer Motion Inc., Santa Barbara, California) was In the 1990s, it was clear that computer-enhanced instru- introduced in 1994. Computer Motion was funded by NASA mentation had the potential of solving limitation of conven- with the goal of creating a robotic arm to be used in space. tional video endoscopic techniques. Instead, a version of the arm found its way into surgical use as a table-mounted laparoscopic camera holder. Aesop gave the surgeon control of the video endoscope. It provided a 3.2 Robotics in Medicine stable field of vision and was directed by voice commands from the surgeon [30–34].

3.2.1 P  UMA (Programmable Universal Manipulation Arm) 560

In 1978, Victor Scheinmann while working at Unimation, the company that produced the first industrial robot, developed PUMA. The PUMA 560 had six degrees of freedom [26]. The first documented use of a robot-assisted surgical procedure occurred in1985 when the PUMA 560 robotic surgical arm was used to orient a needle for a brain biopsy while under computer tomography (CT) guidance during a neurosurgical biopsy.

3.2.5 Zeus The Zeus robotic surgical system (Computer Motion, Santa Barbara, California) was introduced in 1998. The Zeus system is no longer available for clinical use. The Zeus and the da Vinci robotic surgical systems were conceptually similar. They both had a surgeon console connected by an electronic interface to robotic arms that were driven by cables and were used to manipulate the video

3  History of Robotic Surgery

endoscope and the surgical instruments. The Zeus system had an open workstation that gave the surgeon direct external view of the operating room. The Zeus system used a ­traditional monitor with a computer simulated three-dimensional visualization system using special glasses. The Zeus arms consisted of three separate working arms (three ESOPs) that were independently fixed to the operating room table. The Zeus arms had 5° of freedom. ZEUS made its most prominent mark in cardiac surgery. A Canadian study demonstrated ZEUS’s technical ability by successfully harvesting the left internal mammary arteries, using a three-trocar technique, in 19 patients who all subsequently had excellent clinical outcomes [35, 36]. Further studies showed ZEUS’ ability to successfully assist in the anastomoses of closed chest, on-pump and off-pump coronary artery bypass grafting [37]. ZEUS was also capable of long-range telepresence surgery. Using a fiber-optic cable running from the ZEUS console in New York, USA, to the robot operating on the patient in Strasbourg, France, Marescaux successfully performed a telerobotic cholecystectomy in 2001 [38].

3.2.6 da Vinci The da Vinci robotic surgical system (intuitive surgical, Sunnyvale California) was introduced in 1997 (Figs. 3.1, 3.2, and 3.3). The da Vinci system used endowrists with 6° of freedom, with both pitch and yaw, which gave 360° rotation of the instrument dress. In the da Vinci system, the four robotic arms were mounted onto a cart, which was wheeled onto the operating table. The original da Vinci system (standard) was improved with the introduction of the da Vinci S, da Vinci SI, da Vinci XI systems (Figs. 3.4, 3.5, 3.6, 3.7, and 3.8). Fig. 3.1  Arms of the standard daVinci robotic surgical system

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The da Vinci robotic surgical system was the product of research performed by SRI (Stanford Research international). In 1990, SRI received funding from the National Institutes of Health in order to develop a prototype robotic surgical system in conjunction with the Defense Advanced Research Projects Agency (DARPA). Using a telepresence surgery system created by Phil Green, Richard Satava, Joe Rosen, and the Stanford Research Institute (SRI) gave a demonstration of an open intestinal anastomosis to the Association of Military Surgeons of the United States. Following this demonstration, the military assigned Richard Satava to be program manager for Advanced Biomedical Technologies of the government-run Defense Advanced Research Projects Agency (DARPA). As a result, the Green Telepresence Surgery System was developed with the goal of improving surgical capabilities on the battlefield. The model was based on putting the robotic arms in an armored vehicle entitled the Medical Forward Area Surgical Team (MEDFAST) that could be driven directly to the battlefront. The surgeon console would be inside a Mobile Advanced Surgical Hospital (MASH) where the surgeon could operate at a safe distance, about 10–35 km, from the MEDFAST. A pivotal point for the Green Telepresence Surgery System came 1994 when Jon Bowersox, the medical scientist for the program, performed an intestinal anastomosis on ex-vivo porcine intestine using a wireless microwave connection between a MASH test and a MEDFAST vehicle. This landmark event was the first remote telesurgical procedure and prompted Frederick H. Moll, a surgeon and an entrepreneur, to acquire the license to the telepresence surgical system and create Intuitive Surgical Inc. The SRI system was refined by Intuitive Surgical into a prototype known as “Lenny” (short for Leonardo) which was tested in 1997. In March 1997, the first clinical robotic

26 Fig. 3.2  Close-up view of the arms of the standard daVinci robotic surgical system

Fig. 3.3  Surgical console of the standard daVinci robotic surgical system

Fig. 3.4  daVinci S robotic surgical system during a robotic thoracic surgical procedure circa 2011

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3  History of Robotic Surgery Fig. 3.5  Close-up view of the daVinci S robotic surgical system during a robotic thoracic surgical procedure circa 2011

Fig. 3.6  da Vinci Si system

Fig. 3.7  da Vinci Si during a robotic laparoscopic procedure circa 2015

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Fig. 3.8  Consoles of the da Vinci Xi system

procedure, a cholecystectomy, was performed by Cadiere and Himpens in Brussels, Belgium, using a da Vinci robot. The first robot-assisted cardiac procedure was performed with the da Vinci system in May 1998 and the first closed chest coronary artery bypass graft was performed in June 1998. The da Vinci system was approved for general laparoscopic surgery applications in July 2000. In 2001, the da Vinci surgical system was approved for prostate surgery. In 2003, intuitive surgical merged with computer motion which ultimately resulted in the phase out of the Zeus system. As of 2018, there were more than 4986 robotic surgical systems in hospitals worldwide, and more than six million robotic surgical procedures had been performed worldwide.

References 1. Kline M.  Mathematical thought from ancient to modern times. Oxford: Oxford University Press; 1972. 2. Landel JG.  Engineering in the ancient world. Berkeley: Univ. of California Press; 1978. 3. History of Robots: Time line. (Internet) Available from: https:// www.robotshop.com/media/files/PDF/timeline.pdf 4. The history of robots from the 400 BC Archytas to the Boston dynamics robot dog (Internet) Available from: https://interestingengineering.com/ 5. al-Jazari. The book of knowledge of ingenious mechanical devices: Kitáb fí ma’rifat al-hiyal al-handasiyya, transl. & anno. Donald R. Hill. New York: Springer Science+Business Media; 1973. 6. Brown DA. Leonardo (da Vinci), Leonardo Da Vinci: Origins of a Genius. New haven: Yale University Press; 1998. 7. Gabby W. Living dolls: a magical history of the quest for mechanical life. The Guardian, 2002. 8. Do androids dream of horological sheep. A look at Pierre Jaquet Droz and his automata (Internet). Available from: https://www. watchtime.com/featured/ 9. Hankins TL, Silverman RJ.  Instruments and the imagination. Princeton, NJ: Princeton University Press; 1999.

10. A history of robotics iron eagle. (Internet). 2014. Available from: http://robotrecycled.blogspot.com 11. Bradley DA, Seward D, Dawson D, Burge S. Mechatronics and the design of intelligent machines and systems: CRC Press; 2000. 12. Roberts A.  The history of science fiction. New  York: Palgrave Macmillan; 2006. p. 2006. 13. Asimov I. I, Robot. Greenwich: Fawcett; 1950. 14. In AIR.  Astounding science fiction. New  York: Street & Smith Publications Inc; 1942. 15. Bozzini P. der Lichleiter oder beschreinbank einer einfachen vorrichtung und inhern anwendung surerlechtung innerer hohlen und zwischenraume des lebenden ani-malischen korpers: Weimer; 1907. 16. Mitchel JP. Development of the endoscope. In: Endoscopic operative urology. Bristol, UK: Wright PSGG; 1981. 17. Segala GPS. Traites des Retentiones d’Urine. Paris; 1828. 18. Fisher J.  Instruments for illuminating dark cavities. Phila J Med Phys Sci. 1827;14:409. 19. Desormeaux AJ. Endoscopy. Bull Acad Med. 1853; 20. Murphy LYJ.  The history of urology. Springfield, IL: Charles C. Thomas; 1972. 21. Newman D. Lectures of the surgical diseases of the kidney. London, UK: Longmans, Green and Amp, Co; 1988. 22. Smythe WR, Kaiser LR.  History of thoracoscopic surgery. In: Kaiser LR, Daniel TM, editors. Thoracoscopic surgery. Boston, MA, Little, Brown and Co; 1993. p. 1–16. 23. Semm K.  Operative manual for endoscopic abdominal surgery. Chicago, IL: Yearbook Medical Publishers; 1987. 24. Reynolds W.  The first laparoscopic cholecystectomy. JSLS. 2001;5:89–94. 25. Dubois F, Icard P, Berthelot G, Levard H.  Celioscopic cholecystectomy: a preliminary report of 36 cases. Ann Surg. 1990;211: 60–2. 26. Kwoh YS, Hou J, Jonekheere EA, Hayall S. A robot with improved absolute positioning accuracy for CT guided stereotactic brain surgery. IEEE Trans Biomed Eng. 1988;35:153. 27. Harris SJ, Arambula-Cosio F, Mei Q, Hibberd RD, Davies BL, Wickham JE, Nathan MS, Kundu B. The Probot—an active robot for prostate resection. Proc Inst Mech Eng H. 1997;211(4):317–25. 28. Paul HA, Bargar WL, Mittlestadt B, et al. Development of a surgical robot for total hip arthroplasty. Clin Orthop Relat Res. 1992;(285):57. 29. Pransky J. ROBODOC – surgical robot success story. Ind Robot. 1997;24:231–3.

3  History of Robotic Surgery 30. Unger SW, Unger HM, Bass RT. AESOP robotic arm. Surg Endosc. 1994;8:1131. 31. Sackier JM, Wang Y.  Robotically assisted laparoscopic surgery: from concept to development. Surg Endosc. 1994;8:63–6. 32. Jacobs LK, Shayani V, Sackier JM. Determination of the learning curve of the AESOP robot. Surg Endosc. 1997;11:54–5. 33. Allaf ME, Jackman SV, Schulam PG, Cadeddu JA, Lee BR, Moore RG, Kavoussi LR. Laparoscopic visual Weld: voice vs foot pedal interfaces for control of the AESOP robot. Surg Endosc. 1998;12:1415–8. 34. Kraft BM, Jäger C, Kraft K, Leibl BJ, Bittner R. The AESOP robot system in laparoscopic surgery: increased risk or advantage for surgeon and patient? Surg Endosc. 2004;18:1216–23. 35. Kiaii B, Boyd WD, Rayman R, Dobkowski WB, Ganapathy S, Jablonsky G, Novick RJ.  Robot-assisted computer enhanced

29 closed-chest coronary surgery: preliminary experience using a harmonic scalpel and Zeus. Heart Surg Forum. 2000;3:194–7. 36. Reichenspurner H, Damiano RJ, Mack M, Boehn DH, Gulbins H, Detter C, Meiser B, Ellgass R, Reichart B. Use of the voice controlled and computer-assisted surgical system ZEUS for endoscopic coronary artery bypass grafting. J Thorac Cardiovas Surg. 1999;118:11–6. 37. Boyd WD, Rayman R, Desai ND, Menkis AH, Dobkowski W, Ganapathy S, Jablonsky G, McKenzie FN, Novick RJ.  Closed-­ chest coronary artery bypass grafting on the beating heart with the use of computer-enhanced surgical robotic system. J Thorac Cardiovasc Surg. 2000;120:807–9. 38. Marescaux J, Leroy J, Gagner M, Rubino F, Mutter D, Vix M, Butner SE, Smith MK.  Transatlantic robot-assisted telesurgery. Nature. 2001;413:379–80.

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Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rickover and the Nuclear Navy Farid Gharagozloo, Monica Reed, Mark Meyer, Barbara Tempesta, Hannah Hallman-Quirk, and Stephan Gruessner

4.1

Introduction

Robotic surgery (RS) is not about a new surgical instrument; rather, RS represents a “Disruptive Vision” which is bringing about a “fundamental change” in surgery. Therefore, the implementation of a successful robotic surgery program needs to follow examples in other areas of human experience where a “Disruptive Vision” has successfully implemented “fundamental change” in an otherwise conservative organizational culture. The most appropriate example of such a phenomenon is the monumental organizational change which was necessary to transform the US Navy from diesel power to nuclear propulsion. Arguably, this single transformation was responsible for the fact that nuclear weapons were not used during the Cold War, and humanity was saved from the horrors of Nuclear War. Robotic surgery can learn many lessons from this experience and the vision of Admiral Hyman Rickover, the “Father of the Nuclear Navy.” F. Gharagozloo (*) Professor of Surgery, University of Central Florida, Surgeon-in-Chief, Center for Advanced Thoracic Surgery, Director of Cardiothoracic Surgery, Global Robotics Institute, Director of Cardiothoracic Surgery, Advent Health Celebration, President, Society of Robotic Surgery, Director, International Society of Minimally Invasive Cardiothoracic Surgery, Celebration, FL, USA e-mail: [email protected] M. Reed · H. Hallman-Quirk Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA M. Meyer Department of Surgery, Wellington Regional Medical Center, Wellington, FL, USA B. Tempesta Center for Advanced Thoracic Surgery, Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA S. Gruessner Department of Surgery, University of Illinois at Chicago, Chicago, IL, USA Formerly of Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA

This chapter develops the reasoning by: • Examining the problem at hand: divergent views of robotic surgery by the business world, industry, patients, and surgeons • Examining the concepts of culture change and disruptive innovation • Outlining lessons about implementation of culture change and a disruptive innovation from the Navy. • Outlining the process for changing the culture to a culture of greatness • Outlining the need and the importance of changing the culture of the operating room • Outlining the existential imperative of changing the culture of medicine through changing the culture of medical education • Outlining how attention to these concepts adds up to the “entire elephant” in understanding and implementing a successful robotic surgery program

4.2

Varying Views of Robotic Surgery

Robotic surgery is a complex surgical, organizational, and social phenomenon which, heretofore, has not been seen in its entirety by the stakeholders. It can be likened to the Indian parable about the “blind men and an elephant.” The parable is a story of a group of blind men, who have never come across an elephant before and try to understand it by touching the different parts. They then describe the elephant based on their limited experience. Each one describes the elephant based on the anatomic part that they are feeling. No one appreciates the entire elephant. The moral of the story is that feeling parts of the elephant leaves one with an erroneous impression of the whole, namely, the elephant itself. In a similar manner, it would be a mistake to look at robotic surgery in terms of the various parts. To get a complete understanding, robotic surgery must be viewed in its entirety. Unfortunately, presently robotic surgery is viewed in three very different ways based on the perspective of the examiner.

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_4

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4.2.1 R  obotic Surgery as Viewed by the Business Community The surgical robotics market is expected to grow from $3.9 billion in 2018 to $6.5 billion by 2023, at a Compound Annual Growth Rate (CAGR) of 10.4%. Hospitals are using surgical robots for procedures such as prostatectomy, hysterectomy, hernia repair, cholecystectomy, colon and rectal procedures, nephrectomy, sacrocolpopexy, coronary artery bypass, mitral valve repair, lung lobectomies, and transoral robotic surgery. In addition, companies are now focusing on developing miniature-sized and less expensive surgical robots to target smaller hospitals and ambulatory surgical centers. The general surgery segment is expected to grow at the highest rate in the foreseeable future. Surgical robots are being used in the areas of bariatric surgery, Heller myotomy, gastrectomy, hernia repair, cholecystectomy, Nissen fundoplication, transoral surgery, pancreatectomy, and other general surgical procedures. The growth in the number of these procedures is likely to fuel market growth. The use of robotic surgeries for various application areas has also grown due to the advantages of minimally invasive techniques. As compared to the large incisions required in traditional surgery, robotic surgeries can reduce pain and recovery time for many patients. North America is expected to hold a significant share in the market in the next decade. Factors such as the development of advanced surgical robotic technology, increasing adoption of surgical robots, government initiatives, and the availability of funding are driving the growth of the market in North America. • The major vendors in the global surgical robotics market are Intuitive Surgical (USA), Stryker (USA), and Mazor Robotics (USA). These companies have the largest base of installed surgical robotic systems across hospitals and ambulatory surgical centers. Other emerging players involved in this market are Smith & Nephew (UK), Hansen Medical (USA), Medrobotics (USA), TransEnterix (USA), Medtech (France), Renishaw (UK), THINK Surgical (USA), and Medicaroid (Japan) [1].

4.2.2 R  obotic Surgery as Reported in the Media and Perceived by the Public Between January 2000 and August 2012, thousands of mishaps with robotic surgeries were reported to the FDA.  In the vast majority of cases, the patient was not harmed, but among the reports were 174 injuries and 71 deaths related to da Vinci surgery [2]. Researchers at Johns Hopkins have concluded that adverse events associated with the da Vinci are “vastly underreported” [2, 3].

F. Gharagozloo et al.

Documents surfacing in the course of legal action against Intuitive Surgical Inc. have outlined the aggressive tactics used to market the equipment and raised questions about the quality of training provided to surgeons, as well as the pressure on doctors and hospitals to use the robot. The documents show that pressure is exerted even in cases where the use of the robot is not the physician’s first choice and when the surgeon has little hands-on experience with the robot. Expansion of robotic surgery has occurred without proper evaluation and monitoring of the benefits. • Women have been more likely to be harmed during the robotic procedures. Nearly one-third of deaths that were reported to the FDA database occurred during gynecologic procedures, and 43% of the injuries were associated with hysterectomies.

4.2.3 R  obotic Surgery as Perceived by the Surgeons In addition to the risks of open and laparoscopic surgery, including the potential for infection, bleeding, and the cardiopulmonary risks of anesthesia, there are risks that are unique to the robotic surgical system [4, 5]. Not only is there potential for human error in operating the robotic technology, but the surgical robot introduces the added risk of mechanical failure. Multiple components of the system can malfunction, including the camera, binocular lenses, robotic tower, robotic arms, and instruments. The energy source, which is prone to electric arcing, can cause unintended internal burn injuries from the cautery device. Arcing occurs when electrical current from the robotic instrument leaves the robotic arm and is misdirected to surrounding tissue. This can cause sparks and burns leading to tissue damage which may not always be immediately recognized. Cracks in the insulation of the spatula cautery has been reported to cause ventricular fibrillation during cardiac procedures. There is a small risk of temporary, and even permanent, nerve palsies from the extreme body positioning needed to dock the robot and access the pelvis adequately to perform RALP.  Direct nerve compression from the robotic arms can also lead to nerve palsies [6]. Robotic surgery has also been shown to take significantly longer than nonrobotic procedures when performed at centers with lower robotic volume and by surgeons with less experience, and overall, it is more expensive than open surgery [7, 8]. Furthermore, excessively long cases are problematic beyond these concerns. Excessively long robotic cases are associated with the phenomenon of “cognitive tunneling” or fixation. This means that the less ­experienced surgeon is distracted by the technical demands of the robotic procedure and is therefore unable to guide the OR team toward a safe outcome as in a more routine procedure.

4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick…

Clearly, the outcomes of robotic surgery correlate with individual surgeon experience [9]. For example, in cancer surgery, surgeons with more experience are more likely to have clean margins [10–12]. Other studies have documented lower complication rates with an increasing number of procedures [4, 13]. These findings of practice makes perfect are not specific to robotic surgery and indeed apply to all surgical procedures. There are varying reports of exactly how many cases are required to master the robotic learning curve, and the number varies by surgical procedure. For robotic prostatectomy, the range has been reported from as low as 40 to as many as 250 [14]. For robotic hysterectomies, the literature reports a range of 20–50 cases to master the operation and reports that less experienced surgeons have significantly longer operative times [15]. Two other phenomena are at work in terms of the true learning curve for each specific surgeon. The “forgetting curve” relates the complexity of the case to the frequency of the curve during the learning phase. Low frequency of highly complex cases leads to more forgetting in between cases and a more prolonged learning curve. The phenomenon of “Unlearning” means that some of the rules of open surgery are not appropriate for robotics. New habits (largely related to communication and team management) have to be learned in order to be a safe and effective robotic surgeon. In turn, if there is resistance to learning the new habits, the learning curve will be prolonged. Complication rates (including all grades of perioperative complications, from minor to life-threatening) for robotic prostatectomy has been reported at 10% [8, 16]. Multiple risk factors can increase the possibility of complications and errors: patient factors (i.e., obesity or underlying comorbidities), surgeon factors (training and experience), and robotic factors (i.e., mechanical malfunction). The reported complication rate related directly to robot malfunction is very low (approximately 0.1–0.5%) [2, 17]. However, when robotic errors do occur, the rates of permanent injury have been reported anywhere from 4.8% to 46.6% [18], and this literature may suffer from underreporting [3]. Although fewer than 800 complications directly attributable to the robotic operating system have been reported to the FDA over the past 10 years, in a Web-based survey among urologists performing robotic prostatectomy, almost 57% of respondents had experienced an irrecoverable intraoperative malfunction of the robot [18, 19]. The most common areas of complications were malfunction of the robotic arms, joint setup, and camera, followed by power error, instrument malfunction, and breakage of the handpiece. Potential areas for improvement and reduction of error in robotic surgery include more standardized training of surgeons and teams, more rigorous credentialing practices, improved reporting systems for robotic-associated adverse events, and enhanced patient education. Perhaps an area which has had very little scrutiny, but is well known to the surgical community, is the rate of failure

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in terms of Robotic Surgical Programs and surgeons who attempt to adopt robotics into their surgical armamentarium. Some of the reasons for this are the lack of data, definition of success or failure of the programs, and the differences in different surgical specialties. Nevertheless, among the surgical community, there is a sense that there is an inconsistency in the rate of growth in the overall number of robotic surgeries, as compared to the rate of individual surgeon adoption and hospital program success. Many surgeons train for robotic surgery, yet few go on to experience success in terms of adoption, and many individual hospital programs do not experience robust growth of their robotic surgery program. In a retrospective analysis of the data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database between 2006 and 2012, Whellan and coauthors showed that Robotic Coronary Artery Bypass use remained relatively stagnant at 0.97% of total CABG operations despite lower rates of major perioperative complications and no difference in operative deaths [20]. In a presentation at the International Society of Minimally Invasive Cardiothoracic Surgery in 2015, Poston showed that from 2005 until 2015, 372 different institutions instituted a robotic cardiac surgery program. Only 24/372 (6.4%) of the programs performed more than 50 procedures/year. 212/372 (57%) of the programs had failed to perform a single case in the 2 years that preceded the report. This work is yet further evidence of the fact that many institutions have initiated robotic cardiac surgery programs, but few have sustained its integration into routine practice. Furthermore, this author concluded that based on this data, even though surgeon skill plays a role in the high failure rate of adoption of technically demanding robotic procedures, institutional and organizational factors may play an equally, and perhaps more important, role in assuring success [21]. Clearly, the field of robotic surgery is associated with many controversies. Despite the controversies, given the potential benefits of robotic surgery, the only realistic conclusion is that robotic surgery is here to stay. What is required is a rigorous examination of the many factors that are necessary to ensure the success of surgical programs that are based on such a disruptive technology.

4.3

 he Rest of the Story: Concepts T of Change Culture and Disruptive Innovation

The future is not what it used to be! Yogi Berra [22]

Robotic surgery has brought about the dawn of a fundamental change in surgery where surgeons are moving from “tissue and instruments” or “objects and atoms” to “information and energy” or “bits and bytes.” It would be a mistake to see the implementation of such fundamental change as mere

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introduction of new technology. Successful implementation of such fundamental change requires substantial changes in organizational aspects of surgery and education and, indeed, a different emphasis and vision for the delivery of surgical care.

4.3.1 Changing Cultures By nature, although all cultures are inherently predisposed to change, there is great resistance to change. There are dynamic processes operating that encourage the acceptance of new ideas and things, while there are others that encourage changeless stability. Ironically, it is likely that social and psychological chaos would result if there were not for the conservative forces that resist change. Within a society, processes leading to change include invention and culture loss. Culture loss is an inevitable result of old cultural patterns being replaced by new ones. Within a society, processes that result in the resistance to change include habit and the integration of culture traits. Older or more established individuals, in particular, are often reticent to replace their comfortable, long familiar cultural patterns. Habitual behavior provides emotional security in a threatening world of change. Change is an elusive concept. It is inevitable and yet, paradoxically, it depends on the will and the actions of ordinary individuals who are more disposed to continue the status quo. We embrace change, yet something in our nature fiercely resists it. We structure social movements, political campaigns, and business strategies around the need for change; yet we hardly understand how it works. While a great deal has been written about social change in the fields of history, sociology, organizational theory, and even psychology, much of it focuses on the recalcitrance of social systems—how and why they resist change—rather than the change process itself. The cyclical process of birth, growth, breakdown, and disintegration has been a perennial theme in philosophy dating back to the ancient Greeks, and perhaps further. Heraclitus, who is remembered for his maxims “there is nothing permanent except change” and “you can never step into the same river twice,” compared the world order to an ever-living fire, “kindling in measures and going out in measures” [23]. A contemporary of Heraclitus, Empedocles, attributed the changes in the universe to the ebb and flow of two complementary forces which he called “love” and “hate.” Correspondingly, the ancient Chinese philosophers viewed reality as the dynamic reflected in the term they use for “crisis”—wei-ji—which is composed of the characters for “danger” and “opportunity.” While the function of change has preoccupied many of the great Western philosophers, it was not until the late nineteenth and early twentieth centuries that the first comprehensive change theories were articulated.

F. Gharagozloo et al. This is the tragedy of man: Circumstances change and he does not … Niccolo Machiavelli: The Prince [24] Nothing is more difficult than to introduce a new order; because the innovator has for enemies all those who have done well under the old conditions, and lukewarm defenders in those who may do well under the new. Niccolo Machiavelli: The Prince [24]

Based on exhaustive studies of some 30 civilizations, Arnold Toynbee’s A Study of History postulated that the genesis of a civilization consists of a transition from a static condition to one of dynamic activity characterized by effective change [25]. The civilization continues to grow when its successful response to the initial challenge generates cultural momentum that carries the society beyond a state of equilibrium into an overbalance that presents itself as a fresh challenge. In this way, the initial pattern of challenge-and-response is repeated in successive phases of growth, each successful response producing a disequilibrium that requires new creative adjustments. Indeed, these concepts are clearly delineated in the history of the United States and the vision of its founding fathers. All experience hath shown that mankind is more disposed to suffer… than to right themselves by abolishing the forms to which they are accustomed. The Declaration of Independence [26]

Toynbee postulated that when social structures and behavior patterns have become so rigid that the society can no longer adapt to changing conditions, it will be unable to carry on the creative process of cultural evolution. It will then break down and eventually disintegrate. Toynbee’s ideas echo those of Oswald Spengler, Pitirim Sorokin, and other social thinkers who viewed change as fundamentally cyclical in nature [27, 28]. A more recent perspective on change comes from historian of science, Thomas Kuhn. In The Structure of Scientific Revolutions, which has been called the most important book of the twentieth century, he introduced the concept of a Paradigm—a conceptual model or set of assumptions about reality that allows researchers to isolate data, elaborate theories, and solve problems [29]. A scientific paradigm, as Kuhn defined it, can be as all-encompassing as Newtonian physics or as specific as the notion that life exists only on earth. The chief characteristic of a paradigm is that it has its own set of rules and illuminates its own set of facts. In this way, it becomes self-validating and therefore resistant to change. When a new paradigm is articulated—such as robotic surgery—a broad paradigmatic shift occurs. In this way, long periods of “normal” science are followed by brief “revolutions” that involve fundamental changes in basic theoretical assumptions. In Kuhn’s view, the history of science is not one of linear, rational progress moving toward ever more accurate and complete knowledge of an objective

4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick…

truth. Instead, it is one of radical shifts of vision in which a multitude of nonrational and nonempirical factors come into play. Kuhn’s model also sheds light on how change operates in the natural world as exemplified by the metamorphosis of a caterpillar into a butterfly. In metamorphosis, small cells known as imaginal discs begin to appear in the body of the caterpillar. Since they are not recognized by the caterpillar’s immune system, they are immediately wiped out. But as they grow in number and begin to link up, they ultimately overwhelm the caterpillar’s immune system. The caterpillar’s body then goes into meltdown, and the imaginal discs build the butterfly from the spent materials of the caterpillar. These imaginal discs can be likened to the anomalies in Kuhn’s model of paradigmatic change. The caterpillar’s immune system does not recognize them, just as the dominant paradigm in Kuhn’s model fails to account for anomalies. Finally, they overwhelm the system and usher in a new phase. Interesting parallels can also be drawn between imaginal discs and the “creative minorities” in Toynbee’s theory of the rise and fall of civilizations. As Toynbee showed, the seeds of the new civilization are contained within the old one just like the blueprint of the butterfly is contained in the cells of the caterpillar. In a world buffeted by change, many organizations have learned that the only way to survive is by innovating and that the only stability possible is stability in motion. In Managing the Future: Ten Driving Forces of Change for the 90s, Robert Tucker writes: “Two years after In Search of Excellence reported on forty-three of the ‘best run’ companies in America, fourteen of the forty-three firms were in financial trouble. The reason, according to a Business Week study: ‘failure to react and respond to change.’ That ‘change’ and ‘innovation’ have become the bywords of organizational management in the 1990s is reflected in a myriad of business books with titles like Mastering Change: The Key to Business Success, Knowledge for Action: A Guide to Overcoming Barriers to Organizational Change and The Change Masters. As Common Cause founder John Gardner has said, ‘perhaps the most distinctive thing about innovation today is that we are beginning to pursue it systematically. The large corporation does not set up a research laboratory to solve a specific problem but to engage in continuous innovation’” [30]. One of the more influential management books to emerge in recent years is The Fifth Discipline by Peter Senge, director of the Systems Thinking and Organizational Learning Program at MIT’s Sloan School of Management [31, 32]. Senge believes that the greatest challenges confronting organizations today involve fundamental cultural changes. Addressing these challenges requires what he calls collective learning. Organizations must be able to learn in order to survive.

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The traditional approach to dealing with complex problems is to break them down into smaller, more easily managed problems. But this approach could be fatal to organizations, according to Senge. When we reduce complex problems and try to isolate their various parts, we “can no longer see the consequences of our actions; we lose our intrinsic sense of connection to a larger whole,” he writes. “As daunting as it may seem, we must destroy the illusion that the world is created of separate, unrelated forces. When we give up this illusion, we can then build learning organizations.” Unfortunately, these concepts are rarely considered in the process of developing a surgical program or in assessing the need for change in medicine as a whole. The learning organization is one in which various learning disciplines are continually pursued: Personal mastery, “the discipline of continually clarifying and deepening our personal vision, of focusing our energies, of developing patience, and of seeing reality objectively.” Analyzing one’s mental models and envisioning alternative ways of thinking about the world. Working with mental models means exposing our own ways of thinking, as well as making that thinking more open to the influence of others. Building a shared vision, “unearthing shared pictures of the future that foster genuine commitment and enrollment rather than compliance.” Learning as a team, which starts with dialogue and the skill of overcoming defensiveness and other patterns of interaction that keep members from learning—individually and as a team. Thinking systemically, seeing patterns and the “invisible fabrics of interrelated actions, which often take years to fully play out their effects on each other.” Systems thinking ties all the other disciplines together. This kind of thinking involves “a shift of mind from seeing parts to seeing wholes, from seeing people as helpless reactors to seeing them as active participants in shaping their reality.” If one were to explain systems thinking in terms of an equation, he says, it would not be “A causes B” but rather “A causes B while B causes A, and both continually interrelate with C and D.” Senge notes that the significant and enduring innovations come about when people from multiple constituencies work together. Many of Senge’s ideas are echoed by Kanter, Stein, and Jick in The Challenge of Organizational Change [33]. They focus on how organizations learn to change, emphasizing “the sad fact … that, almost universally organizations change as little as they must, rather than as much as they should.” They characterize learning organizations as “self-designing,” “self-renewing,” and “post-entrepreneurial.” They are flexible and open, and all levels of development—individual, team, work group, and organizational—occur simultaneously and synergistically.

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Successful change requires (crucial for Robotic Surgery Programs): • Build new relationships. A crucial first step in any process of effecting change is what David Mathews calls “banding together.” It means forming relationships, organizing, and claiming collective responsibility for a given issue or situation. The key is to develop a sense of group identity as well as a sense of agency. Banding together generates “a sense of the possibility for change.” Being associated with and committed to others gives people a feeling that they are equal to their problems. It is therefore an essential prerequisite to bringing about desired changes. • Discuss and deliberate. All effective change strategies hinge on discussion and deliberation. At a minimum, discussion allows the issues to be named and framed. It also helps individuals develop a shared perspective. Most fundamental change activities break down because those involved in them do not take the time to gain a shared model of reality. At a more fundamental level, dialogue allows a “higher social intelligence.” One of the chief obstacles to change is that we’ve organized our societies by algorithms—that is, by sets of rules by which we try to affect each other like parts of a machine. The result is that we can’t talk with each other about things that are really important. Dialogue helps to eliminate false divisions among people, builds common ground, and allows for the emergence of a more systemic perspective. • Develop shared visions and goals. Setting new directions for the future is one of the most powerful ways of effecting change. When people come together “in such a way that their individual visions can start to interact,” as Peter Senge puts it, a creative tension is established that gives focus, direction, and context to changes as they occur. Some techniques for developing common visions include future commissions, research conferences, and visioning meetings in which participants develop “best-case” scenarios and articulate common goals. As Senge says, “we communicate our individual visions to one another and eventually start to create a field of shared meaning where there really is a deep level of trust and understanding— and we gradually begin to build a shared vision.” This process is very different from such perfunctory strategies as writing “vision” statements. It often involves a great deal of reflection, listening, and mutual understanding. • Foster social capital. The term “social capital” is used to denote the networks and norms of trust and reciprocity that characterize healthy social orders. The term suggests that capital can be measured in social as well as economic terms and that relationships have an inherent value. • Ensure broad participation and diversity. Fundamental change is impossible without the participation of everyone who has a stake in the problem or issue. Without the

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full participation of all concerned, perspectives will be missing, and there is a good chance that some of the issues involved will go unaddressed. Another aspect of this is the inherent value of diversity. Research has shown that homogeneity fosters stability, while diversity invariably produces change. It follows that planned change is best achieved by promoting diversity. Determine leadership roles. There are many types of leaders, but the “right” leaders lend cohesion to a group and act as the catalyst for change. Their vision, drive, and personal commitment can be keys to galvanizing a group into action. Also, leaders are able to champion and protect those who are most willing to risk change. Identify outside resources. Fundamental change tends to be difficult and painful and always involves uncertainty and risk. Since most communities and organizations that embark on the journey need outside help, they need to develop linkages to outside sources of capital and information. These linkages not only facilitate the process of change but also often provide opportunities for lateral learning and growth. Set clear boundaries. When planning for specific kinds of change, it is important to operate within clearly defined boundaries—for both psychological and practical reasons. Boundaries provide frameworks for measuring change and give focus and direction to one’s efforts. Realistic boundaries also provide a sense of what is feasible. On a practical level, clearly defined goals allow one to make realistic plans. Draw on the examples of others. Change takes place in an infinite variety of ways, and there is no single strategy that will work for every individual or group. Still, those seeking to effect change may take comfort and inspiration from the examples of others. Not only does this provide mentors from whom they can learn, but it offers them conviction that their goal is attainable. Adopt a change mindset. It is natural to seek change after a crisis. Necessity, after all, is the mother of invention. However, to be successful, one has to adopt a crisis perspective without a crisis or at least a mindset that is ­constantly attuned to change. What is required is a shift of perception from seeing change as disequilibrium to seeing it as a constant. Strategizing for change ultimately comes down to whether individuals are motivated to change, learn, and grow.

4.3.2 Disruptive Innovation Disruptive Innovation (DI) theory was advanced by the Harvard Business School Professor, Clayton M. Christensen, in 1997, in the book The Innovator’s Dilemma [34–37]. According to Christensen, a disruptive innovation is an

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4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick…

innovation that creates a new market and value network and eventually disrupts an existing market and value network, displacing established market-leading firms, products, and alliances. According to Christensen, disruptive technologies are technologies that provide different values from mainstream technologies and are initially inferior to mainstream technologies along the dimensions of performance that are most important to mainstream customers. He introduced the important aspects of changing performance with time and plotted the trajectories of product performance provided by firms and demanded by customers for different technologies and market segments and showed that technology disruptions occur when these trajectories intersect (Fig. 4.1). In its early development stage, each product based on a disruptive technology can only serve niche segments that value its nonstandard performance attributes. Subsequently, further development raises the disruptive technology’s performance onto a level which is sufficient to satisfy mainstream customers. While improved, the performance of the disruptive technology remains inferior compared with the performance offered by the established mainstream technology, which itself is improving as well. In fact, the performance of the mainstream technology could have exceeded the demand of mainstream customers, resulting in “performance overshoot” with overserved customers. The market disruption occurs when, despite its inferior performance on focal attributes valued by existing customers, the new product displaces the mainstream product in the mainstream market. There are two preconditions for such a market disruption to occur: performance overshoot on the focal mainstream attributes of the existing product and asymmetric incentives between existing healthy business and potential disruptive business. Christensen documented these technology and market dynamics in numerous contexts such as hard disk drives, earthmoving equipment, and motor controls.

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gi olo chn s e t f s eo gre Pac pro Performance

Fig. 4.1  Three critical elements of disruptive innovation are depicted in this figure. First, in every market, there is a rate of improvement that customers can utilize or absorb, represented by the dotted line sloping gently upward across the chart. Second, in every market, there is a distinctly different trajectory of improvement that innovating companies provide as they introduce new and improved products. The third critical element of the model is the distinction between sustaining and disruptive innovation

The problem with conflating a disruptive innovation with any breakthrough that changes an industry’s competitive patterns is that different types of innovation require different strategic approaches. To put it another way, the lessons we’ve learned about succeeding as a disruptive innovator (or defending against a disruptive challenger) will not apply to every instance in a shifting market. If we get sloppy, then managers may end up using the wrong tools for their specific context and reduce their chances of success (think RS). Disruptive innovations are made possible because they get started in two types of markets that are usually overlooked by incumbents: low-end footholds and new market footholds. Low-end footholds exist because incumbents typically try to provide their most profitable and demanding customers with ever-improving products and services, and they pay less attention to less-demanding customers. In fact, incumbents’ offerings often overshoot the performance requirements of the latter. This opens the door to a disrupter that is focused on providing those low-end customers with a “good enough” product. In the case of new market footholds (think RS), disrupters create a market where none existed. Put simply, they find a way to turn nonconsumers into consumers. For example, in the early days of photocopying technology, Xerox targeted large corporations and charged high prices in order to provide the performance that those customers required. School librarians, bowling-league operators, and other small customers, priced out of the market, made do with carbon paper or mimeograph machines. Then in the late 1970s, new challengers introduced personal copiers, offering an affordable solution to individuals and small organizations—and a new market was created. From this relatively modest beginning, personal photocopier makers gradually built a major position in the mainstream photocopier market that Xerox valued.

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Disruptive innovations don’t catch on with mainstream customers until quality catches up to their standards. Disruption theory differentiates “disruptive innovations” from “sustaining innovations.” “Sustaining innovations” make good products better in the eyes of an incumbent’s existing customers. “Disruptive innovations,” on the other hand, are initially considered inferior by most of an incumbent’s customers. Typically, customers are not willing to switch to the new offering merely because it is new, has future potential, or is less expensive. Instead, they wait until its quality rises enough and early wins are recorded. There are subtle aspects to disruptive innovation: • Most every innovation—disruptive or not—begins life as a small-scale experiment. Disrupters tend to focus on getting the business model, rather than merely the product, just right. When they succeed, their movement from the fringe to the mainstream first erodes the incumbents’ market share and then their profitability. This process can take time, and incumbents can get quite creative in the defense of their established franchises. Complete substitution, if it comes at all, may take decades because the incremental profit from staying with the old model for one more year invariably trumps proposals to write off the assets in one stroke. The fact that disruption can take time helps to explain why incumbents frequently overlook disrupters. • Disrupters often build business models that are very different from those of incumbents. For example, by building a facilitated network connecting application developers with phone users, Apple changed the computer game. The iPhone created a new market for internet access and eventually was able to challenge desktops and laptops as mainstream users’ device of choice for going online. • Some disruptive innovations succeed; most don’t. A common mistake is to claim that a company is disruptive by virtue of its success. But success is not built into the definition of disruption: Not every disruptive path leads to a triumph. Rather, it is the manner in which the path is implemented that dictates triumph (think RS). In order to drive disruptive innovation, it is imperative to pay attention to more than the product. Organizational change is the foundation of implementing disruptive innovation in a successful manner. There are four components of organizational preparedness for a disruptive innovation: (1) human resources, (2) organizational culture, (3) resource allocation, and (4) organizational structure. These concepts are highly relevant to RS. Human Resources  There are two subgroups within the scope of human resources, managers and employees. Each subgroup may be responsible for the success or failure of meeting the challenge of implementing a disruptive innova-

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tion. First, senior managers may not understand the promise of the disruptive innovation because their views of the world are deeply entrenched and largely shaped by their current experiences. Most of them have been trained in conventional business programs which teach them to manage organizations that serve established markets with well-defined product lines. Therefore, an additional team at the corporate level is required to be particularly responsible for collecting disruptive innovation ideas and seeing them through to implementation. Moreover, long-term-oriented, subjective-based incentive plans should be adopted instead of short-term-­ oriented, formula-based incentive plans for key executives. This concept ensures that the senior managers will not be confined by rigid incentives which will lead them to avoid the risks of disruptive innovation. Second, since most strategic proposals take their fundamental shape at the lower levels of hierarchical organizations, middle managers also matter. As middle managers usually have the most to lose in any basic change, they are likely to allocate their resources to Sustaining Innovations that bolster their current fiefdom and careers. Third, there may be different performances between founders and professional managers in disruptive innovations. Founders have an advantage in tackling disruption because not only they wield the requisite political clout but also they have the self-confidence to override established processes. Research has also been done to explain the success or failure of disruptive innovations from the employees’ perspective. For example, the team research on a successful disruptive project found that the team members were composed of carefully selected risk-takers and that the firm also recruited outside expertise. In terms of decision-making, Christensen argued that capturing ideas for new growth businesses from people in direct contact with markets and technologies can be far more productive than relying on analyst-laden corporate strategy or business development departments as long as the troops have the intuition to do the first-level screening and shaping themselves. In following process of implementation for the disruptive idea, instead of accepting one-size-fits-all policies, executives should spend time ensuring that capable people work in organizations with processes and values that match the task. Another interesting observation is that disruptive companies are usually founded by frustrated engineering teams from established firms. Hence, the incumbent firms should take measures to prevent disruption from outside due to brain drain of talents and disruptive ideas. One solution to this problem would be to establish spin-offs within the larger organization (think semiautonomous specialty robotic teams). Organizational Culture  A firm’s culture is a critical component of its success. Culture is an effective way of controlling and coordinating people without elaborate and rigid

4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick…

formal control systems. However, culture is a double-edged sword that sometimes results in the failure of innovation. Without constant vigilance, at times cultural inertia is difficult to overcome by managers even when they know that it is needed. Hence, it is important for incumbents to prepare for, and institute, organizational change and unlearn deeply entrenched values in the early phases of instituting a potentially disruptive innovation. On the other hand, some integral elements of culture, such as entrepreneurship, risk-taking, flexibility, and creativity, should be preserved and valued in order to develop disruptive innovations. Therefore, it is appropriate to conclude that: • Although implementing change is necessary and is indeed the lifeline of any organization and humanity as a whole, it is difficult to implement change, especially in a highly established conservative organization. • Introduction and successful implementation of disruptive innovation and change require a multifaceted approach. • Robotic surgery is a disruptive innovation which is introduced to the highly conservative world of surgery, and therefore, the implementation of a successful program in robotic surgery needs to follow the complex and multifaceted approach. • The implementation of nuclear propulsion into the United States Navy is an excellent example of the introduction of a disruptive innovation into a very conservative culture and, therefore, can provide valuable insights and a blueprint for the implementation of a successful program in robotic surgery.

4.4

 essons About Organizational L Change and Implantation of Disruptive Innovation from the Nuclear Navy

4.4.1 Hyman G. Rickover Hyman George Rickover was born in the Polish city of Makow, then part of the Russian Empire, on January 27, 1900. Fleeing from anti-Semitic Russian pogroms during the Revolution of 1905, Rickover made passage to New  York City with his mother and sister in March 1906. Rickover gained admission to the United States Naval Academy in 1918 and was commissioned an ensign in 1922. After services on the destroyer USS Nevada, he returned to the Naval Academy for additional training in electrical engineering. In addition, he received a Master of Science degree in Electrical Engineering from Columbia University in 1929. From 1929 to 1933, he was assigned to the submarine service. While posted to the Office of the Inspector of Naval Material in Philadelphia, Pennsylvania, in 1933, he trans-

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lated the German book on submarines, Das Unterseeboot. The only command of his naval career came in 1937, when he was put in charge of the minesweeper USS Finch. His acceptance as an engineering duty officer in 1939 removed him from consideration for any further commands. During World War II, Rickover served in the Navy’s Bureau of Ships as head of the Electrical Section, where his performance earned him a Legion of Merit medal. Following the war, in 1946, Rickover was one of a group of naval officers sent to the Oak Ridge National Laboratory, Tennessee, to study nuclear engineering. Later, Rickover was reassigned to the Bureau of Ships but also managed an assignment with the newly formed Atomic Energy Commission in its Division of Reactor Development. Skillfully using these twin roles, Rickover built support for the concept of nuclear submarines. When the Bureau of Ships created a Nuclear Power Branch of its Research Division in August 1948, Rickover was made its head. By 1949, Rickover was using his industry connections to advance research initiatives. At the time, two competing concepts for cooling nuclear submarine reactors were available: (1) cooling by pressurized water and (2) cooling by liquid metal. Rickover wanted to try both of them, so he arranged with Westinghouse in 1949 to investigate the pressurized water approach and with General Electric in 1950 to pursue a liquid sodium approach [38, 39]. Hyman Rickover is universally regarded as the father of the US Navy’s nuclear submarine program and indeed “Father of the Nuclear Navy.” Having experienced submarine service before World War II, after the war, Rickover realized that nuclear power had the potential to remove many limitations on submarine design. During the Second World War, submarines comprised less than 2% of the US Navy but sank over 30% of Japan’s navy, including eight aircraft carriers. More importantly, American submarines contributed to the virtual strangling of the Japanese economy by sinking almost 5 million tons of shipping—over 60% of the Japanese merchant marine. However, victory at sea did not come cheaply. The submarine force lost 52 boats and 3506 men. World War II submarines were basically surface ships that could travel underwater for a limited time. Diesel engines gave them high-surface speed and long range, but speed and range were severely reduced underwater, where they relied on electric motors powered by relatively short-lived storage batteries. Recharging the storage batteries meant surfacing to run the air-breathing diesels. Even combat patrols routinely involved 90% or more surface operations. Submarine service was deadly for the enemy, but unfortunately due to the shortcomings of the diesel propulsion technology, it was even more deadly for the men who served on the submarine. Rickover’s vision resulted in the launching of the world’s first nuclear-powered submarine in 1954, the USS Nautilus. Rickover’s faith in nuclear submarines was vindicated, when the USS Nautilus became the first submarine or naval vessel

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of any kind to be propelled entirely with nuclear power and sailed silently and without detection under the North Pole during a 4-day, 1830 mile cruise from the Atlantic to the Pacific on August 3, 1958. The Nautilus employed the pressurized water method of reactor cooling. The Navy’s second nuclear submarine, USS Seawolf, was powered by a reactor using liquid sodium cooling. Rickover was the only officer in the history of the US Navy to be promoted by an act of Congress. When Rickover was not promoted to rear admiral twice due to political issues in the Navy, his many supporters in Congress forced hearings, and by an act of Congress, Rickover was promoted to rear admiral in 1953, vice admiral in 1958, and admiral in 1973. President Richard Nixon attended Rickover’s promotion to admiral in 1973. Nixon’s words clearly summarize Rickover’s legacy: I don’t mean to suggest that he is a man who is without controversy. He spoke his mind… But the greatness of the American Military Service … is symbolized in this ceremony today, because this man, who is controversial, this man, who comes up with unorthodox ideas, did not become submerged by the bureaucracy, because once genius is submerged by bureaucracy, a nation is doomed to mediocrity [40].

Not only did Rickover build the first nuclear submarine, but through his “Leadership and Organizational Principles” which were woven into the fabric of the “New” Navy, he transformed the Navy, America, and indeed the entire World. The US Navy’s fleet of nuclear submarines, starting with the 1954 launching of the Nautilus, undermined the USSR’s assured second-strike capabilities and tilted Cold War geopolitics in the favor of the United States. Admiral Hyman G.  Rickover oversaw the successful development of the nuclear submarine, and in the process, he gathered a team of people that would inculcate a system of continuous improvement into submarines. The technical breakthrough that he oversaw was so significant, and the cultural change he imposed was so vast, that in a few years after the submarine Nautilus first took to the seas, nuclear power had transformed an auxiliary warship of World War I and World War II into a stealth platform that ruled the oceans and unbalanced the Cold War. With nuclear submarines, the United States controlled the surface as well as what moved in the waters below the sea. A warship that had been an afterthought in previous history became, with nuclear power, the point of the spear in the Cold War. Rickover and the Navy built such a superior platform that the US nuclear submarines could go under the ice and into Soviet waters at will. In addition, shrouded in secrecy, Nautilus’ successors could penetrate any and all underwater defenses that the Soviets could develop. Interestingly, in December 3, 1989, during the summit meeting that marked the end of the Cold War, Sergei Akhromeyev—a marshal of the Soviet Union and Mikhail

Gorbachev’s personal military advisor—told George H. W. Bush, “We have read every one of your submarine messages for ten years and have been unable to find or kill even one of them. We quit” [41]. On January 31, 1982, after 63  years of service to his adopted country under 13 different presidential administrations, Admiral Rickover retired. His tenure as head of the Navy’s nuclear program ran so long because, due to his unparalleled insight and knowledge, he was declared exempt from the mandatory retirement age for senior admirals by a Congressional Resolution. Admiral Rickover died on July 8, 1986. Quite fittingly, he is memorialized in the attack submarine USS Hyman G. Rickover (SSN 709).

4.4.2 Why Is Rickover Important? What lessons can robotic surgery learn from Rickover? Until the early nineteenth century, oars powered by men, or the wind, were the principal means of watercraft propulsion. Steam propulsion was introduced and developed in the nineteenth century. First steam was generated using coal. In the early part of the twentieth century, the British Navy, the most powerful navy of the time, switched to using diesel oil for generating steam and later for use in diesel electric propulsion systems. Of interest, the dependence of the British and other Navies on oil became the important determinant of political struggles of the twentieth century. By the end of World War II, diesel electric naval propulsion was the state of the art. Until the dawn of the nuclear age, all naval propulsion systems depended on fuel which was finite and needed to be reloaded at intervals. This represented the “Achilles heel” of the naval vessels. The dawn of the nuclear age brought about the potential of a quantum change in naval propulsion. A nuclear reactor held the promise of inexhaustible fuel and, by extension, allowed for stealth and omnipresence of the naval vessels throughout the world’s waters. As the nuclear propulsion system represented a quantum leap in technology, the resultant organizational changes to the Navy represented a quantum leap in culture change that was necessary for the safe implementation of this potentially uncontrollable force. America’s nuclear fleet was not built in a vacuum. Rather, it was built by the vision and leadership skills of one man, Hyman G.  Rickover. The best measurement of Rickover’s success is in the record for “reactor accidents.” The United States has never had a nuclear reactor accident aboard a submarine. This is in sharp contrast to the Soviet Navy that has had at least 13 “reported” nuclear accidents. What were Rickover’s management methods, and to what extent can robotic surgery learn from that experience?

4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick…

Culture Change: Rickover believed that nuclear technology could not be safely introduced unless the naval culture changed dramatically. Rickover believed that “culture” tends to stifle change and reform. He referred to culture as a “window shade.” The lower the shade, the less glare from the sun inside and the more comfortable it is for the people working in the room. However, with the shades down, outside events may pass unseen. With the shades down, few people inside can recognize that the outside world is changing. As a culture becomes stronger, it is equivalent to pulling the shades even lower. Rickover believed that without change, the very military culture that helps people aggressively engage in conflict and assures individuals that the travails of military service are natural, courageous and patriotic can spell their doom. He believed that military or organizational culture encourages preparation “to fight the last war” as opposed to preparing to fight “the next war.” Indeed, resistance to culture change is the most dangerous path for a military force or any organization. He believed that culture needed to change in order to assure the continued survival of the military, the country, and the species. Rickover believed that humanity’s resistance to change, which emanates from fear and a sense of complacency and weakness, is in direct conflict with nature’s need for evolution and change. It does not require great imagination to extrapolate from the experiences of the military to the culture in the surgical theater and medicine in general. Good ideas are not adopted automatically they must be driven into practice with courageous impatience. Hyman G. Rickover [42]

At great personal and political cost, and at the great displeasure of the Navy, Rickover started by advocating that his nuclear submarines be built by privately owned shipyards. Under this scenario, he believed that the boats would be built to his standards, as he controlled the money. He avoided shipyards commanded by Navy’s admirals who may not have shared his vision. He believed that public shipyards used old processes and procedures and consequently were not suitable for the new nuclear propulsion technology. In what was the most disruptive aspect of the nuclear transformation, Rickover made it clear that most of the officers who had previously served on diesel submarines, the same individuals who had just won the war in the Pacific, were not welcome on nuclear submarines. Clearly, this decision reflected his conviction that the culture needed to change and all efforts needed to be undertaken to be certain that the new culture would not be hindered by habits of old. He respected the culture of the “Old” Navy which was represented by the extraordinary group of brave sailors whose personal boldness compensated for the World War II era submarines’ lack of armor, stealth, and speed. However, he felt that the “new” nuclear submarine force needed a culture

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that emphasized science and safety, in addition to bravery. In short, though the diesel submariners of World War II comprised the highest percentage of servicemen of any branch of the armed forces to have been killed in action during the war, Rickover believed that the nuclear Navy required brains over brawn. Therefore, he set out to train a whole new breed of sailors for America’s Silent Service. Rickover interviewed and personally selected all the officers of the nuclear submarine force. Rickover believed that the “New” culture needed to emphasize absolute safety of the nuclear fleet to the men who served on the ships and, equally importantly, demonstrate safety to the American public. He was convinced that any deviation from perfection of the systems and personnel would bring an end to the nuclear Navy. Therefore, the only requirement demanded by Rickover for his officers and the entire nuclear Navy was absolute perfection. Robotic surgery has a lot to learn from this vision!

4.4.2.1 Planning for Success Many maintain that a real leader can do it all and manage anything. Rickover knew that this was incorrect. He believed that a real leader needs to depend both on a dynamic personality, as well as an absolute knowledge of the field. Rickover believed that all that matters is the job at hand. He believed that the leader needed to have the ability to evaluate a situation without worrying about how the assessment would affect his relationships with other stakeholders. He believed that the difference between a manager and a leader was that a leader had the extraordinary ability to see the future and to recruit individuals who, even though were different from him, could better serve the enterprise. “More than ambition more than ability it is rules that limit contributions; rules are the lowest common denominator of human behavior. They are a cheap substitute for rational thought” [43]. 4.4.2.2 Details, Details, Details Rickover believed that the person in charge must concern himself with details and be realistic. He warned against the natural naïveté of a startup. He felt that in a new endeavor, people become overenthusiastic. As a consequence, those driven by enthusiasm, rather than the details, may well believe that the endeavor is more robust, capable, and survivable than it actually is. The misplaced enthusiasm about the endeavor results in forgetting the main goal. Rickover believed that absolute attention to detail, clear view of the facts, and perfection were paramount in situations where human life was at stake. The devil is in the details but so is salvation Hyman G. Rickover [44, 45]

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Clearly, the world of robotic surgery needs to learn from Admiral Rickover’s principles. There are many examples where enthusiasm about the technology has resulted in adverse results. Surgeons need to be reminded that enthusiasm about the possibilities and potential of robotic surgery cannot take the place of the main goal which is perfection of surgery and the absolute conviction to assure the needs and safety of the human patient.

4.4.2.3 Education Admiral Rickover was an education expert. He believed that he well understood what could be taught and what could not. Rickover believed in education as opposed to indoctrination. Rather than picking engineers like himself and trying to teach charisma, he instead recruited natural leaders who could learn engineering. Rickover believed that just like the natural and much-­ needed periodic change in culture, educational systems, which had been designed for different points in time, needed to change in order to reflect a new paradigm. He believed that the system of education in the military was rooted in the past, and he single-handedly transformed the system and set its path for the future.

Other quotes from Admiral Rickover which clearly reflect his extraordinary vision: sit down before fact with an open mind. Be prepared to give up every preconceived notion. Follow humbly were ever into whatever abyss nature leads or you learn nothing. Don’t push out figures when facts are going in the opposite direction. Hyman G. Rickover [48, 49] One must permit his people the freedom to seek added work and greater responsibility. In my organization, there are no formal job descriptions or organizational charts. Responsibilities are defined in a general way, so that people are not circumscribed. All are permitted to do as they think best and to go to anyone and anywhere for help. Each person then is limited only by his own ability. Hyman G. Rickover [50] It’s a human inclination to hope things will work out, despite evidence or doubts to the contrary. A successful manager must resist this temptation. Hyman G. Rickover [51] Do not regard loyalty as a personal matter. A greater loyalty is one to the Navy or to the country. Hyman G. Rickover [52] All men are by nature conservative but conservatism in the military profession is a source of danger to the country. Hyman G. Rickover [53]

What it takes to do a job will not be learned from a management course …Human experience shows that people, not organizations or management systems get things done. Hyman G. Rickover [46]

To doubt one’s own first principles is the mark of a civilized man. Don’t defend past actions; what is right today may be wrong tomorrow. Hyman G. Rickover [54]

Following Rickover’s example, medical education needs to set aside the ideas of the twentieth century and undertake a different path which is designed to respond to the needs and expectations of the twenty-first century.

We should value the faculty of knowing what we ought to do and having the will to do it…The great end of life is not knowledge, but action. Hyman G. Rickover [55]

4.4.2.4 Responsibility and Owning the Problem Rickover believed that each individual member of the team needs to be responsible for the success of the entire project. He believed that being a cog in a wheel is not a stigma, but to the contrary, depending on how it is perceived, should be a great source of pride. Rickover emphasized that if safety was of paramount concern, no jobs or roles in the nuclear Navy were less important to others. Each role mattered if the ultimate goal was service to a higher ideal, such as safety of a nuclear warship or safety of a nation, as opposed to service to self. Unfortunately, the concept of pride of membership in a collective enterprise is at times mistaken for lack of individualism. Rickover, who was an immigrant to the United States, believed that the greatest source of pride and personal fulfillment was citizenship and service to America. Responsibility is a unique concept … You may share it with others, but your portion is not diminished, You may delegate it, but it is still with you … If responsibility is rightfully yours, no evasion, or ignorance or passing the blame can shift the burden to someone else. Hyman G. Rickover [47]

To summarize, a robotic surgery program, in fact any successful enterprise, would do well to follow the leadership principles from Admiral Rickover that were instrumental in bringing about fundamental change to the United States Navy. Admiral Rickover understood the need for a culture change not only in his program but the entire organization of the Navy, handpicked the naval officers, demanded perfection and ownership of the enterprise, was driven by the truth, focused on the details, instituted a new paradigm in education, and ironically but quite appropriately, was dedicated not to the success of his program but the best interest of the nation. Undoubtedly, success would be the only possible outcome for a robotic surgery program which is designed using this blueprint.

4.4.3 C  hanging to a Culture That Strives for Greatness In following the Rickover blueprint, culture change is Job One. However, the culture needs to change not to any culture but a culture of greatness.

4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick…

The complex problems which face American medicine are well known. However, despite all the challenges in terms of cost and availability of health care, medical care in America remains the envy of the world. Yet, from the standpoint of patients and physicians, there are many shortcomings that must be addressed urgently. This paradox has its roots in the fact that at the point of delivery of health care, everyone expects greatness. Good is not good enough! When it comes to the delivery of health care, and especially complex programs such as those which offer robotic surgery, the expectation, no the demand, of the patients and therefore the surgeons and the entire health-care delivery system must be greatness. In medicine, good does not exist. There is bad, there is great, and all in between is mediocrity. It is imperative to understand that based on the data and observations of the past 20 years, robotic surgery programs, which have been built based on surgical greatness, great patient experience, and the underlying foundation of a great institution, have enjoyed exceptional success. On the other hand, if any of the pillars of greatness were absent, the robotic surgery program has been doomed to fail. These observations lead to one paramount question. How can greatness be assured? In part, the answer comes from the Business Sector. Almost 20  years ago, Jim Collins of Stanford Business School asked the question: Why do some companies make the leap to greatness and others don’t? The answer to this question is the subject of the book Good to Great [56]. Collins and 21 researchers from Stanford Business School examined the business performance of over 1400 companies from 1965 to 1995. They defined business greatness very rigorously. To be included in the study, the company needed to begin with a 15-year cumulative stock return at or below the stock market. To be considered a great company, it needed to go through a transition point, after which its cumulative return was to rise to at least three times the market for the next 15 years. In addition, the growth of the company needed to be independent of its industry. In fact, to be considered as great, the company had to achieve its astronomical market growth in a sagging industry. To illustrate the very high standard for the definition of greatness, Collins pointed out that between 1985 and 2000, a mutual fund comprised of the most successful companies in the United States, 3M, Boeing, Coca Cola, HE, HP, Intel, J&J, Motorola, Pepsi, Proctor and Gamble, Walmart, and Walt Disney, only achieved a cumulative stock return 2.5 times the market, and therefore none of the companies, alone or even as a group, would meet the criteria for greatness. Of the over 1400 companies, 11 met the very high standards for greatness: Abbott, Circuit City, Fannie Mae, Gillette, Kroger, News Corp, Phillip Morris, Pitney Bowes, Walgreen, and Well Fargo. All these historically underper-

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forming companies went through a specific transition point after which they reached the degree of success which could meet the inclusion criteria for greatness. The factors which were responsible for the transition point can provide a clear path to achieving greatness for a company, a program, or an institution. In our experience, these are the very factors that are crucial for building a successful robotic surgery program. Greatness was achieved by the combination of three components: (1) disciplined people, (2) disciplined thought, and (3) disciplined action.

4.4.3.1 Disciplined People An organization achieved greatness by combining “Level V” leadership with the “right” people. Leadership is defined in five levels. A “Level I” leader is a capable individual. A “Level II” leader is a contributing team member. A “Level III” leader is a competent manager. A “Level IV” leader is an effective manager. A “Level V” leader is an individual with an unwavering will to succeed. This leader shows uncompromising commitment to the enterprise rather than self, accepts all responsibility, and attributes all the success to the members of the organization. A “Level V” leader is rigorous but not ruthless and sets the tone for the rest of the organization. In turn, a great organization concentrates on recruiting and retaining the “right” people and, more importantly, disinheriting the “wrong” people. A great organization sees that people are not its most important asset; rather, the “right” people are its more important asset. Unlike most companies, a great organization directs its best people to the biggest opportunities instead of the biggest problems. 4.4.3.2 Disciplined Thought A great organization does not avoid reality; rather, it actively seeks to face the “brutal” facts. It provides a forum in which the truth is heard, adversity is confronted, and decisions are made only after facing the brutal facts. A great organization adheres to the “Stockdale Principle,” named after the senior US prisoner of war officer in the Hanoi Hilton Prison of War Camp during Viet Nam, which outlines an unwavering commitment to prevail regardless of difficulties. We will never give up, we will never capitulate. It might take a long time, but we will find a way to prevail. James Stockdale, Admiral USN [57]

Finally, as the ultimate expression of disciplined thought, a great organization builds a culture around an entrepreneurial spirit which juxtaposes freedom as well as responsibility within the organizational framework. A great organization fills its culture with self-disciplined people with a sense of ownership, who will go to extreme lengths to fulfill their responsibility.

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4.4.3.3 Disciplined Action A great organization defines its mission and work product with absolute clarity and pursues success with a combination of passion, unparalleled excellence, and attention to the economic engine of the enterprise. A great organization strives to be a pioneer in the careful application of technology ahead of the competition. It strives to be a “clock maker” rather than a “time teller.” With absolute compulsion, a great organization pursues a path of driving unrealized potential into results. Finally, a great organization remains on the same path for the long term and resists the doom loop. The doom loop, which characterizes failed organizations, is defined as frequent course changes by leaders who are motivated by ego and self-interest in search of short-term success. Organizations in the doom loop invariably experience greater disappointment and poor performance. In response to these disappointments, without insight into the complex factors, the organizations in the doom loop change leadership, only to begin the doom loop yet again. On the other hand, a great organization sustains its greatness by emphasizing purpose and profit, continuity and change, freedom, and responsibility.

4.4.4 C  ulture of Greatness in the Operating Room We want to believe that the failure of others is due to lack of intelligence or skill because we want to convince ourselves that we would succeed at a similar endeavor despite the obvious risks, when, in fact, most of the mistakes are cognitive traps, independent of intellect or expertise. Educator Michael Roberto [58]

The operating room is a complex environment with a culture that, amazingly, has not changed greatly in more than a century. Recently, there has been recognition of the myriad of cultural problems in the operating room that result in poor patient outcomes. Ironically, despite multiple nationwide and global patient safety initiatives over the past decade, recent reports reveal that adverse event rates for surgical conditions remain unacceptably high and, disappointingly, have remained almost unchanged [59–61]. Adverse events resulting from surgical interventions are actually more frequently related to errors occurring before or after the procedure than by technical surgical mistakes during the operation. These include (i) breakdown in communication within and among the individuals in the operating room, care providers, patients, and their families, (ii) delay in diagnosis or failure to diagnose, and (iii) delay in treatment or failure to treat [62–64]. In general, there is broad agreement that the adverse events in the operating room are mostly the result of (1) communication gaps between the surgeons and staff

and/or patient, (2) lack of organizational processes to prevent errors, (3) miscommunication, (4) lack of a culture of safety, (5) ineffective conflict resolutions, (6) inappropriate leadership and oversight, and (7) lack of specialty-specific surgical and anesthesia teams. Although these factors are crucial for the safe conduct of any surgical procedure, they become even more paramount in establishing a successful robotic surgery program. The most logical processes to improve patient safety in the operating room are as follows: (1) Identify current issues regarding patient safety. (2) Revise systems, education, and training to address known patient safety issues. (3) Educate health-care professionals about the importance of patient safety concepts. Establish a system of checks and balances to reduce medical errors. Ensure practical application of patient safety concepts by training. (4) Enhance patient interaction to reduce errors. It is important to emphasize that based on recent data, even though these and other measures have been instituted throughout the health-care system, in the operating room, the rate of errors has not diminished. Errors are inevitable, but having a system in place to prevent them from occurring, and remedying them when they do occur, improves overall patient safety in the health-care environment. Dante Orlandella and James T. Reason of the University of Manchester originally proposed a model which can help to conceptualize system failure, commonly called the “Swiss cheese model” [65, 66]. Based on this model, to varying degrees, every step in a process has the potential for failure. The ideal system is analogous to a stack of slices of Swiss cheese. Consider the holes to be opportunities for a process to fail, and each of the slices as “defensive layers” in the process. An error may allow a problem to pass through a hole in one layer, but in the next layer, the holes are in different places, and the problem should be caught. Each layer would work as a defense against potential error impacting the outcome. The greater number of defenses, the fewer and the smaller the holes, the more likely you are to catch and stop errors that may occur. The Swiss cheese model of accident causation illustrates that if hazards and accidents are aligned and the layers of defense do not lie between, the flaws in each layer can allow the accident to occur. In the operating room, the “Swiss cheese” concept can be prevented with the implementation of teams. Elite military forces such as the Navy Seals and surgery have a lot in common. They are both examples of high-risk endeavors and environments that result in high risk and high stress. In these and other similar environments, time pressure is significant, there is dependence on functioning proper equipment, and lives are at stake. Elite military forces and all other examples in industry and other fields have learned that a “team” is the key to minimizing risk and maximizing the chances for the successful execution of mission.

4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick…

A number of studies have emphasized that without specific functioning specialty-specific surgical and anesthesia teams, all other measures that are aimed at reduction of surgical errors are doomed to fail. In addition, data from a number of fields, including medicine, has shown repeatedly that “catastrophes” are the result of the failure in communication and lack of coordination of action among individuals who are not part of a team. Nevertheless, the operating room remains the only high-stakes environment that uses interchangeable staff in the conduct of surgical procedures. In the operating room, teams are the exception rather than the norm! Consider this all too common scenario: A complex surgical procedure is scheduled. On the morning of surgery, one of several anesthesiologists is assigned to deliver anesthesia. Operating room (OR) personnel which consist of nurses and surgical technicians are assigned from a general pool to the room. The anesthesiologist and the OR personnel are generalists and work with many surgeons and many surgical specialties. A great of attention is focused on consent forms and the “time-out” procedures. Prior to the start of the surgery, the instruments and sponges are counted by the scrub nurse who begins the case. In the middle of the case, the OR personnel are replaced by other scrub technicians and nurses for “breaks” and “lunch relief.” With each change of personnel, the instruments and sponges are counted again. During the procedure, several changes also occur for the anesthesia personnel. Invariably, by the end of the procedure, a number of OR personnel and anesthesia personnel changes have occurred, the instruments and sponges have been counted multiple times by multiple different people, and the personnel who finish the operation are rarely the same people who started the case. The only constant factor in the operating room was the surgeon and the patient. Clearly, such a common scenario is a potential formula for catastrophic outcomes and is, in large part, responsible for the all too common system-related complications that are reported. Weigmann et  al. showed that lack of operating room teams results in increased surgical errors and disruption of workflow as well as significant loss of overall revenue for the institution [67]. A number of recent studies have shown a correlation between implementation of operating room teams and decreased surgical mortality [68–70]. Neily showed the implementation of formal teams in the operating room correlated with increased efficiency, decreased turnover times, reduced errors, increased staff satisfaction, and increased institutional revenue [69]. Surgery and the aviation industry share some common ground. They are both high-risk and high-stress environments which function based on absolute dependence on the proper function and safety of their respective equipment. An additional area of similarity is that historically both disciplines have relied on a rigid hierarchy for leadership. However, whereas in an attempt to decrease tragic events the aviation

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industry has changed its approach to leadership and teams, regrettably, surgery has remained in the past. Historically, surgeons have used hierarchy in place of a leadership of functioning effective team. In a study by Sexton et  al., surgery teamwork was judged to be far inferior to cockpit crews. The same study found that surgeons have a disproportionately high perception of teamwork and communication in the operating room. 95% of pilots rejected hierarchy and preferred a functioning team. On the other hand, only 55% of surgeons rejected hierarchy [71]. Clearly, a change in the manner of leadership which is provided by surgeons is imperative for a change in culture in the operating room. Surgeon leadership needs to adopt the cockpit crew model. Each individual team member needs to be empowered by ownership and expertise. The surgeon needs to go from being the conductor of the orchestra to becoming the lead in an exquisite ballot that, by definition, does not require a conductor. Much like a world-class ballet company, the hierarchy in the operating room is flattened by the expertise of the team members. Leadership in a crisis is best learned from firefighters whose crisis management and teamwork have been actively studied and improved over time. A sentinel event occurred during a forest fire in Helena Montana in 1949 which revolutionized the training of firefighters for crisis management. In response to a fire in Helena, Montana, 15 randomly selected firefighters were dispatched under the leadership of a senior firefighter, Wag Dodge. These individuals had seldom worked together. Dodge’s initial impression was that the fire was routine. All the team members followed his lead and let their guards down. Suddenly, Dodge sensed that the character of the fire was changing. He ordered the men to go down the hill toward the river. The fire became stronger, raged more quickly, and began to surround them from all directions. Sensing that the situation was out of control, he abruptly ordered the men to drop their tools and run. The men who had not worked with him hesitated and, as the fire began to surround them, instead began running up hill. Seeing that the fire was all around them, Dodge ordered the men to stop and burn the ground around them in order to stop the fire from reaching them. The men who were not familiar with Dodge or the tactic that he was proposing kept running away from the fire. Tragically, 12 of the 14 men died in the fire. Investigation of the tragedy pointed to the need for teams and the importance of team training in response to the crisis. The lessons of the Helena fire are vital for surgery in general and for robotic surgery in particular. Even routine can quickly become a catastrophe as a result of errors in analysis and critical decision-making at the time of changing events and a crisis. A crisis requires skills in advanced technical, communication, and leadership skills. Team dynamics play a fundamental role in the successful management of crises.

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Teams are the nucleus around which the majority of the US military forces are built. This structure allows military teams to accomplish tasks larger in scale and complexity than can readily be accomplished by individual members alone. The collective skills and actions that result when using small units or teams enable the military to quickly and more efficiently accomplish missions [72, 73]. Furthermore, the combination of unique perspectives and backgrounds of team members can enhance creativity and problem-solving. Team science, which has been refined by the military, highlights five major areas: (1) team performance, (2) team processes, (3) team leadership, (4) team staffing, and (5) team training. These lessons are paramount to the establishment of a successful robotic surgery program. Having reviewed more than six decades of research across five areas of team science—performance, processes, leadership, composition and staffing, and training—a number of themes are evident. • Teams can be more effective than the sum of individual team members. Cohesive teams (i.e., strong bonds among members) perform better and stay together longer than do noncohesive teams. Teams can absorb more task demands, perform with fewer errors, and exceed performance based on linear composites of individual performance. • Team cognitive processes play a significant role in team performance. What teams think, how team members think together, and how synchronized team members are in their perceptions and beliefs all significantly contribute to a team’s ability to perform well. • Team processes and performance are cyclical, dynamic, and episodic. Process models provide a structure for understanding and measuring teamwork behavior within and between performance episodes. • Multiteam systems (MTSs) matter. Many teams exist within a broader system of teams; understanding the inter-team leadership, processes, and performance interdependencies is critical to understanding and influencing the performance of any one team. Furthermore, the countervailing and confluent forces within the MTS relationships can create unexpected effects where constructs acting at different levels can reinforce or nullify each other. MTS relationships give teams the on-the-job tools to reflect on their own performance. Synthetic task environments, simulation, give teams a robust environment to focus on learning to work effectively together while performing realistic tasks. Clearly, a successful robotic surgery program needs to be based on a Specialty-Specific Team of individuals comprised of surgeons, anesthesiologist, nurse anesthetists, operating room, and postoperative personnel. The concept of a general robotic team is flawed and has been shown to be ineffective. A func-

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tioning effective team should replace the age-old ineffective method of hierarchical leadership by the surgeon. A functioning and effective team overcomes failure in communication, ensures effective coordination of actions, and ultimately prevents catastrophes. Each individual on the team needs to be empowered, own the enterprise, and strive to excellence in their skill set. The skill of the team members serves to flatten the hierarchy among the various team members. In robotic surgery, even the routine can quickly become a catastrophe through errors in analysis and critical decision-­ making. A crisis requires advanced technical, communication, and leadership skills. Team dynamics play a fundamental role in the successful management of crises.

4.4.5 T  he Culture of Medicine Through Changing Medical Education from Emphasis on Science to Emphasis on the Patient As we will develop in the following discussion about medical education, one of the most important shortcomings of the system which introduces advances in surgery, and in fact the entire mindset in medicine, is that such advances are seen within the context of scientific progress as opposed to the ultimate well-being of the patient. Medicine in the twentieth century developed by attending to science first and patients second. Medicine in the twenty-first century will only succeed by attending to patients first. By extension, the ultimate secret for the success of a robotic surgery program is a change of mindset and singular attention to the ultimate well-being of the patient. Robotics is introduced into medical practice at a watershed moment in the history of medicine. By all accounts, medical education and medical care in the twenty-first century are in a state of turmoil. Consider these facts: • The trust and respect that were extended to the profession have been substantially eroded. • There has been a fall from grace of the “vaunted profession.” • Physicians have lost their authenticity as trusted healers. • The discontent with the doctors’ errors, doctors’ silence about problems in medicine, doctors’ experimentation, doctors’ lack of interest in their patients, and the crass monetary orientation of the profession has been unprecedented and has rivaled similar behavior which stigmatized the profession during the nineteenth century. • The profession appears to have lost its soul while its body is cloaked in a luminous garment of scientific knowledge. • With the loss of its soul, the profession has surrendered its Hippocratic and sacred mission of caring for the sick to

4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick…

business concerns such as health-care organizations and insurance companies which are driven by financial gain and see patients and the ill as a commodity for attaining healthier bottom lines. • Increasingly the direction of health care is determined by individuals with a background in business as opposed to medicine and the healing arts. • “Patient first” has become an overused cliché and a meaningless logo for “big business” in medicine.

4.5

 ow Did This Situation Arise H and What Can Be Done to Save Medicine in the Twenty-First Century?

Undoubtedly, the answer to the future success of health care lies in medical education. Although some believe that medicine is beyond repair or that it needs to be saved by governmental and health-care organizations or even the public, clearly, medicine in the twenty-first century can only be saved by a humanistic system of medical education where future physicians acquire a crucial set of professional values and qualities, at the heart of which is the unwavering commitment to put the needs of the patient first.

4.5.1 T  wentieth-Century Medical Education: The First Part of the Story In the early part of the twentieth century, Abraham Flexner undertook an assessment of medical education in North America. His landmark 1910 report changed the face of American medical education. In the dawn of the twentieth century, medical education was a for-profit enterprise that was producing poorly trained physicians with very little knowledge in the scientific aspects of medicine and even lesser interest in the humanity of their patients. By most accounts, medicine was just another business where financial gain trumped all other considerations. In preparation for his monumental task, Flexner immersed himself in the literature of medical education during the latter part of the nineteenth century and specifically identified with the book Medical Education in German Universities written by the leading surgeon of the time, Theodor Billroth. After visiting some 155 medical schools in the United States, Flexner chose Johns Hopkins as the gold standard for American medical education in the new century. The Hopkins Model which became the standard for university medical education was implemented by William Welch, a pathologist and the founding dean of the Johns Hopkins School of Medicine. Welch had studied the German pedagogic style of medical education and was resolute in the belief that medicine was a scientific discipline that could best

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be realized by a system in which physician scientists were trained in laboratory investigation as a prelude and foundation for clinical training and investigation in university hospitals. In accordance to Welch’s vision, the Hopkins Model was instituted by the first faculty of Johns Hopkins School of Medicine, “The Four Doctors”: William Henry Welch, a Yale-trained Connecticut Yankee and a pathologist; William Osler, a Canadian son of a frontier minister and the first chief of medicine; William Stewart Halsted, a New Yorker, a graduate of Columbia College of Physicians and Surgeons, a student of Theodor Billroth, and the first chief of surgery; and Howard Atwood Kelly, a University of Pennsylvaniatrained gynecologist and the first chief of gynecology. The Hopkins Model dictated that all physicians had the responsibility to generate new information and create progress in medical science. Science as the animating force in the physician’s life was the overarching theme in the Hopkins Model. This concept coincided with the vision for the ideal physician in Flexner’s landmark report. The Flexner report and the Hopkins Model of medical education erected an edifice, not of bricks and mortar but of tradition and science, that became the system of American medical education during the twentieth century. Without a doubt, during the twentieth century, the successful reorganization of medical training had an awesome effect on the breadth and depth of understanding and discovery of disease. Flexner and the Hopkins Model were indeed responsible for creating a pathway that in a short time has taken humankind to the stars. The awe-inspiring achievements of the last century are so evident and widely appreciated as to obviate the need for enumeration. It is hard to believe that in less than a century, medicine has gone from believing in evil humors and ignorance of the microbial world to sequencing the genome. In the face of these monumental strides in human knowledge, ironically, as we enter the twenty-first century, medical education faces yet another period of self-assessment and reform. In the past two decades, more than a score of reports from professional task forces, educational bodies, as well as governmental and nongovernmental organizations have criticized medical education for emphasizing scientific knowledge over the development of a culture of medical education which emphasizes character, compassion, and integrity in the physician who is trained to use an understanding of human biology, clinical reasoning, and practical skills to alleviate human suffering rather than to cure disease. In the century since Flexner’s report, the academic environment has been transformed. Ironically, in academic hospitals, research outstripped teaching in importance, and a “publish or perish culture” emerged. Research productivity became the metric by which faculty accomplishment was judged, and teaching, caring for patients, and addressing broader public health issues were viewed as less important

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activities. In addition to the shift in the importance of research relative to teaching and patient care, medicine in the twentieth century witnessed a transformation in the process of research on human disease from clinical investigation to the molecular aspects of disease. Whereas prior to the 1960s the distinctive feature of American medical education was the integration of investigation with teaching and patient care, with each serving the other’s purposes, after the 1960s, patients were bypassed in most cutting-edge investigations, and immersion in the laboratory became necessary for the most prestigious scientific projects. Clinical teachers found it increasingly difficult to be first tier researchers, and fewer and fewer investigators and medical faculty could bring the depth of clinical knowledge and experience to the education of the new physicians. The education of new physicians was gradually relegated to young inexperienced faculty or physicians outside the university who are engaged in the private practice of medicine. Many clinical teachers in universities across America no longer exemplify Flexner’s model of the clinician investigator. Medical students and residents are often taught clinical medicine either by faculty who spend very limited time seeing patients and honing their clinical skills, and unfortunately see this practice of medicine as a necessary chore for the advancement of their careers as basic science investigators, or by practitioners who have little familiarity with modern biomedical science and see teaching as a distraction to their busy clinical practices. The increasing turbulence of the health-care environment in the past 20 years has generated a second set of conditions which have further eroded the education of new physicians. Clinical teachers have been under intensifying pressure to increase their clinical productivity and generate revenue by providing patient care. The harsh commercial atmosphere of the marketplace has permeated many academic medical centers and is characterized by new terms that have been introduced into the teaching environment: “throughput,” “market share,” “units of service,” and “the bottom line.” The emphasis on the science rather than the patient, and the culture of medical practice which has resulted from the Flexnerian twentieth century system of medical education, has forced physicians in all aspects of medical practice and education to relinquish control to those in the business of medicine. Indeed, at this time, health care as a “big business” threatens the primary mission of medicine as a “calling in service of the ill and humankind.” In the twenty-first century, medical education of the twentieth century is indicted for emphasizing the discovery and transmission of knowledge instead of teaching the values of the profession with an emphasis on humanism as a framework for imparting skills and transmitting knowledge to the new physicians.

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Did the Hopkins model take the profession down a pathway that threatened the loss of what should be nonnegotiable to all physicians? Did this model overlook the ethos of medicine in its blind passion for science and the advancement of medical knowledge? In truth, a firsthand examination of the Flexner report reveals the unfortunate fact that, indeed, in addition to a scientific foundation for medical education, Flexner envisioned a clinical phase of education in academically oriented hospitals, where thoughtful clinicians would pursue research stimulated by the questions that arose in the course of patient care and teach their students to do the same. Counter to widely held yet mistaken belief, to Flexner, research was not an end in its own right; research into disease was important because it led to better patient care and teaching. Clearly during the twentieth century, the way in which future physicians encountered the knowledge base of medicine was profoundly influenced by the assimilation of medical education into the investigational culture of the university. Theoretical, scientific knowledge formulated in context-free and value neutral terms became the primary basis for medical knowledge and reasoning. This knowledge was grounded in the basic sciences; however, by all accounts, there was a less robust accommodation for the practical skills and distinct moral orientation required for successful practice of medicine in the twenty-first century. It is important to note that Flexner had not intended that such knowledge should be the sole or even the predominant basis for clinical decision-­making. Within 15 years after issuing his report, Flexner had come to believe that the medical curriculum placed too much weight on the scientific aspects of medicine to the exclusion of the social and humanistic aspects. In fact, in 1925, he wrote, “Scientific medicine in America—young, vigorous and positivistic—is today sadly deficient in cultural and philosophic background.” Clearly, it appears that medical education of the twentieth century came away with only part of the Flexner vision for reforming medical education. Undoubtedly, he and the architects of the medical education of the twentieth century would be greatly disappointed to see that at some point, the path that they envisioned went awry. Interestingly, the predicament faced by medical education in the twenty-first century was foreseen by one of the “Four Doctors,” William Osler. Osler, who a few years after the establishment of Hopkins Model moved to Oxford, believed that the so-called Flexnerians had their priorities wrong in situating the advancement of knowledge as the overriding aspiration of the academic physician. Although he had great reverence for investigation into new scientific knowledge, he considered the welfare of the patient and the education of the student to that effect as more important priorities.

4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick…

Since Flexner’s day, clearly the knowledge base for medical practice has reached unprecedented levels. However, the education of physicians in today’s vastly more complicated health-care delivery system for a public, which has much higher expectations, clearly requires a culture of humanism as the solid foundation for that knowledge. Regrettably, this is where the twentieth-century system of medical education has failed. This lapse has not escaped the patient population or the critics of the medical system, who have richly documented the poverty of professional ideals now current in medicine. Many from outside and inside of medicine have called for a new Flexner report, a centennial taking stock, to address the shortcomings in medical education that have occurred in the aftermath of the original report.

4.5.2 T  wentieth-Century Medical Education: The Rest of the Story In the turn of the twentieth century when the future of American medical education and American medicine was being debated in Europe and institutions of higher learning in the eastern United States, without notice by the eastern medical intelligentsia, a different seed for the path of American medicine was being planted in the barren plains of southern Minnesota. In an ungodly cold January day in 1864, Dr. William Worrall Mayo placed an ad in the area newspapers announcing that his medical practice was open for business in downtown Rochester, Minnesota, a town of 1400 people, and thus the Mayo Clinic was born. Soon Dr. William and his two sons, Will and Charlie Mayo, transformed American medicine in a different way from Flexnerians and the Hopkins Model and created a mammoth enterprise of medical care which is the envy of the world in terms of patient care, undergraduate and graduate medical education, and the discovery of new knowledge. William Worrall Mayo, a diminutive man in stature referred to by patients as “the little Dr.,” and his surgically gifted sons, “Dr. Will” and “Dr. Charlie,” emphasized the fact that the patients are what really mattered and that the education of physicians and discovery of new knowledge were to be in the service and healing of the sick. It is important to note that Doctors Mayo and the Mayo Clinic entered the same period of turmoil and rapid change in health care as the Flexnerians. Furthermore, the health-­ care environment in the latter part of the nineteenth century was every bit as challenging as the issues that face medicine and medical education today. However, the success of the Mayo Model over the long term was rooted in the singular concept that the work of the physician, the education of the

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future generations, and the quest for new knowledge were solely for the purpose of meeting the needs of patients. This open secret of being deeply rooted in the primary value of putting “humans with an illness first” was the engine which drove education of the future generations of physicians and the discovery of new knowledge at Mayo Clinic. In the same year as the Flexner report, in 1910, Dr. Will Mayo spoke at Rush Medical College in Chicago. In that speech, he emphasized that “the best interest of the patient is the only interest to be considered.” He went on to emphasize that with the interest of the patient and the healing of the sick as the starting point, the training of the future generations of physicians would result in a culture of medicine which better represents the ideals of the profession and assures its survival through the episodic turmoil which characterizes health care. Whereas the Hopkins Model of medical education prioritized investigation and discovery of new knowledge over the training of new physicians and the care of patients, the three shields which comprise the logo of Mayo Clinic exemplified the different approach in terms of priorities in health care in the Mayo Model. The larger central shield symbolizes caring for the sick, while the two smaller shields that juxtapose and intersect the central shield symbolize the integral aspects of educating the next generations and the discovery of new knowledge. Indeed, this concept has been responsible for the constant growth and expansion of the Mayo Clinic during its 150-year history and seems to represent a more appropriate model for health care and medical education in the twenty-­ first century.

4.5.3 M  edical Education in the Twenty-First Century The key goals of medical education in the twenty-first century need to be the inculcation of the humanistic values and culture of the profession as the sound foundation upon which knowledge and skills are taught to the new physicians. Starting with respect for the needs of the patient and dedication to the central mission of alleviating suffering, the manner in which knowledge is imparted and skills are attained requires a radical departure from the past. Although the dictum “see one, do one, teach one” may have characterized the way in which clinical skills were learned in the past, it is now clear that for training in skills to be effective, learners at all levels must have the opportunity to compare their performance with the standard and practice until an acceptable level of proficiency is attained. The appreciation of the importance of practice and the honest admission

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that neophytes cannot perform high-stakes procedures at an acceptable level of proficiency demand that we develop approaches to skills training that do not put our patients at risk in service to education. The use of increasingly sophisticated simulators and virtual reality offers physicians at all levels the opportunity to refresh skills and learn new ones in a safe practice environment. Educational methods that allow the demonstration of mastery at one level, with respect to both technique and judgment, before progression to the next level, teach an important lesson in professionalism. At all phases of medical education, whether in medical school or in residency training, the young physician needs to be mentored by senior faculty who not only impart knowledge and skill but serve as role models and shining examples of the profession. Sociologic studies have noted the importance of socialization and implicit learning in the development of professional attitudes and behaviors. Therefore, explicit instruction in professionalism, combined with effective role modeling and attention to the curriculum of the practice environment, can support the development of a comprehensive and sophisticated understanding of the profession by the new physician. The model of medical education in the twenty-first century needs to emphasize that medical students and residents become sensitive and compassionate “healers” as well as knowledgeable technicians and skillful practitioners. Rigorous assessment of the acquisition of the humanistic healing attributes by the new physician is even more important than the assessment of their knowledge and skills. Undoubtedly, in all areas, assessment drives learning. The new model of medical education needs to rigorously assess the new physician’s embodiment of the culture, the professionalism, procedural skills, judgment, and commitment to patients as human beings. Self-assessment, peer evaluations, portfolios of the learner’s work, written assessments of clinical reasoning, standardized patient examinations, oral examinations, and sophisticated simulations are to be used in order to assess the acquisition of appropriate professional values as well as knowledge, reasoning, and skills. Such a rigorous program of assessments has the potential to inspire learning, influence values, reinforce competence, and reassure the public. Arguably, the most important aspect of medical education of the twenty-first century is to require that the new physicians learn from outstanding experienced senior clinical teachers side by side with the laboratory scientists and physician scientists. The role of the senior clinical teachers is not only to impart knowledge and skill but act and become

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shining examples of professionalism, the humanity, and the morality of the profession. One hundred years ago, Flexner’s critique of medical education converted an evolutionary change already underway in North American medical education into a revolution. With the institution of Flexner’s recommendations, medicine has made transformative advances in the twentieth century. However, after a century, once again, our approach to medical education is inadequate to meet the needs of medicine in the twenty-first century. No one would cheer more loudly for a change in medical education than Abraham Flexner. He recognized that medical education had to reconfigure itself in response to changing scientific social and economic circumstances in order to flourish from one generation to the next. Interestingly, the same understanding for the need of medicine to change is illustrated in the quote from Charles Mayo who said, “The only constant in medicine is change.” Clearly, the flexibility and freedom to change, indeed the mandate to do so, were part of the essential message delivered to American medicine by Flexner, the Hopkins Model, and the Mayo Clinic Model. The only hope for the salvation and future of medicine is a change in medical education. Historically, medicine has been defined by three intersecting circles of patient care, teaching, and research. By this model although the patient has been important, the patient has not been paramount (Fig.  4.2). The modern vision for the interaction of patient care, teaching, and research forms concentric circles with the patient in the center. Teaching and research efforts are only relevant if they can enhance the outcome for the patient (Fig. 4.3).

Teaching

Research

Patient care

Fig. 4.2  Historically, medicine has been defined by three intersecting circles of patient care, teaching, and research. By this model although the patient has been important, the patient has not been paramount

4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick…

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Fig. 4.3  This illustration depicts the modern vision for the interaction of patient care, teaching, and research, which form concentric circles with the patient in the center. Teaching and research efforts are only relevant if they can enhance the outcome for the patient

4.6

In Summary

A successful robotic surgery program is based on many factors. Although the skill, training, and experience of the robotic surgeon are paramount, there are many other programmatic and institutional factors that can “make or break a robotic surgery program.” Without absolute attention to these factors, a robotic surgery program will never reach its potential. These factors are as follows: • Culture change in the institution and the operating room • Institution of specialty-specific robotic surgery teams. Attention to team dynamics, training, proficiency, and experience • Level V leadership by the surgeon • Placing the patient at the center of the three concentric circles with education and research revolving around the needs and well-being of the patient • An absolute insistence on perfection of surgery and refusal to accept anything less than perfection in all aspects of the robotic surgery program

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4. Ahmed F, Rhee J, Sutherland D, Benjamin C, Engel J, Frazier H II. Surgical complications after robot-assisted laparoscopic radical prostatectomy: the initial 1000 cases stratified by the Clavien classification system. J Endourol. 2012;26:135–9. 5. Kirkpatrick T, LaGrange C.  Robotic surgery: risks vs. rewards. (Internet). 2016 January. Available from https://psnet.ahrq.gov/ web-mm. 6. Liss MA, Skarecky M, Morales B, Osann K, Eichel L, Ahlering TE. Preventing perioperative complications of robotic-assisted radical prostatectomy. Urology. 2013;81:319–23. 7. Reza M, Maeso S, Blasco JA, Andradas E. Meta-analysis of observational studies on the safety and effectiveness of robotic gynecological surgery. Br J Surg. 2010;97:1772–83. 8. Liu JJ, Maxwell BG, Panousis P, Chung BI. Perioperative outcomes for laparoscopic and robotic compared with open ­prostatectomy using the National Surgical Quality Improvement Program (NSQIP) database. Urology. 2013;82:579–83. 9. Finkelstein J, Eckersberger E, Sadri H, Teneja SS, Lepor H, Djavan B. Open versus laparoscopic robot-assisted laparoscopic prostatectomy: the European and US experience. Rev Urol. 2010;12:35–43. 10. Stitzenberg KB, Wong YN, Nielsen ME, Egleston BL, Uzzo RG. Trends in radical prostatectomy: centralization, robotics, and access to urologic cancer care. Cancer. 2012;118:54–62. 11. Sooriakumaran P, Srivastava A, Shariat S, et  al. A multinational, multi-institutional study comparing positive surgical margin rates among 22393 open, laparoscopic, and robot-assisted radical prostatectomy patients. Eur Urol. 2014;66:450–6. 12. Kwon EO, Bautista TC, Jung H, Goharderakhshan RZ, Williams SG, Chien GW. Impact of robotic training on surgical and pathologic outcomes during robot-assisted laparoscopic radical prostatectomy. Urology. 2010;76:363–8. 13. Schreuder HW, Wolswijk R, Zweemer RP, Schijven MP, Verheijen RH.  Training and learning robotic surgery, time for a more structured approach: a systematic review. BJOG. 2012;119:137–49. 14. Novara G, Ficarra V, Mocellin S, et al. Systematic review and meta-­ analysis of studies reporting oncologic outcome after robot-assisted radical prostatectomy. Eur Urol. 2012;62:382–404. 15. Erickson BK, Gleason JL, Huh WK, Richter HE. Survey of robotic surgery credentialing requirements for physicians completing OB/ GYN residency. J Minim Invasive Gynecol. 2012;19:589–92.

52 16. Coelho RF, Chauhan S, Palmer KJ, Rocco B, Patel MB, Patel VR.  Robotic-assisted radical prostatectomy: a review of current outcomes. BJU Int. 2009;104:1428–35. 17. Tewari A, Sooriakumaran P, Bloch DA, Seshadri-Kreaden U, Hebert AE, Wiklund P. Positive surgical margin and perioperative complication rates of primary surgical treatments for prostate cancer: a systemic review and meta-analysis comparing retropubic, laparoscopic, and robotic prostatectomy. Eur Urol. 2012;62:1–15. 18. Kaushik D, High R, Clark CJ, LaGrange CA. Malfunction of the da Vinci robotic system during robot-assisted laparoscopic prostatectomy: an international survey. J Endourol. 2010;24:571–5. 19. US Food and Drug Administration. MAUDE—Manufacturer and user facility device experience. Silver Spring: FDA; 2015. 20. Whellan DJ, McCarey MM, Taylor BS, Rosengart TK, Wallace AS, Shroyer AL, Gammie JS, Peterson ED. Trends in robotic-assisted coronary artery bypass grafts: a study of the Society of Thoracic Surgeons Adult Cardiac Surgery Database, 2006 to 2012. Ann Thorac Surg. 2016;102:140–6. 21. Poston R. The influence of hospital culture on the successful implementation of robotic cardiac surgery. Beverly: ISMICS; 2015. 22. DeVito C. Yogi: the life & times of an American original. Chicago: Triumph Books; 2014. 23. Kahn C. The art and thought of heraclitus: fragments with translation and commentary. London: Cambridge University Press; 1979. p. 1–23. 24. Machiavelli, Niccolo, 1469-1527. The Prince. Harmondsworth, Eng. New York: Penguin Books; 1981. 25. Toynbee AJ. A study of history. Oxford: Oxford University Press; 1934. 26. Jefferson T, et  al. July 4, Copy of Declaration of Independence. 07-04, 1776. 27. Allen PJ, Pitirim A. Sorokin in review. Durham: Duke University Press; 1963. 28. Hughes S.  Oswald Spengler. Piscataway: Transaction Publishers; 1991. p. 59. 29. Kuhn TS. The structure of scientific revolutions. 3rd ed. Chicago: University of Chicago Press; 1996. 30. Tucker R. Managing the future: ten driving forces of change for the 90s. Tro: Business News Publishing; 1991. 31. London S. Understanding change: how it happens and how to make it happen. (Internet) Available from http://scott.london/reports/ change.html. 32. Senge PM.  The fifth discipline. New  York: Doubleday/Currency; 1990. 33. Kanter RM, Stein B, Jick TD.  The challenge of organizational change: how companies experience it and leaders guide it. New York: Free Press; 1992. 34. Christensen CM. The innovator's dilemma: when new technologies cause great firms to fail. Boston: Harvard Business School Press; 1997. 35. Christensen CM, Raynor ME.  The innovator’s solution: creat ing and sustaining successful growth. Boston: Harvard Business School Press; 2003. 36. Christensen CM, Horn M. Disrupting class: how disruptive innovation will change the way the world learns. New  York: McGraw-­ Hill; 2008. 37. Christensen CM, Grossman JH, Hwang J. The innovator’s prescription: a disruptive solution for health care. New York: McGraw-Hill; 2008. 38. Evans G, Hyman G. Rickover: excellence. Mil Rev. 2005;65:1–2. 39. Allen TB, Polmar N.  Rickover: father of the nuclear navy. Washington, D.C.: Potomac Press; 2007. 40. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 59.

F. Gharagozloo et al. 41. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 137. 42. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 40. 43. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 11. 44. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 65. 45. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 94. 46. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 27. 47. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 31. 48. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 117. 49. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 110. 50. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 70. 51. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 64. 52. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 100. 53. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 109. 54. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 127. 55. Oliver DA. Against the tide: Rickover’s leadership principles and the rise of the nuclear navy. Annapolis: Naval Institute Press; 2014. p. 135. 56. Collins J. Good to great. New York: N.Y. Williams Collins; 2001. 57. Collins J. The Stockdale Paradox. (Internet) Available from http:// www.jimcollins.com/lab/brutalFacts/. 58. Roberto MA.  The art of critical decision making. Chantilly: The Teaching Company; 2009. 59. O’Connor P, Reddin C, O’Sullivan M, O’Duffy F, Keogh I. Surgical checklists: the human factor. Patient Saf Surg. 2013;7:14. 60. Mascherek AC, Schwappach DL, Bezzola P. Frequency of use and knowledge of the WHO-surgical checklist in Swiss hospitals: a cross-sectional online survey. Patient Saf Surg. 2013;7:36. 61. Stahel P. The 10th year of the “universal protocol”: are our patients safer today? Bone Joint. 2014;360:7–10. 62. Greenberg CC, Regenbogen SE, Studdert DM, Lipsitz SR, Rogers SO, Zinner MJ, et al. Patterns of communication breakdowns resulting in injury to surgical patients. J Am Coll Surg. 2007;204:533–40. 63. Griffen FD, Stephens LS, Alexander JB, Bailey HR, Maizel SE, Sutton BH, et  al. The American College of Surgeons’ closed claims study: new insights for improving care. J Am Coll Surg. 2007;204:561–9. 64. Newman-Toker DE, Pronovost PJ. Diagnostic errors-the next frontier for patient safety. JAMA. 2009;301:1060–2.

4  Blueprint for the Establishment of a Successful Robotic Surgery Program: Lessons from Admiral Hyman R. Rick… 65. Reason J.  Human error: models and management. Br Med J. 2000;320:768–70. 66. Kim FJ, da Silva RD, Gustafson D, Nogueira L, Harlin T, Paul DL. Current issues in patient safety in surgery: a review. Patient Saf Surg. 2015;9:26. 67. Wiegmann DA, El Bardissi AW, Dearani JA, Daly RC, Sundt TM 3rd. Disruptions in surgical flow and their relationship to surgical errors: an exploratory investigation. Surgery. 2007;142:658–65. 68. Young-Xu Y, Neily J, Mills P, et al. Association between implementation of a medical team training program and surgical morbidity. Arch Surg. 2011;146:1368–73. 69. Neily J, Mills PD, Young-Xu Y, Carney BT, West P, Berger DH, Mazzia LM, Paull DE, Bagian JP. Association between implemen-

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tation of a medical team training program and surgical mortality. JAMA. 2010;304:1693–700. 70. Armour Forse R, Bramble JD, McQuillan R.  Team training can improve operating room performance. Surgery. 2011;150:771–8. 71. Sexton JB. Error, stress, and teamwork in medicine and aviation: cross sectional surveys. BMJ. 2000;320:745. 72. Shuffler ML, Pavlas D, Salas E.  Teams in the military: a review and emerging challenges. In: Laurence JH, Matthews MD, editors. The Oxford handbook of military psychology. Oxford: Oxford University Press; 2012. p. 282–310. 73. Goodwin GF, Blacksmith N, Coats MR. The science of teams in the military: contributions from over 60 years of research. Am Psychol. 2018;73(4):322–33.

5

Validating Robotic Surgery Curricula Edward Lambert, Erika Palagonia, Pawel Wisz, Alexandre Mottrie, and Paolo Dell’Oglio

5.1

 he Rationale Behind the Need T for Validated Robotic Surgery Training Curricula

Under the influence of technological evolution, surgery has undergone a major transformation leading to the development and application of minimally invasive surgical techniques. Starting in the early 1980s, minimally invasive surgery quickly and widely became the “gold standard” for many surgical interventions which previously were performed only in the classical, “open” approach. This innovation has allowed for less surgical trauma, postoperative pain, shorter length of stay, better cosmetic results, and earlier functional recovery relative to open surgery [1]. Over the last decades, robotic surgery has emerged as a novel technology which has revolutionized the field of minimally invasive surgery. This innovative technique has become an integral part of many different surgical specialties such as urology, general, thoracic, cardiac, and head and neck surgeries [2–5]. Since the introduction of robotic surgery in the mid1990s, its implementation has increased exponentially, with more than 5,000,000 robot-assisted procedures performed by 2017 with the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, USA) [6]. Moreover, in specific surgical fields, such as urology, robotic surgery has become the preferred surgical approach for several procedures [3, 4, 7–10]. E. Lambert Department of Urology, Onze Lieve Vrouw Hospital, Aalst, Belgium E. Palagonia (*) · P. Wisz Department of Urology, ORSI Academy, Melle, Belgium Onze Lieve Vrouw Hospital, Aalst, Belgium A. Mottrie ORSI Academy, Melle, Belgium P. Dell’Oglio Department of Urology, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy Department of Urology, ORSI Academy, Melle, Belgium Onze Lieve Vrouw Hospital, Aalst, Belgium

However, this innovation has also created new challenges in terms of training and teaching. Robotic surgery comes with specific difficulties since the platform is very different from other forms of surgery [11]. Just as the Fundamentals of Laparoscopic Surgery (FLS), a validated, evidence-based skills program, was born in response to the need for specific training in laparoscopic surgery, the same need for training is developing in robotic surgery. Although seen as an evolution of laparoscopic surgery, the skills needed in robotassisted surgery are unique and cannot be compared to those needed in laparoscopic or open surgery [2, 4, 5, 12, 13]. In robotic surgery, the required skills are mainly for console control, maneuvers without haptic feedback, and communication with the bedside assistant. Conversely, in laparoscopic surgery, the required skills are mainly for 2D surgery with instruments with a restricted range of motion. The guidelines that exist for training in laparoscopic surgery therefore cannot be considered an equivalent to robotic surgery [2, 4, 12]. While the role of robot-assisted surgery is expanding rapidly and widely, there is lack of structured training in robotic surgery. Specified and centralized competency standards for new robotic surgeons do not exist [9]. In 2013, a group of experts expressed concern that robotic surgery training is random and insufficient to ensure patient safety [4]. An independent review from the Emergency Care Research Institute (ECRI), an institute on health technology hazards, in 2015 identified a lack of robotic surgical training as one of the top 10 risks to patients [14]. Therefore, the development of standardized and validated training programs is urgently needed. In order to introduce robotic surgery to surgeons in a safe and efficient way without compromising surgical outcomes and patient safety, new, specific, and structured educational curricula as well as proficiency-based credentialing processes are needed. Furthermore, in robotic surgery, the importance of team training is essential. Specific trainings for all members of the surgical team, consisting of the console surgeon, the bedside assistant, the scrub nurse, the circulating nurse, and the anesthesiologist, are necessary since they all need to understand the spatial relationships

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of the instruments outside the vision of the surgical field to ensure patient safety and avoid involuntary tissue injury [3]. Robotic surgery training curricula increase preclinical exposure avoiding patients to be used as a training module, which is unacceptable from an ethical point of view. Validated curricula will help standardization of training in robotic surgery with accreditation and certification of surgeons for robot-assisted surgery [2–4, 9, 12, 15]. The aim of this chapter is to highlight the aspect of training in robotic surgery. We will discuss the organization and validation of training curricula with robotic surgeon credentialing as a final goal, including an overview of all currently available robotic surgery training curricula and the status of their validation.

Instructions on troubleshooting and the limitations of the operating system are essential. Online modules are available that introduce the basic concepts of the only commercially available system, the Da Vinci Robot (https://www.davincisurgerycommunity.com/Training?tab1=TR). Certification in these online modules is essential before starting any console training [2–4, 15]. After a trainee is well educated on the robotic platform, the training of robotic technical skills can start. The first step consists in performing dry lab exercises on inanimate benchtop models or virtual reality-simulated environments. These exercises are an important step in achieving basic and advanced console skills and improving coordination development, bimanuality, dissection, and suturing techniques. Simulators are cheap to run, well tolerated, convenient, and efficient [2, 4, 12, 15]. However, the exercises that we can 5.2 What Does a Proper Robotic Training perform with virtual reality simulators lack bleeding and do not compare with real-life surgery. Curriculum Look Like? The wet lab should be the next step in training after basic Training should occur in a modular fashion with a well-­ surgical skills are acquired in the dry lab. In the wet lab, surstructured road map (Fig. 5.1) [2]. gical techniques are trained on cadaveric (i.e., dog model) or A training curriculum should start with adequate theo- live animals (i.e., porcine model) or human cadavers. These retical knowledge development. A trainee should become anatomical models are more comparable to real-life surgery, familiar with the robotic technology by education on the spe- allowing the trainees to learn to recognize the robustness and cific robotic device’s parameters and functions. Knowledge consistency of real tissues and to simulate complete surgical and working of the console are of the utmost importance. procedures and emergency scenario such as vascular/organ

Fig. 5.1  The structure of a robotic training curriculum

1. Online E-learning Certification after successfully completing e-learning

2. Dry laboratory training: basic and advanced skills Virtual reality simulators

Inanimate benchtop models GEARS

3. Wet laboratory training: basic and advanced skills Live/cadaveric animal models

Human models GEARS

4. Bedside surgical training Real-life case observation

Patient side training

3. Console training Modular training

Non technical skills training

Supervision by expert surgeons

4. Evaluation Manual vs Automated assessment tools

Global vs Procedure specific assement tools

5. Certification

5  Validating Robotic Surgery Curricula

injuries. However, wet labs imply great costs and a large number of animals to be sacrificed [2, 4, 12, 15]. Worldwide, there are 24 recognized, fully equipped educational centers for wet lab training. In Europe, there are three recognized training centers offering a wet lab: the European Robotic and Minimal Invasive Surgery Institute ORSI Academy (Melle, Belgium), the Center of Advanced Simulation and Education (CASE) (Istanbul, Turkey), and Practicum Clinical Skills Centre (Lund, Sweden). Subsequently, real-life case observation in a training center is essential. This should include patient-side training with learning of basic surgical skills such as patient positioning, establishing pneumoperitoneum, procedure-specific port placement, robot docking, and basic laparoscopic skills [2, 12]. Only after going through all these steps a trainee can start performing supervised surgery in a modular fashion under the supervision of expert surgeons. The presence of a dual console is strongly encouraged, allowing two surgeons to interact and operate at the same time, thus resulting in better control [3, 12, 15]. The learning curriculum ends with independent performance of surgery [3, 4, 12, 15]. Besides training in technical robotic surgical skills, trainees should also be trained in nontechnical skills, including surgical cognitive skills (surgical knowledge, decision-­making, planning, and situational awareness) and social skills (abilities of leadership, communication, and teamwork). Cognitive and interpersonal skills and team organization lead to effective transmission of robotic surgical care, but a lack of nontechnical skills may impact patient safety and can lead to adverse events [2, 8, 9]. Nontechnical skills training and team training therefore must be an integral part of robotic training curricula, with the possibility to learn through a simulation training that can replicate common and emergency scenarios in robotic surgery [16]. The curricula must include a final evaluation that allows to verify the learning of the procedure. Only after positive evaluation, the trainee should be certified as a robotic surgeon. Nowadays, the training in robotic surgery is not organized, and centralized competency standards do not exist. Moreover, the process of robotic surgery certification lacks consistency [3, 4, 9, 17–19]. Therefore, consistent and validated surgical curricula are essential in the standardization of training, accreditation, and certification of surgeons for robot-assisted surgery. An adequate and effective robotic surgery training curriculum should encompass a complete preparation on performing robotic surgery in a safe way with good clinical outcomes. Therefore, the development of these training curricula requires a systematic approach. Once learning needs are identified and integrated in a curriculum, validation is essential before implementation (Fig. 5.2) [4].

57 Need for improvement

Curriculam development

Validation

Implementation

Patient outcomes

Fig. 5.2  Pathway for development of a training curriculum

5.3

 ow to Validate a Robotic Surgery H Training Curriculum

To develop a structured and validated curriculum, it is fundamental first of all to identify the right population to be trained and to assess the time needed for each step of the curriculum [20]. A training curriculum to be validated and implemented should undergo different degrees of validation (face, content, construct, concurrent and predicted validity) and should be reproducible (reliability), feasible (feasibility), and acceptable (acceptability) [21]. Educational impact and cost-­effectiveness are also mandatory to assess before its implementation (Fig. 5.3) [21–23]. The main goal of training curricula in robotic surgery is to objectively demonstrate that performing a proposed training program will result in improved robotic surgical performance in clinical practice, thus proving concurrent validity (Fig. 5.3) [23]. Seen the need of robotic surgeons to have a defined, clear, and coherent training, it is necessary to specify the validation modality of the programs in which these surgeons are trained. The validation of a robotic training curriculum proves its educational impact and its potential to differentiate between different levels of competence and is therefore essential [24]. A recent review performed by Ahmed et al. [24] on observational tools for assessment of procedural skills underlines that the validation process of a study in which technical skills are assessed should be performed in a well-powered, experimental study in a controlled environment. Trainees should be evaluated by different independent and blind assessors (inter-­rater reliability). The results of different test items should be compared for internal consistency (inter-item reliability), and the same assessor should rate the performance of the same subject at two different occasions (e.g., on different times) for test-retest reliability. Construct validity can be determined by dividing different tests for various levels of training, and concurrent validity may be established by

58 Fig. 5.3  Definition of construct

E. Lambert et al.

Validity A test is defined as valid when measuring what it actually intends to measure. The valid evaluation method of clinical competence must have the following characteristics: Face validity: the test seems a sensible measure of the construct in the real world. Content validity: the measure that a test is capable of assessing the skills required of the construct Construct validity: the extent to which an exam or a test discriminates between different levels of experience. Concurrent validity: it is a method to value if the results of the test are correlated with what is settled as the gold standard or with other valid measures Predictive validity: the test score is able to accurately predict the future performance of the construct to which the test belongs. Reliability A measure of reproducibility or consistency of performance, it ,is a measure of a test to generate similar results and to reduce errors due to circumstance. Several methods are applied such as inter-rater reliability, inter-item reliability, inter-test reliability. Feasibility Measure of whether an assessment process is capable of being done or carried out. It allows to establish if and how the activities envisaged by the project can be carried out respecting the constraints posed by the overall environmental context. Educational Impact The ability to improve performance with a specific training. Acceptability It refers to the attitude of the subjects and allows to measure if an evaluation tool is accepted

Fig. 5.4 Recommended design of a curriculum for validation and implementation Validation • Face validity • Content validity • • • • Project

correlating the tool to a gold standard method if available [24]. In practice, the validation of a robotic surgery training curriculum should occur in a randomized study, performed in a robotic surgery center of excellence. The performance of trained and untrained participants should be evaluated and compared objectively by use of validated assessment tools. In order to make the curriculum internationally recognized, the leading, recognized world-governing bodies for the specific specialty must be involved [4].

Construct validity Concurrent validity Reliability Predictive validity

• • • •

Feasibility Acceptability Educational impact Cost effectiveness

Implementation

Before implementation at the institutional level, training curricula need to be evaluated for feasibility, acceptability, educational impact, and cost-effectiveness. Using surveys or interviews with trainees, it is possible to recognize the feasibility and acceptability of the training, while the educational impact can be assessed by providing constructive feedback to the participants. Cost analysis of the process depends on many aspects including the evaluation environment and the geographical area in which the program is run (Fig. 5.4) [23].

5  Validating Robotic Surgery Curricula

5.4

Robotic Surgery Training: Virtual Reality Robotic Surgery Simulators

To familiarize with the robotic system, it is necessary to start the practice with the use of virtual simulators. Indeed, virtual reality robotic surgery simulators are an integral part of all currently available major robotic surgery training curricula. Simulators give a safe environment for trainees to learn how to use the robotic surgery platform and to develop robotic surgical skills. The robotic system is ideal to integrate different forms of simulation next to classical surgical teaching [3, 17]. In this way, trainees may pass their basic learning curve on a simulator and use it as a bridge before starting with real-­ life surgery. Patient safety and surgical outcome are thereby ensued [3, 17, 18]. Evidence suggests that simulators should be integrated into proficiency-based curricula for training in basic robotic surgical skills and procedural tasks prior to independent practice since training on VR training consoles may improve performance in real life [2, 3, 19, 25]. However, there is lack of strong evidence on the predictive validity of the simulators, i.e., the application of skills gained using simulators to real-life robotic surgery [2, 7, 10]. The first virtual reality robotic surgery simulator was introduced in 2010. So far, six virtual reality simulators are commercially available for robotic surgery training: the da Vinci Skills Simulator (by Intuitive Surgical, Sunnyvale, USA), the Robotic Surgical Simulator (RoSS) (by Simulated Surgical Systems, Buffalo, USA), the SEP robot (by SimSurgery, Norway), the dV-trainer (by Mimic Technologies Inc., Seattle, USA), the ProMIS (Haptica, Ireland), and the RobotiX Mentor (by 3D systems, Israel) [2, 4, 10, 26]. All these simulators underwent evaluation of their validity in different studies. Different degrees of validation are possible [2, 10, 12]: • Face validity: The extent to which the simulator resembles a real-life situation. This is generally determined by a group of experts. • Content validity: The extent to which the skills tested by the simulator accurately represent the skills required in robotic surgery. • Construct validity: The extent to which the assessment exercise measures the intended content domain or the extent to which the simulated task discriminates between operators of different levels of surgical skill. • Discriminant validity: The extent to which a simulator is able to differentiate between ability levels within a group with similar experience. • Concurrent validity: The extent to which the simulator scores and actual robotic scores are comparable for a similar task.

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• Predictive validity: The extent to which the performance on the simulator predicts future performance on the robotic platform when used clinically. All simulators (regardless of add-ons) have been evaluated in literature to have at least face, content, and construct validity, except for RoSS which did not show evidence of construct validity [2, 27]. The most frequently used simulator today is the da Vinci Skills Simulator (dVSS). This simulator is actually a customized computer package that runs on the actual surgical console. It exists for both the Si and the Xi da Vinci systems and offers basic to advanced training modules [12]. The simulator allows instant feedback with an overall score that takes into account both performance efficiency in time, movement economy, and penalty metrics. Modular training add-ons for specific complex procedures, such as radical prostatectomy and hysterectomy, are available. Face, content, construct, concurrent, and predictive validity have been proven in literature [12, 26, 28–30]. The Mimic dV-Trainer (MdVT), RoSS, and RobotiX Mentor are stand-alone virtual reality robotic surgery simulators that mimic the da Vinci Surgical System. All three simulators offer multiple basic to advanced training modules with comprehensive performance metrics, evaluated by an automated, integrated system [3, 12, 17, 26, 31–34]. MdVT, RoSS, and the RobotiX Mentor offer procedure-­ specific modules in which trainees interact with a 3D virtual reality anatomical environment. Maestro AR, the procedure-­ specific add-on of the MdVT, offers training in right partial nephrectomy, hysterectomy, inguinal hernia repair, and radical prostatectomy for both da Vinci Si and Xi [2, 26]. The Tube 3 module of the MdVT is specifically designed to train the vesicourethral anastomosis, thereby increasing the performance of trainees in one of the most complex steps in robot-assisted radical prostatectomy [26, 34]. The Handson-­Surgical Training (HoST) add-on of RoSS offers training in radical hysterectomy, radical prostatectomy, radical cystectomy, and extended lymph node dissection [2, 26]. The RobotiX Mentor offers training in complete surgical procedures such as radical prostatectomy, hysterectomy, lobectomy, inguinal hernia repair, and right hemicolectomy [17, 26, 35]. Both the RobotiX Mentor and the MdVT offer a laparoscopic assistant component in parallel with the virtual reality console. This allows simultaneous training of both a surgeon and a bedside assistant, improving coordination, communication, and teamwork. For the MdVT, this is a specific add­on called the Xperience Team Trainer [2, 26, 36–38]. The SimSurgery Educational Platform (SEP) Robot and the Da Vinci-ProMIS surgical simulator are two robotic surgery simulators that are modifications of previous laparoscopic simulators. In these simulators, the basic lapa-

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Table 5.1  Properties of currently available robotic surgery simulators Name EndoWrist manipulation Camera control and clutching Fourth-arm control System settings Needle driving Energy and dissection Performance measures Developed for robotic surgery Cost (US dollars)

dVSS Yes Yes Yes Yes Yes Yes Yes Yes 89.000

MdVT Yes Yes Yes Yes Yes Yes Yes Yes 158.000

RoSS Yes Yes Yes Yes Yes Yes Yes Yes 120.000

SEP Yes No No No No No Yes Yes 62.000

ProMIS No No No Yes Yes No Yes No 35.000

RobotiX Mentor Yes Yes Yes Yes Yes Yes Yes Yes 95.000

EndoWrist manipulation: The instruments are designed to have seven degrees of freedom and to reproduce the movements of the surgeon’s hand Camera control and clutching Fourth-arm control: It allows to integrate the movement of the fourth arm and to reason on its use System settings: Settings for the console Needle driving: Needle control, movements that help surgeons to manipulate needles Energy and dissection: Modules that help user to understand the different type of energy instruments and change type of energy and arm with the footswitch panel Performance measure: A score after all the module is given and it values, for example, economy in motion, instruments conflict, time to complete the entire module, etc.

Table 5.2  Overview of currently available robotic surgery simulators and add-ons and the status of their validation Name Da Vinci Skills simulator (dVSS) Mimic dV-Trainer (MdVT) Maestro AR Tube-3 Module Xperience Team Trainer Robotic Surgery Simulator (RoSS) SimSurgery Educational Platform (SEP) Robot simulator ProMIS RobotiX Mentor

Face validity Yes Yes No Yes Yes Yes Yes

Content validity Yes Yes No Yes Yes Yes Yes

Construct validity Yes Yes No Yes No No Yes

Concurrent validity Yes Yes No Yes Yes No No

Predictive validity Yes No No Yes No No No

Yes Yes

Yes Yes

Yes Yes

No No

No No

roscopic instruments have been replaced by the wristed instruments with seven degrees of freedom as found in the da Vinci Robot. The SEP robot is a virtual reality simulator which offers different exercises in which trainees are evaluated based on instrument tip trajectory, time, and error scores [39]. Although being a cost-effective alternative to other simulators, SEP has a lot of shortcomings: it does not offer the possibility to train clutching, needle control, and driving or dissection exercises as in other simulators. Furthermore, a fourth robotic arm, three-dimensional images and performance feedback are not provided by SEP [3, 26]. The da Vinci-ProMIS surgical simulator is a hybrid simulator in which the da Vinci Surgical System is docked to the ProMIS bodyform, a plastic mannequin covered with neoprene. Inside the simulator, three camera-tracking systems detect the instruments inside the simulator, offering evaluation of time, economy of motion, and instrument path length for both virtual and physical training models [26, 40].

Properties of all virtual reality robotic surgery simulators and the status of their validation are summarized in Tables 5.1 and 5.2 [22].

5.5

Training Curricula in Robotic Surgery

Although multiple, well-developed training programs exist for both open and laparoscopic surgical skills development, the versatility in training curricula in robotic surgery is much smaller. A large number of available “training curricula” are available worldwide (Table 5.3). However, the term “curriculum” is broad. Some curricula are industry-led short training sessions which lack any formal assessment of competency, whereas others are all-inclusive fellowship-style courses that take months to complete [5, 43, 59]. Of all existing curricula for robotic surgical training, only a few were validated [9, 18, 19, 43, 59].

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5  Validating Robotic Surgery Curricula Table 5.3  Currently available robotic surgery training curricula and the status of their validation Robotic surgery training curricula

2013

Dry lab/ Wet Modular Real-life simulation lab training surgery Validation Yes No Yes No Not validated Yes No No No Validated

2013

Yes

Yes

Yes

No

Volpe et al. [19] Dulan G et al. [42] Foell K et al. [43] Rusch P et al. [44]

2014

Yes

Yes

Yes

2012

Yes

No

2013

Yes

2018

Valdis M et al. [45] Macgregor JM et al. [46] Not published [47]

Name Fundamentals of robotic surgery (FRS) Fundamental Skills of Robotic Surgery (FSRS) Roswell Park Cancer Institute Robot-­Assisted Surgical Training (RAST) program

Study Smith R et al. [13] Stegemann AP et al. [18] Attalla K et al. [41]

Year 2014

ERUS robotic surgery training curriculum Proficiency-­based robotic curriculum University of Toronto Basic skills training curriculum (BSTC) Society of European Robotic Gynaecological Surgery (SERGS) curriculum “Western Protocol” Cardiac Surgery Virtual reality curriculum Fundamentals of robotic surgery: Orlando group Association of Program Directors for Colon and Rectal Surgery (APDCRS) Robotic Colorectal Surgery Training Program East Carolina University (ECU) robotic surgery training program Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Robotic Surgery Curriculum University of Pittsburgh Medical Center (UPMC) Center for advanced robotics training (CART) Robotic Head and Neck surgery program University of Pittsburgh Medical Center (UPMC) Center for advanced robotics training (CART) thoracic surgery robotics training program University of Pittsburgh Medical Center (UPMC) Center for advanced robotics training (CART) Surgical oncology Robotics Training program British Association of Urological Surgeons (BAUS) Robotic surgery curriculum University of Alabama at Birmingham (UAB) Robotic surgery Curriculum Samaritan Hospital General and Colorectal Surgery group Robotic Surgical Training program

Specialty Multispecialty Multispecialty Multidisciplinary

Yes

Not validated but uses FSRS Validated

No

No

Validated

Multidisciplinary

No

No

No

Validated

Multidisciplinary

Yes

Yes

Yes

Yes

Validated

Gynecology

2015

Yes

No

No

No

Validated

Cardiac surgery

2012

Yes

No

No

No

Multidisciplinary

2017

Yes

No

No

Yes

Not validated Not validated

Chitwood WR et al. [48]

2001

Yes

Yes

No

No

Not validated

Hanky EJ et al. [49]

2005

Yes

No

No

No

Not validated

Mitral valve repair, cholecystectomy, Nissen fundoplication General surgery

Not published [50]

2015

Yes

Yes

No

No

Not validated

Head and neck surgery

Not published [50]

2015

Yes

Yes

No

No

Not validated

Thoracic surgery

Not published [50]

2015

Yes

Yes

No

No

Not validated

General surgery and hepatopancreaticobiliary surgery

Not published [51]

2015

Yes

Yes

Yes

Yes

Not validated

Urology

Not published [52]

NA

Yes

No

Yes

Yes

Not validated

Gynecology

Madureira FAV. et al. [53]

2017

Yes

Yes

Yes

Yes

Not validated

General surgery and urology

Urology

Colorectal surgery

 (continued)

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Table 5.3 (continued) Robotic surgery training curricula Name Texas Association of Surgical Skills Laboratories (TASSL) Training collaborative Robotic Training Network Curriculum Fellowship of International College of Robotic Surgeons (FICRS) Transoral Robotic Surgery Curriculum (TORS) Training curriculum Emory University School of Medicine Robotic Surgery Training Curriculum

Fig. 5.5  Structure of the European Association of Urology Robotic Training Curriculum. (Reproduced with permission [19])

Study Lyons C et al. [54]

Year 2013

Dry lab/ Wet Modular Real-life simulation lab training surgery Validation Yes No No No Not validated

Not published [55] Not published [56] White J et al. [57]

NA

Yes

No

Yes

Yes

NA

Yes

No

No

Yes

2018

Yes

Yes

No

No

Not published [58]

NA

Yes

No

No

Yes

Not validated Not validated Not validated

Gynecology and general surgery Multidisciplinary

Not validated

General surgery

Otorhinolaryngology

Baseline evaluation

A

B

Specialty Multidisciplinary

Operating room observation (bedside-console)

E-learning module

Simulation-based training (1-wk intensive course)

C

Virtual reality simulation

Dry lab

D

Modular console training

E

Transition to full procedural training (Video recording of a full case of RARP)

F

Final evaluation

5.5.1 T  he European Association of Urology Robotic Training Curriculum The European Association of Urology Robotic (ERUS) training curriculum (Fig.  5.5) is a 3-month comprehensive training course which was developed based on an expert panel discussion with the robot-assisted radical prostatectomy as index procedure [19]. After undergoing a specifically developed e-learning module, trainees observe and assist during live surgery for 3 weeks. This is followed by an intensive week of simulation-based training, including virtual reality simulation (using the dVSS), dry lab, and wet lab training platforms. The technical robotic skills included are EndoWrist manipulation, camera movement and clutching, use of energy and dissection, and needle driving.

Wet lab

Improvement of technical skills is assessed by comparing the scores at baseline and on final assessment using the inbuilt validated assessment metrics on the dVSS [9, 19]. After the simulations, trainees move on to the fellowship stage, which consists of a supervised modular training program in robot-assisted radical prostatectomy with proficiency-­based, progressive training of surgical steps with increasing complexity. The training continues until trainees fulfill a complete robot-assisted radical prostatectomy. During these procedures, the surgical quality of each step is assessed by use of a validated RARP procedure-specific scoring scale. Procedural skills are evaluated by the mentor using the validated Global Evaluative Assessment of Robotic Skills (GEARS) score [9, 19].

5  Validating Robotic Surgery Curricula

63

A video of the final RARP performed by the trainee is recorded and reviewed by two blinded expert robotic surgeons. They use a generic dedicated scoring criterion for each procedural step to make a final overall score for each trainee, which can then be compared to the score of expert robotic surgeons. Volpe et al. [19] assessed the validity of the ERUS training curriculum, enrolling ten international fellows in the training program. All trainees completed the e-learning module and passed the final test for the assessment of theoretical knowledge successfully. Afterward, the trainees observed and witnessed a minimum number of procedures (>12 cases) during 3 weeks. The trainees then followed an intensive week of laboratory training, after which their overall score for dVSS tasks significantly increased. In the next 8 weeks, trainees started with supervised modular training, in which they were involved as surgeons in, on average, 18 operations. After completing the curriculum, 80% of trainFig. 5.6  Structure of the European Association of Urology Robotic Training Curriculum (Update). (Reproduced with permission [9])

ees was deemed able by their expert supervisors to perform a RARP independently, effectively, and safely. Volpe et al. [19] proved that the structured 12-week ERUS training curriculum is feasible, acceptable, and effective in improving the robotic technical skills and abilities of young surgeons with limited robotic experience to perform the crucial steps of robotic radical prostatectomy [9, 19]. The face, content, and construct validity of the ERUS training curriculum have been demonstrated [9, 19, 59]. In 2016, an update of this training was published that extends the training period of 3 months for a total of 6 months (Fig.  5.6) so that even the most inexperienced participants are confident to continue and finish the training with the awareness of having the time to improve [9]. A model of this type could represent the ideal training opportunity for naïve surgeons who need both theory-based and practical (domain and technical knowledge) for a specific surgical procedure [9].

Week 1–4: Live case observation and tableside assistance at host center

Week 5: Advanced robotic skill course

Procedure-specific theoretical training

Hands-on training: Simulator Dry lab Wet lab

Nontechnical skills training

Month 2–6: Modular robot-assisted radial prostatectomy console training at host center: Bladder detachment (at least 20 cases) Endopeivic fascia incision (at least 20 cases) Bladder neck incision (at least 15 cases) Section of vasa and preparation of seminal vesicles (at least 15 cases) Dissection of the posterior plane (at least 10 cases) Dissection of prostalic pedicles (at least 10 cases) Dissection of neurovascular bundles (at least 5 cases) Ligation of the Santorini plexus (at least 10 cases) Apical dissection (at least 10 cases) Urethro-vesical anastomosis (at least 15 cases)

Full-procedure training: video recording of a full case of robot-assisted radical prostatectomy

Final evaluation: The fellowship will be finalized with a video assessment evaluation score by robotic experts

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5.5.2 F  undamental Skills of Robotic Surgery (FSRS) The Fundamental Skills of Robotic Surgery (FSRS) training curriculum is a validated, structured, simulation-based training program that was created by the Roswell Cancer Institute in Buffalo, USA. The curriculum consists of four modules (orientation, motor skills, basic and intermediate surgical skills) with a series of 16 tasks, with each task containing three difficulty levels and an evaluation phase (Fig. 5.7). The curriculum is performed on the validated RoSS simulator, which automatically records and saves performance metrics of trainees. The tasks were specifically created by a group of expert robotic surgeons with integration of previously validated tasks from the Fundamentals of Laparoscopic Surgery curriculum [18, 59]. In the validation study of the FSRS, 53 participants without any previous robotic surgical experience were included whose performance was assessed by three tasks that had to be performed three times each on the da Vinci Surgical System: ball placement, suture pass, and fourth-arm manipulation. The participants were randomized in two groups: an experimental group (EG) and a control group (CG). Participants of both groups received a didactic session to introduce the

da Vinci Surgical System, led by an experienced operator. Participants included in the EG completed the FSRS training curriculum once in three to four sessions before completing the three tasks, while participants of the CG had to complete the tasks without completing the FSRS curriculum. Finally, after completing the three tasks, the participants included in the CG were offered to complete the FSRS curriculum and redo the three tasks afterward as a crossover group (CO). The participants’ performance on the three tasks was evaluated by video assessment by two trained, blinded, and independent reviewers. Assessment parameters included time to complete the tasks, the number of camera and clutch movements, the number of collisions, the number of drops, and the number of movements of instruments outside of the field of view. These assessment parameters were scored for each of the three takes of each task, and mean values were used for comparison of performance of the different study groups. Participants in the EG demonstrated significantly less drops and moved their instruments outside the view of the camera significantly less often than the CG. When comparing the results of the CG and CO participants, there was a significant improvement in time to completion and a significant decrease in number of errors with significantly less drops and movements of instruments outside of the camera’s

Module 1 Basic console orientation

Tast 3: Coordinated tool control Tast 2: Camera control

Knowledge

Tast 1: Instrument control

Tast 4: 4th Arm control

Tast 5 & 6: Ball placement Tast 7 & 8: Spatial control Tast 9 & 10: Needle handling

Tast 12: Tissue cutting

Tast 13: Tissue retraction Module 4 Intermediate surgical skills

Surgical application

Tast 11: Basic electrocautery

Tast 14: Blunt tissue

Integration of knowledge and skills

Module 3 Basic surgical skills

Technical skills

Module 2 Psychomotor skills training

Tast 15: Vessel dissection Tast 16: Knot tying

Fig. 5.7  The Structured Fundamental Skills of Robotic Surgery (FSRS) curriculum. (Derived from Stegemann et al. Reproduced with permission [18])

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5  Validating Robotic Surgery Curricula

view. Therefore, Stegemann et al. [18] demonstrated that the FSRS curriculum is a valid and feasible training curriculum that can improve trainees’ basic robotic surgical skills. In 2014, construct validity of the FSRS curriculum was demonstrated by Raza et al. [60]. Sixty-one surgeons of variable surgical experience (49 novices and 12 experts) were evaluated when performing four tasks (ball placement, coordinated tool control, fourth-arm control and needle handling and exchange), which were selected on expert consensus and represented the core of the three modules of the FSRS curriculum. The performance of participants was assessed by use of the built-in software in the RoSS, which evaluated 10 metrics in each task. Depending on their surgical experience, participants were able to perform one or three preliminary levels of each task, before the final evaluation started. Raza et al. [60] demonstrated that the expert participants performed significantly better than the novices at all aspects of the individual tasks, thereby proving construct validity of the FSRS curriculum. The Robot-Assisted Surgical Training (RAST) program is a 5-day to 3-week training curriculum that was developed at Roswell Park Cancer Institute and consists of the validated FSRS curriculum combined with other forms of hands-on training, including HoST training and wet lab training. Attalla et  al. [41] showed that RAST has an educational impact on trainees [59].

5.5.3 Proficiency-Based Robotic Curriculum The proficiency-based robotic curriculum is a validated, comprehensive training program created by the University of Texas Southwestern Medical Center. The curriculum consists of three curricular components: an online tutorial (by Intuitive Surgical) covering fundamental aspects of robotic surgery, a half-day interactive session, and hands-on practice with nine inanimate exercises (Fig. 5.8, Table 5.4) [5]. These exercises were developed by interviewing robotic surgery experts and through observation of live robotic surgery and aim to train 23 unique robotic skills (Fig. 5.9). The exercises are performed on a standard da Vinci system with box trainer and show increasing degrees of complexity to facilitate proficiency-­based skill acquisition. It takes 2 months to complete the training program, and trainees have to self-practice the nine exercises. All exercises are assessed using an objective scoring system based on the validated FLS approach time and errors [5]. Content and face validity of the proficiency-based robotic curriculum were demonstrated by Dulan et al. [61] when 12 expert robotic surgeons rated each of the 23 deconstructed skills and performed the 9 exercises. They concluded that all 23 deconstructed skills were highly relevant and that all 9 exercises effectively measure relevant skills [59]. Dulan

Online tutorial (Multiple choice questions)

1/2 day interactive session (Global rating scale)

9 inanimate exercises (Scoring based on time and errors)

Fig. 5.8  The proficiency-based robotic curriculum. (Reproduced with permission [5])

Table 5.4  List of nine inanimate tasks of the proficiency-based robotic curriculum Exercise number 1 2 3 4 5 6 7 8 9

Task description Peg transfer Clutch and camera movement Rubber band transfer Simple suture Clutch and camera peg transfer Stair rubber band transfer Running and cutting rubber band Pattern cut Running suture

et  al. [42] also demonstrated construct validity of this curriculum in a group of eight expert robotic surgeons and four novice trainees (medical students). After watching a video showing error avoidance strategies and the correct method to perform the nine exercises of the curriculum, the participants completed the nine exercises themselves. Every task of each participant was scored by a single trained proctor for time and accuracy using modified FLS metrics. Expert surgeons were found to achieve significantly better performance than inexperienced students according to each of the nine task scores [59].

5.5.4 Basic Skills Training Curriculum (BSTC) The basic skills training curriculum (BSTC) [43] is a validated 4-week training program developed by the

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E. Lambert et al. Rating scale

Not relevant or required in any case

Relevant in a few cases

Relevant or necessary in some cases

Relevant or necessary in a majority of cases

Relevant or necessary for every case

2

3

4

5

1 Content domain

Description

1. Console settings 2. Docking

Setting up and adjusting console settings as needed during surgery Surgeon guides OR nurse in positioning bedside robot and attaches arms to trocars

3. Robotic trocars 4. Robotic positioning

Appropriate port location strategies and placement technique Placing the bedside cart in the location where the operative field is most accessible

5. Communication

Closed loop communication between console surgeon, bedside assistants and OR team

6. Energy sources 7. Robot component names 8. Camera 9. Clutching 10. Instrument names 11. Instrument exchange 12. 4th arm control

Activation and control of cautery or other energy sources Knowledge of robotic component terminology Maneuvering the Camera to obtain a suitable view Maintaining comfortable range of motion for manual controls Knowledge of instrument terminology Changing out instrument used in the operation Activating the fourth arm through clutching and using it in the operation

13. Basic eye–hand coordination

Using the manual controls to accurately manipulate bedside instruments and perform tasks

14. Wrist articulation

Understanding and using the full range of motion of the EndoWrist (Intuitive Surgical)

15. Depth perception 16. Instrument to instrument transfer 17. Atraumatic handling 18. Blunt dissection 19. Fine dissection 20. Retraction 21. Cutting 22. Suturing interrupted

Appreciating spatial relationships of instruments and tissue Passing objects between the instrument Using graspers to hold tissue or surgical material without crushing or tearing Using instruments to seperate tissue bluntly Using instruments to perform precise dissection of delicate structures Holding tension on an object to facilate surgical manipulation Using the scissors to cut at a precise location Suturing single stitches with the robot

23. Suturing running

Suturing continuous stitches with the robot

Fig. 5.9  Task deconstruction list of 23 unique and necessary surgical skills. (Reproduced with permission [5])

University of Toronto. Trainees undergo a series of didactic lectures and self-directed online training modules (including Fundamentals of Robotic Surgery) before being introduced to the da Vinci Robot. The theoretical module, focusing on the cognitive objectives of the BSTC, includes advantages and disadvantages of robotic technology, analysis of the various robotic systems and its equipment, introduction to the patient cart, surgeon console and vision cart, review of the robot installation principles, placement of trocars, docking, exchange of tools, grafting and resolution of common technical problems, and several practical training sessions. After the theoretical module, a 2-hour hands-on robotic training session starts, focusing on the topics dealt with in the ­theoretical module. Thereafter, trainees start exercising basic skills on the dVSS such as EndoWrist manipulation and camera

navigation, instrument clutching, instrument and thirdarm functionality, object manipulation, needle guidance, suturing and binding of the nodes, cauterization, and dissection. This standard set of exercises is repeated for three individual 1-hour sessions on the simulator organized at weekly intervals. The robotic surgical skills of the trainees are evaluated by the built-in assessment tool of the simulator. A trainee passes the test when at least 80% of success has been achieved. Wet lab or real-life surgery training is not included in this training curriculum. Pre- and post-course skills tests have been conducted on two skill exercises standardized with inanimate models: ring transfer and needle passage. Studies have demonstrated improvement of robotic surgical skills among trainees, regardless of specialty, previous robotic experience, or level of training [43, 59].

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5  Validating Robotic Surgery Curricula

5.5.5 S  ociety of European Robotic Gynaecological Surgery (SERGS) Curriculum The Society of European Robotic Gynaecological Surgery (SERGS) curriculum [44] is a fellowship-styled, validated tri-modular training curriculum that was designed after the ERUS training curriculum (Fig. 5.10) [19]. The SERGS curriculum uses radical hysterectomy and pelvic lymphadenectomy as index procedures. The curriculum starts with a didactic introduction at the home education center. It consists of 2 days of e-learning and 1  month of assistance in robot-assisted gynecological procedures. E-learning is evaluated by online test modules. In this first module, trainees are encouraged to perform virtual reality exercises. After completion of the evaluation tests, the second module starts and consists of a 1-week hands-on procedural training at a European education center for robotic surgery. This includes half a day of theoretical system training, followed by 3–4 days of both dry lab training on the dVSS and wet lab training on live anesthetized pigs and cadaver models. Fig. 5.10  The SERGS curriculum

Module 1: Basic training 1 month

Module 2: Training course 1 week

Module 3: Mentored work 6 months

Trainees perform hysterectomies, adnexectomies, and pelvic and para-aortic lymphadenectomies under supervision of an expert robotic surgeon. The progress of robotic surgical skills for each individual trainee is evaluated by comparing the overall score on a dVSS virtual training test at the beginning and the end of the week. At the end of the training, the performance is assessed by Non-Technical Skills for Surgeons (NOTSS) for modular training and by Global Evaluative Assessment of Robotic Skills (GEARS) and Objective Structured Assessment of Technical Skills (OSATS) for procedural training. Finally, trainees move on to the last module, which focuses on in-house training with supervised real-life surgery. In this stage, trainees perform moderate to complex gynecological procedures under direct supervision of an expert robotic surgeon. Certification as a robotic gynecological surgeon is possible after formal approval of a completed logbook and assessment of video-recorded surgery by an SERGS expert. Rusch et al. [44] presented data in which four fellows performed a hysterectomy after completion of the SERGS curriculum. Videos of their performance were assessed by the

• E-learning (2 days) • Assistance in robot-assisted surgery (1 month) • Virtual reality training • Evaluation : Online or written knowledge test, built in (VR) basic skills test

• Theoretical system training (1/2 days) • System and basic procedure training in dry-and wet-lab environment (3-4 days) • Live case observation and discussion (1 day) • Evaluation : NOTSS, GEARS, OSATS

• Theoretical training (stepwise training of index procedures) • Assisting in gynaecological robotic surgery • Team training (emergency scenarios, team decision making, docking) • Modular performance of robotic surgery under supervision of at least 10 cases • Observing peri-operative care and outcome • Evaluation: GEARS, OSATS, Video assessment by an external reviewer

• Logbook submission • Positive assessment of surgical video by external reviewer Certification

E. Lambert et al.

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validated GEARS assessment tool. All trainees were able to perform a hysterectomy without supervision of their mentor with good or acceptable surgical quality. After 1  week, all participants performed better on the virtual reality simulator compared to their baseline performance [11, 44].

5.5.6 “ Western Protocol” Cardiac Surgery Virtual Reality Curriculum In this virtual reality curriculum, participants train different robotic surgical skills exercises on the dVSS that are needed in cardiac surgery, more specifically in the harvesting of the internal thoracic artery (ITA) and in mitral valve annuloplasty (Table 5.5) [45]. The training protocol consists of nine exercises that were selected according to the robotic skills needed for these two surgical procedures, which were defined by two expert robotic cardiac surgeons. For the validation study of this curriculum, Valdis et al. [45] recruited 20 surgeons with little experience with the Da Vinci console or with robotic simulators. The study included a video of the interventions to highlight the basic operative techniques and the relevant anatomy. The training program includes an initial evaluation of a surgical procedure on a porcine chest wall with the aim of collecting a length of 10 cm of the ITA peduncle. Subsequently, the trainees had to perform a suture on a pig cardiac model of the mitral valve, completing the first three sutures of an annuloplasty valve. Each activity was performed only once by each student and was timed and evaluated using the time criteria of the Laparoscopic Fundamentals program. Of the 20 participants in the study, half were able to practice on the simulator several times (up to 80 times to reach the level of competence established by experts). The other half did not receive any additional training (control group). After the training period, the trainees were compared again on the robotic procedure on the animal model. Intraoperative Table 5.5  The nine exercises of the Western protocol cardiac VR curriculum Virtual reality simulation exercise Matchboard Pegboard Camera targeting Energy switching Matchboard

Level 2 2 2 2 3

Ring walk

3

Energy dissection Suture sponge

2 3

Vertical defect suturing

Skill tested EndoWrist manipulation EndoWrist manipulation Camera control Energy control Fourth-arm manipulation Fourth-arm manipulation Energy control Needle driving—advance Needle driving—advance

surgical skills were assessed by GEARS [45]. Trainees randomized to the VR group were faster than the control group for both surgical procedures and scored significantly higher with the intraoperative scoring tool. Furthermore, trainees included in the VR group achieved a proficiency level similar to the experts for both time-based scores and the intraoperative assessment, whereas the control group was not able to meet this level of proficiency for any of the primary outcomes. Hereby, Valdis et al. [45] proved that the Western Protocol Cardiac VR Curriculum significantly improves the efficiency and quality of learning in robotic cardiac surgery.

5.6

Assessment Tools to Evaluate Performance of Robotic Surgery Trainees

Although credentialing is essential to guarantee safe clinical practice, there is currently no official credentialing process for robotic surgeons needed to perform robotic surgery. Standardized, proficiency-based and procedure-specific training curricula are an important step toward this credentialing process since the performance of participants is evaluated stepwise before performing live surgery [3–5, 8, 12]. Assessment of skills during, at the end of, and beyond training thus is an important factor for credentialing since this forms the basis for validation of training curricula. Increasing complexity of health-care technologies and the decrease in exposure of trainees as a result of working-time regulations have led to an even more distinct need for objective assessment of performance and competence. Different tools exist to assess performance of trainees during their training.

5.6.1 Global Assessment Tools The most commonly used validated rating scale in surgery is the Objective Structured Assessment of Technical Skills (OSATS) [3]. This scale evaluates general surgical technical skills and the surgeon’s knowledge of a specific procedure and flow of an operation. OSATS has been used to evaluate robotic training. However, since it was not specifically designed for robotic surgery, it cannot evaluate all aspects of robotic surgical skills properly [7, 8]. Therefore, the Robotic Objective Structured Assessment of Technical Skills (ROSATS) was developed. This is an assessment tool specifically created for evaluation of robotic surgical skills in which four categories of skills are assessed: depth perception and accuracy, force and tissue handling, dexterity, and efficiency. Each category is scored subjectively from 1 to 5 [62]. In 2012, the Global Evaluative Assessment of Robotic Skills (GEARS) tool was developed by Goh et  al. [7] by including features unique to robotic into a validated tool for

5  Validating Robotic Surgery Curricula Fig. 5.11  The Global Evaluative Assessment of Robotic Skills (GEARS) assessment tool

69

Depth perception

• Overshoots target, slow correction • Some overshooting or missing target, quick correction • Accurately directs to target

1 3 5

Bimanual dexterity

• Use only one arm, poor coordination • Not optimize interaction between the two hands • Expertly use of two hands with best exposure

1 3 5

Efficiency

• Uncertain movements, constantly changing without progress • Organized slowly movements • Safe conduct, fluid and confident movements

1 3 5

• Poor control, injuries nearby structures, suture breackage • Less trauma of nearby structure, rare suture breakage • Right tension, no injures, no suture breakage

1 3 5

• Not able to compare task, even with tips • Able to complete task with some tips • Able to complete task alone

1 3 5

Force sensitivity

Autonomy

Robotic control

• Not optimize view, hand position and more collisions 1 • Occasionally arms relocation, collisions and rare not optimize view 3 • Optimal control fo camera and arms, no collision 5

intraoperative laparoscopic skill assessment surgery, Global Operative Assessment of Laparoscopic Skills (GOALS). GEARS is the first consistent, validated, and standardized clinical assessment tool for intraoperative robotic surgical skills. It was modeled after global rating scales for open and laparoscopic surgery by expert robotic surgeons. In practice, GEARS is a rating scale in which six domains (depth perception, bimanual dexterity, efficiency, force sensitivity, autonomy, and robotic control) are subjectively evaluated by use of a Likert scale ranging from 1 to 5 (Fig. 5.11) [7]. An overall score is created by summing all scores, in which higher scores resemble better performances. GEARS hereby provides a valid, reliable, and reproducible measure of intraoperative robotic surgical skills [7, 8] in dry lab, wet lab, and real-life surgery environments. Studies show that GEARS scores of specific steps in robot-assisted radical prostatectomy are associated with patient outcomes, such as continence and readmission [7, 8]. In 2014, a validated assessment tool was developed related to robotic microsurgery, the Structured Assessment of Robotic Microsurgery Skills (SARMS) [63]. This tool for robotic microsurgical evaluation originates from the Structured Assessment of Microsurgery Skills (SAMS) in which domains strictly related to robotic surgery have been added. The domains included into this tool are dexterity, visuospatial ability, operative flow, camera movement, depth perception, wrist articulation, atraumatic tissue handling, and atraumatic needle handling. The evaluation is assigned with a score ranging from 1 to 5 [63]. The Assessment of Robotic Console Skills (ARCS) [64] is a validated assessment scale which consists of six catego-

ries that identify a group of skills to be acquired at the da Vinci Robot console for its proper use: bimanual wristed manipulation, camera control, master clutching activating energy sources, appropriate depth perception, and awareness of forces applied by instruments [64]. The Generic Dedicated Scoring Criteria (GDSC) [19] is a validated evaluation tool used in the European Association of Urology Robotic Training Curriculum to assess the quality of video-recorded surgical steps of trainees. Parameters evaluated were instrument use, tissue handling, errors made, and the end result, with each parameter being scored from 1 to 4. Global assessment tools such as GEARS are able to evaluate essential and basic robotic surgical skills. Therefore, these tools are primarily used in lab settings and preclinical training in order to evaluate if trainees can safely move on from training labs to the operating theater (Table 5.6) [8].

5.6.2 Procedure-Specific Assessment Tools Next to global assessment tools, different procedure-specific assessment tools exist for more detailed evaluation of specific surgical steps (Table 5.7) [8]. These tools provide cognitive evaluation of surgical skills in a task-deconstructive fashion, identifying specific steps for improvement for individual trainees. There are different examples of procedure-­ specific assessment tools, of which most were created for urological robot-assisted procedures. The robot-assisted radical prostatectomy (RARP) assessment score [73] is a validated evaluation tool for RARP. The procedure was divided into 17 crucial phases and 41 subpro-

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Table 5.6  Robotic surgical technical skills evaluated by global assessment tools Tissue handling/force sensitivity Instrument manipulation Instrument movement efficiency Depth perception Bimanual dexterity Use of assistants and third arm Camera control Master manipulator workspace Energy application Autonomy Bleeding or organ damage Flow of operation Knowledge of specific procedure

OSATS Yes Yes Yes No No Yes No No No No No Yes Yes

ROSATS Yes No Yes Yes Yes No No No No No No No No

GEARS Yes Yes Yes Yes Yes No Yes Yes No Yes No No No

SARMS Yes Yes Yes Yes Yes No Yes No No No No No No

ARCS Yes Yes No No Yes Yes Yes Yes Yes No No No No

GDSC Yes Yes No No No No No No No No No No No

OSATS Objective Structured Assessment of Technical Skills, ROSATS Robotic Objective Structured Assessment of Technical Skills, GEARS Global Evaluative Assessment of Robotic Skills, SARMS called Structured Assessment of Robotic Microsurgery Skills, ARCS Assessment of Robotic Console Skills, GDSC Generic Dedicated Scoring Criteria Table 5.7  Procedure-specific robotic surgical skill assessment tools Tool Robot-assisted radical prostatectomy scale (RARPS) Robotic Anastomosis Competency assessment and competency evaluation (RACE)

Study Volpe et al. [19] Raza et al. [65] Ghani et al. [66]

Year 2015 2015 2016

Peabody, et al. [67]

2015

Prostatectomy Assessment and Competency Evaluation (PACE)

Hussein et al. [23] Ghani et al. [23]

2017 2016

Pelvic Lymphadenectomy appropriateness and Completion Evaluation (PLACE) Cystectomy Assessment and Surgical Evaluation (CASE) Scoring for Partial Nephrectomy (SPaN) Robotic Hysterectomy Assessment score (RHAS) Competence Assessment in Colorectal Robotic Surgery (CACRS) Robot-assisted radical prostatectomy assessment score

Hussein et al. [68]

2017

Evaluation Review by experts Review by experts Crowd-­sourced assessment vs experts Crowdsourced assessment vs experts Review by experts Crowd-­sourced assessment vs experts Review by experts

Hussein et al. [69] Hussein et al. [70] Frederick et al. [71] Petz et al. [72]

2018 2018 2017 2016

Review by experts Review by experts Review by experts Review by experts

Yes Yes Yes No

Lovegrove et al. [73] Lovegrove et al. [74] Lovegrove et al. [75] Bruce et al. [76]

2016 2017 2017 2016

Review by experts Review by experts Review by experts Review by experts

Yes No Yes Yes

Robot-assisted partial nephrectomy assessment score

cesses. Unlike other assessment tools, it is the only one that also analyzes the surgeons’ learning curve. All phases are evaluated with a score of 1 to 5 assigned by expert surgeons. The robot-assisted partial nephrectomy (RAPN) assessment score [75] is a similar tool to evaluate the performance of a surgeon in RAPN. It was created by identifying all possible failure modes and most dangerous steps in the procedure. It consists of 6 phases with 26 processes and 50 subprocesses. The six phases are “preparation of operative field”; “exposure of surgical field”; “dissection and control of hilum”; “preparation for hilar clamping and tumor excision”; “hilar clamping, warm ischemia time, and tumor excision”; and “finalizing and closure” [75, 76]. Another procedure-specific assessment tool for minimally invasive partial nephrectomy is the “Scoring for Partial

Validation Yes Yes No No Yes No Yes

Nephrectomy” (SPaN) tool [70]. It is a scoring system that can offer objective and structured feedback on technical skills of trainees. This assessment tool was created by deconstruction of the critical steps of a robot-assisted partial nephrectomy into six domains (exposure of the kidney, ureteral and gonadal vessel identification and dissection, hilum dissection, tumor localization and exposure, tumor clamping and resection, and renorrhaphy). Each domain is then assessed for surgical skills by a Likert score from 1 (worst) to 5 (best). The Robotic Anastomosis Competency Evaluation (RACE) [65] assessment tool analyzes bladder urethral anastomosis in robotic radical prostatectomy. It consists of six domains (needle positioning, needle entry, needle driving and tissue trauma, suture placement, tissue approximation, and knot tying) which are all scored independently. Scores

71

5  Validating Robotic Surgery Curricula

range from 1 (the worst performance) to 3 (intermediate) to 5 (the ideal performance) [65]. The Prostatectomy Assessment and Competency Evaluation (PACE) [23] is a validated assessment tool that was created by the analysis of RARP by 12 expert robotic surgeons. The procedure was subdivided into seven key points (bladder drop, prostate preparation, bladder neck dissection, posterior/seminal vesicle dissection, neurovascular bundle preservation, apical dissection, urethrovesical anastomosis), which are evaluated with a 5-point Likert scale [23]. The Pelvic Lymphadenectomy appropriateness and Completion Evaluation (PLACE) [68] is a validated, structured intraoperative scoring system to measure and quantify pelvic lymph node dissection (PLND) in robot-assisted radical cystectomy. It was created by a panel of 11 surgeons, who divided the PLND template into three zones. PLNDs of trainees may be evaluated using PLACE, in which the performed PLND is compared with a “perfect” PLND [68]. The Cystectomy Assessment and Surgical Evaluation (CASE) tool [69] was developed for radical cystectomy in men and provides a subdivision of the procedure based on eight key steps (pelvic lymph node dissection, development of the peri-ureteral space, lateral pelvic space, anterior rectal space, control of the vascular pedicle, anterior vesical space, control of the dorsal venous complex, apical dissection). Scores on each step are assigned by a 1–5 Likert scale [69]. These procedure-specific assessment tools evaluate both surgical technical skills and surgical knowledge, thereby assessing the competence of a surgeon to perform a specific procedure independently and safely. These tools could be used for robotic surgeon credentialing and licensing for specific robotic procedures. Although promising, there are currently no data on procedure-specific assessment tools that correlate with patient outcomes. Major disadvantages of manual assessment tools are that they are time-consuming to the evaluators, that they are making evaluation of complete procedures difficult, and that they are exposed to subjective bias, limiting inter-rater reliability [8].

5.6.3 Automated Assessment Tools Automated performance metrics (APMs) are other tools that allow to evaluate the performance of trainees in surgical curricula (Table  5.8). APMs integrate objective data that is acquired automatically during surgical training using recording devices, robotic instrument kinematic tracing data, system events data, and surgical video data. Many of these APMs have shown a good ability to distinguish different levels of expertise between surgeons. These data are processed by learning algorithms, and meaningful evaluation and feedback are based on automatically recorded data (computer-­ aided automated evaluation).

Table 5.8  Examples of recording devices offering analysis of automated performance metrics Name trakSTAR

ProMIS

Application Programmer’s Interface dVLogger

Creator Ascension Technology (Shelburne, USA) Haptica (Dublin, Ireland) Intuitive Surgical (Sunnyvale, USA) Intuitive Surgical (Sunnyvale, USA)

Study Tausch TJ et al. [77]

Year 2012

Validation Yes

Chandra V et al. [40].

2010

Yes

Kumar et al. [78]

2012

Yes

Hung AJ et al. [79]

2018

Yes

The implementation of APMs in evaluation of trainees holds many advantages: APMs eliminate the bias of human judgment and make robotic surgical technical skills quantifiable. Furthermore, the evaluation of trainees does not longer require major time investments of evaluators since data is collected automatically. On top, performance metrics on complete procedures can be recorded, offering comprehensive evaluation of complete surgeries. Large-scale surgical evaluation, surgeon credentialing, and recredentialing could be performed by computer-aided automated evaluation of surgical technical skill. However, assessment of surgical skills by computer-aided evaluation of APMs is still in early stages of development [8].

5.6.4 Nontechnical Skills (NTS) Assessments Next to training and evaluation of technical skills, nontechnical skills (NTS) play an important role in robotic surgery and have the potential to impact patient safety and adverse events [16]. Different assessment tools for NTS have been developed and validated, such as the Non-Technical Skills for Surgeons (NOTSS) [80] and the observational Teamwork Assessment for Surgery (OTAS) [81]. However, specific assessment tools for NTS evaluation in robotic surgery do not exist [16, 82].

5.7

Conclusions

Over the past decades, a rapid diffusion of robot-assisted surgery in different surgical fields was observed. In order to introduce robotic surgery in a safe and efficient way without compromising surgical outcomes and patient safety, training is mandatory and should be structured in specific, validated proficiency-based training curricula.

72

Currently, there is no international consensus on credentialing for robotic surgeons. General, centralized competency standards do not exist. Validated training curricula in which the performance of trainees is evaluated by validated assessment tools are a crucial first step toward robotic surgery credentialing. These training curricula should be organized in a modular fashion with a well-structured road map in which trainees start with knowledge development, followed by basic and advanced skills training in dry- and wet lab environments before moving on to console training. Besides technical robotic surgical skills training, nontechnical skills training should be included in these robotic surgery training curricula as well. The validation of training programs is essential since this proves their educational impact and potential to differentiate between different levels of competence. Validation of robotic surgery training curricula can be obtained by well-powered, randomized studies in which the performance of trained and untrained participants is compared by independent and blind assessors in a center of excellence. Several training curricula exist; however, only few were validated. Of these validated training programs, only two followed the aforementioned structure and offer online education, dry- and wet lab training, and real-life surgical modular training under direct supervision. These training programs are the ERUS training curriculum [19] and the SERGS curriculum [44]. The ERUS training curriculum is the first validated training curriculum in which participants are trained in a modular fashion to perform a complete surgical procedure alone. It is feasible, acceptable, and effective in improving the robotic technical skills and abilities of young surgeons with limited robotic experience to perform the crucial steps of robot-assisted radical prostatectomy. Technological evolution will continue to bring new innovations in the field of minimally invasive surgery, and training should evolve accordingly. The evaluation of surgical skills is essential, and great future lies within computer-aided automated evaluation of surgical technical skills.

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73 44. Rusch P, Kimmig R, Lecuru F, Persson J, Ponce J, Degueldre M, et  al. The Society of European Robotic Gynaecological Surgery (SERGS) Pilot Curriculum for robot assisted gynecological surgery. Arch Gynecol Obstet [Internet]. 2018;297(2):415–20. Available from: https://doi.org/10.1007/s00404-017-4612-5. 45. Valdis M, Chu MWA, Schlachta CM, Kiaii B.  Validation of a novel virtual reality training curriculum for robotic cardiac surgery: a randomized trial. Innov Technol Tech Cardiothorac Vasc Surg. 2015;10(6):383–8. Available from: https://doi.org/10.1097/ imi.0000000000000222. 46. Macgregor JM, Kim RS, Gallagher JT, Soliman MK, Ferrara A, Baldwin K, et  al. Fundamentals of robotic surgery, Society of American Gastrointestinal and Endoscopic Surgeons Annual Meeting 2012; San Diego. 2012. 47. Association of Program Directors for Colon and Rectal Surgery. APDCRS Homepage [Internet]. 2019 [cited 2019 Feb 17]. Available from: http://www.apdcrs.org/wp/ 48. Chitwood WR, Nifong LW, Chapman WHH, Felger JE, Bailey BM, Ballint T, et al. Robotic surgical training in an academic institution. Ann Surg. 2001;234(4):475–86. 49. Hanly EJ, Zand J, Bachman SL, Marohn MR, Talamini MA. Value of the SAGES Learning Center in introducing new technology. Surg Endosc Other Interv Tech. 2005;19(4):477–83. 50. University of Pittsburgh Medical Center (UPMC). Center for advanced robotics training (CART) [Internet]. 2015 [updated 2015, cited 2019 Feb 17]. Available from: https:// w w w. u p m c . c o m / h e a l t h c a r e - p r o f e s s i o n a l s / e d u c a t i o n / advanced-robotic-surgery-training. 51. BAUS business: robotic surgery curriculum, guidelines for training. British Association of Urological Surgeons Web site. Updated 17 August 2015. https://www.baus.org.uk/professionals/ baus_business/publications/83/robotic_surgery_curriculum. 52. University of Alabama at Birmingham. Robotic surgery Curriculum [Internet]. [cited 2019 Feb 17]. Available from: https://www. uab.edu/medicine/obgynresidency/18-academic-curriculum/ academic-curriculum/78-robotics-curriculum-v15-78. 53. Madureira FAV, Varela JLS, Madureira Filho D, D’Almeida LAV, Madureira FAV, Duarte AM, et al. Modelo de programa de treinamento em cirurgia robótica e resultados iniciais. Rev Col Bras Cir [Internet]. 2017;44(3):302–7. Available from: http://www.scielo.br/scielo. php?script=sci_arttext&pid=S0100-69912017000300302&lng=pt &tlng=pt. 54. Lyons C, Goldfarb D, Jones SL, Badhiwala N, Miles B, Link R, et  al. Which skills really matter? Proving face, content, and construct validity for a commercial robotic simulator. Surg Endosc Other Interv Tech. 2013;27(6):2020–30. 55. Robotic Training Network. Robotic Training Network Homepage [Internet]. 2019 [updated 2015, cited 2019 Feb 17]. Available from: https://robotictraining.org/. 56. International College of Robotic Surgeons. Fellowship of International College of Robotic Surgeons (FICRS) [Internet]. 2012 [updated 2012, cited 2019 Feb 17]. Available from: http:// icrsonline.org/fellowship.html. 57. White J, Sharma A.  Development and assessment of a transoral robotic surgery curriculum to train otolaryngology residents. ORL J Otorhinolaryngol Relat Spec. 2018;80(2):69–76. 58. Emory University School of Medicine. Department of Surgery: Training [Internet]. 2019 [updated 2019, cited 2019 Feb 17]. Available from: http://www.surgery.emory.edu/training/index. html. 59. Fisher RA, Dasgupta P, Mottrie A, Volpe A, Khan MS, Challacombe B, et al. An over-view of robot assisted surgery curricula and the status of their validation. Int J Surg. 2015;13:115–23. 60. Raza SJ, Froghi S, Chowriappa A, Ahmed K, Field E, Stegemann AP, et al. Construct validation of the key components of fundamen-

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6

Defining and Validating Non-technical Skills Training in Robotics Oliver Brunckhorst and Prokar Dasgupta

6.1

Introduction

Table 6.1  Components of social and cognitive non-technical skills [4–6]

Teamwork and The skills required for working In recent years, there has been a changing attitude towards Social communication within a team, including setting up non-technical skills (NTS) in robotic training. There is a skills a shared perception of current growing realisation that a surgeon’s ability is no longer situations and enabling effective defined purely on his technical ability. This becomes clear completion of tasks Leadership An individuals’ ability to facilitate when considering that more surgical errors occur due to non-­ individual and collective efforts operative factors than due to surgical technique alone [1]. In for the completion of shared addition to affecting patient safety, it is important to consider objectives that these errors pose a large financial strain on healthcare Cognitive Situational The product of an individual’s systems via litigation [2]. The ever growing literature on the skills awareness perception and comprehension of the available current information components, training and assessment of these skills reflects and being able to place this in the this change in attitude. However, despite this, there is still a context of the future course of a lack of translation of this research into current educational situation practice. In recent surveys, only 41% of urology trainees Decision-making The ability to effectively diagnose a situation and utilising available believe their current NTS training is sufficient for their first information to reach a conclusion day of practice as an independent clinician [3]. When you about the need and method of a combine this with the reducing hours trainees now experinecessary action ence due to working time restrictions and the rapidly increasing use of new technology such as robotics which requires further training, it is clear to see why there is a need for not only awareness of NTS, but also improved implementation of its training. We aim to therefore provide an overview of with the personal resource factors an individual possesses the components of NTS and how to best implement training also being important [4, 7, 8]. Social skills are the most and assessment of these skills in modern robotic education. common skill sets attributed to NTS and encompass communication, leadership and teamwork. Communication and teamwork skills are an important aspect in operating envi6.2 Components of Non-technical Skills ronments with particular emphasis required on effective exchanges of information, establishment of shared underWhen discussing NTS in surgery, the skill sets which are standing and coordination of team activities [4]. Similarly, encompassed can be categorised into three categories effective  leadership  is essential  in effective coordination (Table 6.1) [4–6]. These include cognitive and social skills, of large surgical teams,  with important elements including managing resources and tasks, maintaining standards and implementing decisions made [5, 9]. When considering O. Brunckhorst robotic surgery specifically, these social skills are of vital MRC Centre for Transplantation, King’s College London, London, UK importance. The robotic environment is unique with the surgeon operating away from the bedside, meaning that comP. Dasgupta (*) MRC Centre for Transplantation, Guy’s Hospital, King’s College munication with the assistant, who is at a distance, must be London, London, UK optimised [10]. Additionally, due to the increased number of e-mail: [email protected]

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_6

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team members present during robotic surgery, other aspects such as teamwork and leadership also require special attention. It is therefore easy to see the importance of all of these social skills to ensure safe robotic surgery. Cognitive skills are often less immediately apparent but remain just as important as other NTS components. These skill sets include processes such as decision-making, situational awareness and planning. Situational awareness in robotic surgery is vital with the surgeon being at a distance from the patient by the robotic console and is in itself a complex skill set [10]. It is an ongoing process within a dynamic environment consisting of perception of the environment elements, comprehension of these elements and projection of their meaning for future situations [6]. Decision-making is considered one of the more advanced cognitive skills and has generated a large amount of research interest to understand its process [11]. It has previously been described as a three-­stage process starting with an assessment of the situation [12]. This is followed by the more complex reconciliation cycle. This is in itself is divided into gaining information, weighing its components up and subsequently projecting the decision. Finally, the decision made must be implemented which may require other components of NTS to be carried out, including communication. Furthermore, it is important to consider that this process may be a subconscious or a conscious process, both of which are  heavily reliant on previous experiences [13]. An experienced individual is able to draw on a larger selection of previous subconscious cognitive maps of the procedure, as well as greater knowledge of available options and how to implement these once a conscious process has to occur [13, 14]. It is because of these factors that decision-making is acknowledged as an advanced skill set that improves exponentially with increasing experience [15]. Finally, it is important to consider the personal resource factors an individual possesses. This broadly consists of the ability of a surgeon to deal with external stressors and fatigue. With the operating room having the potential to be a fast-moving and stressful environment, the ability of a surgeon to deal with interruptions, distractors and complications is vital [16]. It is well known that these factors can not only have an adverse impact on the technical skills of a surgeon but additionally on other NTS such as decision-making and communication [17, 18]. It is known that experts are able to cope with stressors and distractions better than novices, meaning that similar to other NTS, these skill sets can be developed via training and experience [17].

6.3

Training Non-technical Skills

With increasing awareness of the components of NTS, there has been increasing development on the methods of training them. Delivery of this teaching is broadly categorised into

two methods: didactic delivery and simulation-based training. Despite the majority of the time of trainees being spent in theatres and daily clinical practice, there are at present few structured training methods within day-to-day practice, despite the acknowledged educational potential for developing NTS that is present during activities such as multidisciplinary meetings [19].

6.3.1 Didactic Teaching The didactic delivery of NTS consists primarily of descriptions of its key components with examples of good and bad behaviours for each of these presented in either a written or visual manner [11]. This can be delivered in a variety of methods, including interactive workshops, lectures, short courses and more recently e-learning. Electronic delivery of these skills has a large potential for offering a flexible and cost-effective method of delivery, which has already been demonstrated to be useful for NTS training specifically [20, 21]. Regardless of the method of didactic delivery of NTS training, the aim of this teaching is to increase awareness of the key skills and improve self-reflection which can begin to change attitudes [22]. However, there are limitations to this teaching method. Whilst it can introduce the concepts of NTS and how to implement them, it does not offer the opportunity to practice and implement these skills which are vital, particularly for the development of more advanced skill sets such as decision-making [23, 24]. Didactic teaching therefore is unlikely to be a suitable method of training NTS on its own but instead as an adjunct within a comprehensive curriculum which incorporates practical implementation of skills learnt via simulation-based training.

6.3.2 Simulation-Based Training Using simulated scenarios and procedures is a well-­ established practice in surgical education. However, more recently, the focus is moving away from a purely technical skills development in these scenarios as the importance and teachability of NTS become more apparent. The delivery of simulation-based training for NTS usually involves the use of scenarios within high-fidelity operating environments which utilise multiple team members across a range of procedures [25, 26]. The scenarios themselves can range from simple partial or full procedure simulation for the d­ evelopment of more basic skill sets, all the way to simulations of complications and emergencies, often termed crisis resource management scenarios [27]. When looking at robotic surgery specifically, there is actually limited data surrounding the use of these scenarios for developing NTS.  This is  likely due to limitations posed by the robotic system itself through

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6  Defining and Validating Non-technical Skills Training in Robotics

the large amount of equipment and staff required for this. However, there is little doubt in terms of the effectiveness of simulation based-training in other disciplines in the short term [28–32]. Furthermore, when looking at crisis resource management specifically, there is further good evidence to show improvements in most NTS categories with specific emphasis on the ability to manage stress [32–35]. Despite this extensive evidence base surrounding simulation for NTS training, whilst it is likely this correlates with improved operative  performance and indeed better patient outcomes, the objective evidence for this in the literature is unfortunately still lacking. One of the most important aspects of using simulation as a training tool for NTS development is the presence of a structured debriefing [11]. Scenarios can be recorded and played back to those undergoing it, with discussion of behaviours facilitated by a trained member of the team [36, 37]. There are different styles of debriefing within simulation-based training: facilitator-led post-scenario debrief, self-guided post-­ scenario and facilitator guided within the scenario debriefing such as freeze framing [38]. Whilst there are distinct differences, there is little evidence to suggest one method being superior from another. However, what is important is that the method utilised is structured to be as effective as possible. There should be a briefing prior to the start of the process to let participants know what to expect, and the debriefing process should last for as long as the scenario itself in general [37]. Furthermore, the presence of a script to guide the process can be of use either to refocus the conversation back to NTS or to standardise the process [37, 39]. One such script may come in the form of validated assessment scales which can give prompts and ideas for areas of discussion, as well as objective parameters to mark against [40]. It is therefore clear that more consideration must go into the development of simulation-based NTS training than just the scenario itself, with particular emphases on what happens after the scenario has been conducted.

training, similar incorporation of NTS and technical skills training in curricula have been seen in large centrally organised training pathways as seen by the British Association of Urological Surgeons (BAUS) and the European Association of Urology (EAU) [44, 45]. It is therefore clear that despite the current lack of evidence of specific NTS training modalities in robotic surgery, there is an increasing incorporation of training methods into widely utilised curricula which have acknowledged the importance of developing these skill sets. The next step within robotic NTS training will be to ensure that these developed curricula are not only used, but also that further assessment is conducted to demonstrate that they result in improved skills and skills transfer into the operating room and ultimately provide improved patient outcomes.

6.4

Assessment of Non-technical Skills

There are numerous available assessment tools for NTS at present (Table 6.2) [40, 46] with varying levels of validation specifically within the robotic environment. These tools are an important method to not only assess competency, which can be used for progression along training, but also as training tools [47]. They act as a structured method of providing feedback and allow for self-reflection on specific areas that require further development. Generic training tools are largely divided into those which provide specific NTS feedback for individual surgeons and those which are aimed at surgical Table 6.2  Assessment tools available for non-technical skills [40, 46] Type of assessment tool Rating scale Individual Non-technical Skills surgeon for Surgeons (NOTSS)

Interpersonal and Cognitive Assessment for Robotic Surgery (ICARS)

6.3.3 Non-technical Skills Curricula It is important that any NTS training conducted is not utilised as a stand-alone or one-off intervention [41]. Previous robotic curricula have previously strongly focused on technical skills development; however, there is a greater emphasis of integration of non-technical skills alongside this recently [42]. It is important to not only integrate both technical and non-technical training, but additionally the various training modalities that are available within a curriculum to gain the benefits of each. Outside of robotics, there is growing evidence to demonstrate the effectiveness of such developed curricula, which have been validated and implemented on a national scale in some cases [28, 43]. Within robotic

Team-based

Observational Teamwork Assessment for Surgery (OTAS)

Oxford NOTECHS I and II

Key components Situational awareness, decision-making, communication, teamwork and leadership Checklist and console Communication and team skills Leadership Decision-making Situational awareness Stress and distractors Communication Coordination Cooperation Leadership Situational awareness Communication and interaction Situation awareness Cooperation and team skills Leadership and management Decision-making (continued)

O. Brunckhorst and P. Dasgupta

78 Table 6.2 (continued) Type of assessment tool Rating scale Surgical Teamwork Individual non-technical Tool skills components

Surgical Leadership Inventory

Multifactor Leadership Questionnaire

Key components Shared leadership qualities Open to suggestions Sharing of key information Confirmation of information receipt Coordination of clinical tasks Management of errors Maintaining standards Managing resources Making decisions Directing, training and supporting others Communication Coping with pressure Identifies leadership characters and type into three subtypes: transformational, transactional and passive

Surgical DecisionMaking Rating Scale

Cognitive load

Anatomic recognition Management of current task Immediate surgical planning Avoidance of complications Higher-level planning NASA Task Load Physical demand Index (NASA-TLX) Mental demand Temporal demand Performance Effort Frustration Electroencephalography Cognitive load (EEG) Cognitive state High-level engagement Distractors

teams as a whole [40]. Of the training tools available for individual surgeon feedback, the most widely investigated across numerous surgical specialties is the Non-Technical Skills for Surgeons (NOTSS) tool [40]. It has numerous studies demonstrating its validity and reliability across both simulated environments and operating rooms [11]. It is broadly categorised into four domains along with the components of NTS: situational awareness, decision-making, leadership and communication and teamwork. However, despite the extensive investigation NOTSS has undergone, there is at present very little data on its use within robotic surgery specifically. It is only recently that specific individual surgeon training tools have been developed that acknowledge the difference in skill

sets required for robotic procedures. The Interpersonal and Cognitive Assessment for Robotic Surgery (ICARS) rating tool has been validated for this purpose, assessing social, cognitive and personal resources skills of individuals operating on the console [48]. Of the assessment tools developed for team-based evaluation, the most widely investigated include the Observational Teamwork Assessment for Surgery (OTAS) and the Oxford NOTECHS I and II [40]. Both are based on previous aviation scale rating systems and possess good validation evidence of their reliability and validity [11]. Their assessment focus is more on the social skills present within a team including communication, coordination, cooperation and leadership. However, they still acknowledge other skill sets such as decision-making and situational awareness. Similar to NOTSS, there is however  limited evidence for their use in robotic surgery teams specifically, with no procedure-­ specific tools available [46]. Whilst it is likely that these tools provide a valuable adjunct to team-based assessment in robotic surgery, the objective evidence for this is unfortunately still lacking.

6.5

 he Future of Non-technical Skills T in Robotics

6.5.1 I ndividual Non-technical Skills Components Training and Assessment With the growing knowledge of NTS, there has been a shift towards more individualised training. This has predominantly come in the form of the training of individual NTS components. These have come in the form of specific training methods and programmes as well as assessment tools developed. When looking at social skills, there is a great focus on communication and teamwork skills specifically with various simulation programmes looking at these specifically [31, 49]. Furthermore, there has been the development of specific training tools, with the Surgical Teamwork Tool Developed which focuses on coordination of tasks, sharing of information, shared leadership and management of errors [50]. Similarly, leadership has generated a lot of research interest with an increasing knowledge regarding the different styles of effective leadership [5, 9, 51]. Simulation is one of the acknowledged tools for developing leadership specifically [52]. Furthermore, validated assessment scales are now available that can be utilised in these scenarios for leadership training and assessment via the Surgical Leadership Inventory and the Multifactor Leadership Questionnaire [53, 54]. These focus around managing resources, maintaining standards and coping with pressure and different types of leadership. When looking at cognitive skills, there is a similar research interest surrounding their teaching and training. There have

6  Defining and Validating Non-technical Skills Training in Robotics

been numerous methods of training decision-making skills which have been investigated including didactic teaching, e-learning, simulation and short mixed methods courses [55– 59]. These specific training methods have all shown good educational value to improve decision-making skills. There is additionally the availability of the Surgical Decision-­ Making Rating Scale which can be used to as an adjunct to these as an assessment and training tool [60]. Situational awareness training has proven more difficult. Again, whilst specific simulation training is known to improve these skills, there are as of yet no specific assessment tools for this skill set reflecting itscomplexity [6]. Whilst it is clear that training individual NTS components is proving beneficial in various surgical specialties, as is the case with most of NTS training, there is still limited evidence of it in robotic surgery specifically. This is important to consider and address in view of the unique NTS requirements that robotic procedures pose.

6.5.2 Cognitive Training and Assessment The use of cognitive training, or alternatively also called mental imagery training, describes the use of mentally rehearsing a sequence of motions or even full procedures and its elements without conducting the physical movement itself [61]. This has been a well-utilised tool in music, flight and elite sport training for several years. Whilst it has been used in an unstructured fashion by surgeons for mental preparation of procedures for a long time, it is only recently that it is being structured in a more effective manner [62]. Cognitive training offers a potentially cost-effective and self-directed training method which could be utilised as an adjunct for training skills in robotic surgery and could accelerate understanding of a procedure and reduce overall training times [63]. It is a demonstrated effective training modality for developing technical skills across numerous surgical procedures [61]. However, importantly there is also evidence to suggest its use to improve NTS. It has seen to be useful in training situational awareness, decision-making, anticipation of problems and reducing stress [63–65]. When looking at robotics specifically, cognitive training has at present less evidence base. It has been assessed for urethrovesical suturing tasks in a simulated environment demonstrating improved technical performance [66]. However, at present, the evidence for NTS in robotics specifically is not available, but it seems likely that it has an important role in view of its previous efficacy and will therefore play an important role in future NTS training. In addition to cognitive training for improving skills, there has been a rise in the use of cognitive assessment methods with research available in robotic surgery specifically. These vary significantly with regard to methods utilised. A commonly used tool which has been extensively evaluated is the NASA Task Load Index (NASA-TLX). It is a subjec-

79

tive self-assessment tool to evaluate cognitive workload with domains including physical, mental and temporal demand as well performance, effort and frustration. There is good evidence for its use in robotic surgery, with demonstrated utility in simulated and operative scenarios and a good applicability as a training tool as well [46]. A less subjective assessment method that is being investigated within robotics is the use of electroencephalography (EEG) as a real-time measurement of cognitive load, state and high-level engagement during procedures. There is some evidence to demonstrate good differentiation between novices and experts and correlation with task performance [67–69]. However, whilst further work is certainly required at present to further evaluate this as an assessment tool and its role as a training aid, this may in future have a role in NTS training and assessment.

6.6

Conclusion

The importance of NTS in robotics cannot be underestimated. Their role in surgical error is clear and as such has a huge impact on clinical practice. As this realisation sinks in, the knowledge surrounding these skills is exponentially increasing, and importantly how to train these skills alongside with it. There are now numerous modalities which have demonstrated effectiveness for this,  with the most important of these being didactic and simulation-based training. At present, there is however certainly a further requirement of the evaluation of these methods for robotic surgery specifically. Nevertheless, this has not prevented the integration of these methods into well-structured and well-defined curricula across large centralised bodies. Furthermore, numerous assessment tools are available which can be utilised for competency assessment as well as a training tool. Finally, there is a growing trend of training individual NTS components, such as leadership and decision-making, with cognitive training and assessment also becoming an increasingly investigated modality. Overall, the future looks bright for greater incorporation of NTS training in robotics, with the aim to ultimately demonstrate a positive impact on patient outcomes which will ultimately follow.

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7

Secrets of the Robotic Dance (The World’s Busiest Surgical Robot) Jeffrey G. Nalesnik and Shahab P. Hillyer

7.1

Introduction

Over the last two decades, the robotic platform has revolutionized minimally invasive surgery, allowing for the evolution of complex open techniques into less traumatic, minimally invasive procedures. The promise of shorter convalescence, better cosmesis, less pain, and less blood loss has rocketed robotics to the cutting edge of surgical procedures among many surgical specialties. Dispersion among community surgeons has exponentially increased robotics utilization, prompting hospitals to address cost and logistical issues arising from the significant increases in the number of robotic procedures performed annually. The da Vinci Surgical System by Intuitive Surgical remains the leading robotic platform used in cardiac, thoracic, general, urological, gynecological, head and neck, bariatric, and colorectal surgeries. This volume rise has contributed to a higher demand for operating room time for robotic procedures along with an inflation of hospital operative room costs. As the number of hours in a day is a constant of nature, many surgeons have begun to look for time by the old adage of increasing efficiency in both surgical techniques and in such mundane things as turning over the operating room in a more expedient manner. The human factor involved here, in many ways, is often the rate-limiting step in how many robotic procedures we can complete in a day. In this chapter, we will describe a choreographed strategy developed at Kaiser Permanente in West Los Angeles, almost a decade ago, for decreasing the human factors involved in the dreaded operating room turnaround time. This can often make or break how many surgical cases can ultimately be performed in 1 day. Surgeons affectionately named this strategy the “Robotic Dance.” In developing the robotic dance, multiple data points were analyzed to identify factors involved with improving J. G. Nalesnik (*) · S. P. Hillyer Department of Urology, Kern Medical, Bakersfield, CA, USA e-mail: [email protected]

robotic utilization time, ultimately reducing hospital cost and improving operating room efficiency. As a by-product of this, surgeons were able to perform more cases in 1 day (three or four cases instead of one or two) on a single da Vinci S robot. This single robot ultimately won the unofficial designation of the “busiest surgical robot in the world” by Intuitive Surgical. It became a source of excitement for the staff as well as the Intuitive Surgical vendors that worked with us and a case study robot for determining the utilizations of a single machine. Interestingly, as parts became worn out due to high case volumes, the entire robot was essentially replaced with all new parts within almost 3 years of use.

7.2

Operating Room Costs

The increase in operating expenses, outpacing operating revenues, over recent years has consequentially encouraged hospitals to evaluate all cost-cutting strategies in order to provide the highest level of care while containing cost as much as possible. An Advisory Board Report estimate based on 150 hospitals and health systems from 2015 to 2016 data demonstrated a margin decrease from 3.4% to 2.7%, respectively [1]. New technologies such as Intuitive Surgical’s da Vinci Robotic Surgical Systems (Figs.  7.1a, b (Services, 2017)) present a higher cost than open and laparoscopic cases as demonstrated in a study by Laydner et al. demonstrating a $632 median cost increase for robotic partial nephrectomies as compared to laparoscopic partial nephrectomies [2]. Hospital strategies have revolved around operative efficiencies in order to reduce the ballooning costs while providing a cutting edge and superior experience for patients. Hence, developing strategies such as “the Robotic Dance” improve operative time efficiencies while simultaneously reducing hospital cost. Table 7.1 demonstrates the mean turnaround times (18  min) after implementation of the “Robotic Dance” to be significantly lower than prior to “the Robotic

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_7

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a

b

Fig. 7.1 (a) Da Vinci Robot. (© Intuitive Surgical, Inc.). (b) DaVinci Robotic System Console. (© Intuitive Surgical, Inc.)

Table 7.1  Operative times measured in median time before and after “robotic dance technique” Robot case # Mean time Fastest time

Operative times prior to dance 46 min 28 min

Operative times after dance 18 min 11 min

Dance” (46 min). Of note, in California, 1 min of operating room (OR) time is estimated to cost $36–$37 per minute, according to a study published in JAMA Surgery [3]. In prior decades, OR cost for 1 min of OR time was quite variable and ranged from $7 to over $100 depending on location and surgeon [3]. Nonteaching hospitals had higher economic growth rates compared to teaching hospitals, which spent about $8 less per minute operating room cost likely due to more prudent oversight and lower operative room times [3], consequently creating a strong motivation for faster operating room turnaround times.

7.3

Robotic Dance Development

Anticipation of what is to happen next and fluidity and efficiency of motion have long been principles of surgical dogma. This can be applied to surgery scheduling (i.e., same-­sided consecutive nephrectomies on consecutive patients on the same day to minimize changing room configuration), turning the OR around more efficiently by using techniques like those presented here and overall operating room efficiency as well. Methods involved in the Robotic Dance are described in further detail in this chapter. Looking at this technique that improves efficiency and productivity in the operating room, the Robotic Dance essentially links a series of trigger points at key moments of a robotic procedure with assigned duties for each member of the operating room staff, including the robotic surgeon. Table  7.2 shows six individuals involved in “the Robotic Dance” with assigned duties in order. The number of participants and the duty list can be tailored to each individual

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7  Secrets of the Robotic Dance (The World’s Busiest Surgical Robot) Table 7.2  Robotic dance participation scheme Trigger point

Back table open Patient (Pt) in room Patient draped Ports placed

Surgeon off console Incisions closed

Surgeon Calibrates system

Circulator Open back table

First assist Help open back table Set up back table

Scrub Open scope and place robot drapes Set up back table Drape robot Assist Dock robot/insert instruments Assist Undock and clear table

Position Pt

Get patient Position pt/prep

Incision Dock robot

Connect Bovie/gas Roll in robot

Clean scope Insert instruments

Console Scrub in and close

Paperwork/charting Roll out robot and undrape Patient to recovery room

Assist Undock and assist Turnover room

Turnover room

Anesthesia Set up

Attendant Turnover room

Get Pt Intubate

Pt to recovery

Turnover room

operating room at any hospital (as many robotic surgeons do not use an assistant surgeon). By incorporating this more organized approach to efficiency management, operative times were reduced, ultimately decreasing hospital operative time costs. Though conflicting studies exist that dispute the role of operative times in overall hospital cost per minute [3], the institutional analysis of the robotic dance used at Kaiser West LA demonstrated a significant value with OR time reduction.

7.4

The Human Factor

Just like with many other advanced technologies, the human Fig. 7.2  Lockheed Martin F-22 Raptor factor tends to be the limiting variable when it comes to maximizing performance. For example, the wings of the $150 M Lockheed Martin F22 Raptor (Fig. 7.2) can withstand more than 30Gs before snapping off, where at 20Gs a human’s vertebrae is crushed. Thus, the performance of this aircraft is limited by the pilot’s humanity. Similarly, the fragility of our humanity tends to be a rate-­ limiting step with regard to turning the OR around efficiently. The robot can work 24/7 without food, occasional emotional support, or a bathroom break. It just requires the presence of a continuously moving surgeon to keep continuously moving. The Robotic Dance minimizes the human factor involved in operating room delays by providing structure and team communication. In most robotic centers, with practice and a constant team, this communication transcends to become nonverbal communication where participants in the dance play off of cues from each other and the robotic procedure itself. Leadership, workload, situational awareness, and decision-making (Fig. 7.3) are tenets of human factors that can affect operative efficiencies, ultimately decreasing ­productivity and increasing cost. Our goal with the Robotic Dance was to address every conceivable principle of the Fig. 7.3  The human factor. (Copyright 2019 Global Air Training human factor by creating modifiable trigger points with LTD.)

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Fig. 7.4  Robotic Dance operating room duties and tasks checklist

data-­driven evaluation. We began doing this by physically constructing a large poster (Fig.  7.4) that was hung in our operating room with the roles of each team member involved and the timing of the tasks, and we developed a choregraphed motion to reduce the “time sink” of inefficient robotic turnaround times. Similarly, when looking at the number of cases that can be performed on a daily basis, the human factor was the rate-limiting step, unnecessarily increasing operative room costs. The robot exemplifies durability and reliability, fundamentally signifying the human element remains one of the main modifiable factors in rapid operative times. The da Vinci S Robotic System tracks all surgical cases performed on their robotic systems, allowing data acquisition of operative times and volumes of cases on any da Vinci robot that has an internet connection. In 2012, Intuitive Surgical evaluated international robotic case volume statistics performed on each single robotic system in use across the globe and was able to crown the da Vinci S at Kaiser Permanente West Los Angeles with the title of “the world’s busiest surgical robot.”

participation of the operating surgeons, as well as surgical technologists and the dedicated cleaning staff. Through teamwork and starting the turnaround process before the previous robotic case was actually finished, turnaround times improved to a mean time of 18 min (looking at wheels out to wheels in time). Most efficient procedure turnaround time was reported at 11 min using the robotic dance down the street at Kaiser Permanente’s Downey Medical Center. Best times were typically reached after the 25–30 case mark. In some cases, turnaround times proved to be too efficient (if there is such a thing) as surgeons found themselves with limited time to update families after procedures, place postoperative orders, and address our other basic fragile human needs such as bathroom breaks and eating lunch. Nevertheless, operative times and hospital cost decreased after application of “the Robotic Dance,” allowing Kaiser WLA to possess the world’s most efficient single surgical robot.

References 7.5

Conclusion

Achieving the busiest robot in the world designation was largely due to the described method of minimizing the turnaround time between our robotic cases. This was accomplished through teamwork which included active

1. Moody’s Investor Services. Hospital Profit Margins declined from 2015 to 2016, Moody’s finds. Advisory Board) (Services, 2017). 2. Laydner H, Isic W, Autoriino R, et al. Single institutional cost analysis of 325 robotic, laparoscopic, and open partial nephrectomies. Urology. 2013;81(3):533–8. 3. Childers CP, Maggard-Gibbons M. Understanding costs of care in the operating room. JAMA Surg. 2018;153(4):e176233.

8

Credentialing and Privileging for Robotic Surgery in the United States Richard H. Feins

8.1

Introduction

In the United States, the responsibility for proper credentialing and privileging of health-care providers is entrusted to each individual health-care facility or system. While it is fully recognized that robotic surgery is now performed all over the world, credentialing and privileging internationally is beyond the scope of this chapter. It is hoped that a summary of practices and challenges in the United States will be helpful to our international colleagues, many of whom are leading the way in robotic surgery. Guidelines and rules for surgical privileging are provided by the Center for Medicare Services (CMS) [1], the Joint Commission [2], and individual state laws. Many people do not realize that the definitions of credentialing and privileging are technically not the same. Credentialing is the process of obtaining, verifying, and assessing the qualifications of a practitioner to provide care or services in or for a health-care organization. Credentials are documented evidence of licensure, education, training, experience, or other qualifications. Examples of credentials are certificates, letters, badges, or other official identification that confirms somebody’s position or status [3]. Privileging concentrates on the specific procedures or care that a member of the health-care staff may perform. For example, a surgeon may be granted privileges to perform general surgery but be required to have separate privileges for laser surgery or robotic surgery. This distinction is especially germane to the introduction of new technology. While the process for granting general credentials is fairly well defined by the organizations cited above, this is not true for granting privileges specific for robotic surgery and varies considerably from institution to institution. In addition, three different types of surgeons can be involved with requiring robotic privileges: the surgeon just completing residency

R. H. Feins (*) Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA e-mail: [email protected]

where robotic training occurred, the surgeon who has been performing robotic surgery and moves to another institution, and the practicing surgeon who wishes to add robotic surgery to his or her list of procedures. Each group has its own set of challenges and will be outlined in this chapter.

8.2

Residents Completing Training

It is the responsibility of each institution or health-care system to verify that a surgeon is capable of performing robotic surgery in a safe and efficient manner. For those completing residency training, the appropriate board member of the American Board of Medical Specialties (ABMS) sets the standards that must be met during residency training and in some cases additional fellowship training (e.g., surgical critical care, congenital heart surgery, surgical oncology) to be certified as capable of performing surgery independently. The responsibility for ensuring that a resident has an education that meets the specialty board requirements rests with the various residency programs. Oversight is provided by the Accreditation Council for Graduate Medical Education (ACGME) through individual specialty Residency Review Committees (RRCs). These safety nets for surgical training have been extremely effective in the past, but it is fair to say that they have not kept up with the increasingly widespread adoption of robotic surgery. In a review of the case requirements for residents in urology, obstetrics and gynecology, and general surgery, there are no specific RRC or board requirements for training in robotic surgery. Rather, they are included in the overall numbers for laparoscopic surgery. It is therefore technically possible for a resident to meet the case requirements for board eligibility in the three specialties heavily involved with robotic surgery without having any real training in robotic surgery. The American Urological Association has set criteria which in some cases are very specific. For example, a urology resident must participate in at least 20 robotic cases with ten being at the console performing key portions of the operation. There is also a

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Fundamentals of Urologic Robotic Surgery in which a 13.5hour introductory course is available [4]. However, these are not requirements set forth by the RRC-Urology which officially governs urology resident training. This, of course, presents a problem for institutional credentials committees. In many cases where robotic training during residency does occur, program directors will validate the degree of robotic training separately by a letter or even an unofficial certificate. Most institutions will grant at least temporary robotic privileges to a graduated resident with verification from the program of a satisfactory robotic experience with acceptable performance. However, at this point in time, there are serious questions about the adequacy of robotic training in specialties other than urology and obstetrics and gynecology which have a much longer history of resident robotic training. George [5] surveyed general surgery programs and found that while 73.68% of the 20 respondents did have a formal robotic curriculum, 52.63% felt more time needed to be dedicated to it and 55% believed that the training should occur in a postgraduate year. At the present time, while a number of Minimally Invasive Surgery and Robotic Surgery fellowships exist, none are formal ACGME fellowships which means there are no set standards for them. This has left robotic training in residency without the oversight that other surgical training enjoys. In an interview of residents and attending staff at 13 high-tier teaching institution, Bean found that very often, learning robotic surgical techniques was achieved in the clinical setting by “unsupervised struggle” [6]. At present, most institutions use a letter from the residency program director attesting to satisfactory performance and a robotic case log upon which to grant at least temporary privileges. There is often a requirement for a defined number of proctored or precepted cases. Again, no nationally accepted standards exist for institutions to use in granting robotic privileges to new graduates from residency training.

8.3

 xperienced Robotic Surgeon Moving E to a New Institution

Surgeons who have been successfully performing robotic surgery at a previous institution are usually granted at least temporary robotic surgery privileges at a new institution once it has been confirmed that the surgeon historically performed an adequate number of robotic cases without issues. Confirmation comes from the prior institution and the surgeon’s former department chair. A case record is very helpful as is outcome data if available. Again, each institution has its own process and requirements.

8.4

Experienced Surgeon Wishing to Incorporate Robotic Surgery in Practice

The privileging process for the experienced surgeon wishing to incorporate robotic surgery in practice is a very difficult one for institutions and as will be shown is woefully inadequate. The practicing surgeon faces many challenges to learning robotic surgeon or for that matter any new technology. He or she may be the first and only one attempting to do robotic surgery or a particular robotic procedure at the institution. There are none of the advantages of residency training in terms of number of cases available, experience within the institution including an experienced team, time available to train without loss of income, and ACGME and ABMS oversight. Credentialing committees have had to rely on recommendations from some surgical societies, unregulated courses provided by other institutions, privileging criteria adopted at other institutions, or training provided by industry. An example of privileging criteria for robotic surgery at UNC Hospitals is shown in Fig.  8.1. Most institutions in the United States, according to a survey done by the Institute for Surgical Excellence in 2019 (to be published), have very similar criteria. Basically, the surgeon must take a 3-hour course provided by Intuitive (as is also required by the FDA) to learn how the robot functions, observe two robotic procedures by an experienced robotic surgeon, and be proctored on two clinical cases within 12 months of completing the course. Recredentialing occurs every 2 years and requires the surgeon to have done 12 cases. To its credit, Intuitive has been heavily involved with courses to help surgeons correctly adopt the da Vinci platform, and completion of its online course is a requirement for privileges at most institutions. Intuitive Surgical’s Online System Training Module can be accessed free of charge at http://www.davincisurgerycommunity.com. All companies which will be producing surgical robots will also be providing education for surgeons wishing to adopt their technology. However, training surgeons how to do robotic surgical procedures is actually the responsibility of the profession and not industry. Several surgical specialties which have been heavily involved with robotic surgery almost since its inception have created guidelines for granting robotic surgery privileges and in some cases formulated comprehensive robotic curricula. All guidelines call for some type of introductory course about the robot, a simulation experience, observing the actual procedure, and proctoring and case reviews once clinical work begins (Table 8.1). The American Urologic Association has a detailed description of what it considers proper proctoring of cases but sets no definitive number of proctored cases or

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8  Credentialing and Privileging for Robotic Surgery in the United States Fig. 8.1  Criteria for granting robotic privileges at the University of North Carolina (UNC Hospital)

Table 8.1  Surgical specialty recommended guidelines for robotic surgery privileging without residency training

Intuitive course(s) Specialty-­ based course Other courses

Simulation Observation Proctoring

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) [8] Unspecified

American Association of Gynecologic Laparoscopics (AAGL) [7] Unspecified

Unspecified

Unspecified

Unspecified

Yes Unspecified

Yes #Unspecified Yes #Unspecified Yes #Unspecified

Yes #Unspecified Yes #Unspecified Yes #Unspecified

Yes Computer-­ based unspecified Yes Specified Yes One case Yes Two cases

American Urologic Association (AUA) [4] Yes Specified Yes Specified

a standard of performance other than being signed off on by the proctor. It is recommended that the surgeon achieve an 80% correct score on the post course exam to qualify for privileges [4]. The American Association of Gynecologic Laparoscopists published guidelines for privileging in 2014

[7]. These guidelines recommend that surgeons first be required to do 15 basic cases without complications before going on to advanced procedures. They outline the oversight that should occur during the process. In 2007, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) published its Consensus Document on Robotic Surgery. This too emphasized general requirements for robotic privileging but left most of the specifics to the individual institutions which have the responsibility for granting privileges. SAGES has also produced a book outlining a Master’s Program in Robotic Surgery [8] which covers indepth general surgery robotic procedures.

8.5

Maintenance of Robotic Privileges

Once robotic surgery privileges have been granted, it is the responsibility of each institution to monitor performance and outcomes and set criteria for renewal of those privileges. In fact, the Joint Commission in 2007 mandated that every institution seeking certification institute an Ongoing Professional Practice Evaluation (OPPE) procedure which is “a screening tool to evaluate all practitioners who have been granted privileges and to identify those clinicians who might be delivering an unacceptable quality of care” [9]. For robotic surgery, this is usually done under the direction of a robotic surgery committee or robotic peer review committee of some

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type. Evaluation criteria can involve case volumes, clinical outcomes, operative times, conversion to open surgery, and hospital length of stay, for example. Most institutions require some minimal caseload to maintain privileges usually between 10 and 20 cases per year. No national agreed-upon criteria exist.

8.6

 eficiencies in Present Privileging D Process for Robotic Surgery

As with many new technologies, the process by which new clinicians are granted privileges for robotic surgery has significant room for improvement. Most importantly, the process does not provide the appropriate data to institutional credentialing committees by which the competency of a surgeon to perform the robotic operation successfully prior to embarking on actual clinical work can be determined. There is no consensus on what didactic courses must be taken, how much simulation practice must be done and what that simulation should entail, how many cases should be observed or proctored, what qualifications a proctor should have and how are they provided, and most importantly what criteria should be used to measure proficiency. Further, unlike graduate medical education which is heavily monitored for educational quality by the ACGME, no such organization exists that oversees the education of practicing surgeons in new procedures. There is also no equivalent to the board certification process. This leads to wide variation in training, the criteria for granting privileges, and quite probably the quality of the Fig. 8.2  Examples of questions used in the ISE consensus conference Delphi process

surgery. It also leads to what many feel is an inappropriate amount of time on the learning curve occurring in the clinical setting.

8.7

I nstitute for Surgical Excellence’s Consensus Conference on Robotic Surgery Credentialing

The Institute for Surgical Excellence (https://surgicalexcellence.org) organized a conference in February 2019 to address the lack of consensus in robotic credentialing and privileging. Representation included leading robotic surgeons, health-care system executives, simulation-based training experts, operating room nursing and support personnel, and the major robotic companies. The conference addressed these three major areas of robotic privileges: 1 . Requirements prior to credentialing 2. Quantitative metrics for assessing the surgeon’s performance 3. Ongoing assessment and renewal of privileges Examples of the questions for each area are listed in Fig.  8.2. An extraordinary number of issues were identified which have been presented for consensus by the Delphi methodology under the leadership of Dr. Justin Collins. The Delphi method was developed by the Rand Corporation in 1950 and “entails a group of experts who anonymously reply to questionnaires and subsequently receive feedback in the form of a statistical representation of the “group response,”

8  Credentialing and Privileging for Robotic Surgery in the United States

after which the process repeats itself. The goal is to reduce the range of responses and arrive at something closer to expert consensus [10]. The results of the ISE Consensus Conference and the subsequent Delphi process should provide a much clearer picture of where consensus lies with respect to robotic credentialing.

8.8

 he Role of Simulation-Based T Training in Robotic Privileging

Although it is recognized that surgical experience in the clinical space leads to improved quality, it should still be the goal to shorten the learning curve on patients as much as possible. Under present training methodology, substantial learning curves still exist in the clinical environment. Mazzon et al. [11] reviewed the literature for the learning curve for robotic-­ assisted laparoscopic prostatectomy (RALP) and found the learning curve ranged from 50 to 200 cases. Pernar [12] reviewed returned 647 abstracts for manuscripts published between March 1999 and July 2015 and found learning curves of 25–75 cases for colorectal, 10–95 for foregut or bariatric, and 10–80 for solid organ surgery. Lenihan [13] reported a learning curve of 50 cases based on operative time for experienced laparoscopic surgeons. It is clear from these numbers that thousands of patients have undergone robotic surgery while the surgeon was still in the basic learning curve. Simulation-based training in robotic surgery has advanced tremendously over the last decade and now offers the possibility of significantly shortening the clinical learning curve and giving credentialing committees the metrics they need to determine competency in robotic surgery before the surgeon actually operates on patients. Simulation-based training occurs in three basic platforms: computerized virtual reality, live animals and/or cadavers, and real tissue animated models. Examples of computerized virtual reality simulators are the ROSS II produced by Simulated Surgical Systems, LLC, the RobotiX Mentor (RM; 3D Systems, Rock Hill, South Carolina, USA), the dV-­ Trainer (dVT; Mimic Technologies, Inc., Seattle, Washington, USA), and the da Vinci Skills Simulator (dVSS; Intuitive Surgical Inc., Sunnyvale, California, USA). The first three simulators are stand-alone devices, while the da Vinci Skills Simulator piggybacks on the standard da Vinci operating console. These simulators provide basic skills training and full procedure training, and although there has been some validation for each [14], a gap still exists for most surgeons between learning in the computerized space and learning on real tissue. Live animals and cadavers have been used for the real tissue experience, but there remain ethical and financial concerns with this environment. Based on research done at the University of North Carolina, real tissue-animated mod-

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els for basic skills and most complete robotic procedures have been developed and are available commercially from KindHeart Inc., Chapel Hill, NC. In these models, real animal tissue of the appropriate anatomy taken from normal food production is preserved for extended periods of time, reanimated and perfused in a manner that closely simulates a live animal, and placed in a humanlike mannequin. These simulators have most all of the advantages of real living tissue without the use of live animals. The KindHeart real tissue cardiac surgery simulated has been validated for training that improves patient safety in a 3-year multicentered study reported in the Annals of Thoracic Surgery [15]. Simulators have the advantage of allowing for deliberate practice, independent operating, and training in adverse events without risk to patients. It is quite likely that simulation training will be significantly expanded throughout residency and postgraduate training in robotic surgery allowing for a better privileging process-based on achievement of proficiency milestones prior to clinical work. It has been shown in multiple studies that simulation-based training can significantly shorten the clinical learning curve.

8.9

Robotic Team Training

Robotic surgery involves very advanced technology, and its successful introduction into the operating room is highly dependent on the entire robotic team. The team includes circulators, scrub nurses, bedside assistants, schedulers, central sterile supply, and surgeons plus an overall robotic coordinator. Oversight of the OR team (except for the surgeons and advanced practice practitioners) usually is the responsibility of the operating room administration. Again, there is no national standard for how to educate, validate proficiency, or monitor ongoing performance. Lack of consistency in the staff is one of the biggest concerns in many robotic programs. In addition to the team training provided by Intuitive Surgical and that of other robots as they are introduced, there are programs provided by institutions and robotic heavy societies. Perhaps the most comprehensive robot team training course is given at the Nicholson Center in Celebration, Florida, under the sponsorship of the Society of Robotic Surgeons [16]. Most all surgeons who perform robotic surgery would agree that having some means of ensuring the competency of the OR robotic team is critically important.

8.10 Conclusion Privileging in robotic surgery at present has no set national standard and has wide variation from institution to institution. For residency training, the RRCs for each specialty

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will need to adopt specific performance criteria for robotic surgery for board eligibility. For the practicing surgeon who wants to learn robotic surgery in order to incorporate it into his or her practice, the need exists for an independent governing body or bodies which can ensure the quality of education provided and certify achievement of agreed-upon proficiency metrics. Possibilities for this governing body include the American College of Surgeons, the surgical specialty societies, or new organizations along the lines of the ACGME and ABMS. The work of the Institute for Surgical Excellence Consensus Conference on Robotic Credentialing should contribute significantly to arriving at consensus with regard to robotic privileges. The advantages of simulation-­ based training using computerized and real tissue models will need to be expanded to allow surgeons to reach and prove proficiency prior to starting clinical work. There is no doubt that robotic surgery will continue to be adopted at an increasingly rapid pace with the introduction of new robotic platforms and new surgical application. Robust initial granting of robotic surgical privileges and ongoing review of surgeon performance both in the clinical area and in simulation must be a central part of ensuring the best possible robotic surgery with the best outcomes.

References 1. CMS Privileging Guidelines available from: https://www. cms.gov/Medicare/Provider-Enrollment-and-Certification/ SurveyCertificationGenInfo/Downloads/SCletter05-04.pdf. 2. The Joint Commission Privileging Guidelines available from: https:// www.jointcommission.org/ahc_credentialing_privileging_tips/. 3. The Joint Commission Privileging Credentials available from: https://www.jointcommission.org/assets/1/18/AHC_who_what_ credentialing_booklet.pdf.

R. H. Feins 4. AUA Robotic Privileging Guidelines available from: https://www. auanet.org/guidelines/robotic-surgery-(urologic)-sop. 5. George LC, O'Neill R, Merchant AM. Residency Training in Robotic General Surgery: A Survey of Program Directors. Minim Invasive Surg. 2018;2018:8464298. https://doi.org/10.1155/2018/8464298. eCollection 2018. 6. Beane M.  Shadow learning: building robotic surgical skill when approved means fail. Adm Sci Q. 2019;64(1):87– 12. Cornell University. SC Johnson College of Business. Available from: https://journals.sagepub.com/doi/pdf/10.1177/ 0001839217751692. 7. AAGL. Guidelines for privileging for robotic-assisted gynecologic laparoscopy. J Minim Invasive Gynecol. 2014;21(2):157–67. 8. SAGES Robotic Guidelines. Available from: https://www.sages. org/publications/guidelines/consensus-document-robotic-surgery/. 9. OPPE Program. Available from: https://www.jointcommission.org/ jc_physician_blog/oppe_fppe_tools_privileging_decisions/. 10. Delphi Process. Available from: https://www.rand.org/topics/delphi-method.html. 11. Mazzon G, Sridhar A, Busuttil G, Thompson J, Nathan S, Briggs T, Kelly J, Shaw G. Learning curves for robotic surgery: a review of the recent literature. Curr Urol Rep. 2017;18:89. 12. Pernar L, Robertson F, Tavakkoli A, Sheu E, Brooks D, Smink D.  An appraisal of the learning curve in robotic general surgery. Surg Endosc. 2017;31(11):4583–96. https://doi.org/10.1007/ s00464-017-5520-2. Epub 2017 Apr 14. 13. Lenihan J, Kovanda C, Seshadri-Kreaden U.  What is the learning curve for robotic assisted gynecologic surgery? J Minim Invasive Gynecol. 2008;15(5):589–94. https://doi.org/10.1016/j. jmig.2008.06.015. 14. Hertz A, George EI, Vaccaro CM, Brand TC.  Head-to-head comparison of three virtual-reality robotic surgery simulators. JSLS. 2018;22(1):e2017.00081. https://doi.org/10.4293/ JSLS.2017.00081. 15. Feins RH, Burkhart HM, Conte JV, Coore DN, Fann JI, Hicks GL Jr, Nesbitt JC, Ramphal PS, Schiro SE, Shen KR, Sridhar A, Stewart PW, Walker JD, Mokadam NA. Simulation-based training in cardiac surgery. Ann Thorac Surg. 2017;103(1):312–21. https:// doi.org/10.1016/j.athoracsur.2016.06.062. Epub 2016 Aug 25. PMID: 27570162. 16. Nicholson Center Robotic Team Training m: https://www.nicholsoncenter.com/events/robotics.

9

The Current State of Robotic Education Danielle Julian, Todd Larson, Roger Smith, and J. Scott Magnuson

9.1

Introduction

Robotic surgery education originated and developed following a pattern that is common for most complex medical devices. Initial training was created and led by the medical device company offering the robot. These courses were structured around the incremental knowledge and expertise that a practicing surgeon would need to be able to add robotic cases to their portfolio of skills. The courses were also condensed so that a practicing surgeon would be able to attend and complete them in a reasonable time that could be taken away from practice. This structure and style dominated the educational offerings for more than a decade until proficient practicing surgeons began to organize their own courses, often associated with academic teaching colleges. From here, the educational offerings have continued to spread to create a rich and diverse set of opportunities as described in more detail throughout this chapter.

9.1.1 History of FLS In 1997, two surgeons who cochaired the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) Continuing Education Committee discussed the concept of a standardized training program to teach the fundamentals of laparoscopic surgery. Lee Swanstrom, MD, FACS and Nathaniel Soper, MD, FACS considered developing a course that would teach knowledge, judgment, and technical skills specific to performing laparoscopic surgery. With the sup-

D. Julian (*) Nicholson Center, Advent Health, Celebration, FL, USA e-mail: [email protected] T. Larson · J. S. Magnuson AdventHealth Nicholson Center, Celebration, FL, USA R. Smith AdventHealth, Celebration, FL, USA

port of SAGES, the American College of Surgeons, and other educators, a standardized course was created and launched in 2004, the Fundamentals of Laparoscopic Surgery (FLS). FLS is made of two components: cognitive and technical skills. The cognitive section teaches preoperative considerations, intraoperative considerations, basic laparoscopic procedures, and postoperative considerations. This online material is self-paced and followed by a written test given at a testing center. The technical skills section teaches four manual tasks. These include PEG transfer, pattern cutting, endoloop placement, and extra- and intracorporeal suturing. These tasks are also tested in a testing center using a simulation model, the “FLS Box.” Like Advanced Trauma Life Support (ATLS) and Advanced Cardiac Support (ACS), the importance of this FLS was recognized in 2008 when the American Board of Surgery included it as a required prerequisite of the ABS Certification Exam. All ABS diplomats must pass FLS prior to taking the ABS Certification Exam. The development of FLS has made an impact on the way surgery is taught by creating a standardized model for surgical training. It is a measurable model of competency to perform surgical tasks as well as clinical knowledge. As one of the pioneer surgical training programs, FLS has laid the groundwork for other education programs like the Fundamentals of Robotic Surgery (FRS).

9.1.2 History of FRS Following FLS, there have been multiple efforts to define a fundamental curriculum in robotic surgery. However, these have generally been carried out within a single organization and validated for use only within that organization. The goal of the Fundamentals of Robotic Surgery (FRS) project was to arrive at outcome measures, a curriculum, and validation results which would be accepted by the entire community and can be accredited by surgical boards as a means of credentialing surgeons for robotic surgery.

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_9

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To accomplish this, the organizers began by ensuring that this project would be free of bias from any single organization. The funding which supports this work was free of any influencing effects by medical providers, equipment manufacturers, or other entities which have a financial interest in the outcome of the work. Invitations to participate in the consensus conferences were sent to the boards, professional societies, and associations which represent practitioners and regulators of robotic surgery. The organizers of this project invited the boards and societies to nominate a representative who could speak for them and their members. The organizations who were invited to send representatives are shown in Table 9.1. The Fundamentals of Robotic Surgery was developed through a series of four consensus conferences described later. The development of the FRS is conceived as a “full life cycle” development of the curriculum (Fig. 9.1).

Table 9.1  Organizations participating in FRS Accreditation Council of Graduate Medical Education (ACGME) American Association of Gynecologic Laparoscopy (AAGL)a American College of Surgeons (ACS) American Congress of Obstetrics and Gynecology (ACOG) American Academy of Orthopedic Surgeons (AAOA) American Association of Colorectal Surgeons (ASCRS) American Association of Thoracic Surgeons (AATS) American Board of Surgery (ABS) American Urologic Association (AUA)a Association of Surgical Educators (ASE) European Urology Association (EUA) Minimally Invasive Robotic Association (MIRA)b Society of American Gastrointestinal and Endoscopic Surgeons (SAGES)a Society for Robotic Surgery (SRS) Residency Review Committee (RRC) – Surgery Royal College of Surgeons – Australia (RCSA) Royal College of Surgeons – Ireland (RCSI) Royal College of Surgeons – London (RCSL) US Department of Defense (DoD)b US Department of Veterans Health Affairs (VHA) Official representative participation Funding organizations

a

b

The underlying goal of the project was to identify the outcomes that must be measured to certify that a surgeon has the most basic of cognitive and psychomotor technical skills for robotic surgery. These outcomes are organized as a list of tasks that a surgeon must be able to perform successfully, a list of the most common errors associated with each task, and the metrics that will be used to measure competency in that task. The material developed under FRS in this work focused on measuring the most basic skills that a surgeon must possess in order to perform robotic surgery. Although some of these skills require a background of general surgical knowledge, most measures of competency in FRS were technical (both cognitive and psychomotor) skills specifically required and essential to robotic surgery. The scope was limited to actions performed by the surgeon in preparing, performing, and after finishing a robotic procedure as well as the more common errors in each of these areas. The actions of the entire surgical team were not part of the project, though team leadership by the surgeon was included in the curriculum.

9.1.2.1 FRS Methodology Four consensus conferences were convened consisting of the organizations and individuals listed earlier. Each event was attended by a slightly different subset of the individuals, with a core of a dozen in attendance at every event. The Curriculum Consensus Conference was conducted during a 2-day period using a modified Delphi methodology. The participants consisted of subject matter experts from 14 different surgical specialties that use robotic surgery, as well as representatives from a number of the certifying surgical specialty boards and surgical education societies, as well as the Department of Defense and the Veterans Administration (VA). Many of the participants are members of the American College of Surgeons—Accredited Education Institutes (ACS-AEI) and of the Alliance of Surgical Specialties for Education and Training (ASSET). After the evaluation of existing materials and curricula, a task deconstruction was

Fig. 9.1  Full life cycle development process

Outcome measures & metrics

Curriculum development

Simulation development

Curriculum validation

High stakes examination

Outcome registries

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performed to identify the tasks, subtasks, and errors that needed to be measured. A matrix was then created that matched metrics to the tasks, skills, and errors. Following the conference, a second round classic Delphi anonymous rating was used to ensure concurrence, to prioritize the ranking of the tasks, and to eliminate low-scoring tasks.

9.1.2.2 FRS Results The results provide a matrix of specific robotic surgery tasks that are matched to their common errors, a description of the desired outcome, and the quantitative metrics that support those outcomes. Extensive details in tables and matrices are available in Smith, Patel, and Satava (2013) [1] and Satava et al. (2019) [2]. Table 9.2 provides a shortened summary of the tasks to be included and the nature of the skill, psychomotor, cognitive, or communication skill. The second consensus conference focused on the development of specific tasks which could be assessed to judge performance levels of the prescribed skills. Participants in Table 9.2  Robotic skills tasks identified as universal to all specialties Task Situational awareness Eye-hand instrument coordination Needle driving Atraumatic handling Safety of operative field Camera Clutching Dissection (fine/blunt) Closed loop communication Docking Knot tying Instrument exchange Cutting Energy sources Foreign body management Robotic trocars Suture handling Wrist articulation Ergonomic positioning System settings Multi-arm control OR setup Respond to system error Undocking Transition to bedside assistant

Type Com P P P C, P P P P Com Com, C, P P Com, C, P P C, P C, P C P P C C C, P C C Com, C Com, C

P psychomotor, C cognitive, Com communication

the FRS event had experience with this challenge through their own personal and organizational efforts to construct single institute curricula on earlier projects. As a result, the group considered multiple tasks which had proven effective in previous studies, many of which appeared in the published literature. Participants in this conference settled on a list of exercise tasks that would satisfy the need to measure performance of each of the essential skills (Table 9.3). At the third consensus conference, the work to identify specific skills devices and cognitive educational material continued. The psychomotor exercises selected or designed as shown in Table 9.3 were organized into the design for a single physical device. The desire of the committee was to use a single device for both assessment and potentially for training the skills. Early diagrams and physical prototypes led to a dome-shaped foundation upon which all the exercises could be positioned. Figure 9.2 illustrates some of the early dome concepts and their iterations. Figure 9.3 illustrates each of the physical exercises that were incorporated into the final production of the dome device. Through discussions and extensive testing of the exercises and the dome framework, the device solidified as the “FRS Dome” device shown in Fig.  9.4. This design was then carried through the productization process by members of the committee so that it could be purchased by interested parties. Because of the independent funding that supported the project and the agreement by all participants to forego any claim to the intellectual property contributed during the project, the design of the FRS Dome and the contents of the curriculum are open source, patent, and copyright-free. All the documentation of the process and the results, including the CAD diagrams of the physical device, are open and available to any party that has a need to use them. Because the documentation and CAD designs were made open source, this enabled the leading robotic surgery simulator companies to create virtual reality versions of those exercises which could be presented within their simulator products. Simulation versions of FRS exercises were incorporated into three simulators—the da Vinci Skills Simulator (Intuitive Surgical Inc., Sunnyvale, CA), dV-Trainer (Mimic Technologies Inc., Seattle, WA), and RobotiX Mentor (3D Systems/Simbionix, Tel Aviv, Israel). These simulators allow surgeons to practice and develop skills in all the exercises without the costs associated with purchasing the physical dome.

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Table 9.3  Essential robotic skills aligned with mode of training and assessment Metric Eye-hand instrument coordination Needle driving Atraumatic handling Safety of operative field Camera Clutching Dissection (fine/blunt) Docking Knot tying Instrument exchange Cutting Energy sources Foreign body management Suture handling Wrist articulation Multi-arm control

Running suture S

Dome with four towers P

Vessel dissection + clipping S

UTSW fourth-arm retraction + cutting S

Energy and mechanical cutting S

P S

P

P S

P

S

P

P

P P

S

S P

S

P P P P

P P

P

S Skill, P Performance Measure

Prototype concept

Prototype 4

Fig. 9.2  FRS Dome prototype concepts

Prototype 1

Prototype 5

Prototype 2

CAD design

Prototype 3

1st 3-D printed model

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Ring tower transfer

4th arm cutting

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Knot tying

Railroad track

Puzzle piece dissection

Vessel dissection/division

Fig. 9.3  Psychomotor skills exercises incorporated into the FRS Dome device

There are many different varieties of curricula currently available. Examples include: • • • •

Fig. 9.4  Final FRS Dome design

9.2

 urrent State of Robotic Training C During Residency

Currently, there are no standardized curriculum requirements for residency training in robotic surgery. Each institution determines the best way to train residents utilizing ­recommended curriculum developed by the surgical boards, the ACGME, surgical societies, industry, and third-party programs.

da Vinci Technology Training Pathway Fundamentals of Robotic Surgery (FRS) Fundamental Skills of Robot-Assisted Surgery (FSRS) Robotic Training Network (RTN)

The robotic curricula listed above provide didactic courses with a great deal of content variability. Also, the experiential nature and psychomotor skills development of these curricula are not consistent; therefore, any future standardized residency training curriculum should be developed with a blended training approach in mind.

9.2.1 G  raduate Medical Education Standardized Training Curriculum 9.2.1.1 Urology The urology community has taken a proactive approach to residency and postgraduate education in robotic-assisted surgery. Robotic surgery is now included in the core curriculum for ACGME Program Requirements for Graduate Medical Education in Urology. Also, the American Urological

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Association (AUA) has included in their Standard Operating Procedures (SOP) recommendations for robotic surgery training and credentialing [3].

5. Submit copy of online training certificate, case log, and letter of verification to da Vinci representative

9.2.1.2 Gynecology In an opinion paper dated March 2015 (Number 628), the American College of Obstetricians and Gynecologists Committee on Gynecologic Practice (Society of Gynecologic Surgeons) discusses robotic surgery in gynecology. Although the committee provides postgraduate credentialing and privileging recommendations and criteria, robot-assisted surgery was not part of the newly adopted milestones in obstetric and gynecologic residency training. The Council on Resident Education in Obstetrics and Gynecology is developing criteria for training in robot-assisted surgery [4].

9.2.3 Third-Party Training Curriculum

9.2.1.3 General Surgery Currently, robotic surgery training is not a part of the ACGME core curriculum for general surgery, and there is no standardized curriculum for training general surgery residents in robotic-assisted surgery. Most of the robotic training for general surgery residents are developed at each individual institution or are industry supported; consequently, there is a need for a standardized robotic surgery training curriculum for general surgery residents [5].

1 . Phase I: Cover bedside assisting (first assistant training) 2. Phase 2: Cover the surgeon console (psychomotor skill development) 3. Phase 3: Maintenance of skills (currently in development)

9.2.1.4 Thoracic Surgery The Integrated Thoracic Surgery Residency Program does not offer a standardized curriculum for training residents in robotic-assisted surgery. Given this fact, hospitals must arrange for postgraduate robotic surgical training in order to credential and privilege them in robotic-assisted surgery [6].

9.2.2 Industry Training Since many residency programs do not offer any formal standardized curriculum for robotic surgery training, Intuitive Surgical Inc. developed the da Vinci Resident and Fellowship Training Equivalency Certificate Program. This training pathway does not address clinical competence; it only focuses on the technical training on the use of the da Vinci Surgical System [7]. The current requirements include the following: 1. Complete da Vinci Surgical System online courses and assessment for residents and fellows 2. Complete da Vinci system overview in-service training 3. Perform da Vinci procedures in primary role of console surgeon (minimum of 20) and primary role of bedside assistant (minimum of 10). 4. Solicit letter of verification of da Vinci Technology System training and procedures completed from chief of surgery or program director

The Robotic Training Network (RTN) was developed to standardize robotic surgical curriculum and education for residents and fellows. RTN is led by a multidisciplinary team of surgeons who are Fellows in the American College of Surgeons (FACS) and the American Congress of Obstetricians and Gynecology (FACOG). Currently, there are over 50+ institutions participating in the RTN program. The RTN program is divided into three phases. They include the following:

Each phase outlines activities for completion and assessments of the resident/fellow’s performance. Much of the learning is self-directed and includes simulation, medical knowledge, practice-based learning, and laboratory and operating room experiences. This curriculum is largely being utilized by both the gynecology and general surgery communities [8].

9.2.4 Resident Training Recommendations Although there are many different curricula available for training residents, there is still no agreed-upon standardized program for robotic-assisted surgery training. Since we will see new robotic platforms enter the market in the next 3–5 years, it will be important to develop a training curriculum that is somewhat agnostic and can be applied to multiple robotic surgical platforms. Below outlines a high-level overview of what components would may be included in such a curriculum: 1 . Completion of online industry training 2. Hands-on orientation to the robotic surgical platform 3. Review of literature that focuses on the following: • Patient selection • Surgical approaches • Potential complications 4. Blended training experience to include the following: • First assisting • Simulation • Dry/wet laboratories • Surgical case experience

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5. MIS Basic to Advanced Procedure progression by postgraduate training year 6. Yearly evaluation and competency assessments and recommendations for improvement Ideally, an integrated residency training curriculum that serves all surgical specializations would be the most appropriate. A curriculum of this nature would allow ACGME programs to share resources and assist with credentialing and privileging for robotic-assisted surgery. A standardized resident training curriculum will be particularly more important as digital surgery expands and new robotic surgical programs enter the market.

9.3

Training Beyond Residency

Providing a trainee with experience on an actual da Vinci system can be difficult due to the associated costs and resources required. Hospitals must make a large capital investment when adopting a robotics program and subsequently must recoup their investment via robotic procedures in the operating room. This often limits access to the system for training to time outside of normal operating room working hours. Along with accessibility limitations, training with the actual system requires the use of Intuitive’s surgical instruments, which incur an additional cost and may limit the amount of supervised cases for the students to experience during their apprenticeship years. When a surgeon becomes interested in learning robotics, there are limited avenues for training. Robotic surgery training may have never been offered during the years in apprenticeship, so students may not receive training until after the completion of their surgical education. Even after completion of the students training, if a surgeon is interested in robotic surgery, they often must seek training from outside institutions (mostly industry driven). Industry-driven courses (i.e., Intuitive’s da Vinci system training) typically provide the surgeon with instruction on the necessary psychomotor skills in isolation from the cognitive and perceptual skills and may only perform these skills in an integrated manner during a single-day course. To help alleviate this training issue, multiple training facilities have created courses focused on training the technical knowledge and basic surgical skills for robotic surgery, specifically for da Vinci robotic platforms. The section below describes several available robotic training courses (nonindustry lead).

9.3.1 C  urrent Continuing Medical Education Robotic Training Courses A review of surgical training facilities was completed in order to capture the current robotic surgical training courses offered for surgeons beyond residency. This search revealed

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several training facilities and universities that offered robotic training courses that were not industry driven (i.e., offered or sponsored by Intuitive Surgical). During this search, we discovered that the robotic surgical content is offered either at a basic level (e.g., technical components, basic skills) or at an advanced level (e.g., procedural specific) of training. The following sections outline some of the current robotic surgical training courses, divided by basic and advanced course content.

9.3.2 Basic Robotic Surgical Training The Nicholson Center (Celebration, Florida) and the STAN Institute (Nancy, France) teams offer an experiential robotic surgical training course utilizing a series of simulation training technologies and techniques, the Basic Robotic Surgery Course. This training is implemented through 47  hours of hands-on training spanning 5  days. Five teams of two (ten total learners) rotate through several simulated exercises for a full experiential training. Specifically, the attendees’ experience includes exposure to discussions on robotic surgical technology, human factors adjustments for robotic surgery, robotic surgical skills evaluation tools, robotic surgical platform training, hands-on simulation, wet and dry lab experiences, surgical case observation, team training for a robotic operating room, and competency development in the skills required to safely operate the Intuitive Surgical da Vinci Robot. Forty of the 47 course hours utilize some form of simulation training. The material was leveraged from the content from the Fundamentals or Robotic Surgery (FRS), Intuitive Surgical Manufacturers Robotic Surgical Platform Training, and several subject matter experts (SMEs). The students first train using a virtual reality simulator to develop the basic skills needed to successfully utilize specific da Vinci technology (e.g., camera movement, third arm clutch). This course utilizes Mimic Technologies dV-­Trainer. The simulated curriculum within the program is built to provide a progressive skill development experience. That is, the course requires that basic exercises are completed with proficiency before moving to more difficult exercises. These basic exercises can be as simple as picking up colored jacks with virtual robotic instruments and placing them in corresponding colored bowls (Fig. 9.5). While this exercise seems simple, it helps to train skills such as wrist manipulation and acclimation to the simulated environment and hardware. The course requires that these skills are developed before introducing another primary robotic skill like camera movement. This format and the simulators ability to provide automated objective measures allow the trainee more autonomy. Multiple dry lab simulations are used throughout the course. Trainers like silicon pads developed to resemble the feel of actual tissue allow the students to practice basic needle handling and suturing skills. Because the da Vinci

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ing boxes, and dry lab training using the actual da Vinci system. They require the student to perform specific movements accurately during the video before the operation will proceed. The dry lab exercises provide the opportunity to transfer the skills acquired via the VR simulations to the real application of the robotic platform. The dry lab exercises are completed using the actual da Vinci surgical platform. Here, the students practice basic tasks, such as suturing on synthetic tissue and completing an anastomosis on an inanimate model. This certification level also includes an expert evaluation during the final lab. The assessment tool used here is the Robotic Anastomosis Competency Evaluation (RACE) [9]. The intermediate certification provides the attendees with the basic certification plus operating room observation. During this portion of the course, expert robotic surgeons from multiple disciplines complete robotic-assisted cases Fig. 9.5  Basic VR robotic surgical exercise while the attendees are directed to observe specific tasks. The attendees are required to observe surgical techniques, system doesn’t offer any tactile feed, training suturing skills technical components of the da Vinci platforms, tips and helps surgeons to develop force sensitivity and control with- tricks regarding the docking process, insertion and removal out feedback. The dry lab simulators reinforce several core of instrumentation, and troubleshooting. The advanced cerrobotic skills that were introduced during the crawl phase. tification includes both packages listed above with an addiNext, turkey thighs with imposed FRS exercises are used to tional wet lab training and a digital textbook. However, train advanced surgical skills first learned on the VR simu- all iterations of this course focus on training basic robotic lators (e.g., energy application and dissection) utilizing the knowledge and skills and do not train advanced procedural actual robotic system. specific robotic skills. The final phase is a complete, assessed animate procedure Olv Vattikuti Robotic Surgery Institute (ORSI) (Ghent, in a simulated operating room. The students are expected Belgium) offers multiple European Accredited Continuing to successfully complete all program objectives in this cap- Medical Education Credits. While ORSI does not offer a stone simulation. The students are responsible for the techni- blanket basic robotic skills course, they do offer beginner cal and clinical configurating of the robotic system before course for certain robotic specialties. ORSI’s basic robotic the “patient” enters the operating room, prepping the robotic skills course is for robot-naïve urology surgeons. Before system, team communication, and robotic surgical compe- attending, students must complete their e-learning modtencies during the robotic surgical procedure. Surgical com- ules associated to the training course. This course is 5 days petencies are measured using the GEARS assessment tool, in length and provides the learner with 35 European CMS and communication and technical platform skills are moni- credits. Just as the other courses, this program starts with tored by faculty during the simulation. a technical system overview and then utilizes VR simulaRoswell Park Cancer Center, Buffalo, New  York, offers tion training to train basic robotic skills before moving on several versions of their “Fundamentals Skills of Robotic-­ to dry and wet lab trainings. This course uses the da Vinci Assisted Surgery (FSRS)” course. This center offers basic, Skills Simulator (dVSS) created by Intuitive Surgical and intermediate, and advanced programs. All certification equipped with several other simulation company’s software. programs aim to train proficiency in robotic-assisted sur- After training on the VR simulator, the attendees are then gery but with varying course durations, training curricula, able to practice skills like energy dissection and cutting on an and training tools. The course is 3 days in length and pro- avian model. Later in the course, the attendees attend a full vides the surgeons with a full introduction to the da Vinci day of robotic urology case observations. The third part of Surgical System, including the instrumentation and basic the training curriculum uses a “real-life” in-house training. docking process, and how to maintain the robotic system. Here, the attendees translate their learned skills and practical Beyond this, the surgeons receive hands-on training using knowledge learned previously into a robotic simulated case. virtual reality (VR) simulators for robotic (Robotic Surgical The course attendees are to perform a urological procedure Simulator, Simulated Surgical Sciences) and laparoscopic utilizing the da Vinci platform on a porcine model. During skills (LapSkills Simulator, InoVus), laparoscopic train- the final procedure, the faculty collects data on the attendee’s

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performance using the GEARS assessment tool (explained later in this chapter) [10].

9.3.3 A  dvance Robotic Surgical Training Courses The purpose of a basic or introductory robotic surgical curriculum is to provide robotic-naive surgeons with the technical knowledge about the surgical platforms and the knowledge and skills required to safely operate these platforms. As far as robotic surgical skills, these courses aim to train basic robot-specific skills and overcoming the learning curve associated with robotic surgery and the da Vinci systems and often do not train robotic procedural skills and knowledge. Advanced robotic courses aim to train the variety of robotic surgical procedures, highlight robotic surgical interventions, and provide hands-on training that is specific to the attendee’s surgical specialty. Several insinuations offer advanced robotic surgical training for a variety of surgical specialties. Institute for Research against Cancer of Digestive System (IRCAD) offers a large variety of advanced minimally invasive surgical training and education courses via multiple institutions (France, Brazil, Taiwan). IRCAD’s facilities include classrooms for didactic training, wet laboratories for live animal and cadaveric specimens, and two mock operating rooms for robotic surgery training. Currently, IRCAD does not offer basic-level robotic surgical training; however, each institute offers advance robotic course for several surgical specialties (i.e., colorectal, bariatric, upper GI, and urology). During the advanced courses, a broad spectrum of surgical procedures, complications, technical interventions, and hands-on training for the corresponding surgical specialty are covered in detail. Specifically, the students can practice surgical and technical skills specific to their specialty. The advanced courses held at IRCAD cover patient positioning, port placement, docking, instrumentation, scope selection, and specialty-specific surgical skills in detail, beyond that of a basic robotic course. These advanced courses are a one-day course that incorporate an interactive blend of theoretical and video session between faculty and attendees, live and prerecorded operative demonstrations, and practical training on anatomical specimens under expert tutorial. Such advanced courses allow practicing robotic surgeons the opportunity to hone robotic surgical skills specific to surgical procedures [11]. Other facilities listed above offer advanced robotic surgical courses as well. Both the Nicholson Center and ORSI provide specialty-specific, advanced robotic surgical courses.

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9.3.4 C  urrent Training Tools Used for Robotic Training 9.3.4.1 Virtual Reality Robotic Surgical Simulators The use of VR surgical simulators has been shown to improve subsequent clinical performance and can shorten the learning curve associated with the acquisition of a new technological skill [12–14]. Often, training centers use VR simulators to ease the learners into the introduction on the technology itself (i.e., the robotic platform), “buttonology” (e.g., functionality of buttons, pedals, and switches), and the basic skills needed to use the robotic system (e.g., how to control the instruments and camera). Several stand-alone virtual reality simulators have been created and are currently being utilized in robotic training courses. Currently, there are four stand-alone robotic surgical simulators developed for the da Vinci robotic system: • da Vinci Skills Simulator (Intuitive Surgical Inc., Sunnyvale, CA) • dV-Trainer (Mimic Technologies, Inc., Seattle, WA) • Robotic Surgical Simulator (Simulated Surgical Skills LLC, Williamsville, NY) • RobotiX Mentor (Simbionix USA Inc., Cleveland, OH) Each simulator utilizes hardware and software comparative to the da Vinci system for training and surgical rehearsal and provides the learner with objective metrics and an automated scoreboard.

9.3.4.2 Robotic Dry Lab Trainers Another crucial part of robotic surgical training is hands-on practice both with the technical components of the robotic platform and the development of robotic surgical skills. To aid in training technical components, informal hands-on practice with the robotic platform allows trainers to practice skills like robotic docking, instrumentation insertion and exchange, and the controls of the surgeon console in a low-­ stress environment [15]. The use of inanimate dry lab exercises is often used in training to aid in basic robotic surgical skill development. To do so, dexterity trainers, silicone suture pads, and box trainers are used to provide the trainee affordable, repetitive training to hone robotic skills like instrument movement and articulation and camera and clutch navigation and to become familiar with the three-­dimensional environment, all of which are requisite skills necessary to perform more complex procedural tasks. Individually, these simulators train one or two robotic skills at a time. During the development of the FRS curricula,

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SMEs wanted to create a dry lab trainer that contain exercises that trained multiple robotic specific skills. In order to provide an all-encompassing robotic surgical training experience, the FRS Dome was created. This device houses 16 robotic surgery concepts which are directly linked with psychomotor skills (see Fig. 9.4). Unfortunately, unlike traditional laparoscopy where all that is needed is a pelvic box trainer, laparoscopic instruments, and a camera with monitor, dry lab robotic training requires access to a fully functional robot and dedicated space to hold the training. This type of educational experience may not be feasible at all training centers. Therefore, alternative teaching strategies for this portion of the curriculum have been developed and are becoming more prevalent in training programs mentioned above.

9.3.4.3 Wet Lab Training Another important component training is practice on an animate or cadaveric model. This allows the trainees to put the previously learned skills into a more complex procedural task at a high level of fidelity. This modality of training provides an interactive simulation opportunity to practice a culmination of learned skills like a live clinical experience at a low-stake environment [13]. However, this level of training is expensive and resource exhaustive. Often, this level of training will only be offered during a more advance robotic training program. 9.3.4.4 Current Assessments Traditionally for laparoscopic and open practice, trainees have relied on an expert surgeon’s feedback for their performance in the operating room [15]. Mirroring operating room leaning, a trainee could perform robotic simulation in a dry lab setting and receive performance assessment from an observing surgeon [16, 17]. These methods are reliant on the mentor’s personal assessment of proficiency and therefore highly variable. For robotic surgical programs, there are multiple available assessments that are currently being used or that could be used for robotic surgical education. Several evaluations can be collected throughout the courses. Knowledge assessment is often collected through a pretest/posttest. These tests can differ from institute to institute. The technical and knowledge assessments can be created in-house (e.g., ORSI e-learning), or some facilities may rely on industry-driven tests to capture technical knowledge (e.g., ISI e-learning). Skill development is assessed through several avenues. Majority of the institutes listed above incorporate VR simulation into their coursework. All the virtual reality robotic surgical simulators created for the da Vinci systems capture a variety of scoring metrics. The objective skills measure within the VR simulators provides passing thresholds and scores that deem the learners proficient with the simulated

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skills. These metrics provide both the students and the trainers with a visual representation of each of the performance on each exercise. The simulator metrics capture data on how far the virtual instruments travel, time to complete an exercise, force on the instrumentation, and if instrumentation remained in the surgical field. Other subjective measures are also commonly used to capture data on skill development. For laparoscopic and open surgery, several subjective measure tools are used. Two of the most prominent of which were Global Operative Assessment of Laparoscopic Skills (GOALS) and Objective Structured Analysis of Technical Skills (OSATS), respectively. From these, Dr. Goh created the Global Evaluative Assessment of Robotic Skills (GEARS) metric tool specifically for evaluating performance with a robotic surgery device [11]. This tool extends the approaches that were previously used for evaluations in laparoscopic and open surgery. The GEARS assessment is the most popular and deemed “the gold standard.” GEARS is a Likert scale-standardized assessment tool for robotic surgical skills that is simple to administer and can differentiate levels of robotic surgical expertise (Goh et al., 2012) and is a validated, standardized assessment tool specific to robotic surgical skills. This tool was developed for collecting quantitative data for intraoperative technical skill during robotic-­ assisted procedures. Expert surgeons often utilize this tool to assess novice and intermediate robotic surgeons on skills specific to robotic surgery. More recently, Lui et al. developed another quantitative skills assessment tool, Assessment of Robotic Console Skills (ARCs). The ARC assessment, like GEARS, consists of several robotic-specific domains and a Likert grading scale. Most robotic training institutes utilize one or both assessment tools to collect quantitative data of intraoperative technical skill during robotic-assisted procedures. Some institutes, like Roswell Park, utilize their own assessment tool developed in-house (i.e., RACE). As mentioned previously, establishing assessment tools to certify competency is crucial to curriculum development and deployment of robotic training programs. Establishing which assessments work best for each program is imperative. Assessing students frequently and consistently allows the learner and faculty to have a full understanding of the trainee’s competency throughout the training program(s).

9.4

Conclusion

Historically, surgical education followed an apprenticeship model where the master teaches through demonstration and the student learns by performing the examples of the master. The master provides feedback to the student that allows the student to learn in a stepwise manner. In this model, the student reaches competency in tasks at the discretion of the master. There is a great amount of variability

9  The Current State of Robotic Education

in the quality of learning between students of different masters. Additionally, there is no standardization between masters to determine the competency of the students. Medical technology is evolving faster in this digital, computerized era than previously. Advances in surgery in the twentieth century were largely procedural and less device related. Today, new medical devices are introduced in surgery in almost less time required to complete surgical training. This rapid development of technology has created the need to develop standardized education curricula that can ensure competency of use of the technology. The curricula must meet the needs of not only the students but also the masters who are also new to the technology. Slowly, surgical societies are recognizing the importance of standardized training and certification with new technology. While there are no consensus training requirements with the societies, each society is introducing recommendations for training that include standardization in training important to each separate society. As medical device companies introduce similar products to perform surgical tasks, training curricula must be generic, or agnostic enough, to include all devices. In other words, there should not be training curricula for each separate device but, instead, one curriculum that includes all devices. Several of the training programs reviewed in this chapter meet that requirement. It is the task, and not the device, that is the focus of education. By emphasizing the task, standardization of curriculum is possible.

References 1. Smith R, Patel V, Satava R.  Fundamentals of robotic surgery: a course of basic robotic surgery skills based upon a 14-society consensus template of outcomes measures and curriculum development. Int J Med Robot Comput Assist Surg. 2014;10(3):379–84. 2. Satava RM, Stefanidis D, Levy JS, Smith R, Martin JR, Monfared S, Timsina LR, Darzi AW, Moglia A, Brand TC, Dorin RP. Proving the effectiveness of the fundamentals of robotic surgery (FRS) skills

103 curriculum: a single-blinded, multispecialty, multi-­ institutional randomized control trial. Ann Surg. 2019; 3. Robotic surgery (urologic) standard operating procedure (SOP). 2018. www.auanet.org. http://www.citationmachine.net/springervancouver/cite-a-website/manual. Jul 2019. 4. Robotic surgery in gynecology. Committee opinion no. 628. American College of Obstetrician and Gynecologist. Obstet Gyncol. 2015; 125; 760–7. 5. Tom CM, Maciel JD, Korn A, Ozao-Choy JJ, Hari DM, Neville AL, de Virgilio C, Dauphine C.  A survey of robotic surgery training curricula in general surgery residency programs: how close are we to a standardized curriculum? Am J Surg. 2019;217(2):256–60. 6. Raad WN, Ayub A, Huang CY, Guntman L, Rehmani SS, Bhora FY.  Robotic thoracic surgery training for residency programs: a position paper for an educational curriculum. Innovations. 2018;13(6):417–22. 7. Intuitive Surgical, Inc. daVinci residency & fellowship training equivalency certification requirements. 2016. PN210352rC 02/2016. 8. Curriculum. Robotics Training Network. 2019. https://robotictraining.org. Aug 2019. 9. Fundamental skills of robot-assisted surgery (FSRS). Roswell Park Comprehensive Cancer Center. https://www.roswellpark.org/ education/atlas-program/testing-training/fundamental-skills-robotassisted-surgery-fsrs. Jun 2019. 10. Robotic skills course. ORSI Academy. 2019. https://www.orsi online.com/en/training/robotic-skills-course. Jun 2019. 11. Goh AC, Goldfarb DW, Sander JC, et al. Global evaluative assessment of robotic skills: validation of a clinical assessment tool to measure robotic surgical skills. J Urol. 2012;187:247–52. 12. Riener R. Virtual reality in medicine. London: Springer; 2012. 13. Wright AS.  Validity in educational research: critically important but frequently misunderstood. Arch Surg. 2010;145:20. 14. Maithel S, Sierra R, Korndorffer J, et al. Construct and face validity of MIST-VR, Endotower, and CELTS: are we ready for skills assessment using simulators? Surg Endosc. 2006;20:104–12. 15. Lee JY, Mucksavage P, Sundaram CP, McDougall EM.  Best practices for robotic surgery training and credentialing. J Urol. 2011;185(4):1191–7. 16. Ramos P, Montez J, Tripp A, et  al. Face, content, construct and concurrent validity of dry laboratory exercises for robotic training using a global assessment tool. BJU Int. 2014;113:836–42. 17. Kiely DJ, Gotlieb WH, Lau S, Zeng X, Samouelian V, Ramanakumar AV, et al. Virtual reality robotic surgery simulation curriculum to teach robotic suturing: a randomized controlled trial. J Robot Surg. 2015;9(3):179–86.

Real Tissue Robotic Simulation: The KindHeart Simulators

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Richard H. Feins

10.1 Introduction In 2003, Dr. Paul Ramphal, a surgeon and surgical educator at the University of the West Indies–Mona in Jamaica, had a problem. He didn’t not have enough clinical material to train his residents sufficiently before they went to Scotland to complete their training. In the United Sates, a similar problem was arising as the use of the operating room for surgical training was becoming more and more problematic. More and more, surgeons were being judged on volume, surgical educators were being replaced by more “private practice”oriented surgeons, and surgical residents were finding it harder to get the supervised increase in responsibility essential for independent practice after graduation. Pass rates for the certifying board examinations for the American Board of Surgery and the American Board of Thoracic Surgery were significantly declining, reflecting a decline in clinical exposure. Ramphal’s solution was to create a heart surgery simulator that would allow him to teach the basic surgical skills of heart surgery in as realistic way as possible. Existing simulation was being done on virtual reality computers, plastic organ models, or live animals. To accomplish his goal, Ramphal created a real tissue simulator that took a pig’s heart (known to have very similar anatomy to the human heart), reanimating it by placing balloons in each ventricle to simulate the beating heart, perfusing the heart with simulated blood, preserving the organ in an alcohol-based solution, and placing the organ in a human mannequin. Dr. Daniel Coore, Chair of Computer Science at UWI, Mona, built a computer program that controlled balloon inflation to reflect all important heart rhythms. Dr. Michael Craven from Liverpool provided the mechanical engineering help. The result was an extremely realistic heart surgery simulator that used moving and perfused tissue real tissue without using live animals (the R. H. Feins (*) Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA e-mail: [email protected]

hearts used were by-products of animals used for food). This significantly enhanced the resident training that Ramphal could provide. The work was published in the European Journal of Cardiothoracic Surgery in 2005 [1] along with an online short video of the simulator in action (Video 10.1) where it was essentially ignored until 2007 when it was discovered by Dr. Richard Feins, then-Chair of the American Board of Thoracic Surgery, who was looking to improve applicant performance on the ABTS certifying exam by improving the quality of resident education. Through a collaboration between Ramphal and Feins and his laboratory at the University of North Carolina at Chapel Hill, the cardiac surgery simulator was made available in the United States to widespread acclaim as it allowed for cardiopulmonary bypass, aortic valve replacement, and on and off pump coronary bypass surgery, all on real animated tissue without risk to patients. Using the basic principles of real tissue simulation employed in Ramphal’s simulator, the lab at UNC subsequently created a real tissue simulator for lung surgery which employed a pig heart lung block with a beating heart and perfusion through the pulmonary artery and pulmonary veins (Fig. 10.1). This provided a very realistic simulator for teaching both open and thoracoscopic lung surgery, particularly left upper lobectomy. It has now been used at the annual Thoracic Surgery Directors Associations Resident Boot Camp for the last 12 years as will be described later in this chapter. Importantly, it has been modified to become an integral part of training in robotic lobectomy. The success of the real tissue cardiac surgery simulator and the subsequent lung resection simulator in enhancing surgical skills acquisition resulted in the creation of KindHeart Inc., a company to make the simulators readily available and to further expand the concept of animated real tissue simulation-based training into other areas of surgery. KindHeart has subsequently created a real tissue basic skills simulator, an intestinal anastomosis simulator, a foregut simulator for anti-reflux and bariatric surgery, and a pelvic surgery simulator for low anterior colon resection. Because the

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Fig. 10.1  The KindHeart Real Tissue Thoracic Surgery Simulator with robot-assisted vessel dissection for left upper lobectomy

KindHeart real tissue simulators simulate patients, they can be used for open, laparoscopic, and robotic surgical training using all of the same instruments and devices used in clinical surgery both now and in the future. In addition, they provide simulation-based training in handling operative adverse events, training essential to performing safe surgery. The remainder of this chapter will describe the uses of the KindHeart real tissue simulators as they are used in robotic surgical training.

10.2 Thoracic Surgery Simulator The KindHeart Thoracic Surgery Simulator (TSS) was the first real tissue simulator used for thoracic surgery training that did not involve live animals or cadavers. First used at the Thoracic Surgery Directors Association’s National Resident Boot Camp for open lobectomy training in 2008, the model was shown to provide an excellent experience for learning hilar dissection, handling and securing pulmonary vessels, and using endostaplers. It has been a part of the boot camp for the last 12 years. This year, the model was also used at boot camp to train 50 residents on the basics of robotic lobectomy. Part of this training was a collaboration with Intuitive Surgical Inc. to test new methods of measuring proficiency using instrument motion tracking and video reviews. The results of this work are pending but could help to solve one of the major problems with granting robotic privileges: evaluation of competency by credentialing committees prior to clinical work. The TSS uses a block of real porcine tissue which includes the heart and left lung (Fig. 10.1). The right lung is not used because of the variable anatomy including a tracheal bronchus. The lung is not inflated, simulating the practice in clinical surgery. The heart beats and the pulmonary arteries and pulmonary veins are perfused giving a very high level of fidelity and suspension of disbelief when doing the training.

While the pig anatomy is somewhat different than the human anatomy most notably in more vascular and bronchial branches and the presence of a left azygos vein coming over the proximal left pulmonary artery, the model has been found to be the best means of transitioning from virtual reality simulators to the clinical setting. In addition, adverse events such as excessive bleeding, ventricular fibrillation, and emergency conversion to open surgery can be orchestrated for repetitive training, something not available in the clinical setting. The simulator has a left thoracotomy mannequin with rib cage covered by a reusable soft tissue chest wall for training in proper port placement. The TSS has become a mainstay in robotic training for lobectomy and lymph node dissections. It is anticipated that model as a right thoracotomy will soon also be used for robotic esophagectomy (Video 10.2).

10.3 Real Tissue Skills Platform In 2018, KindHeart introduced the Real Tissue Skills Platform for real tissue training in basic robotic skills such as suturing and knot tying, vessel dissection and ligation, dissection and excision of solid tumors, and use of coagulation devices (Fig. 10.2). The simulator can be used by all robots and simplified for easy portability. The platform can be customized for the particular skill set required. Working out the basic skills where multiple repetitions are possible has proven to be very effective in preparing trainees for real tissue full-procedure simulation prior to clinical work. The block is preserved in an alcohol-based solution and vacuum-packed which allows for a shelf life in excess of 1 month, easy shipping, and easy cleanup (Video 10.3).

10.4 Abdominal Hernia Simulator The KindHeart Abdominal Hernia Simulator is a real tissue simulator providing training for both left and right inguinal hernias and abdominal wall hernias (Fig. 10.3). The inguinal hernia model allows for real tissue peritoneal dissection, reduction of the hernia, placement of the appropriate mesh, and closure of the peritoneum. All major anatomic landmarks are demonstrated. The model is most applicable for the transabdominal preperitoneal (TAPP) procedure but can be used for the totally extraperitoneal (TEP) repair with some modification of the model. All usual robotic instruments can be used along with any commercially available hernia meshes. The real tissue blocks are preserved in the alcohol-based solution and vacuum-packed to allow for easy shipping and cleanup. The cassette fits into the KindHeart abdominal mannequin (Video 10.4).

10  Real Tissue Robotic Simulation: The KindHeart Simulators Fig. 10.2  The KindHeart Real Tissue Surgery Skills Platform customized for training to do robot-assisted resection of embedded tumors. Vessels to the tumor are perfused and pulsatile

Embedded tumors for dissection

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Fig. 10.3  The KindHeart Inguinal Hernia Simulator Cassettes for left and right inguinal hernia repair. Placement of mesh during robot-assisted TAPP procedure

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10.5 Colon Resection Simulator

10.6 Bariatric and Foregut Simulator

The colon resection simulator allows for training in ligation of the appropriate mesentery vessels, resection of a short piece of bowel, and anastomosis using a surgical gastrointestinal endostapler. Right, tranverse, and descending resections are possible (Fig. 10.4). The simulator uses the cassette model, allowing for easy replacement in the KindHeart Abdominal MIS mannequin. Because of the spiral nature of the pig large bowel, sections of small bowel placed anatomically as large bowel is used. This appears to be quite satisfactory for learning the above described skills. Multiple repetitions can be performed on a single cassette by restricting how much bowel is resected each time (Video 10.5).

The bariatric and foregut simulator is perhaps the most versatile of the KindHeart real tissue simulators (Fig.  10.5). Using a preserved block of esophagus, stomach, and duodenum and a length of small bowel with mesentery, the model allows for the performance of a gastric sleeve and a gastric bypass with gastrojejunostomy and bowel reconstruction with a jejunal-jejunostomy on real tissue. All applicable staplers and energy devices can be used. In addition, the model can be used to train in Heller myotomy, hiatal repair, Nissen fundoplication, Dor fundoplication, Toupet fundoplication, and preparation of the stomach as a gastric conduit for esophagectomy. Inclusion of the liver in the block also allows for robotic cholecystectomy to be performed. The model has

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Fig. 10.4  The KindHeart Real Tissue Colon Resection Simulator in the patient mannequin. Stabled colon reanastomosis

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Fig. 10.6  The KindHeart Real Tissue Pelvic Surgery Simulator, in development, which will allow for training in robot-assisted hysterectomy and low anterior colon resection

been used at the American College of Surgeons’ foregut course at its clinical congress (Video 10.6).

10.7 Pelvic Surgery Simulator The pelvic surgery simulator is presently in development by KindHeart (Fig.  10.6). When completed, it will allow real tissue robotic training on a variety of pelvic procedures. The low anterior colon resection requires complex instrument angulation in a very confined space as the sigmoid colon is mobilized deep into the pelvis. With its many degrees of articulation, robotic assistance is ideally suited for this procedure. Real tissue modeling for hysterectomy is a challenge in the four-legged animal as the uterus is bifid. KindHeart intends to use its technique of anatomic repurposing where real tissue from other organs are fashioned to better simulate the human anatomy. This is also being applied to the prosta-

Fig. 10.5  Performance of gastrojejunal anastomosis for gastric bypass surgery. The model also allows for gastric sleeve and anti-reflux procedures

tectomy model which has similar challenges in the pig. The model does allow for mobilization of the lateral pedicles with cautery, energy, or direct dissection as these planes are preserved in the model. It is expected that this model will be available in early 2020 (Video 10.7). For most surgeons, a real tissue training experience is essential to gain the skills necessary to operate on patients and the confidence needed to do so. Unfortunately, that experience has either been unavailable or is done on live animals. The KindHeart real tissue simulators allow for component task and full-procedure training for most all robotic surgical operations on a cost-effective and convenient platform without using live animals. A further advantage of the KindHeart simulators is the trainer can create and orchestrate adverse events such as intraoperative bleeding from the pulmonary artery (Video 10.8). This type of training is essential for safe robotic surgery and is obviously not possible in the clinical setting. They have also been shown to reduce the time required on the clinical learning curve before proficiency is reached.

10  Real Tissue Robotic Simulation: The KindHeart Simulators

Work is presently underway to incorporate performance on real tissue simulators as part of hospital privileging.

Video Legends Video 10.1 KindHeart-Ramphal Cardiac Surgery Simulator showing the beating, perfused pig heart in the human mannequin. Video shows aortic and venous cannulation, off pump coronary bypass and aortic valve procedures (https://youtu.be/C2YN7SLz-lM) Video 10.2 KindHeart Thoracic Surgery Simulator. Allows for performance of all components of left upper lobectomy. Model allows for use of cautery, energy vessel closure, and robotic staplers. Procedure was performed by Dr. Mark Onaitis while at Duke University (https:// youtu.be/wnz6qRv2DTM) Video 10.3 KindHeart Real Tissue Platform showing resection of embedded tumors. The platform is customizable depending upon which component skills training is desired (https://youtu.be/ roV4cBBkVhE) Video 10.4 KindHeart Real Tissue Hernia Repair being used for training in Transabdominal Preperitoneal Repair (TAPP). Models are available for both left and right hernia repairs using all available meshes (https://youtu.be/ vkwIBEH8pc4)

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Video 10.5 KindHeart Real Tissue Surgery Simulator showing dissection and division of mesenteric artery and resection and stapled anastomosis of the bowel. Multiple anastomosis can be performed on a single model (https://youtu.be/ uvR1-Lh2nnk) Video 10.6 KindHeart Real Tissue Bariatric and Foregut Surgery Simulator showing gastric sleeve resection and gastric bypass with Roux-en-Y gastrojejunostomy. Procedure was done laparoscopically but can be readily adapted for robot-assisted surgery (https://youtu.be/ jLVXIyczZZo) Video 10.7 KindHeart Pelvic Surgery Simulator, in development, demonstrating the pig pelvic organs available for training (https://youtu.be/ OPqW1j-iKhc) Video 10.8 Bleeding from the pulmonary artery demonstrated on the KindHeart Thoracic Surgery Simulator. A significant advantage of simulation-­based training is to train in how to deal with adverse events such as bleeding (https://youtu.be/6-Wj_pxGccU)

Reference 1. Ramphal PS, Coore DN, Craven MP, Forbes NF, Newman SM, Coye AA, Little SG, Silvera BC. A high fidelity tissue-based cardiac surgical simulator. Eur J Cardiothorac Surg. 2005;27(5):910–6.

The Institute for Surgical Excellence: Its Role in Standardization of Training and Credentialing in Robotic Surgery

11

Jeffrey S. Levy, Martin A. Martino, Dimitrios Stefanidis, John Porterfield Jr, Justin William Collins, Richard H. Feins, and Ahmed Ghazi

11.1 Introduction The Institute for Surgical Excellence (ISE) is a 501(c)(3) public nonprofit organization (www.surgicalexcellence.org) formed in 2014. Its mission is to create lasting solutions for complex healthcare problems related to emerging surgical technologies, with the ultimate goal to improve patient outcomes and safety. ISE utilizes a consensus-driven approach by bringing together key stakeholders including surgeons, educators, researchers, hospital leadership, government, and industry innovators to create new surgical standards. ISE facilitates the process of identifying issues with the use of new technology, setting clearly defined goals to address them, promoting collaboration among stakeholders, deter-

J. S. Levy (*) Institute of Surgical Excellence, CaseNetwork, Newtown Square, PA, USA e-mail: [email protected] M. A. Martino Department of Gynecologic Oncology, University of South Florida, Tampa, FL, USA Minimally Invasive Robotic Surgery Program, Lehigh Valley Cancer Institute, Lehigh Valley Health Network, Allentown, PA, USA D. Stefanidis Department of Surgery, Indiana University School of Medicine, Indiana University Health, Indianapolis, IN, USA J. Porterfield Jr Department of Surgery, University of Alabama at Birmingham, Birmingham, Alabama, USA J. W. Collins Department of Urology, University College London Hospital, London, UK R. H. Feins Department of Surgery, University of North Carolina at Chapel Hill, Chapel Hill, NC, USA

mining and filling gaps in knowledge, and promoting information sharing with healthcare consumers. ISE is the only cross-specialty organization that has a strategic plan to create and manage a Full-Cycle Model for Education, Training, Assessment and Surveillance for robotic-assisted surgical (RAS) procedures. The Full-Cycle Model is depicted in Fig.  11.1, and each area will be described in this chapter. Each component of the full-cycle model was addressed through a series of consensus conferences to develop new standards for RAS. ISE organized, facilitated, and managed most of these 11 consensus conferences that will be described in this chapter and members of the ISE leadership team participated in all of consensus conferences. The Delphi process was conducted for each of the consensus conferences to drive consensus of the subject matter experts. The Delphi method is a structured process to effectively drive consensus of a group of individual experts when addressing complex issues, especially where there are not evidence-based standards. A modified Delphi method was used to generate key questions for the Delphi survey based on facilitated discussions during live meetings. The final Delphi survey was then distributed anonymously in a classic Delphi format via the Internet (Google forms) to participants in three successive rounds. After each Delphi round, participants received feedback in the form of a statistical analysis of the group response. Questions in which there was ≥80% concurrence were removed from the next round of the survey. Repeated iterations of anonymous voting continued over three rounds, where an individual’s vote in the next round was informed by knowledge of the entire group’s results in the previous round. After the three rounds, the consensus views that represented at least 80% of the expert panel were distributed to all stakeholders and in many cases published in peer-reviewed journals.

A. Ghazi Department of Urology, University of Rochester, Rochester, NY, USA © Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_11

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Fig. 11.1  Full-Cycle Model for Education, Training, Assessment and Surveillance for robotic-assisted surgical (RAS) procedures Outcome Measures & Metrics

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11.2 F  undamentals of Robotic Surgery (FRS) Consensus Conferences With leadership from Drs. Richard Satava, Roger Smith, and Vipul Patel, the backbone of RAS standardization is the four consensus conferences of the FRS initiative. FRS was funded through a Department of Defense grant and an unrestricted educational grant from Intuitive Surgical. FRS is a multispecialty, proficiency-based curriculum of basic technical skills to train and assess surgeons to safely and efficiently perform robotic-assisted surgery. It was developed by over 80 national and international robotic surgery experts, behavioral psychologists, medical educators, statisticians, and psychometricians. The clinical robotic surgery subject-matter experts represented all of the major surgical specialties in the United States that currently perform robotic-assisted surgical procedures, the Department of Defense, and the Veterans Administration (VA) [1].

11.2.1 FRS Outcome Measures Consensus Conference In the first FRS consensus conference, called “Outcomes Measures,” subject matter experts from multiple surgical societies, educational societies, surgical boards, and other governing organizations agreed upon the critical skills and tasks that needed to be included in a comprehensive basic curriculum. All stakeholders, including the accrediting bodies, were involved from the very beginning of the process to ensure the final curriculum and assessment methods would meet the rigorous requirements of determining proficiency, meeting standards, and possibly even fulfilling certification criteria. A task deconstruction was performed to identify the specific skills and potential errors that need to be measured. A modified Delphi methodology was used to create a matrix of

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specific robotic surgical skills that are matched to their common errors, a description of the desired outcome and the quantitative metrics that support those outcomes. Following the conference, a classic Delphi survey was conducted through anonymous rating to ensure concurrence, to prioritize the ranking of the tasks, and to eliminate low-scoring tasks. As a result of this process, 25 key outcome measures were identified and prioritized to include in the FRS curriculum listed below [1]: • • • • • • • • • • • • • • • • • • • • • • • • •

Situation awareness Eye-hand instrument coordination Needle driving Atraumatic handling Safety of operative field Camera Clutching Dissection — fine & blunt Closed loop communication Docking Knot tying Instrument exchange Suture handling Energy sources Cutting Foreign body management Ergonomic position Wrist articulation Robotic trocars System setting Multi-arm control Operating room setup Respond to robot system error Undocking Transition to bedside assistant

These identified outcome measures were the basis of future curriculum development.

11  The Institute for Surgical Excellence: Its Role in Standardization of Training and Credentialing in Robotic Surgery

11.2.2 FRS Curriculum Planning Consensus Conference The second FRS consensus conference, called “Curriculum Planning,” began the process of curriculum development and determined the methods for training and assessing the full range of technical skills (cognitive, psychomotor, team training, and communication) that are necessary to safely use a robotic surgery system. Several goals were formulated including the following [1]: • Reviewing the consensus-driven outcome measures developed in the first consensus conference • Breaking the 25 outcome measures into seven basic tasks that must be mastered by robotic surgeons. Each task should include a description, skills being assessed, objective measures, and potential errors that can occur • Reviewing and adapting the curriculum template from the Alliance of Surgical Simulation for Education and Training (ASSET), which developed and published a curriculum template with wide consensus from surgical societies [2] • Creating a curriculum outline and beginning the actual curriculum development process

11.2.3 FRS Curriculum and Simulation Development Consensus Conference In the third FRS consensus conference, development of the comprehensive multispecialty curriculum and the simulation training were initiated. The four modules that were created are described below [1] (Fig. 11.2): • Introduction to Surgical Robotic Systems—A technological revolution occurred with the introduction of laparoscopy and other minimally invasive surgeries. This first module of the curriculum provides a primer for surgeons who choose to pursue robotic surgery. It includes robotic components and instrumentation, as well as the advantages and disadvantages of robotic surgery. • Didactic Instructions for Surgical Robotic Systems— This module contains the cognitive skills required to conduct safe and successful basic RAS procedures in the preoperative, intraoperative, and postoperative phases. • Psychomotor Skills Curriculum—The goals and objectives of the basic skills and tasks for robotic surgery are to train and assess the proficiency of the psychomotor robotic skills of the surgeon. This will ensure that only the surgeons who are skilled and well trained in robotic surgery perform such complex procedures, making the patient the ultimate benefactor.

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• Team Training and Communication Skills—The use of a robotic system creates unique demands, which are beyond those demands in open and laparoscopic surgery. The principle difference is the physical separation of the primary surgeon from the patient, the operative team members, and operative site. The result is that the surgeon must rely even more upon team participation and clear, unambiguous communication with team members. After each module, there is a summative assessment and report of the learner’s performance. From the beginning, FRS has been developed as a cross-­ specialty and device-agnostic curriculum. Therefore, significant attention was paid to basic robotic principles that will be applicable for future robotic surgery systems and simulators. The psychomotor skills curriculum was developed to train and assess surgeons interested in performing basic robotic surgery. A proficiency-based progression (PBP) model was utilized that trains a surgeon to perform a specific task to a defined “expert benchmark” (Fig. 11.3). In PBP, the benchmark must be consistently met before allowing the surgeon to progress to the next task usually at a higher level of difficulty. It has been demonstrated that training to quantitative, evidence-based, proficiency standards result in expedited skills acquisition, less errors, improved efficiency, and greater patient safety [3–6]. The 25 key outcome measures that were identified and prioritized in the first consensus conference were incorporated into seven tasks that together train and test the basic skills needed by all robotic surgeons. In the online curriculum, each one of these tasks included a description of task to be performed, skills being assessed, metrics used for each task (both an objective numeric psychomotor metric test and a subjective Global Evaluative Assessment of Robotic Skills rating scale), and potential errors that can occur. These assessment tools were the basis of the FRS validation trial that will be described later in this chapter. The seven tasks that were developed include (and are depicted in the image below) [1]: • • • • • • •

Task 1: Docking/Instrument Insertion Task 2: Ring Tower Transfer Task 3: Knot Tying Task 4: Railroad Track Task 5: Fourth Arm Cutting Task 6: Puzzle Piece Dissection Task 7: Vessel Dissection/Division.

These tasks were delivered in identical physical (FRS Dome) and VR simulation models that were developed and tested to provide the most effective and efficient psychomotor training. Several iterations of the physical model were

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Fig. 11.2 (a) Module 1: Introduction to robotic surgical systems. (b) Module 2: Didactic instructions. (c) Module 3: Psychomotor skills curriculum. (d) Module 4: Team training and communication skills

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Fig. 11.3  Setting the expert benchmark

Fig. 11.4  Experts discussing the first physical training model prototype

developed and tested until a final model was agreed upon by subject-matter experts. Experts are seen in Fig. 11.4 discussing the first physical training model prototype. The FRS physical dome prototyping stages are depicted in Fig. 11.5. The final FRS physical dome is shown in Fig. 11.6 with the seven psychomotor tasks that were developed.

11.2.4 Consensus Conference for the FRS Curriculum Effectiveness Evaluation Study Design In the fourth FRS consensus conference, the design of the FRS effectiveness study was discussed by clinicians, psychologists, researchers, and psychometricians. This study

was designed to meet the most rigorous evaluation that would satisfy criteria for high stakes testing and evaluation [1]. Topics discussed at the consensus conference included defining the research questions; developing hypotheses within construct validity; defining what constitutes an “expert” for benchmarking purposes; defining novice criteria, determining criteria for international institution participation. In addition, there were extensive discussions regarding what types of validity and reliability would be measured along with usability and acceptability. Study design phases were identified and included the following: • Phase 1: Pilot testing to determine logistics and refinements to study model

11  The Institute for Surgical Excellence: Its Role in Standardization of Training and Credentialing in Robotic Surgery Prototype Concept

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• Phase 2: Obtaining feedback from the society leadership and boards • Phase 3: Obtaining validity evidence at test sites • Phase 4a: Demonstrating concurrent validity with video correlations • Phase 4b: Demonstrating predictive validity through the full research study at twelve research sites. The study design is depicted in Fig. 11.7. Following this consensus conference, a multi-­ institutional, multispecialty, single-blinded, parallel group, randomized control trial was conducted and managed by the ISE. The abbreviation was established previously in the paper. Participating institutions

were selected based on a competitive process and had to be an American College of Surgeons’ Accredited Education Institute (ACS-­AEI), have a minimum of three separate surgical specialties that were performing robotic surgery, availability of participants with variable experience in robotic surgery, and easy access to a robotic surgical system both in a simulated and clinical environment for training and testing. The institutions that participated in the study included the following [1]: • • • •

Madigan Army Medical Center, Tacoma, WA Carolinas Medical Center, Charlotte, NC Hartford Hospital, Hartford, CT University of Pisa, Pisa, Italy

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Numeric Psychomotor Metric Test

Numeric Psychomotor Metric Test

GEARS

GEARS

Fig. 11.7  FRS Curriculum Effectiveness Evaluation Study Design

DVSS

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• • • • •

Duke University Medical Center, Durham, NC Imperial College London, London, UK Lahey Hospital & Medical Center, Burlington, MA Lehigh Valley Health Network, Allentown, PA Methodist Institute for Technology, Innovation, & Education, Houston, TX • University of Athens Medical School, Athens, Greece • University of Pennsylvania, Philadelphia, PA • University of South Florida Center for Advanced Medical Learning and Simulation, Tampa, FL

experienced surgeons, was obtained. In this study, the attending surgeons out-performed residents and fellows at baseline and on posttest. Lastly, by demonstrating better performance of those trained using FRS compared with controls, the authors argued for the wide adoption and implementation of FRS across training programs [1]. ISE manages the FRS website and online curricula, which can be found at https://surgicalexcellence.org/programs/fundamentals-of-robotic-surgery/ [8].

A PBP training model was utilized in the study. Participating experts setting expert benchmarks had to have a minimum of 50 robotic cases performed as a primary surgeon and be actively performing at least two robotic cases per month. Randomized subjects in the trial were novices defined as surgical residents, fellows, and faculty who had participated in less than five robotic cases. The ISE study coordination center assigned participants by simple randomization to the four study groups at the beginning of the study: the FRS physical Dome, the da Vinci Simulation System (DVSS), and the dV-Trainer training groups, and a control group. Each novice participant had to successfully complete the online cognitive component of the curriculum before proceeding to the psychomotor tasks. A pretest was then performed on an avian tissue model that was identical to the posttest to determine the baseline psychomotor skills of each participant. The novice was then randomized to a control group or to one of the three experimental groups where training was conducted on the FRS physical dome, the DVSS, or the dV-Trainer, then required to reach the expert benchmark set for each task before going onto the next task. After reaching proficiency in each task, the novice underwent a final test on an avian tissue model that was video recorded. After study completion, each participant video was reviewed by two blinded raters who recorded task duration in seconds and task errors using a 32-criteria task-specific checklist (numeric psychomotor metric test). Raters also completed the Global Evaluative Assessment of Robotic Skills (GEARS) rating scale [7]. In Fig. 11.8, the FRS VR Dome (Fig. 11.8a), 3D-printed FRS physical Dome (Fig.  11.8b), and avian tissue model (Fig. 11.8c and d) are depicted. In this international multi-institutional, noninferiority blinded, randomized control trial, evidence was provided for the effectiveness of the FRS cognitive curriculum and the psychomotor skills training utilizing proficiency-based progression methodology in a physical model and virtual reality simulation platforms for robotic skill acquisition for basic robotic surgery. In addition, validity evidence for the use of the avian tissue model in performance assessment, which was able to discriminate between more experienced and less

11.2.5 RTN Consensus Conference Another example of RAS curriculum development that followed a similar path to the FRS curricular design and testing includes the Robotic Training Network (RTN) curriculum. The vision of RTN is to standardize the robotic surgical curriculum and education for residents and fellows-in-training for all surgical specialties utilizing robotic-assisted surgery. It is a collaborative network of nine institutions with a common vision to design a standardized approach to teach basic robotic surgical skills in a stepwise fashion to trainees throughout Graduate Medical Education training programs. The founding group included the following: • • • • • • • • •

Beth Israel Deaconess Medical Center Celebration Hospital Florida Cleveland Clinic Duke University Johns Hopkins University Lehigh Valley Health Network Newark Beth Israel Medical Center University of North Carolina Wright State University

Over the last several years, over 60 ACGME approved residency/fellowship training programs have been collaborating as part of the Robotic Training Network with a mission to develop an educational curriculum to teach the basic principles of robotic surgery. The RTN Education and Training Course contains nine online modules with interactive content and questions. • • • • • • • • •

Module 1: Overview Module 2: Pretest Module 3: Background Knowledge Module 4: Posttest Module 5: Introduction to the Robotic System Module 6: Bedside Assistant Module 7: Console Surgeon Module 8: Team Training and Communication Module 9: Specialty-specific Education and Training

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c

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Fig. 11.8 (a) FRS VR dome, (b) 3D-printed FRS physical dome, (c) and (d) avian tissue model

Once all nine modules are completed, the trainee receives a certificate and can proceed to the psychomotor skills training and assessment. There are five skill drills in the RTN curriculum. • Tower transfer—Transfer of rubber band from the inner small towers to the outer graduated height towers. • Roller coaster—Manipulate the rubber band around wire loop. • Big dipper—Place the needle into sponge in various arcs through prespecified dot patterns.

• Train tracks—Place a running suture with the needle entering and exiting through the dots. • Figure of eight—Place a figure of eight stitches with the needle entering and exiting through dots followed by a square knot. The skills tasks are depicted in the images of the physical model in Figs. 11.9 and 11.10.

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Fig. 11.9  Outside and inside views of the RTN physical training model components

cialty specific robotic education and training are also needed. In response to this need, ISE conducted two specialty-­ specific consensus conferences described below and is currently developing others. The first specialty specific consensus conference was for gynecologic robotic surgery. It included representatives from all major gynecologic society stakeholders and others including:

Fig. 11.10 RTN Virtual Reality Trainer (developed by Mimic Technologies, Inc)

Similar to FRS, identical skills can be performed on VR simulators, as well. In addition, RTN designed and provided validity evidence for an assessment tool to complement their educational robotic surgical training curriculum called the Robotic— Objective Skills Assessment Test (R-OSATS) [9] (Fig. 11.11). ISE manages the RTN website and online curricula, which can be found at https://surgicalexcellence.org/programs/robotic-training-network/ [8].

11.2.6 Specialty-Specific Curricula Consensus Conferences—Gynecology The FRS curriculum and task trainers are designed to be basic education and training for robotic surgeons across all specialties performing robotic surgery. More advanced spe-

• American College of Obstetricians and Gynecologists (ACOG) • American Association of Gynecologic Laparoscopists (AAGL) • Council on Resident Education in Obstetrics and Gynecology (CREOG) • American Board of Obstetrics & Gynecology (ABOG) • Society of Gynecologic Oncology (SGO) • American Urogynecologic Society (AUGS) • American Society for Reproductive Medicine (ASRM) • Society of Gynecologic Surgeons (SGS) • American Medical Association (AMA) • Joint Commission on Accreditation of Healthcare Organizations (JCAHO) Based on the groundwork set by the original four FRS consensus conferences, all elements of outcome measures and metrics, curriculum design and early development, simulation design, and team training and communication were accomplished during a three-day specialty-specific consensus conference. Gynecologic RAS-specific issues were addressed in the new Fundamentals of Robotic Gynecologic Surgery (FRGS) curriculum, including instrumentation used, unique patient positioning requirements, trocar placement, and robotic and team positioning, to mention a few. Examples of screenshots from the curriculum are provided in Fig. 11.12.

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Depth Perception/Spatial Orientation/Academy 1 Constantly overshoots target, slow to correct

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3 Some overshooting but quick to correct

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5 Accurately directs the instruments to targets

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5 Handles model, suture, and/or needle well; traction is appropriate

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5 Expertly uses both hands; always transfers rings or bands without dropping. Optimal needle or suture management

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5 Confident, fluid progression, adjusts quickly

Force/Tissue Handling 1 Breaks model, ring, or suture; damages needle

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3 Moves or bends wire; minor trauma to model or needle, frays suture Dexterity

1 Poor coordination of hands; repetitively drops ring or band; inappropriately drops needle or poor suture management

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3 Suboptimal interaction between hands, any drops of ring or band. Suboptimal suture or needle management

Efficiency 1 Uncertain movements with little progress

2

3 Slow, but movements seem reasonably organized

Fig. 11.11  Robotic—Objective Skills Assessment Test (R-OSATS)

A task deconstruction was completed for a hysterectomy, which is the “signature” procedure for gynecology. The 25 basic skills identified in the FRS consensus conferences were reviewed as were the seven basic FRS tasks. These served as a prerequisite to the more advanced gynecologic tasks. Four new advanced tasks were identified that are related to the successful completion of a hysterectomy. They included the following: • • • •

Dissection of the bladder flap Ureter dissection/exposure Anterior and posterior colpotomy incisions Vaginal cuff closure

Some of the participating gynecologic robotic experts also worked with simulation companies to develop and refine the new gynecologic specific tasks. Examples of the VR simulations (developed by 3D Systems) are shown in Fig. 11.13. In addition, new team training scenarios were developed that correlate to additional communication skills that are unique to gynecologic surgical procedures.

11.2.7 Specialty-Specific Curricula Consensus Conferences—Thoracic Surgery The second specialty-specific consensus conference was for thoracic RAS. It included 18 thoracic robotic surgeons from the US and one from Europe representing a European thoracic robotic curriculum development consortium. The Society of Thoracic Surgeons (STS) and the American Association for Thoracic Surgery (AATS) were also represented at the consensus conference. Similar to the gynecology consensus conference, based on the groundwork set by the FRS, all elements for the Fundamentals of Thoracic Robotic Surgery (FTRS) ­curriculum were determined during a 3-day specialty-specific consensus conference. A task deconstruction was ­completed for a thoracic “signature” procedure, lobectomy, which included the following: • Takedown of inferior pulmonary ligament, division of pleura • Dissect subcarinal posterior/paratracheal/ hilar nodes • Dissect/divide superior vein

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Fig. 11.12  Examples of screenshots from the Fundamentals of Robotic Gynecologic Surgery (FRGS) curriculum

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124 Fig. 11.13  Examples of the VR simulations (developed by 3D Systems). (a) Bladder flap, (b) colpotomy, (c) vaginal cuff, (d) ureter dissection

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Fig. 11.14  Medical illustrations developed for the FTRS curriculum

11.2.8 Train-the-Trainer Consensus Conference—Curriculum Development

Fig. 11.15  VR lobectomy simulation (developed by 3D Systems)

• • • • •

Dissect superior hilar/peribronchial nodes Dissect/divide pulmonary arteries Dissect/divide bronchus Complete posterior/horizontal fissure Management of PA Injury

For each of these steps, training items and potential errors were identified. New medical illustrations were developed by ISE to support the curriculum, as well as more than two dozen video examples. These were all included in the curriculum (Fig. 11.14). Thoracic robotic surgery experts have worked with a simulation company to make the VR lobectomy procedure more realistic and anatomically accurate. An example of the VR lobectomy simulation (developed by 3D Systems) is shown in Fig. 11.15.

ISE hosted two international Train-the-Trainer (TTT) Consensus Conferences and brought together experts and stakeholders from the United States and Europe to determine the key elements of a core TTT RAS curriculum through an expert consensus process. In the first TTT conference, the Delphi methodology was used to develop consensus-driven guidelines for selecting and verifying trainers in robotic surgery. A TTT curriculum for RAS training was initiated with the goal to improve cognitive education, psychomotor training, training around errors, team communication, expert feedback, assessment tools, scoring systems, and remediation. After three rounds of Delphi surveys, consensus was obtained in more than 60 elements in six different categories that are described below. This laid the foundation for the development of proficiency-­based progression models for robotic trainers.

11.2.8.1 Category 1: Consensus on Terminology Uniform communication language is important for understanding roles in surgical training, because if there is ambiguity in the “surgical training” terminology, it may have negative implications in various clinical settings. Thirty terms were defined and agreed upon [10], including Master Trainer, Delegate, Trainer, and Trainee (Fig. 11.16).

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Fig. 11.16 Train-the-trainer terminology

11.2.8.2 C  ategory 2: Prerequisites for TTT Course Selection and TTT Qualifications The panel reached consensus view that TTT delegates should be experts in their field and that there should be defined selection criteria for getting a place on a TTT course. The panel agreed that while delegates should be experts in their field, all good surgeons are not necessarily good trainers. The panel also concluded that important individual qualities for a surgical trainer include being knowledgeable, interested, enthusiastic, supportive, and a good communicator. The surgical trainer should also enjoy training, have time to train, and have the restraint and wisdom to know when it is appropriate to “take over” in simulation vs. clinical setting [10]. The best trainers are those who know when to give progressive responsibility and autonomy to trainees [11]. 11.2.8.3 C  ategory 3: Objectives and Focus of a TTT Course The panel agreed there should be clearly defined objectives for the TTT course and that it should focus on both educating the delegate to become a verified trainer and how to set up a “training program.” Identified by the panel as a key focus point and essential for the TTT course included instruction on how to optimize guidance on defined technical skills and training in providing feedback and debriefing, following technical skill assessment. The panel also recognized the need for training on technical skills rating and calibration exercises and the importance of psychometric robustness of these technical skills assessment tools. In addition, the TTT course should provide opportunities to practice rating training skills in the operating room and laboratory/simulation setting [10].

11.2.8.4 Category 4: Pre-course Considerations The group considered what needs to be included in a “checklist” of basic requirements for setting up a TTT course. The group’s guidance for pre-course e-learning modules was that it should include the following [10]: • Details of the TTT course content and clearly defined objectives of the TTT course. • List of skills to be taught. • Definitions for terminology. • Defined role-play tasks and aims of role-play. • Educational theory information related to the course. • Relevant subject-matter details related to future training courses (e.g., FRS TTT course should describe the FRS). • Procedural-based TTT courses should describe important standardized content to be given by the trainers (e.g., the important anatomy, port placement, and surgical steps). • Pre-course evaluation should include an assessment of the delegate’s knowledge of the course subject matter and/or technical procedure aspects to be given in the training course. There was consensus agreement within the panel that completion of e-learning related to the TTT course should be a basic requirement before attending the TTT course. Furthermore, it is important to identify the participant’s gaps in knowledge of the proposed training program they will run and address them before the TTT course commences.

11.2.8.5 C  ategory 5: Theory and Course Content The panel reached agreement on multiple areas of educational theory and course content for a standardized TTT course. Areas of agreement that related to subject matter include the following [10]:

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• Highlight the importance of team contribution to training and describing the behaviors of “good” team members • How to deal with the difficult trainee • Guidance on how to avoid “taking over” as the trainer. Explanation of the “Six Steps” of safe mentoring[12]. • Cognitive task analysis • Describe and explain “deliberate practice” • Description of proficiency-based progression • How to reflect and the importance of reflection • How to debrief • How to give informative feedback • Task deconstruction • Describe and explain “Performance enhancing feedback” • Take-home messages need to be identified Areas of agreement related to exercises, feedback, and assessment tools include the following: • • • •

• • • •

Practical demonstrations/role-play/tasks/group participation Task repetition to demonstrate deliberate practice Example of task deconstruction Explanation of the Six steps: 1. Stop; 2. Identify; 3. Explain; 4. Structured Teaching; 5. Elicit Check of Understanding; 6. Proceed if Safe.[12] Proficiency-based progression exercises Role-play exercise that describes and explains the effect of cognitive load [12]. Informative feedback exercise [12]. Practical training role-play: role-play scenarios played out with delegate interaction and assessment of trainer’s performance with open discussion and feedback

11.2.8.6 Category 6: Measuring Outcomes The panel identified that RAS assessment includes technical skills, cognitive assessment, and nontechnical skills. The robustness of technical skills assessment tools is important for the continuum of training [10]. Technical skills are currently commonly assessed with Likert scale measures such as GEARS. Whereas proficiency-based progression is based on objective metrics that often relate to the completion of tasks and the avoidance of errors. For proficiency-based progression, delegates should have the opportunity to repeat the scenario until they achieve proficiency. At the end of the course a post-course evaluation test of the delegates should be compared with the pre-course test, and informative feedback should be given to the delegates on their performance. Delegates should also have the opportunity to comment on the various aspects of the course with a written questionnaire to evaluate both the course and the master trainer. Finally, the panel identified that there is poor standardization around the definition of errors, causes and consequences of errors, classification of errors, outcome measures and met-

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rics needed to evaluate errors, and training to prevent errors. In response to this need, a second train-the-trainer consensus conference was convened.

11.2.9 Train-the-Trainer Consensus Conference—Teaching to Train and Assess Regarding Errors The second train-the-trainer consensus conference focused on defining errors and to standardize how to train trainers to properly educate the avoidance, recognition, and treatment of errors. There is very little standardization worldwide regarding errors, which are of course a key element in determining patient safety. ISE implemented a consensus-driven approach by inviting three dozen master trainers from around the world to ensure a scholarly and practical method to develop the highest quality of training and assessment. The first step accomplished in the consensus conference was to agree on a taxonomy for errors (Fig. 11.17). The second task was to develop a standardized algorithm for errors (Fig. 11.18). The third task was to have expert robotic surgeons do task deconstructions of the signature robotic procedures from each specialty. Any associated potential errors were included for each step of the procedure. The potential errors were then prioritized regarding which ones would be most important to teach with consideration of the teaching methods. The ability to effectively handle adverse events is essential to safe surgery. The relative rarity of these events in clinical practice makes simulation an essential component in training the surgeon and surgical team how to handle adverse events and in confirming proficiency [13]. At the present time, there are very few models that teach about errors in a standardized way. It was determined that simulations should start with generic adverse events applicable to all RAS such as controlling bleeding from blood vessel injury. More advanced training would include procedure-specific adverse events such as ureteral injury during a hysterectomy or sigmoid resection. Emphasis should be placed on properly identifying the problem and the most appropriate next response. Expert presentations were provided at the consensus conference describing some of the most effective real tissue simulators for teaching full procedures and associated errors like the KindHeart, Inc., Chapel Hill, NC (Fig. 11.19). Full procedure simulation can also be accomplished with sophisticated synthetic 3-D printed tissue models that are very realistic, like those developed by the University of Rochester, Rochester, New  York. The models were fabricated at their Simulation Innovation Laboratory where they developed a number of organ models for use as minimally

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Fig. 11.17 Consensus-driven standardization of taxonomy for errors

Errors

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Anatomy Operative Steps Judgment

indications Pre-Op Prep Post-Op Care

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Cognitive Psychomotor Perceptual/ Visual Spatial Dexterity

Fig. 11.18 Consensus-driven standardization of algorithm for errors

Teamwork/Team Training Communication Leadership Situational Awareness Decision Making

Device Related Organized/ Systems Unclassified

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Error of No Consequence (No Action Needed)

Potential Consequence (ACTION NEEDED)

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Error of No Consequence

Potential Consequence

Not Fixed or Fixed Incorrectly

Severity / Patient Outcome

Fig. 11.19  KindHeart training model (developed by KindHeart, Inc.)

invasive surgical simulation platforms (e.g., RAS) using a patented process of 3-D printing and hydrogel [Polyvinyl Alcohol (PVA)]. Examples of models are shown in Fig. 11.20. ISE and its advisory board are presently working with VR simulation companies to develop new simulators that incorporate the avoidance, recognition, and management of adverse events to help standardize them across all simulation platforms. During the second TTT consensus conference, there was universal agreement that comprehensive training in handling adverse events cannot and should not occur in the clinical setting. The real tissue and synthetic full procedure simulations have the clear advantages of allowing the complete orchestration and control of the event (the degree of bleeding, for example), the application of a predefined curriculum,

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Fig. 11.20 (a) Perfused hydrogel kidney in its corresponding 3-D printed mold, (b) RAPN simulation platform after completion of the simulation and removal of the tumor (inferior vena cava, aorta, colon, and spleen seen in the background), (c) prostatectomy hydrogel model

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with bladder, urethra, and dorsal venous complex with incorporated stretch sensors, (d) RARP simulation platform after completion of the simulation and removal of the prostate (bilateral neurovascular bundles left intact after full nerve sparing)

Fig. 11.21 (a) Mild bleeding from pulmonary vein. (b) Moderate bleeding. (c) Severe bleeding

and an unlimited number of repetitions allowing for deliberate practice while putting no patients at harm’s way. As a result of consensus achieved at the second TTT consensus conference, an Adverse Event Curriculum including simulations is presently under development for intraoperative bleeding. Unexpected intraoperative bleeding has been broken down into minimal, moderate, and

massive bleeding. Videos of each level of bleeding are used to train surgeons to correctly identify the level of bleeding occurring (Fig. 11.21). For each level of emergency, an action plan has been developed and the component technical tasks identified. For minimal bleeding, the first line of management is pressure control with possible cautery/energy application, or topical

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application of clotting materials. In moderate bleeding, pressure control is utilized to prepare for vessel ligation with suture, clips, or energy application, or possible vessel repair. With massive bleeding, it is imperative to stabilize the situation with pressure control until an emergent conversion to an open procedure can be accomplished. Appropriate ­communication should accompany the simulation exercise. With massive bleeding, the surgeon is expected to request appropriate blood products, notify the anesthesiologist and surgical team of the emergency situation, and call for surgical backup/assistance. Once proficiency in these component tasks and communication skills has been achieved, the trainee performs a full specialty-specific procedure with adverse event management. Full validation of this Adverse Event Bleeding Curriculum will be needed before any expansion of the curriculum into other adverse events such as intraoperative organ injury (spleen, bowel, liver, ureter, and bladder), difficulty with abdominal distention, stapler misfiring, robotic malfunction, and others.

11.2.10 Credentialing Consensus Conference As with any complex new surgical procedure, technique, or technology, there is generally a steep learning curve. There is no exception to surgeons developing skills to perform RAS.  The rapid growth of RAS has presented significant challenges since there are no accepted standards for credentialing and privileging to demonstrate the surgeon, and the entire team are proficient in performing safe robotic-assisted procedures. Unlike the aviation industry where pilots go through standardized intense training and simulation and are tested every 6 months to determine maintenance of skills, once surgeons become board certified, there are minimal or no requirements to maintain surgical skills or prove proficiency. In response to these serious gaps, ISE organized and hosted a Robotic Surgery Credentialing Consensus Conference that brought together 36 representatives from institutions with extensive robotic surgery credentialing experience, surgical societies, medical associations, government, and industry. The goal of the meeting was to help develop standards regarding how hospital systems evaluate the qualifications of applicants who wish to perform robotic-­ assisted procedures or renew privileges in their facilities to ensure the highest quality and safety of surgical care. The first part of the consensus conference was information gathering from seven top robotic institutions that described their present credentialing process (i.e., how they assess the qualifications of physicians or other healthcare professionals) and privileging criteria (i.e., determination of

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specific surgical conditions and procedures that a surgeon will be allowed to perform at a healthcare institution). In addition, seven major surgical societies presented their robotic credentialing recommendations. The participating institutions and societies included the following: Institutions • • • • • • •

AdventHealth Emory Northwell Health Lehigh Valley Health Network Memorial Sloan Kettering Kaiser Permanente SUNY Downstate Societies

• American Urology Association (AUA) • American College of Obstetricians and Gynecologists (ACOG) • Society of Robotic Surgeons (SRS) • Society of Thoracic Surgeons (STS) • Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) • American Association of Gynecologic Laparoscopists (AAGL) • European Urology Society (EUS) In addition, Dr. Dimitrios Stefanidis led the efforts prior to the conference to review robotic credentialing policies from 39 institutions, including both academic institutions (56%) and community programs (44%). He summarized the policies and presented them at the consensus conference. He found that there was tremendous variability between the details of the various policies, but many included general criteria in the following areas: • • • • • • •

Prerequisites Competency assessment Proctoring of initial cases Delineation of basic vs. advanced procedures Surgery outcome assessment Team training criteria Maintenance certification

With this background information, three working groups were formed to discuss various aspects of the credentialing/ privileging process including the following: • Prerequisite Education and Training Qualifications • Assessing the Surgeon’s Performance—Quantitative Metrics • Ongoing Monitoring and Surveillance

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Following several hours of discussion each group presented their conclusions. These conclusions were converted into a questions format and submitted for the Delphi process. Three rounds of the Delphi process achieved greater than 80% consensus on 76/91 (83.5%) questions in the survey. A few of the important consensus items include a need for [14]: • A common credentialing pathway for basic robotic surgery skills created across all specialties that use robotic surgery • A separate but common pathway for credentialing of advanced robotic surgery procedures • Documenting cognitive, technical, and non-technical training in specialty specific robotic procedures for which there is intereste in obtaining privileges • A proficiency-based training paradigm with objective metrics • Proficiency obtained as a first assistant before serving as a primary surgeon • Monitoring the surgeon’s initial cases through random audit of operative videos by independent experts and supplemented by chart review as needed. • Specific parameters to be monitored for maintenance of privileges.

11.2.11 Registry Consensus Conference The new era of information science has resulted in immediate availability, analysis and sharing of real-world data (RWD) that is available at the time of the occurrence—at the pace of innovation and change. However, the potential benefit of emerging technologies and innovations are slowed by the continued use of prospective clinical trials, peer-review evaluations, and the submission of research publications, which require rigorous and careful evaluation and prolonged completion time. One solution that has emerged is the development of “registries”—databases which are created in near-real time and which reflect data that are available at the time of occurrence, as opposed to the traditional practice of stored data that are awaiting review and possible publication. Implementing this solution, healthcare professional communities of individual physicians, hospitals, medical governing bodies and societies, industry, and federal agencies can work together using information before it has become obsolete, allowing for real-­ time analysis and decisions that reflect the current status in the process of dynamic change. Due to the rapid innovation and transformation of RAS devices, it was determined that an RWD robotic surgery registry was needed to serve a diverse group of stakeholders including: • Physicians to evaluate their operative performance for self-improvement

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• Educators to develop standardized training programs and certification processes for ongoing education, remediation, and privileging • Hospitals to develop quality measures, effectiveness, and risk assessment for quality improvement • Industry to assess the performance of their devices to promote more rapid iterations toward improved functionality and safety • Government to maintain minimal safety and effectiveness standards and stay informed of new developments that could influence policies • Patients to participate in quality initiatives to continuously improve surgical outcomes In an effort to design, develop, and successfully implement the RWD RAS registry, ISE organized and hosted a Robotic Registry Consensus Conference that brought together 44 robotic surgery experts, registry experts, the FDA, MDEpiNet, society representatives, and industry representatives from eight present and future robotic manufacturers. Through a diligent Delphi process, the participants of the Robotic Registry Consensus Conference developed a consensus-­driven core minimal data set that included the following: • • • • • •

Patient demographics and patient history Procedure information Robotic device and instruments information Information about intraoperative issues/events Postoperative information and claims data Surgeon and OR staff experience/training

Each element of the data set was then analyzed to determine how it would be most efficiently and effectively collected (e.g., electronic health record, OR staff, and robotic information system). A pilot registry is being planned to collect in near real-time device-related and process-related data from the core minimal data set and test the system and assumptions. It will be interoperable with clinical databases and utilizes those data to improve device safety, surgeon/ team performance, and public health. A technology company, Medstreaming/M2S, was selected to develop and manage the registry. It has a long history in developing and launching large registries in partnership with societies in several procedural/surgical areas. At the time of writing this chapter, ISE is in final stages of recruiting institutions that will participate in the pilot registry. In an effort to be inclusive of all stakeholders, ISE has provided updates to the FDA through the Q-Sub process, presented at several national society meetings, and hosted a meeting between the FDA and industry to discuss anticipated uses and benefits of the robotic registry data. Once the pilot is completed and the results analyzed, lessons learned from the pilot will be implemented into a

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Fig. 11.22  Consensus conferences hosted and facilitated by ISE

national robotic-assisted surgery registry that will include all surgical specialties that are performing robotic procedures. ISE is partnering with the Society of Robotic Surgery (SRS) and other surgical societies for the successful implementation and dissemination of the robotic registry. ISE will also work closely with MDEpiNet to ensure there is interoperability with other existing registries in the United States and internationally.

11.3 Closing Remarks ISE’s Full-Cycle Model for Education, Training, Assessment, and Surveillance for RAS procedures is providing a roadmap for areas where consensus is needed and standardization can be achieved. Through ISE’s development and participation in these 11 consensus conferences, significant progress toward standardization has been made. As Martin Luther King, Jr., so eloquently said, “If you can’t fly then run, if you can’t run then walk, if you can’t walk then crawl, but whatever you do you have to keep moving forward.” ISE plans to continue to move forward with these consensus-driven efforts. There is still so much to do. To maximize results, this work must be done in partnership with hundreds of robotic surgical experts from around the world, researchers, surgical societies, government, industry, and with input from patients. Together, we will fly! (Fig. 11.22).

References 1. Satava RM, Stefanidis D, Levy JS, et al. Proving the effectiveness of the fundamentals of robotic surgery (FRS) skills curriculum, Ann Surg. 2019, In Press.

2. Zevin B, Levy JS, Satava RM, Grantcharov TP.  A consensus-­ based framework for design, validation, and implementation of simulation-based training curricula in surgery. J Am Coll Surg. 2012;215:580–6. 3. Gallagher AG.  Metric-based simulation training to proficiency in medical education: what it is and how to do it. Ulster Med J. 2012;81(3):107–13. 4. Gallagher AG, O’Sullivan GC.  Fundamentals of surgical simulation: principles & practice. New York, NY: Springer; 2011. 5. Gallagher AG, Ritter EM, Champion H, et al. Virtual reality simulation for the operating room: proficiency-based training as a paradigm shift in surgical skills training. Ann Surg. 2005;241(2):364–72. 6. Stefanidis D. Optimal acquisition and assessment of proficiency on simulators in surgery. Surg Clin North Am. 2010;90(3):475–89. 7. Aghazadeh MA, Jayaratna IS, Hung AJ, et al. External validation of global evaluative assessment of robotic skills (GEARS). Surg Endosc. 2015 Nov;29(11):3261–6. 8. Institute for Surgical Excellence website. www.surgicalexcellence. org. 9. Smith JR, Del Priore G, Coleman RL, et al. An atlas of gynecologic oncology: investigation and surgery. Baca Raton: CRC Press; 2018. p. 293–300. 10. Collins JW, Levy J, Stefanidis D, et al. Utilising the delphi process to develop a proficiency-based progression train- the-trainer course for robotic surgery training. Eur Urol. 2019;75(5):775–85. 11. Wojcik BM, Fong ZV, Patel MS, et al. Structured operative autonomy: an institutional approach to enhancing surgical resident education without impacting patient outcomes. J Am Coll Surg. 2017;pii: S1072–7515(17):31919–1. 12. LapCo Manual. Editors Mark Coleman and Tom Cecil. CRC Press, Baca Raton, FL, 2017. 13. Stefanidis D, Korndorffer JR, Sweet R, et al. Comprehensive healthcare simulation: surgery and surgical subspecialties. Book chapter: simulation in robotic surgery. Switzerland: Springer International Publishing; 2019. 14. Stefanidis D, Huffman EM, Collins JW et al. Expert Consensus Recommendations for Robotic Surgery Credentialing. Ann Surg 2020. Accepted for publication.

Opportunity Cost Analysis of Robotic Surgery

12

Robert Poston and Safraz Hamid

12.1 Introduction A surgical robot adds costs to surgery that are not seen with conventional laparoscopic or open procedures. The additional costs of a surgical robot are said to “add value” if they create benefits for patients (e.g., improved quality adjusted life years and quicker return to work productivity) that are not seen with the alternatives. The decision whether to initiate, support, and sustain a surgical robotics program requires resources that are always scarce relative to needs. Maximizing the return on these resources is critical to the financial success of any hospital. Rational decisions about scarce resources recognize that commitment of money to one purpose prevents its use in other ways. In a similar manner, a more accurate financial picture of robotics emerges when comparing the results expected with the next best alternative (i.e., open or laparoscopic surgery), a form of financial reasoning known as an opportunity cost analysis [1]. Previous studies evaluating costs of robotic surgery have found surprisingly similar results across many surgical specialties: a robotic approach adds ~$3000 surgical cost per case [2, 3]. This has proven true whether costs are measured based on billing records or in-depth review of the medical records. Only one company, Intuitive Surgical, supplies the robotic technology, and all its revenue comes from system, service, and instrument sales. This company’s financial statements disclose its total revenue and the total number of annual cases performed robotically across all specialties [4]. Comparing these two numbers shows that hospitals pay an additional ~$3000 for every robotics case that is performed, confirming that this estimate of robotic costs is highly reproducible. R. Poston (*) Chairman, Board of Governors, Chief of Cardiothoracic Surgery, Chief of Robotic Surgery, Three Crosses Regional Hospital, Las Cruces, NM, USA e-mail: [email protected] S. Hamid Department of Surgery, SUNY Downstate Medical Center, Brooklyn, NY, USA

There is much less agreement about whether this $3000 cost adds value. Many say the robot yields no proven benefit while some suggest it avoids costs associated with the longer recovery period after open surgery and mitigates other drivers of variable costs by reducing postoperative complications and length of hospital stay. However, few studies have employed an opportunity cost framework to address this question of value in a more comprehensive manner. The purpose of this chapter is to use an opportunity cost analysis to show the value added to the hospital by robotics, specifically a cardiac robotic program. Cardiac robotic surgery differs from open surgery in that access to the heart is gained through small incisions between the ribs (minithoracotomy) rather than the sternum (sternotomy). Given the strength of the evidence from our opportunity cost analysis, it is natural to ask why more cardiac surgical programs have not adopted robotics. Accordingly, we will describe systemic factors and biases that have likely hindered the strong impact that an opportunity cost analysis would be expected to have on cardiac surgery and the wide range of other surgical specialties contemplating a surgical robotics program. Several studies from almost every surgical specialty have documented that less invasive surgical methods reduce costs [5]. The field of cardiac surgery has been one of the slowest to adopt these techniques. Conventional, open chest cardiac surgery is critically important to the viability of a hospital, in part because of its solid track record of financial contributions [6]. Yet there is clearly an opportunity for improvement. The risk of a prolonged length of stay due to a complication is higher than almost any other elective procedure, and the volume of cases performed at most centers has been steadily declining for the last two decades. These issues increase the variable and fixed costs of cardiac surgery, respectively [7, 8]. Robotic cardiac surgery was first introduced two decades ago. Since that time, several expert cardiac surgical centers have proven this procedure to be as safe and effective as open cardiac surgery and associated with quicker recovery and

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less complications [9, 10]. Thus, for hospitals that perform only open cardiac surgery, a viable alternative creates an opportunity cost that is defined by the forgone advantages and disadvantages of the robotics:

12.2 V  alue Forgone by a Program Choosing Not to do Robotics 12.2.1 Robotics Reduces the Risk of Postoperative Complications The typical cardiac surgery program has about 200 coronary artery bypass grafting (CABG) cases/yr. With this volume of cases, a program is likely to have 30 patients per year suffer major postoperative complications. It has been estimated that each of these events increases costs by approximately $50 K/case. Stroke and mediastinitis are the two most costly complications after CABG.  By avoiding aortic manipulation and the sternotomy, the robotic approach is inherently well-­suited to reduce the risks of these events. Evidence demonstrates that the cost reduction is the greatest in those patients that are the highest risk for postoperative complications [11, 12]. Cost calculation: It is reasonable to predict that diverting 100 out of 200 cases/yr to a robotics approach would prevent 10 complications/yr. Each complication adds $50  K in expenses that go unreimbursed given fixed DRG payments. Therefore, this impact from a robotics program yields a savings of $500 K/yr.

12.2.2 Robotics Reduces Never Events (i.e., Mediastinitis) Compared to Sternotomy One of the most obvious advantages of robotic surgery is the ability to avoid sternal infection and its costs that are conservatively estimated at $50  K/case. This complication has recently been designated as a “never event” by Medicare, which means that the costs of mediastinitis are unreimbursed. This creates an important financial risk to open CABG programs, particularly for those with a high proportion of patients with obesity, active smoking, and diabetes, risk factors that increase the risk for sternal infection. By avoiding a sternal incision, robotic CABG mitigates mediastinitis, even for the highest risk cases. Cost calculation: Avoiding the sternotomy for a portion of cardiac surgery cases (100 robotic cases/yr) is expected to prevent two annual cases of mediastinitis per year, particularly since case selection for robotics is based in part on the risk of a sternal infection. At $50  K/case, this advantage would provide the hospital with $100,000/yr.

R. Poston and S. Hamid

12.2.3 Robotics Improves the Quality Rating Leading to a Medicare Bonus Payment Less risk of complications with robotic surgery improves a publicly reported score called the “STS composite quality rating.” This is used by many patients and referring providers to select surgical programs. Medicare uses these same measures to derive its pay-for-performance plan, called the Merit-Based Incentive Payment System [13]. Centers rated as achieving exceptional performance (i.e., “three stars” by STS) are eligible for up to a 13.5% bonus payment [14]. Cost calculation: This bonus is based on Medicare part B reimbursements, which for a cardiac program of 200 cases/ yr is approximately $700 K/yr. If robotics enabled a three-­ star rating, it would yield a bonus to the hospital for exceptional performance of $94,500.

12.2.4 Robotics Uses Bottleneck Resources More Efficiently There is often insufficient OR and ICU space to meet demand, which restricts the throughput of patients into and through a hospital. Cardiac surgery patients require more OR and ICU resources than other surgical patients. Therefore, the routine discharge of robotic cardiac surgery patients two or three days sooner than expected is a particularly valuable advantage. When this happens at hospitals at or near full occupancy, it allows a new patient to be admitted into that open bed who would have otherwise been turned away. Beds saved by robotics are most likely to be filled by patients within the same specialty, which enables new revenue to be captured by the CT service line [15]. Cost calculation: Earlier discharge after a robotic case provides two extra bed-days compared to open cardiac surgery. Given a volume of 100 robotic cases/yr, this yields 200 bed-days. For a hospital at full capacity, each of these extra days provides $10,000/day of incremental reimbursement or $200,000 additional revenue to the hospital per year.

12.2.5 Increased Case Volume An explosive growth of health information has led to a consumer base as well informed as it has ever been. This creates a unique opportunity to market distinctive programs such as robotic surgery directly to consumers. Prior evidence has shown that patients often have unmet information needs about less-invasive surgical options [16, 17] and view a hospital’s marketing efforts in this area as a helpful and legitimate source for information [18, 19]. Cost calculation: Our previous experience with marketing efforts focused on robotic surgery generated 50 additional

12  Opportunity Cost Analysis of Robotic Surgery

cases per year via word of mouth or self-referral. Assuming typical profit margins of $5000 per case, an additional 50 cases that come to the hospital solely for robotic cardiac surgery would yield $250,000.

12.2.6 Improved Hospital Reimbursement Hospital revenues directly relate to how much reimbursement they receive from insurance companies, which is determined the proportion of admitted patients who have private insurance (“payer mix”) and by the complexity of cases that the hospital treats (“case mix index,” CMI). Some payers reimburse cardiac surgery enough to yield profits of nearly $20  K/case (e.g., Blue Cross-Blue Shield). Medicare and Medicaid provide very little profit per case, but increase their payments for all beneficiaries in response to factors that increase the hospital’s CMI.  Cardiac surgery cases have a diagnosis-related group (DRG) relative weight that is six to eight times higher than the typical hospital inpatient. Anything that increases the number of highly weighted cases will drive up both the CMI and Medicare reimbursement to the hospital. The idea of surgical robotics is highly marketable, which means that a new robotics program has the potential to recruit a significant number of patients into the hospital from outside the typical catchment area. This generally results in a patient population with a more favorable payer mix [20, 21]. One year after the introduction of robotic cardiac surgery at Boston Medical Center, it was noted that the ratio of “government” (Medicare/Medicaid) to private payers changed from 2:1 to 1:2 [22]. Quicker return to work of the patient is highly valued by employers, which gives the hospital leverage to negotiate contracts and increase reimbursement for their surgical services. Cost calculation: As a result of a more favorable payer mix and the ability to negotiate better contracts, robotic cases at our center were reimbursed $2000 more than sternotomy CABG. For a program performing 100 robotic cases/yr, this differential is expected to yield a net benefit of $200,000/yr. An additional volume of 100 robotic cardiac cases/yr was noted to increase the hospital’s CMI from 1.31 to 1.55. This increased Medicare reimbursement at our center by $200 for every patient (our hospital has 10,000 admissions per year), which led to a total added revenue of $1 million/yr.

12.2.7 Higher Levels of Patient Satisfaction Less invasive surgery is a distinctive therapy and has an established track record at improving patient satisfaction in a variety of surgical fields, including cardiac surgery. Satisfaction scores are now publicly reported, and this infor-

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mation is being sought after by prospective patients online. It is imperative for hospitals to have an effective plan for maximizing these scores. One option is to develop patient-friendly surgical innovations like robotic surgery, which is less costly than other common proposals such as reducing patient-to-­ nurse ratios or changing semiprivate beds to private [23]. Cost calculation: Initiating a robotic cardiac program may involve added costs, but this is generally reimbursed by insurance at no cost to the hospital. The cost of the other two strategies are unreimbursed and typically cost the hospital $200–500 K/yr. If a robotics program improves satisfaction alone, it can avoid the need to take on these other costs.

12.2.8 Better Performance in “Bundled Payment” for Care The cost of hospitalization to perform surgery has been reimbursed as part of a global payment called a diagnosis-related group (DRG). Other various aspects of surgical care such as professional fees and postacute care are covered a la carte. Medicare has initiated a new program for paying for certain types of surgery that limits these additional hidden costs. Going forward, Medicare (and likely followed by other insurers) will provide a bundled payment that covers all aspects of care for a 90-day period surrounding surgery [24]. This reimbursement model creates a financial risk to the hospital depending on whether the actual costs required for surgery are less than or more than the payment received. Robotic surgery has been shown to reduce the need for postacute care compared to open surgery from 30% to 15% of discharges (15 less cases sent to rehab per year) and therefore can reduce this financial risk [22]. Cost calculation: The costs of inpatient rehab are $10 K/ case and are avoided in 15 patients/yr with robotics. This results in a $150,000 savings. In a bundled payment model, this savings is split with CMS, so $75  K goes to the hospital.

12.3 Value of Avoiding Robotics 12.3.1 A Full Sternotomy Minimizes Perceptions of Poor Safety Depending on the status of the patient, the operative plan for any less invasive surgical case can always suddenly change to an open procedure. This conversion from robotic to open creates a risk for preventable patient harm that would not happen if the case were done open from the start. Deciding when, if and how to employ a so-called bailout maneuver increases the complexity of robotic surgery. However, it does not make it inherently unsafe. A metaphor for its safety is the

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generation of electricity from nuclear power compared to conventional methods. Nuclear energy adds new hazards that are well known since Three Mile Island. However, the vigilance of teams that operate these plants have eliminated any impact on the US public from nuclear hazards in the 40 years since that accident. Cost calculation: A robotic program must strive for the same high performance of nuclear power plants in order to be safe. This requires resources well beyond what is available to the status quo procedure. Staff must be dedicated to robotics with no substitutions and given the necessary time off for regular training and debriefing sessions. In order to focus on robotic cardiac surgery, OR staff will not be available with non-CT surgery cases, and these staff are not easily replaceable. This shift in resources might reduce the overall number of OR cases by one case per day (200/yr) at a hospital with ORs at full capacity. The return on investment is greater for cardiothoracic surgery than most other surgical services ($5000 vs. $2000 K/case), which would mitigate the revenue losses. However, this would increase costs during the first year of the program by around $200 K.

12.3.2 There Is No Learning Curve for Open Surgery All robotic programs must endure an initial long and potentially hazardous initial phase of on-the-job learning where team performance gets worse before it gets better [25]. This phase—not associated with mature procedures like open surgery—is well known to degrade performance as measured by longer OR times, more complications, and other inefficiencies. Cost calculation: Prior analyses of cases performed during the learning curve phase (typically 100 cases) showed $4000 added costs/case compared to cases performed after the learning curve phase [26]. The total added costs of the learning curve: $400 K.

R. Poston and S. Hamid

Cost calculation: These one-time expenses are incurred at the outset of the program and vary depending on the hospital’s available budget. As an example, Boston Medical Center spent $350 K to advertise robotic CABG at the outset of their program [21]. The other start-up costs approach $300 K.

12.4 F  actors Irrelevant to the Opportunity Costs of Robotics 12.4.1 Costs of Poor Team Morale Robotics adds complexity to already challenging procedures like cardiac surgery. When patients suffer complications after robotic surgery, it can lead staff to perceive that added complexity as unsafe and to become demoralized about the program. Problems with morale are often reflected in HR costs such as increasing staff turnover and absenteeism. However, this is often inappropriately attributed to robotics. Any task as complex as cardiac surgery – whether done open or robotically  – is vulnerable to problems with safety and morale. Multiple prior studies have documented that roughly 50% of complications after open cardiac surgery are caused by preventable errors like poor communication and ineffective teamwork [27, 28]. Other industries that routinely navigate high risk and complex tasks such as aviation or nuclear power plants have dramatically reduced teamwork errors by creating a culture known as the high reliability organization. According to a recent publication from the Joint Commission, there are no hospitals in the US that have the fundamental aspects of a high-reliability organization [29]. The link between morale and outcomes exists for either procedure. Because of this, HR costs associated with morale problems is not a relevant opportunity cost of robotics.

12.4.2 Capital Costs of the Robot

Many cost-effectiveness studies consider the capital costs of the robot in their comparisons with open surgery. Amortized 12.3.3 Open Surgery Avoids the Need costs are highly dependent on usage of the robot, which varfor Start-Up Costs ies greatly between institutions and whether robotic costs are spread across multiple surgical specialties. Purchasing a Open surgery is well understood to patients and their refer- robot entails a “sunk cost,” meaning a cost that cannot be ring providers, but robotic surgery is not as well known for recovered once it has been incurred. Such costs are highly many specialties. A study of robotic marketing demonstrated relevant to a decision to purchase the robot based on underthat the strong valance of robotics as an advertising message standing the total cost-benefit of ownership [30]. However, it can lead to new patient referrals [21]. This potential for new is not economically rational to include amortized cost when volume, along with the hospital’s desire to show a return on analyzing the cost-effectiveness of robotic procedures done investment, creates a strong rationale to market robotic pro- after its purchase. This can be compared to the cost of buildgrams, and this costs money. In addition, there are other one-­ ing a hybrid operating room for transcatheter aortic valve time expenses for equipment, labor, supplies, and training replacement (TAVR). The cost of a hybrid OR has not been required to start the program. incorporated into any of the analyses comparing TAVR to

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12  Opportunity Cost Analysis of Robotic Surgery Table 12.1  Opportunity costs of providing only open cardiac surgery and not developing a robotic program Forgone value More complications More “never events”

500 100

Lower MIPS score

94.5

Less efficiency with bottleneck resources Less-favorable payor mix Improved CMI Less volume Lower patient satisfaction Reduced success with bundled payment plans Subtotal Total

200

Costs avoided Increased OR costs $3000/case Costs required to have dedicated staff Inefficiencies of the learning curve Start-up costs

300 200

400 650

200 1000 250 200 75

-2,619,500 $1,069,500

+1,550,000

traditional aortic valve replacement [31, 32]. It is inappropriate to hold robotics to a different standard than for other innovations (Table 12.1).

12.5 Summary of Analysis An opportunity cost analysis of robotic cardiac surgery demonstrates that a program performing 100 cases/yr would likely yield an incremental profit of over $1 million in the first year. The added profit would be expected to increase to $1.5 million/yr thereafter because the expenses associated with a shift in staffing, learning curve, and other startup costs are only incurred during the first year of the program. While our analysis of robotic surgery is relevant to any surgical specialty, the magnitude financial benefit is likely to be less favorable in fields outside of cardiac surgery. The Canadian Agency for Drugs and Technologies in Health performed an economic analysis of robotic-assisted surgery across multiple specialties [33]. Their report estimated cardiac surgery to show the greatest financial benefit from robotics among all specialties, with a net program cost of less than $1 million over 7 years. The financial value in cardiac surgery was attributed primarily to a relatively greater impact on hospital stays and complications versus other specialties.

12.6 R  obotic Costs: Perception Versus Reality Our opportunity cost analysis adds to a growing evidence base in support of the value proposition of robotics, particularly for those specialties with the most morbidity and longest lengths of stay after open surgery (e.g., cardiac and thoracic surgery). However, the majority view remains skeptical about the value of robotics in CT surgery [34, 35]. Misperceptions about the long-term financial value of this program make it more difficult for hospitals to invest fully in the required start-up costs. Without these investments, robotic programs are more likely to struggle with the learning curve and ultimately fail. The judgment if the long-term value of a proposed project justifies the up-front startup costs is an important fiduciary duty. The accuracy of any decision is influenced by two facts: (1) up-front costs are tangible, explicit, and easy to quantify and (2) evidence of long-term value is often intangible and implicit, particularly if value is defined mainly by opportunity costs. Psychological research shows that most decisions are based on information that is explicitly presented and available to decision-makers [36]. This set of circumstances creates a tendency for stakeholders to ignore opportunity costs, which biases decisions against innovations whose value is defined by implicit concepts like opportunity costs. Other biases influence how the finances of a new robotics program is interpreted. The principle of loss aversion motivates people to place a higher priority on avoiding extra costs than to acquire equivalent gains. This creates undue concerns about the added costs of the learning curve. The certainty effect, time discounting, and projection bias make people overvalue outcomes that are certain and available immediately. The learning curve phase has an unpredictable impact on costs and varies widely between surgical programs, which creates uncertainty about financial risk. The need to go through a learning curve phase means that the value of robotics does not become fully evident until sometime in the future. Any benefit that must be deferred into the future— even though it might serve long-term goals—is perceived as less valuable than one produced right away. All these cognitive errors lead surgeons and hospital administrators to perceive the learning curve as overly problematic even as the robotic program contributes to the financial bottom line. Decisions about robotics can also be distorted by emotional factors. Traditional open cardiac surgery is a procedure that has created a strong sense of ownership among its many stakeholders. This promotes an “endowment effect,” or an irrational tendency to overvalue open cardiac surgery and underestimate its opportunity costs. Trying to persuade many

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surgeons about the value of robotics is like trying to convince skeptics about global warming. The root cause of the p­ roblem is not a lack of understanding of the data but a conflict of interest [37]. Progress in medicine does not depend just on the search for truth but also on a social process in which proponents of robotic must convince others of how the evidence should be interpreted. Surgeons whose reputations and even sense of self are tied to the status quo have little incentive to accept these interpretations.

12.7 Conclusions There are many legitimate reasons why a hospital and surgical team may prefer to use only the traditional open techniques for their patients referred for surgery at their program. However, our opportunity cost analysis illustrates that concerns about value should not be one of those reasons. While the costs of robotic surgery are increased at the outset of the program, these costs are quickly compensated for by improvements in postoperative costs and other factors that increase reimbursements relative to open surgery. The learning curve triggers cognitive and emotional biases that lead decision-makers to overemphasize financial hazards and ignore opportunity costs. These biases can cause irrational financial decision-making and serve as another source of financial risk [38]. Knowledge of these biases can reduce the judgmental errors in financial decision-making.

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Political Aspects of Robotic Surgery

13

Robert Poston and Fabrizio Diana

13.1 Introduction Robotic surgery is a high-risk, high-profile innovation that evokes an array of complex social dynamics including controversy and opposition. Sustainable success of these programs inevitably depends not just on great patient outcomes but also on the ability to implement this program within a culture that is highly conservative and often skeptical of new ideas. Political skills—often discounted as merely backstabbing and manipulation—are undervalued in surgeons compared to the obvious importance of technical skill and knowledge. However, politics also includes constructive activities like the ability to negotiate, influence, engage, convince, and persuade others, which are obviously required to skillfully navigate the challenges of a new robotics program. A fundamental political problem for robotic programs is a long and potentially hazardous initial phase of on-the-job team learning [1]. Teams get worse before they get better. This is an agonizing and well-known problem with any innovation. Start-up companies in Silicon Valley call it “Death Valley” because of the high frequency of bankruptcies [2]. Surgeons prefer a more euphemistic term: the “learning curve” [1]. Another phenomenon happens at the same time: expectations about the impact of robotics are overly enthusiastic, or hyped, to a degree that vastly overshoot the reality of the learning curve [3]. The flaws of the program are eventually uncovered and the pendulum swings toward negative expectations. This increases the chances of withdrawal of support from important stakeholders and administrative closure of the program. Teams that survive foster a strong learn-

R. Poston (*) Chairman, Board of Governors, Chief of Cardiothoracic Surgery, Chief of Robotic Surgery, Three Crosses Regional Hospital, Las Cruces, NM, USA e-mail: [email protected] F. Diana Department of Surgery, SUNY Downstate Medical Center, Brooklyn, NY, USA

ing environment and high team morale in order to actively reinvent the procedure. This strengthens confidence from the organization (Fig. 13.1). The premise of this chapter on the politics of robotic surgery is that surgeon-leaders that foresee all the political problems several weeks prior to them happening are likely to improve the chances of success for their robotic program. The ability to predict future swings in expectations about a new program might enable strategies to be employed that mitigate the impact of problems before they result. Since miscommunication has been the rule rather than the exception, we describe the common communication mistakes and propose tactics to correct those mistakes and meet the intense political demands of a robotic surgery program.

13.2 Three Phases of a Robotic Program 13.2.1 Hype Phase The term “hype” signifies a large gap between expectations and reality. This gap makes people first underestimate the problems and later overreact to the struggles of a new robotics trying to get off the ground. In itself, that overreaction serves as the fuel to propel those that oppose the idea of robotic surgery (i.e., the late laggards) to go from passive to active resistance. We all appreciate—at least in theory—that a learning curve is inevitable. Unfortunately, the hype about robotic surgery peaks at the exact time that the learning curve is at its steepest and results are at their worst. The paradoxical overlap of hype and team learning soon leads to the impression of a program that has overpromised and underdelivered, even if it is a failure to deliver against totally unrealistic expectations. This feeling sets people toward becoming active resistors [4]. It is an easier task for an established surgery team to take on a new robotic surgery program than for a team with no history of working together. A new team learning a novel procedure forces two learning curves together simultaneously—one for learning the procedure and one for team

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_13

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142 Fig. 13.1  The correlation of the learning curve phenomenon with the hype cycle over a time frame that typically encompasses 2–3 years. Both processes are known to accompany the introduction of novel technological innovations

R. Poston and F. Diana High

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members to learn how to work together. Teams go through distinct stages of development on their way to gaining expertise. The first, which happens right after everyone on the team is introduced, is known by the Tuckman model as the “forming stage” [5]. In this stage, everyone is overly polite and pleasant and trying to figure out their role. Most are excited to start something new and to be on a new team. However, if they develop concerns about the program, feedback is suppressed, particularly if their viewpoint might be viewed as critical. The forming stage of team development aggravates the hype cycle in three ways. First, it prolongs the learning process. Robotic surgery is not a one-size-fits-all proposition. The details of how best to do these cases must be adapted to the strengths and weaknesses of a specific institution. Adopting robotics requires adapting to it, and no two hospitals do it the same. A systematic process of trial and error are needed to address the myriad of endpoints that initially get worse—longer case times, higher risk for complications, more bleeding, greater costs/case, and problems with team morale. For instance, a case that takes too much operating time would prompt team members to brainstorm on how to make their tasks more efficient and save time on the next case. When a complication happens, new equipment might be purchased or a new protocol developed to avoid repeating the error in the future. These examples show the need for a constant loop between communication and feedback so that the lessons are learned and outcomes improved. This loop is broken in a team in its “forming stage” that is reluctant to provide critical feedback. Without it, learning is delayed, progress with the learning curve stalls, and complications are more common than expected. The overlap of the learning curve and the hype phase makes it inevitable that many of the initial

expectations for the program will be unmet, even for teams that learn fast. Those responsible for the monitoring and oversight of a new robotic program go through their own learning curve. Understanding robotic surgery can be a formidable task, particularly since the outcomes of new robotic programs are far more dynamic over time than the established track record of the mature open operation [6]. Speeding up the learning process of these administrators requires a level of open and honest communication that does not typically occur between groups of people as disparate as those in OR and hospital boardroom. CEOs and other executives often have no clinical background and rarely communicate directly with those on the front lines [7]. Accurate and timely information is needed to avoid succumbing to the hype, make decisions responsive to the needs of program, respond appropriately to dynamic conditions, and correct problems before they escalate. The fact that this information is hard to come by makes it hard to monitor the program in real time and learn from mistakes [8]. The learning curve for achieving effective oversight leads to a second and more important problem caused by the forming stage of team development. Even in those cases where the CEO is good at communication, team members in their forming stage have not yet acquired the ability to cross-­ evaluate each other, and shy away from providing constructive criticism on how to improve performance. This poses a major safety problem. Not all surgeons have the aptitude or capacity to succeed in fields that are technically demanding, complex and risky, such as robotic surgery. Teams working with surgeons unable to meet the challenge often have a good idea after only a few cases. Hospitals use a system based on the team’s feedback about a surgeon’s performance to determine the minimum competency needed to perform

13  Political Aspects of Robotic Surgery

robotic surgeries. In light of that consideration, it is natural to observe a vertical suppression of the team’s input [9]. This is particularly true if the leaders of an institution are enamored with their own hyped expectations about the new strategic investment in robotics. This lack of feedback impedes the identification of surgeons who lack the necessary skills to lead a successful program, bad programs persist longer than they should and patient harm results. The third problem with the forming stage is that it suppresses negative feedback even from those that are most opposed to the idea. It is important to note that robotics, like any innovative idea, creates a spectrum of enthusiasm ranging from “early adopters” to “late laggards.” A robotic surgery program can be an existential threat to surgeons who are competent only in open techniques and are not sold on the value of this new idea (late laggards). It may seem counterintuitive that late laggards would stand by on idle as the hospital develops an overly optimistic picture about a robotics team that is struggling with its learning curve. One might predict that they would be quick to point out the fallacy of their hyped expectations. However, late laggards go through their own early phase in which their input is self-censored. According to the grief model described by Kübler-Ross [10], people grieve in response to a major threat first by denial. Surgeons in denial about the program may oppose the concept of robotics in theory, but their frame of mind makes them unavailable to provide critiques to good programs and support the policing of bad programs. The hype is not helpful but it persists in part because of a natural human bias to believe rather than to question such claims [11]. Overturning an initial assessment that everything is fine requires a critical mass of below expectation events, such as an excessive number of patients with postoperative complications or prolonged OR times. However, these events also occur after traditional surgical cases, so proof is based on ambiguous judgments, and amassed from uncertain, incomplete, and changing evidence. In addition, adverse events trigger unconscious psychological processes in team members such as ego defense, dissonance reductions, self-serving biases, and confuse the judgments even further [12]. Bottom line: a long time can pass before teams or hospital administrators recognize a program that in retrospect was clearly off track.

13.2.2 Trough of Disillusionment Hype never lasts. Eventually the hospital realigns and recalibrates its expectations. This coincides with a team that transitions from its forming stage to a new phase in development known as “storming” [3]. In the storming stage, the reality and weight of completing the task at hand have now hit everyone. The initial feelings of excitement and the need to

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be polite have worn off. Personalities may clash and members disagree over how to complete a task or question group leaders. Simultaneously, late laggards transition in their grief cycle from denial to anger [10]. They exploit the new tendency of the team to overreact to bad outcomes and help promote a continual decline in expectations. The end of this phase is known as the trough of disillusionment, the most common point in which teams give up on robotics. Surgical programs are integral to the success of hospitals. A decline in confidence might initially apply to the robotic program but can expand into a broad-based crisis of confidence in hospital leadership. There are two common ways that the leaders in charge respond to a crisis: the right way and the wrong way [13]. The right way unfolds as the byproduct of high levels of trust. Organizations that deal effectively with complex and hazardous crises on a regular basis, known as high reliability organizations, operate around several key principles. One is that their leaders defer to the person with the most knowledge relevant to the problem that is being confronted [14]. Important decisions are deferred to those with the relevant technical expertise, not just those with the most seniority. High-reliability cultures are less punitive and use errors as opportunities to learn. Surgical teams are more willing to collaborate and communicate when they don’t fear punishment after the crisis is resolved. As a result, administrators are more likely to be given the critical information needed to resolve the crisis in a way that is rational, well informed, and best for the institution. The wrong response is centralized decisions informed by poor collaboration and little communication with those that have the necessary expertise. It reflects what people often do when they are attached to initial expectations and then later confronted with the idea that those expectations were wrong. It can lead to distancing and disgust with robotics, and even anger and resentment for overcommitting to a still immature and functionally limited technology. The best decision-­ makers recognize that this period of over-negativity is as transient as the earlier phase of excessive hype. Weak decisions tend to be based on overestimating the duration of this turmoil. This promotes panic and drives forward quick solutions like denying that there is a problem (ignoring a bad program and allowing it to fester) or overreacting (cutting short a good program). A metaphor of the robotic team that is prone to fail comes from the Buddhist parable of “The Blind Men and an Elephant,” in which several blind men asked to describe were feeling what an elephant was, based on touching only one of its parts for the first time. One felt the ear and described the elephant was a fan. One felt the leg and said the elephant was like a tree trunk. Others said whip (tail), sword (tusk), etc. Disagreements over their perceptions became heated arguments. The story concludes that men tend to claim their truth, no matter how limited and subjective it may be, but it is also

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a partial truth. These blind men are an excellent metaphor for the OR team struggling to adopt robotics. Good surgical outcomes require the right information to be put together at the right time so that good decisions are made when things suddenly shift course. Bad communication causes poor teamwork and failure of situational awareness, which increases the risk of harm to patients and closure of the program.

13.2.3 Establishing a New Normal Some robotic programs persist and reach the final stage of team development, the “norming stage,” as illustrated by reaching a plateau of higher performance. They weathered the trials and tribulations of this program by developing effective strategies for trial and error. The strategy for most teams is a deliberate effort to change how they view error. Their culture shifts away from one that blames and shames individual clinicians purported to be responsible toward a new norm that views error as an opportunity to learn and improve. This shift opens up communication between leaders in the OR, those in the hospital boardroom and those on the front lines so they start understanding what the whole elephant looks like. This final phase is when the true value of robotics becomes a reality. For most, the transition is quicker than one might have originally predicted. However, experience is necessary but not sufficient to reach this stage. Not all teams with experience become expert teams. Some teams enter into a state of arrested development where experience no longer leads to improvement [15]. This is usually because the conditions for learning were not optimal, often due to the following problems: (1) the same exact team members were not present to perform the cases, (2) the frequency of cases was too low for the team members to remember the lessons learned (i.e., there is a steep “forgetting curve”), (3) there is no strategy for deliberate practice to accelerate and amplify learning in its early phase (e.g., no routine and formal “debriefing” sessions, surgeon not provided coaching to improve performance), (4) team members become demoralized and disgruntled about the new procedure, and (5) systems issues that compromise the safety of this program are not identified and addressed rapidly.

13.3 U  sing Politics to Make Robotic Surgery Sustainable 13.3.1 Avoid Hype Hype is created when the focus on a new technology is only on its benefits (e.g., robotics reduces bleeding and infection) while ignoring trade-offs (e.g., risk of adverse events seen

R. Poston and F. Diana

with robotics but not open surgery). It is helpful to provide frequent reminders to the team about adverse events that are unique to robotics and the bailouts that are done in response [16]. During the “time out” prior to skin incision, team members are briefed on what negative outcomes are possible during this case. They are instructed to mentally practice how to manage those possible negative outcomes by imagining how to deploy their strengths. This activity breeds confidence [17]. The team that is confident it can handle the worst-case becomes less anxious about the new program. They start to realize that the worst could happen—the patient is urgently converted to an open procedure—and yet a good outcome is still possible. This illustrates the philosophical power of negative thinking and is the basis for adversity training. On the political front, it mitigates hyped expectations and increases the trust of team members when they are given a more nuanced understanding of pros and cons at the outset.

13.4 Create a High-Performing Team Another way to reduce the gap between hype and reality is to make team learning as fast and effective as possible. The optimal environment for learning happens by promoting better teamwork [18]. High-performing teams are created by recruiting, training, and motivating team members that would thrive on this type of a team. Airlines became a high-­ reliability organization once they started hiring pilots for their leadership ability, not just for technical capabilities. Making these selections of who’s on your team is what Jim Collins, the author of Good to Great, describes as beginning with “who” rather than “what.” If you have the wrong people, it doesn’t matter whether you’ve discover the perfect strategy for your hospital to become an HRO [19]. You “still” won’t succeed. Great vision without great people is irrelevant. A second way is to establish the required prerequisites for a high-performing team. First, team members must be as assertive and responsible for safety as the person in charge. For instance, if a pilot is having a bad day and doesn’t want to go through the safety checklist, the co-pilot and others on the plane are encouraged and even obligated to stop the flight from taking off. Hospitals have no such training. Based on how poorly they have trained clinicians on the use of electronic health records, any advanced type of team training like this is unlikely to be part of any hospital’s core competencies for a long time [20]. So, by default, this training becomes the responsibility of the surgical leader. Briefings and debriefings during a case and weekly team meetings provide the right venue for teaching these lessons. Leaders create high performance and rapid learning by fostering a culture of psychological safety, which is the belief that team members won’t be punished when they make a

13  Political Aspects of Robotic Surgery

mistake. OR team members fail to speak up and share their perspectives when (1) they are in some way punished when they do so, (2) their opinion is not acknowledged or is not met by follow-through, and (3) they feel they don’t have enough expertise or knowledge or the situation is too ambiguous to warrant speaking up [9]. Without feeling safe, the team does not provide its feedback and the process of learning stalls. A politically savvy leader understands that this creates a problem that extends well beyond slow team learning. When team members don’t speak up, they are less committed to the overall goals of the program and unlikely to show strong accountability and collaboration with other team members, particularly during periods of stress [21]. Above all else, a high-performing team is accountable to their results. There are established tactics for leaders to enhance team member accountability [22]. The first is to be very clear on the ground rules for how performance is being evaluated. The ultimate measure is the surgical outcomes that the team produces—patient mortality and major morbidity. It is also helpful to evaluate metrics that mediate those outcomes—like the use of behaviors known to help avoid preventable errors. Introducing a new surgical technique like robotics causes a major change in the team’s routine, which increases the risk of a preventable error. Additional risk factors for error are cognitive overload and emotional tension [23]. Team members should be tasked with developing their own tactics for addressing these issues. Ideas that often work include encouraging the use of copilots in order to alleviate cognitive overload and team briefings and debriefings to improve communication and mitigate interpersonal conflict.

13.4.1 Improve Open and Honest Communication Two-way communication means that surgeons not only speak to their teams but also find ways to get their teams to speak up. There are tools available to promote more effective communication from the staff to the surgeon. Our team uses a preoperative checklist as outlined by the World Health Organization [24], modified to include pertinent topics for the types of cases performed by our team. During this timeout, separate reports are given by the anesthesiologist and perfusionist so that their concerns are addressed. The circulating nurse confirms whether all the topics that are on the list have been appropriately addressed. The use of the checklist provides “permission” for team members to speak up during the timeout but is less practical as a guide for communication after the case is started. We train team members to use other techniques for this purpose. A communication tool called SBAR (situation, background, assessment, recommendations) provides a framework for presenting important information clearly and succinctly. The

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most important aspect of SBAR is for team members to state explicit recommendations for action. This part is often underemphasized, particularly with nurses, but it is the best way to put any interpretations of the patient’s status in the proper context and quickly gauge the urgency of the problem. Every surgical case has critical moments in which patient harm can result unless key information is communicated in an accurate and timely fashion. Critical information in the OR is exchanged using closed loop communication. Accountability is placed on the sender to make sure the message was received. Our mantra is that “if you didn’t hear it repeated back, then you didn’t say it.” We also receive training in conflict resolution in order to assure that important debates about tasks or processes are not derailed by poor interpersonal relationships [25].

13.4.2 Develop a Strategy for Late Laggards The foundation of a team that is performance-driven is clear expectations. Regular performance evaluations are invaluable for identifying and removing team members that are not a good fit. As long as the review and development process are transparent and done on a regular basis, those team members given critical feedback will respect and embrace this tactic, particularly those that are worthy of retaining. A behavior that warrants a poor evaluation is that of a “late laggard”—someone who does not buy-into the new robotic program and tries to sabotage its success. These people spread disruptive criticism rather than helpful feedback. A red flag that identifies the late laggard is when they rarely show up to the team meetings and share their negative opinions face to face with other team members present [26]. If their criticisms contain any value for improving the program, it should be incorporated. This is a potential way to win over the laggard because people don’t oppose their own ideas. More often there is nothing helpful in their criticisms, and these people must be removed from the team permanently. It is important not to mistake someone who is outspoken with critical yet helpful feedback about the team’s progress. Falsely labeling this person as a laggard and saboteur can have a chilling effect on further feedback from the team. A checklist that discriminates between criticism and feedback can be helpful. Negative feedback is nonjudgmental and descriptive rather than accusatory, focuses on results of the behavior rather than the intent, deals with specifics rather than generalities, does not exaggerate and use hyperbole, assumes that the issue can be changed, is not condescending, is designed to inform rather than attack, and less about winning an argument than resolving a problem. Negative feedback should always be encouraged as the fuel that drives rapid learning.

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13.4.3 Mitigate Disillusionment Stakeholders naturally lose their initial overenthusiasm for robotics, but when it happens too rapidly or the pendulum swings too far, it creates a crisis that presses hospital administration into action. An effective response is more likely when the team that performs robotic surgery and the team responsible for oversight of the program enjoys a high degree of trust prior to the onset of the crisis. Trust is built when the lead surgeon is transparent about the outcomes of the program from the beginning and willing to accept feedback from all sources. Trust happens when administrators provide the support needed to create an optimal learning environment. Regular meetings between the surgeon and the CEO starting at the outset of the program help to create realistic expectations, which go a long way toward mitigating the bad decisions that accompany an overreaction. The results of trust are that resolving problems with the program can be delegated to those as close to the source as possible, which is the only place where optimal solutions are developed.

13.4.4 Choose a Hospital That Can Support Innovation Developing a culture that can support innovations like robotics starts at the top. Not all hospitals have CEOs that are up to the task. Extensive evidence proves that the most effective leaders are those that have expert knowledge of their core business  – for hospitals this is medicine and surgery [27]. There are a variety of reasons why this technical expertise is necessary. First, the greater a CEOs expertise, the more credibility he/she will have with medical colleagues. This increases the chance of influencing physicians. They are the lifeblood of hospitals because they control the core business: diagnosis and treatment of patients. Nonclinical administrators may be masters at managerial skill, but this gains them no credibility with physicians. So nonclinical CEOs often give up on physicians and steer their leadership focus onto nurses and other employed staff that respond to command and control. This shift makes a nonexpert CEO a more efficient manager but his/her core business is left without leadership. Second, being an expert means that the CEO shares the same values of those he/she is trying to lead. Those that come from the same “in group” have an increased interpersonal attraction and greater odds that they will be able to influence each other’s decisions [28]. As Steve Covey has argued, the best way to influence someone is to be willing to be influenced by them. A third issue important to a CEO’s job is the need to set standards. At an HRO, these standards are incredibly high—zero preventable harm—which is a feat no hospital has achieved. The mere mention of this as a goal is laughable unless it comes from a technical expert who

R. Poston and F. Diana

knows what it takes. A standard bearer must first be able to bear the standards. Finally, a hospital board that hires a true technical expert sends a strong message. They are making it clear that they are willing to step outside their comfort zone of hiring CEOs that are nonclinical. It shows their own willingness to hire someone that is not like them. This willingness to take a risk and think outside the box would be noticed by physicians. Another issue is to make the financial accounting of innovation more honest. Most financial analysts in health care have been reluctant or unable to consider the dynamic changes associated with costs of the learning curve [29], inherent inefficiencies of training, and the opportunity costs of sticking with the status quo [30]. CFOs at innovative hospitals know that not everything important is on the balance sheet. They understand that investments in the learning curve are worth their weight in gold because they are the driving force behind culture change. The problem is there is no easy way to quantify the impact of culture change. So it becomes the type of expense that is frowned upon for CFOs that only consider the numbers. Steve Jobs once said: “stay hungry, stay foolish.” Those words encompassed his pursuit of perfecting his vision, while remaining dauntless in mixing it with the “foolishness” of thinking outside the box. Innovation in the healthcare settings can benefit from taking some risk in having a competent clinician be a strong executive as well. That is a welcome message to physicians who accept that, in a hospital led by this type of executive, innovation is bound to thrive.

References 1. Bonatti J, Schachner T, Bernecker O, Chevtchik O, Bonaros N, Ott H, et al. Robotic totally endoscopic coronary artery bypass: Program development and learning curve issues. J Thorac Cardiovasc Surg. 2004;127(2):504–10. 2. Auerswald PE, Branscomb LM.  Valleys of death and Darwinian seas: financing the invention to innovation transition in the United States. J Technol Transfer. 28:227-239 2003. 3. Fenn J, Raskino M.  Mastering the hype cycle. Boston: Harvard Business Press; 2008. 4. Saint S, Kowalski CP, Banaszak-Holl J.  How active resisters and organizational constipators affect health care-acquired infection prevention efforts. Jt Comm J Qual Patient Saf. 2009;35(5):239–46. 5. Tuckman BW, Jensen MAC.  Stages of small-group development revisited. Group Org Stud. 1977;2(4):419–27. 6. Barkun JS, Aronson JK, Feldman LS, Maddern GJ, Strasberg SM.  Evaluation and stages of surgical innovations. The Lancet. 2009;374(9695):1089–96. 7. Adelman K.  Promoting employee voice and upward communication in healthcare: the CEO’s influence. J Healthc Manag. 2012;57(2):133–47. 8. Argyris C.  Good communication that blocks learning [Internet]. Harvard Business Review. 1994. Available from: https://hbr. org/1994/07/good-communication-that-blocks-learning

13  Political Aspects of Robotic Surgery 9. Okuyam A. Speaking up for patient safety by hospital-based health care professionals: a literature review. BMC Health Serv Res. 2014;14:61. 10. Kübler-Ross E. On death and dying. New York: Macmillan; 1969. 11. Levine TR.  Truth-Default Theory. J Lang Social Psychol. 2014;33(4):378–92. 12. Sherwood GG.  Self-serving biases in person perception: a reexamination of projection as a mechanism of defense. Psychol Bull. 1981;90(3):445–59. 13. Barton L.  Crisis in organizations: managing and communicating in the heat of chaos. The Bulletin of the Association for Business Communication. Cincinnati: South-Western Publishing Company; 1993. 14. Godlock GC, Miltner RS, Sullivan DT.  Deference to expertise: making care safer. Creat Nurs. 2017;23(1):7–12. 15. Hashimoto DA, Sirimanna P, Gomez ED, Beyer-Berjot L, Ericsson KA, Williams NN, et  al. Deliberate practice enhances quality of laparoscopic surgical performance in a randomized controlled trial: from arrested development to expert performance. Surg Endosc. 2015;29(11):3154–62. 16. Moscoso Ludueña M, Rastan AJ.  Complications and conversions in minimally invasive aortic valve surgery. Ann Cardiothorac Surg. 2015;4(1):94–948. 17. Deborah J, Mitchell J, Russo E, Pennington N. Back to the future: temporal perspective in the explanation of events. J Behav Decis Mak. 1989;2:25–38. 18. Cozens J.  Cultures for improving patient safety through learning: the role of teamwork. Qual Health Care. 2001;10(Suppl II):ii26–31. Available from: http://www.pubmedcentral.nih.gov/ articlerender.fcgi?artid=1765756&tool=pmcentrez&rendertype= abstract 19. Collins J, Zaenuddin Hudi Prasojo R Good to great: why some companies make the leap…and some others don’t. Al-Albab. 2012;1(1).

147 20. Monica K.  Poor staff training contributed to trying cerner implementation [Internet]. EHR Intelligence. 2018. Available from: https://ehrintelligence.com/news/ poor-staff-training-contributed-to-trying-cerner-implementation. 21. Sargeant J, Loney E, Murphy G. Effective interprofessional teams: “Contact is not enough” to build a team. J Contin Educ Health Prof. 2008;28(4):228–34. 22. Leach LS, Myrtle RC, Weaver FA. Surgical teams: r3ole perspectives and role dynamics in the operating room. Health Serv Manage Res. 2011;24(2):81–90. 23. Leape LL, Brennan TA, Laird NM, et  al. The nature of adverse events in hospitalized patients. Results of the Harvard Medical Practice Study II. N Engl J Med. 1991;324(6):377–84. 24. Fourcade A, Blache JL, Grenier C, Bourgain JL, Minvielle E.  Barriers to staff adoption of a surgical safety checklist. BMJ Qual Saf. 2012;21(3):191–7. 25. Baldwin DC Jr, Daugherty SR. Interprofessional conflict and medical errors: results of a national multi-specialty survey of hospital residents in the US. J Interprof Care. 2008;22(6):573–86. 26. Saint S, Kowalski CP, Banaszak-Holl J, et al. How active resisters and organizational constipators affect health care-acquired infection prevention efforts. Jt Comm J Qual Patient Saf. 2009;35(5):239–46. 27. Goodall AH, Pogrebna G. Expert leaders in a fast-moving environment. Leadersh Q. 2015;26(2):123–42. 28. Civey Robinson J.  Similarity/Attraction Theory [Internet]. Encyclopedia.com. 2019. Available from: https://www.encyclopedia.com/social-sciences/applied-and-social-sciences-magazines/ similarityattraction-theory 29. Steinberg PL, Merguerian PA, Bihrle W, Seigne JD. The cost of learning robotic-assisted prostatectomy. Urology. 2008;72(5):1068–72. 30. Kurian D, Gorcos J, Meinke S, Thirumavalavan N, Mizrahi I, Kiani S, et al. Change management and an innovative approach to heart bypass surgery. Physician Exec. 2011;37(6):30–7.

Achieving Financial Optimization of a da Vinci Robotic Program While Achieving Best Clinical Outcomes

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Josh Feldstein and Herb Coussons

14.1 Introduction Today, there is a steady and highly desirable migration from open to minimally invasive surgery (MIS) worldwide [1]. Yet, the number of annual global MIS cases, estimated at 20 million, represents only a small percentage of the total 100 million surgeries performed globally each year [2, 3]. Within the subset of MIS cases lies da Vinci-based robotics, with its comparatively small—but steadily increasing—robotic case volume, estimated at approximately one million surgeries annually, performed at an estimated 3000 US and 2000 European/Asian da Vinci robotic programs worldwide [4]. Even though growth in robotic surgery demands the attention of administrative and clinical leadership, robotic surgery still plays a relatively minor role in the overall surgical program compared to other surgical service lines. However, when the annual case volume of surgical service lines such as orthopedics, neuro/spine, cardiac, and trauma is added to the da Vinci case volume, the total number of robotic cases becomes considerably more significant. The overall global minimally invasive surgery market is forecast to be worth $36.5B USD in 2018, and it is forecast to grow to $58B USD in 5 years [5]. Robotic programs are thus expected to continue their steady growth over the coming decade and beyond. Real-world experience suggests that this expansion is rooted in factors ranging from improved clinical experience for patients and surgeons to fiscal factors, aggressive vendor marketing, surgeon preference, and hospital-to-­ hospital competition in order to attract patients and to recruit new and established robotic surgeons and personnel. Moreover, hospital administrators and surgical leadership face an increasing number of robotic vendors and technologies, creating considerable pressure to launch new—or expand existing—robotic programs across an ever-growing

J. Feldstein (*) · H. Coussons CAVA Robotics International, LLC, Amherst, MA, USA e-mail: [email protected]

array of surgical service lines and case types. Additional challenges faced by hospitals include the onus of rigorous documentation requirements for evaluating surgeon skills, outcomes, and ongoing performance. This collectively necessitates more comprehensive approaches to robotic program governance, expansion in supply/reposable management, improved approaches to surgeon and crew training, the need for ever more powerful data management and superior analytics, and more.

14.2 Creating a Robotic Program One common oversight of many new and even existing robotic programs is the belief that having robotic surgeons and one or more robots means that the hospital has a robotic program. A robotic program, to be sure, requires surgeons and technology, but that does not qualify as a program. To achieve desired programmatic outcomes, the seamless integration of robotic stakeholders—governed by a unified body of planning, objectives, policies, and procedures—is needed to achieve the goal (Fig. 14.1). Administration, surgeons, and technology, working together, must incorporate operational goals, strategic planning, tactics, clearly defined stakeholder roles and responsibilities, comprehensive approaches to surgeon and crew training, performance benchmarking, team communication, accountability, and continuous improvement processes. These initiatives must be aimed at driving the value of robotics and new robotic technologies. The bottom line is that improved quality together with lower costs contributes value to the healthcare system. All stakeholders must align on these goals, identify the available metrics and data necessary to corroborate improved performance, and work as a team to achieve these improvements and best practice standards. In the absence of strong provider-administration alignment—or faced with poor surgeon performance metrics, or lack of governance policies, or weak data management and

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Fig. 14.1 Robotic stakeholder integration and interreliance

analytics—significant programmatic dysfunction likely results. Patients will suffer from increased risk and lower quality clinical outcomes, and the hospital will suffer from increased cost and lower margins. Given that robotics is a “team sport,” the optimal contribution of all stakeholders across multiple categories of activities is essential.

14.3 F  rom Program Launch to Best Practice: The Path to Maturity In the early phase of a new robotic program, most hospitals depend on their robotic technology vendor(s) for basic training and “quick start” program support. Once the program advances to even modest annual case volumes, however, a wide range of critical management issues typically emerge, thus begging the question how does a hospital or integrated delivery network (IDN) optimize its massive, and usually ever-expanding, investment in robotic technologies? At this point, the vendor–client relationship typically becomes less helpful programmatically. To be clear, the management of a robotic program to a level of best practice requires knowledge that goes considerably beyond what the robotic technology vendor provides, and beyond what most hospital administrators and clinicians acquire during their hard-fought robotic program on-the-job training experience. Vendor-sponsored “solutions” to program management often leave customers questioning their recommendations and materials, given the obvious commercial motives of industry to sell more technology and supplies to end users.

14.4 Appropriate Robotic Patient Selection Not all MIS cases should be performed robotically for a variety of reasons; appropriate robotic patient selection is therefore very important. A more comprehensive surgical strategy should be implemented to derive maximum value from

robotics for the hospital/IDN and its patients. The fact is, understanding comprehensive robotic performance metrics beyond merely the cost of capital equipment and ongoing robotic supply acquisition is outside the scope of the vendor relationship. This is why such things as surgeon credentialing, privileging, clinical outcomes data management, staffing decisions, nonrobotic supply utilization, payer issues, case scheduling, robot access strategies, and policies—and many other “local decisions”—should not be influenced by vendors who are motivated by sales and increasing case volumes. Another important component of every robotic program is surgeon training. Hospitals with adequate clinical and financial data on historical open and laparoscopic cases are better positioned to make wise choices regarding how best to train their robotic surgeons. The long-range goal is always to achieve improved comparative value in robotics vs open and laparoscopic cases. Adequate case volume to support the learning curve is a key component of surgeon selection: low volume robotic surgeons may never progress through the learning curve itself [6].

14.5 Cases Complexity Designations Another framework to help assure appropriate case selection lies in the use of classifying robotic case complexity. For example, some robotic programs classify cases as either low complexity (simple or basic cases) as opposed to complex (or advanced) cases. In general, surgeons should use simpler procedures for approximately the first 20 robotic cases until comfort with the robotic controls is second nature and attention can be focused on the steps of more complex cases rather than the robotic controls. Best practice programs also recognize that low margin cases are better for training than high margin cases. This is because, from a financial perspective, longer operating room (OR) times, typical during the learning curve, are more acceptable in cases with lower prof-

14  Achieving Financial Optimization of a da Vinci Robotic Program While Achieving Best Clinical Outcomes

itability. Said another way, longer case times may have an unacceptable, negative impact on higher margin cases, thus impacting the profitability of surgery as a whole in the hospital. Often, it becomes clear that some surgeons and some cases are not appropriate robotic cases; in these situations, surgery should continue to be done laparoscopically [7]. At the end of the day, achieving strong fiscal and clinical return on investment remains a key—yet often illusive— objective for many administrative and clinical leaders, commonly faced with running their robotic program through trial and error, peer-to-peer exchange with colleagues, findings provided in peer review literature, and limited vendor-based intel—for better and for worse.

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robotic case times and increased cost with similar outcomes to laparoscopy at best). As scores of early papers studying robotics emerged in the peer review literature during this era, clinical and financial outcomes largely centered around urologic- and gynecologic- specific robotic surgery that reinforced the perception of robotics costing too much and taking too long vs. laparoscopy. Soon, this perception became reality for many surgeons and administrators as they too generated similar results at their institutions due to lack of understanding that robotic surgery is not a modification of laparoscopy, but rather is a paradigm shift in the way surgery is performed. With the notable exception of prostate surgery, this viewpoint is still common today. However, during this phase of robotic development, some insightful surgeons also began to observe an emerging trend. As 14.6 Stumbling Blocks: Defining a surgeon’s annual robotic case volume increased, the efficiency of his or her cases increased (i.e., shorter case times) together the Problems with reduction in costs (associated with less consumption of da Robotic surgery entered the market in the era of big data Vinci and non–da Vinci supplies). In the hands of increasingly development [8]. Heading into the 2020s, electronic medical experienced robotic surgeons, with an eye to appropriate case records (EMR), cost accounting, and supply data are cap- selection, certain performance metrics (i.e., reduced length of tured to a degree unknown 30 years ago during the launch of stay (LOS) and readmissions vs. laparoscopy) for certain robotic laparoscopy. This significantly more-focused orientation case types began to equal or even overtake equivalent laparotoward data, which coincided with the advent of value-based scopic cases, notably in hysterectomy and other benign Gyn healthcare, helped drive the desire to assess to what degree case types. Robotic patient satisfaction scores were also higher robotic surgery was equivalent to, if not better than, open and in many areas, centered around reduced pain and qualitative faclaparoscopic surgery both financially and clinically [9]. tors like perceived faster return to work [10]. Additional clinical The initial comparison of robotic surgery to laparoscopy evidence developed supporting improvements in blood loss, was also driven by the regulatory approval process followed transfusion risk, infection rates, wound complications, readmisby the FDA and Intuitive Surgical. The benchmark for safety sions, reoperations, and case-specific outcomes improvements. and equivalency was laparoscopy. Robotics was not treated Studies were also published that attempted to quantify the like a new technology, but rather as a comparative technol- robotic surgery learning curve as well as case volumes necesogy to laparoscopy. As a result, clinical efficacy data were sary to attain proficiency [11]. lacking at launch; it would be at least a decade before case-­ As time went on, some leading robotic surgeons began to specific efficacy data were published in the literature. advance the notion that, to achieve more cost-effective This focus on comparing robotics to laparoscopy served robotic surgery, it was very important for surgeons to underto introduce several confounding variables into the early stand that robotic surgery should be thought of as more clinical and financial results. No new procedure codes were closely aligned with open surgery in its use of supplies rather introduced, meaning that robotic case reimbursement was than being a duplicative surgical approach mirroring laparosand remains nearly equivalent to laparoscopy despite some copy, except with an extra layer of expensive robotic techearly hospital billing practices that attempted to upcharge for nology added on top of it. Expensive single-use disposable robotic surgery. Clinical outcomes and costs associated with devices to mitigate the shortcomings of laparoscopy were no robotic surgery were also reported in the literature early on longer needed for robotic surgery. Improved suturing capaas uptake of robotics was developing and at a time when sur- bility and reposable energy devices could replace these geon learning curves had a powerful impact on operative single-­use devices. This key insight helped to shift the cost times, supply utilization, clinical outcomes, and costs. Yet equation in robotics toward not only equality with lap in a during the first decade of robotic surgery adoption, the learn- large number of Gyn and general surgery cases, but even ing curve was almost ignored in the comparative studies. As superiority in some procedures [12]. a result, the fiscal and clinical findings pertaining to robotic While robotic programs struggled to untangle the guiding surgery in the early 2000s were not compelling, but also not principles, policies, and procedures necessary to codify and dissimilar to that of laparoscopy in the late 1980s. scale these early insights into a systematic approach to runBy 2008, the quality and efficiency of robotic surgery was ning a robotic program, the burgeoning demand for robotic viewed as inferior to laparoscopic surgery (i.e., longer technologies pushed program management into the

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b­ ackground. There was no robotic program play book to rely upon as patient demand, market demand, aggressive vendor marketing, and surgeon preference ruled the day. Adding more complexity to this dynamic were the challenges faced when IDNs sought to integrate disparate robotic programs from among multiple hospitals within a single system (each facility often with a different program scope and performance level, sometimes using differing EMR or accounting software) into a unified program and governance body. The net result was a blank check mentality on the part of hospital administration who felt compelled to support robotic programs and robotic surgery despite a lack of coherence regarding program governance, and in many cases, demonstrated clinical or fiscal value.

14.7 Data as the Critical Denominator Looking for a common denominator to address this operational challenge, data were, and remain, the key. Data must be recorded on case times, costs (both da Vinci- and non–da Vinci-related), clinical performance, and select quality parameters (such as estimated blood loss, length of stay, and complications), though those endpoints remain infrequently captured. For most institutions, the question was whether the needed data were available. If it was, was it accurate? How should it be analyzed? What fiscal and operational performance benchmarks could be used? How could a surgeon, let alone a nonclinical administrator, make sense of such comparative data on cost, or case time, or clinical quality? In the early going of robotic surgery, there were few reliable answers to these questions. Fifteen years later, although many more answers are available, many institutions continue to struggle through these issues [13]. Although they operate in a robust data Fig. 14.2 Program excellence

environment, it is one typically maladapted to the strategic needs of institutional leadership, that is, the desired data exist to some extent, but without a structured approach to integration, normalization, and analysis.

14.8 D  ata Management Must Include Powerful Analytics Data accuracy is critical for a robotic program to achieve optimal financial and clinical performance. However, facilities must also include the analytics that derive from the normalized, audited data. Whether this capability is achieved through a custom-designed software application or through a consultant/third-party vendor, robotic program leadership must have access to essential data analytics in order to achieve lower costs, financial performance improvement, and superior program efficiency/clinical quality. The goal is reliable, fully transparent performance reporting, aligned with best practice robotic benchmarks, to drive improvement in cost, profitability, case time, throughput efficiencies, supply and reposable utilization, case selection, comparison of surgeon performance metrics, complications, readmissions, reoperations, patient satisfaction, and many other quality and operational metrics (Fig. 14.2). One example of an analytic platform that facilitates robotic program optimization is summarized, in part, below. Called CAVAlytics™ (CAVA Robotics International, LLC), this software application and real-world surgical performance database ingests and translates hospital EMR, cost accounting, and supply data into actionable information for hospital leadership. The software sits on a large surgical database of open, laparoscopic, and robotic cases that enables the data of a given hospital/IDN to be sorted, filtered, and compared in a meaningful way to assess per-

PATHWAY TO ROBOTIC PROGRAM EXCELLENCE

PHASE I: DATA AND ANALYTICS

PHASE II: PROGRAMMATIC CHANGE MANAGEMENT

PHASE III: OPERATIONAL IMPROVEMENT

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Fig. 14.3  Example of a Robotic Program Data Analytic Platform. © 2019 CAVA Robotics International, LLC. (Reprinted with permission)

formance and to drive change. Ingested data include audited clinical, cost, and supply records. The platform filters data for date ranges, individual surgical procedures, and any specific robotic surgery case type or surgeon in the database. Time study metrics are included examining robotic team performance such as patient in room to incision time, incision close to patient out of room to recovery in the post-anesthesia care unit (PACU), and many others. All time stamps captured by the EMR or other facility software can be analyzed or filtered by location, case type, surgeon, or any other custom-designed metrics. These filters carry forward throughout the analyses of supplies to enable screening for high-cost items, comparing individual surgeons’ supply variation and average usage on any given month or day. Monthly reports are provided for committee meetings, providing transparent illustration of comparative surgeon-by-surgeon benchmarking, including cost, supplies, case time, and select quality metrics (Fig. 14.3).

14.9 P  rogram Optimization: Other Key Factors Once the full complement of data management and analytics are in place, a central and significant component of the program’s infrastructure has been realized. But excellent data management and analytics by itself does not produce robotic program optimization. Other key factors include the following:

• Engaged clinical personnel • Clearly defined vision/objectives for the program • Strong clinical and administrative leadership with excellent alignment • Program infrastructure: committee/governance structure and policies • A well-trained, experienced robotic coordinator • A surgeon training program and policies, including simulation • Clear surgeon credentialing and privileging pathways • An OR crew training program • Credentialing and privileging policies and procedures • A high-quality business plan and pro forma focusing on healthy growth • Stakeholder accountability • A robotic culture of performance transparency • A clearly defined technology footprint and contracting • Superior scheduling policies and procedures • Technology management and troubleshooting • A vendor management policy As noted earlier, robotics is truly a team sport when performed at the highest level. Taken as a whole, the key dimensions of functionality in the list above integrate into a well-run robotic steering committee, driven by an experienced robotic coordinator and supported by an engaged robotic chair, a surgeon steering committee, and administration, all of whom cross reference each other in a path to best practice performance optimization.

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14.10 The Stages of Program Maturity Moreover, there is a continuum of maturity that a robotic program moves through, encompassing close to two dozen distinct categories or dimensions of activity. Each one of these dimensions effectively stages the status of the robotic program, charting not only its progress but illuminating what work remains going forward to achieve the desired best practice performance objectives. Examining the stages of maturity for each element of program performance, there are four distinct stages: Ad Hoc, Reactive, Good, and Best Practice (Table 14.1). Most robotic programs begin, as noted earlier, in a state of weak overall management. Many of the key dimensions of

J. Feldstein and H. Coussons

program optimization are unknown or approached in a makeshift manner. This stage of program management is categorized as “Ad Hoc.” As a program advances, it becomes clearer that there are indeed many different elements at play in the operation of the robotic enterprise, yet a largely passive approach continues, with stakeholders typically reacting to issues on an ongoing basis. Appropriately, this stage of management is categorized as “Reactive.” Both the Ad Hoc and Reactive stages of robotic program management leave a program experiencing highly significant programmatic variability in terms of supply and reposable use, surgeon ­performance/training, operational efficiency, and patient satisfaction, and almost always results in higher

Table 14.1  Robotic program maturity

ROBOTIC PROGRAM MATURITY CAVA Robotics Program Category

Ad hoc

1. Program Vision and Strategy 2. Administrative Leadership 3. Surgeon Selection, Credentialing, and Privileging 4. Surgeon Training, Mentoring, and Learning Curve 5. Surgeon Quality Metrics 6. Crew and RN Training and Performance Standards 7. Program Governance, Policies, and Procedures 8. Clinical and Med Exec Leadership Integration 9. Data Collection, Integrity, and IT Management 10. Data Analytics and Reporting 11. Stakeholder Accountability 12. Reposible and Supply Management 13. Optimizing Patient Outcomes 14. CAVA Best Practice Program Design 15. Cost-Effectiveness 16. Financial Performance and Cost Accounting 17. Vendor Management, Data Sources, and Tools 18. Technology Footprint and Agnostic Planning 19. Centralized Communications 20. Med Mal / Risk Management 21. MIS and Robotics: Planning for the Future

© 2019 CAVA Robotics International, LLC. Reprinted with permission.

Reactive

Good

Best Practice

14  Achieving Financial Optimization of a da Vinci Robotic Program While Achieving Best Clinical Outcomes

costs and weak overall financial performance together with suboptimal quality. The next stage in robotic program maturity is categorized as “Good.” A simple term, but with important performance implications, the Good stage reflects a robotic enterprise that has a proactive, strategic, and planful approach to each clearly defined area of its program. It has crafted a defined vision. Administrative leadership is engaged and aligned with the mission and performance targets of its surgeons. Surgeon credentialing, training, and policies are drafted and integrated into Med Exec functions and oversight. The program operates on the basis of sound data management and analytics. Governance of the robotic committee and the performance of all stakeholders are coordinated in an environment of accountability and transparency. The program is profitable and patients are consistently pleased with their robotic surgical experience. Next, the most advanced stage on the robotic program maturity map is “Best Practice,” achieved when a Good program achieves top tenth percentile performance or better in each quantifiable clinical and financial category, and it is concurrently in alignment with best practice policies and procedures in all other operational and qualitative categories.

14.11 Management of the Surgeon Learning Curve Every robotic program faces the challenge of providing training and clinical support to its surgeons regarding ongoing performance quality. This challenge is most pronounced

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during the learning curve for all new robotic surgeons. During this phase, the robotic surgeon’s focus is on skill acquisition and gaining clinical and technical experience, with case efficiency and cost-consciousness set aside. The objective for all stakeholders is to move the surgeon through the learning curve phase as safely, quickly, and correctly as possible. The faster and better this occurs, the shorter the period of risk to the patient as well as to the bottom line of the robotic program. Management of the surgeon learning curve presents a steep incline for the vast majority of robotic programs, and quite often, it results in a scenario where, unbeknownst to administration, a large percentage of a hospital’s robotic surgeons remain in the learning curve for an unacceptably long, costly period of time. Some surgeons, in fact, never progress through it, despite the fact that they may be into their 50th robotic case or beyond. Ongoing monitoring of case volume, operative times, cost, and a few basic clinical metrics can help identify surgeons who are lagging in development. Figure 14.4 illustrates an actual IDN’s scattergram of weighted composite quality metrics (case time and case costs) associated with a distribution of its robotic surgeon. Here, more than 50% of the surgeons failed to meet the minimum overall quality performance level target, defined by the dotted red trend line. If a robotic surgeon is represented below the learning curve, that surgeon exposes the patient and the hospital to increased clinical risks and costs the hospital more due to increased supply and reposable consumption together with the costs associated with increased OR time. Moreover, and sometimes far more significantly, the total cost of care goes up, due to increases in reoperations

Composite score and Learning Curve Composite score by Volume 12

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Fig. 14.5  Transition of surgeon quality scoring pre–post intervention

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and readmissions. The robotic surgeon learning curve also has an impact on patients in terms of realizing (or failing to realize) all the potential clinical benefits that MIS offers. The bottom line is that the value of robotics goes down when costs go up and quality goes down. What steps can be taken to address this weakness in the path to program optimization? Often, it is very difficult for a program to extract and assess the kind of insight they need to assess learning curve issues. They may have limited data access, or they may have a wide variation in software and systems within their IDN making head-to-head surgeon performance comparisons difficult to track in a meaningful way. Creating a weighted scoring system can help manage this issue under these circumstances. For example, what is plotted in Fig. 14.5 is a distribution of weighted surgeon quality performance scores before a quality improvement intervention; the same surgeons are then plotted post quality improvement. Interventions included video case capture reviewed by senior mentor robotic surgeons; specific live OR training with surgeons and crew when needed; and a curriculum of simulation and training. Transparent reporting of all clinical and financial performance data often results in surgeon improvement because peer-to-peer monitoring and reporting drives competitive surgeons to strive toward personal improvement. The scattergram pre-intervention has a red trend line that mimics the majority of other robotic learning curves seen in the published literature [14–16]. Below, the red trend line is surgeon performance/quality metrics that need to improve to above the red tend line, even if it means dropping case volume for a short period of time. The goal was for the hospital to have as many of its surgeons

tightly parked in the upper left corner, above the red trend line, postintervention, which it accomplished.

14.12 S  tandardized Cost Accounting Methods Another key to driving a robotic program to financial and clinical optimization and best practice performance is being certain that robotic cost accounting methodologies are consistent and applied in an equivalent manner to those of laparoscopic technology. Capital and service costs are often included for the robot and are distributed across the case volume equally, whereas capital costs associated with laparoscopy are usually never applied in this way to the laparoscopic cases. Complicating such an assessment is the lack of standardized cost accounting methodologies among hospitals. Robotic capital costs are frequently amortized across all robotic cases. Yet when capital costing data are pulled for traditional laparoscopy, orthopedics, and other procedure-­based service lines, facilities frequently follow different cost accounting methodologies. Comparing the actual direct and total costs of a da Vinci robot vs. other surgical technologies is therefore challenging. For example, some hospitals place robotic surgery in the highest cost tier and add a per-minute surcharge to the case for specific portions of the case to cover the high instrument cost. Some capitalize the cost of the instruments. Some track the use of each instrument in order to capture the actual cost per use. Only when compared c­orrectly to lap and other service lines is it possible to achieve an equitable comparative cost assessment with robotics.

14  Achieving Financial Optimization of a da Vinci Robotic Program While Achieving Best Clinical Outcomes

14.13 S  ummary: The Key Steps to Robotic Program Optimization Achieving financial optimization of a da Vinci robotic program while achieving best clinical outcomes is a team process requiring multiple concurrent, proactive, data-driven steps by clinical and administrative stakeholders working together closely, guided by a clear programmatic vision, policies, procedures, accountability, and performance transparency. The vision and goals should always focus on improved value directly related to improved clinical quality at a lower cost. Alignment with the guidelines outlined in this chapter helps a program advance from the earlier stages of a program’s life cycle to that of a mature, well-structured, strategically sound enterprise that enjoys profitability, efficiency, and, above all, high-quality healthcare delivery to patients seeking the significant benefits of minimally invasive surgery in general and robotic surgery in particular.

References 1. Tsui C, Klein R, Garabrant M. Minimally invasive surgery: national trends in adoption and future directions for hospital strategy. Surg Endosc. 2013;27:2253. 2. Weiser TG, Regenbogen SE, Thompson KD, et al. An estimation of the global volume of surgery: modelling strategy based on available data. Lancet. 2008;372(9633):139–44. 3. Weiser TG, Haynes A, Molina G, et  al. Size and distribution of the global volume of surgery in 2012. Bull World Health Organ. 2016;94(3):201–209F. 4. Intuitive Surgical Annual Report. 2018. p 45.

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5. Minimally invasive surgery market: global industry trends, share, size, growth, opportunity and forecast 2019–2024. Research and Markets. 6. Woelk JL, Casiano ER, Weaver AL, et  al. The learning curve in hysterectomy. Obstet Gynecol. 2013;121(1):87–95. 7. Heemskerk J, van Gemert WG, de Vries J, et al. Learning curves of robot-assisted laparoscopic surgery compared with conventional laparoscopic surgery: an experimental study evaluating skill acquisition of robot-assisted laparoscopic tasks compared with conventional laparoscopic tasks in inexperienced users. Surg Laparosc Endosc Percutan Tech. 2007;17(3):171–4. 8. Islam MS, Hasan MM, Wang X, et  al. A systematic review on healthcare analytics: application and theoretical perspective of data mining. Healthcare (Basel). 2018;6(2):54. 9. Feldstein J, Schwander B, Roberts M, Coussons H. Cost of ownership assessment for a da Vinci robot based on US real-world data. Int J Med Robot. 2019;15(5):e2023. https://doi.org/10.1002/ rcs.2023. 10. Giri S, Sarkar DK. Current status of robotic surgery. Indian J Surg. 2012;74(3):242–7. 11. Schreuder HWR, Wolswijk R, Zweemer RP. Training and learning robotic surgery, time for a more structured approach: a systematic review. BJOG. 2012;119:137–49. 12. Feldstein J, Coussons H. Achieving robotic program best practice performance and cost versus laparoscopy: Two case studies define a framework for optimization. Int J Med Robot. 2020;1–8. https:// doi.org/10.1002/rcs.2098. 13. Mehr S, Zimmerman M.  Robotic-assisted surgery: a question of value. Am J Manag Care. 2014. 14. Hopper AN, Jamison MH, Lewis WG. Learning curves in surgical practice. Postgrad Med J. 2007;83(986):777–9. 15. Maruthappu M, Duclos A, Lipsitz SR, et  al. Surgical learning curves and operative efficiency: a cross-specialty observational study. BMJ Open. 2015;5:3. 16. Mazzon G, Sridhar A, Busuttil G, et  al. Learning curves for robotic surgery: a review of the recent literature. Curr Urol Rep. 2017;18:89.

The Senhance® Surgical System

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Mohan Nathan

15.1 O  verview of the Senhance Surgical System The Senhance Surgical System (TransEnterix, Morrisville, NC, USA) is a multiport robotic surgical system for use in abdominal laparoscopic surgery. The system consists of multiple (three or four) operative arms (referred to as manipulator arm) and a surgeon console. The system features reusable instruments that attach to each manipulator arm. The surgeon sits at the console and uses laparoscopic master controllers to maneuver the instruments. The laparoscope may be controlled via a novel eyetracking system which follows the surgeon’s gaze to pan and zoom with either 2D or 3D imaging systems. Additionally, the Senhance is a unique digital surgery system which offers haptic force feedback to the surgeon seated at the console (Fig. 15.1).

15.2 History of Senhance Surgical System

with a disposable drape. The arms offer a significant range of motion in the horizontal and vertical axis in order to maximize the range of motion and space allowed between each arm. The arms themselves do not require an attachment to a specialized trocar but rather may use any conventional laparoscopic trocar access system that is appropriate for the diameter of instruments used. The system features a novel technology that leverages haptic sensation for the identification of the fulcrum point which provides the remote center of motion around which each instrument or the laparoscope pivots. This is done once an instrument has been safely introduced into the trocar by pressing a button at the patient side on the manipulator arm. Once done, the system saves this fulcrum point. If the system identifies an increase in forces at the fulcrum point beyond a certain threshold, the surgeon is alerted. This technology allows the system to avoid connecting directly to the patient and may offer the ability to monitor and minimize any excessive port site forces (Fig. 15.2).

The Senhance was first described in the literature in 2012 as a novel telesurgery system with haptic feedback [1]. The system was, at that time, referred to by the name Telelap ALF-­X. The technology was developed with support from the Joint Research Centre (JRC) of the European Commission in collaboration with SOFAR S.p.A. in Milan, Italy. The technology was acquired and further developed by TransEnterix Inc. in 2015.

15.3 System Components and Architecture 15.3.1 Manipulator Arms The Senhance features three or four independent manipulator arms which may be positioned around the perioperative field. Each arm is individually draped to maintain sterility M. Nathan (*) TransEnterix, Inc., Morrisville, NC, USA e-mail: [email protected]

Fig. 15.1  The Senhance Surgical System

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Fig. 15.3  Senhance surgeon console

Fig. 15.2  Senhance Manipulator Arm

15.3.2 Surgeon Console The Senhance surgeon console is an open cockpit that sits outside the sterile field which allows the surgeon to sit upright while performing surgery. The console features a monitor which is capable of presenting 2D, 3D, or 4K imaging. There is an eye-tracker system built into the cockpit which allows for the surgeon’s eye movements to direct the scope control for pan and zoom. The surgeon activates the eye tracker by pressing two buttons located on the laparoscopic handles at the console. This allows the surgeon the ability to operate both the left- and the right-hand ­instruments and move the camera simultaneously if so desired. Each surgeon saves a calibration sequence to personalize the eye tracker to their characteristics. The surgeon may utilize the eye tracker to also select and change instruments assignment to handle controls or change settings such as motion scaling. Alternatively, the surgeon may assign scope control to a handle to manage movement using the handles. This appears to be the first use of eye tracking to manage the scope movement in a commercially available surgical platform. The handles are designed to mimic laparoscopic motion (as opposed to open motion) and feature a fulcrum point with movement controls for X, Y, Z, roll, and internal articulation on select instruments. Haptic

force feedback is transmitted to the surgeon at the console via the handles. Infrared sensors in each handle indicate surgeon presence at the controls. In order to activate motion, the surgeon depresses an activation pedal at the console. When the surgeon wishes to freeze movement or reposition their hands to a more comfortable position, they may clutch by lifting their foot from the pedal. Energy activation may be performed by using standard third-party foot pedals placed at the console (Fig. 15.3).

15.3.3 Instrumentation The system utilizes a broad array of instrumentation in standard 5 and 3  mm diameters in multiple operative lengths. Passive, monopolar, and bipolar standard instruments are available in a variety of commonly used end-effector designs. The instruments are designed to be fully reusable without any preset life limitation. This is intended to offer instruments that may be used over time to keep the costs per procedure as low as practicable. The instruments are taken apart with a rigid, non-articulating, reusable insert and an adapter where the specific insert is attached for each instrument. There is an optional advanced instrument, the Senhance Ultrasonic, available with its own generator, foot pedal, and adapter for use with the system. In certain markets, select articulating instruments are currently available which offer additional internal degrees of freedom when used with the system. The instruments are attached to the manipulator arm by connecting them to the instrument actuator on the manipulator arm which is covered by a sterile drape. Mechanical motion is transmitted through the drape to the instrument, although specialty adapters do exist with additional connec-

15  The Senhance® Surgical System

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Fig. 15.4 Senhance instrumentation

Fig. 15.5  Senhance system in use in surgery

tors or motors to transmit electrical signals and mechanical motion to control additional features on select instrumentation (Fig. 15.4).

15.3.4 Open-Source Design Architecture As far as possible, the Senhance Surgical System has been designed to be an open-source platform to work with existing equipment in the operating room ecosystem used in minimally invasive laparoscopic surgery. This is done both to reduce the capital costs associated with initiation of use and to offer maximum flexibility in surgeon’s preference for energy and visualization technology. Several adapters are available for commonly used laparoscopes in both 5 and 10 mm diameters. Vision systems which utilize ICG fluorescence technology are also compatible with Senhance. A traditional laparoscopic scope is inserted into the sterile adapter in order to attach it to the Senhance Manipulator Arm for teleoperation. The scope may be used both in a

handheld fashion and when attached to the Senhance with the adapter attached. There is no modification to the scope which prevents it from being also used in traditional laparoscopic surgery without Senhance.

15.4 Regulatory Status The Senhance Surgical System has received both CE Mark and FDA Clearance. The system has also been cleared by Japanese regulatory authorities. The indications for use vary in specific markets within the field of laparoscopic surgery. In CE markets, the system is intended for use in laparoscopic surgery in the abdomen and pelvis and limited uses in the thoracic cavity. In the United States, the system is intended for use in laparoscopic gynecologic surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. Since the first clearance of the system, the indications and markets for the Senhance Surgical System have expanded over time (Fig. 15.5).

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15.5 Summary of Clinical Experience Multiple case series have been published in the literature on the feasibility, safety, and efficacy of the Senhance Surgical System across a broad range on procedures and specialties. A few series are discussed here in greater detail. One series of 146 patients was prospectively included and reported in gynecologic surgery at a single center by multiple surgeons treating patients with presumed benign and early-stage malignant adnexal and uterine disease. Sixty-two patients (32.5%) underwent adnexal procedures, 4 patients (2.7%) myomectomy, 46 patients (31.5%) total hysterectomy, and 34 patients (23.3%) radical hysterectomy with endometrial cancer staging. In this series, Fanfani et  al. [2] report on mean operative times (OT) of 35 minutes (range 17–145) for the adnexal procedures and mean OT of 40 minutes (range 10–50), 133 minutes (range 58–320), and 160  minutes (range 69–290). The median number of surgeries performed by each surgeon was 25 (range 9–47). Of note, the authors observed a mean 7-minute docking time across all surgeries which they suggested was encouraging in terms of ease and speed of setup. A statistically significant learning curve was observed in the study, but it must be noted that this series included multiple surgeons performing a varying number of procedures. All but seven of the cases (4.8%) were completed using the robot with five procedures finished with traditional laparoscopy and two laparotomies across all groups for reasons not device related. One postoperative complication requiring readmission for vaginal bleeding was reported. The authors concluded that the system showed feasibility, safety, and efficacy in a large, heterogenous series of benign and malignant gynecology surgery. Stephan et al. [3] reported on an experience of 116 cases performed within the first 6  months of starting use of the Senhance Surgical System in general surgery. The procedure range included inguinal hernia repair, ventral hernia repair, Nissen fundoplication, cholecystectomy, and sigmoidectomy. Of note, the authors concluded that the learning curve was observed to be short and that their console time for an inguinal hernia repair corresponded approximately to the incision to suture time of a normal laparoscopy without Senhance after about 30 cases. Only one case required completion by normal laparoscopy due to the presence of strong adhesions, and no conversions to open surgery or postoperative complications were reported in this series. The mean docking time (including the learning curve) of all operations was reported as 8  minutes, which the authors describe as rather short. They concluded that their study supports the Senhance as suitable and safe for procedures in general and visceral surgery. Samalavicius et  al. [4] reported on a prospective series of their first 100 robotic cases at a single site across mul-

M. Nathan

tiple specialties. Utilizing the Senhance Surgical System, 39 patients underwent general surgery procedures, 31 patients underwent urologic procedures, and 30 patients underwent gynecologic procedures. Among the general surgery procedures, 8 were inguinal hernia repairs, 16 were cholecystectomies, and 15 were colorectal procedures with variation between segmental resections, TME, and low anterior resections. The urologic procedures were primarily radical prostatectomy (27 out of 31), and the gynecologic procedures were primarily hysterectomies with bilateral salpingo-­ oophorectomy (23 out of 30). Of note, 49% of all cases were performed for malignant disease which showed feasibility in the use of the system for both benign and malignant conditions across a range of general surgical, urologic, and gynecologic procedures. There were no reported conversions, and two patients required reoperation for complications with favorable outcomes. The authors state that their experience with different types of surgery with Senhance shows feasibility and safety for use in general surgery, gynecology, and urology. Other series have been published in the literature, describing the feasibility and safety in other procedures or with 3 mm instruments. Of note, Alletti et al. [5] report on the first evaluation of 3  mm Senhance robotic hysterectomy. Montlouis-Calixte et al. [6] report on the initial feasibility in the literature of gynecologic and general surgery procedures with 3  mm instrumentation and the Senhance Surgical System. Rossitto et al. [7] reviewed the cost of robotic interventions utilizing this technology and concluded the low consumption of robotic materials could offer specific advantages in terms of cost.

15.6 Conclusion There has been a tremendous growth in the interest and adoption of robotic surgery for 20  years, and few new entrants have arisen in the field of abdominal surgical robotics. The Senhance Surgical System has emerged as a commercially available, cleared device with active clinical use in multiple countries. Haptic force feedback and eye-tracking camera control are new additions to the capabilities present in robotic or digital surgery systems. The Senhance has an emphasis on maintaining low costs per procedure through reusability of standard instruments. The system is designed to build on the foundation of traditional laparoscopic movement, technique, and equipment. Since introduction, the system has advanced with technology such as ultrasonic energy, 3  mm instruments, and select instrument articulation. Through the Senhance Surgical System, new robotic surgery modalities with differences in features, cost, and design architecture are now available to surgeons, patients, and hospitals.

15  The Senhance® Surgical System

References 1. Stark M, Benhidjeb T, Gidaro S, Morales ER. The future of telesurgery: a universal system with haptic sensation. J Turk Ger Gynecol Assoc. 2012;13(1):74–6. https://doi.org/10.5152/jtgga.2012.05. eCollection 2012. 2. Fanfani F, Monterossi G, Fagotti A, Rossitto C, Alletti SG, Costantini B, Gallotta V, Selvaggi L, Restaino S, Scambia G.  The new robotic TELELAP ALF-X in gynecological surgery: single-­center experience. Surg Endosc. 2015;30:215. https://doi. org/10.1007/s00464-015-4187-9. 3. Stephan D, Salzer H, Willeke F.  First experiences with the new Senhance Telerobotic system in visceral surgery. Visc Med. 2018;34(1):31–6. https://doi.org/10.1159/000486111. 4. Samalavicius NE, Janusonis V, Siaulys R, et  al. Robotic surgery using Senhance® robotic platform: single center experience with

163 first 100 cases. J Robot Surg. 2019;14:371. https://doi.org/10.1007/ s11701-019-01000-6. 5. Gueli Alletti S, Perrone E, Cianci S, et al. 3 mm Senhance robotic hysterectomy: a step towards future perspectives. J Robot Surg. 2018;12:575. https://doi.org/10.1007/s11701-018-0778-5. 6. Montlouis-Calixte J, Ripamonti B, Barabino G, Corsini T, Chauleur C.  Senhance 3-mm robot-assisted surgery: experience on first 14 patients in France. J Robot Surg. 2019;13:643. https://doi. org/10.1007/s11701-019-00955-w. 7. Rossitto C, Alletti SG, Romano F, Fiore A, Coretti S, Oradei M, Ruggeri M, Cicchetti A, Marchetti M, Fanfani F, Scambia G. Use of robot-specific resources and operating room times: the case of Telelap Alf-X robotic hysterectomy. Int J Med Robot. 2016;12:613. https://doi.org/10.1002/rcs.1724.

Humanizing the Robot: Medicaroid’s Vision for the Future of Robotic Surgery

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Leila Bahreinian

16.1 Introduction Joseph Hashimoto dreamed to have robots support humans in a collaborative fashion. This view may appear in contrast to what one might observe in the mainstream media, where images similar to those in Terminator and Westworld depict a world overpowered by artificial intelligence and robots at odds with the human well-being. Hashimoto, the Managing Executive Officer of Kawasaki™ Heavy Industries which includes Kawasaki Robotics, envisioned the human-robot collaboration for betterment of human health and took the first step to realize his dream with support of his old friend and business partner, Kaoru Asano, now Senior Executive Officer of Sysmex™ Corporation, and President of Medicaroid, Corporation when they established Medicaroid Corporation, a joint venture between Kawasaki and Sysmex, in 2013 in Kobe, Japan. Medicaroid™ aspires to provide healthcare professionals worldwide with viable surgical robotic solutions that surgeons and surgical teams can trust, even rely on, to further improve patient care. Medicaroid’s vision is to use surgical robotic solutions in supporting everyone, from surgeons to surgical teams to patients and their families, enhancing life and quality of healthcare (Fig. 16.1). Medicaroid is committed to advancing surgery by improving outcome and efficacy through robotic solutions that help reduce cost and increase versatility in the operating room and providing economy of space through accurate and coordinated motion and placement plus customizable and programmable devices that collaborate with each other to meet specific needs in different situations. Medicaroid also envisions enhancing safety and reliability through customized ergonomics and reduced strenuous tasks by healthcare providers, eliminating error L. Bahreinian (*) Meditus, Inc., Los Gatos, CA, USA BahrNow Consulting, Los Gatos, CA, USA Formerly, Vice President, Medicaroid, San Jose, CA, USA

through real-time guidance and feedback via data connectivity, plus providing comprehensive training that enables implementation of such advanced technologies in a safe and dependable fashion. Medicaroid believes in enabling clinical innovations through abovementioned initiatives in robotic surgery (Fig. 16.2). In keeping with their commitment to provide choices, the Medicaroid products are being designed and developed on an open platform philosophy, allowing healthcare providers to continue using the tools they trust while sharing its strengths with the global medical device community.

16.2 History of Medicaroid Medicaroid Corporation was established in Kobe, Japan, in August 2013. Soon after, an office was established in San Jose, California, with the mission to explore business viability and implement headquarters’ plans in the United States and beyond, which later was named Medicaroid, Inc. Medicaroid is a joint venture start-up in the sense that it began with a vision of transforming available enabling technologies into a viable business of surgical robotic solutions. Yet this young start-up has more than 50 years of global medical and robotic experience through its parent companies (Fig. 16.3). Sysmex Corporation is a Japanese company based in Kobe with a legacy of innovation and automation in medical diagnostics and pathology. They started in Japan in the 1960s and later came direct to Europe and then to the United States in the late 1970s. At that point, the automated diagnostic systems were an established market conquered by giants such as Coulter. Through quality and innovation in design and sincerity and reliability of service, which are what Japanese enterprises are well known for, Sysmex demonstrated to healthcare providers that they were providing a solution they could trust. Sysmex went on to become the market leader in the United States. This commitment to product quality and sincerity in service is a value shared at Medicaroid (Fig. 16.4).

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_16

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Fig. 16.1 Medicaroid’s mission statement

TO SUPPORT AN AGING SOCIETY WHERE EVERYONE LIVES IN PEACE

Medical Professionals

Fig. 16.2 Medicaroid’s solution designed on an open platform

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Designed on an OPEN PLATFORM Safety & Reliability Less Risk & Burden

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Comprehensive Training

Economical Data Connectivity Economy of Space

Sensory Feedback’ Real-time Guidance

Versatility

Supervised Autonomy

Clinical Innovation

Fig. 16.3  Medicaroid’s name from medical and Android as the result of joint venture between Sysmex and Kawasaki

Kawasaki Heavy Industries started in Tokyo in the late 1800s in ship design. They are a multifaceted heavy industry company who entered into robotics in the 1960s when they acquired the patent to the American robotic company, Unimation. Kawasaki has a legacy of multi-industry robotic applications. They have been market leaders in large-scale factory automation including automotive, semiconductor, and food sectors. Interestingly, even as the leader, they continued to innovate and customize their product offering based on voice of customer, empowering their customers’ potential through reliable robotic technologies. This commitment to empowering customers through trusted robotic choices is a value Medicaroid shares (Fig. 16.5).

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Fig. 16.4  Sysmex’s history of innovation

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Fig. 16.5  Kawasaki robotics’ history of customization

16.3 Medicaroid’s Robotic Operating Table Medicaroid developed a robotic operating table, SOT-100 Vercia™ Robotic Operating Table, that was cleared through Japan PMDA in 2017. The table is robotized and programmable for patient positioning in operating rooms. Medicaroid envisions integrating the table with roboticassisted surgical devices to improve patient placement during surgery.

16.4 Medicaroid’s Robotic-Assisted Surgical System Medicaroid developed a new robotic-­assisted surgical (RAS) system, hinotori™ Surgical Robot System based on the global customer needs, which was cleared through Japan PMDA in August 2020. They committed to design and evaluate their concepts soliciting input from masters in the field of surgery and finalized the design accordingly with an obsession to satisfy validated unmet needs that would attain societal trust (Fig. 16.6).

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In developing a new RAS device, Medicaroid leveraged its parent companies’ expertise. Sysmex’s global medical expertise has been the beacon of guidance to the Medicaroid start-up. Along with their novel approach in customer training, their online on-time quality control for smart and

Fig. 16.6  Hinotori Surgical Robot System

p­ reemptive services, plus their global regulatory expertise to maximize product value to healthcare providers, Sysmex facilitates Medicaroid’s ambitions to enter the highly regulated field of medical devices (Fig. 16.7). Through unsurpassed attention to unmet needs of the market, Medicaroid recognized the challenges in robotic-­assisted surgery and envisioned how collaborative and effective robotic technologies can improve procedural efficacy and safety in surgery. Kawasaki’s robotic experience depth and breadth provides Medicaroid with a head start in developing surgical robotic solutions, from technical design to telemanipulation, allowing advanced development opportunities (Fig. 16.8). Many of Kawasaki Robotics’ applications in heavy industry has inspired Medicaroid to envision human-level dexterity and form factor portraying robots work safely and effectively side by side humans. Medicaroid recognized that industrial robots, where Kawasaki Robotics shines as a leader, were mainly intended and developed for autonomous mass productions; however, in the field of surgery, dexterity

Fig. 16.7  Medicaroid leverages Sysmex’s expertise

Robotics

Telemanipulation Touch Panel Display

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Joy Stick Master Foot

Fig. 16.8  Medicaroid leverages Kawasaki Robotics’ expertise

Augmented Intelligence

16  Humanizing the Robot: Medicaroid’s Vision for the Future of Robotic Surgery

and human compatibility are paramount. Therefore, Medicaroid has been eyeing more compatible robots from Kawasaki such as the teachable duAro robot which allegedly devises the same dexterity and area of motion as human. Such applications from Kawasaki Robotics are more relevant to Medicaroid’s vision into the future of surgery and collaboration between human and robots and, therefore, have been considered in developing their surgical solutions. Furthermore, Medicaroid envisions expanding on existing artificial intelligence technologies validated through

Fig. 16.9 Rendering of Kawasaki Robotics’ duAroTM dual-arm SCARA robot on production line side by side human

Fig. 16.10 Medicaroid’s vision into the future

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Kawasaki, allowing Medicaroid to conceptualize supervised automation to optimize surgical operation through machine learning (Fig. 16.9). In order to enable a global business, complete with products plus required service and support, Medicaroid has an exceptional advantage of access to already established support infrastructure through Sysmex and Kawasaki’s global business network.

16.5 Summary Medicaroid was established in Japan in 2013 followed by a US subsidiary in 2014 with the plan to extend human and robot collaboration into the field of surgery. Medicaroid is planning to compete in the field of robotic-assisted surgery, providing advanced instrument choices in different robotic configurations, robotic and smart operating table integration, and, when regulatory support allows, with supervised autonomy in surgery enabled by robotic technologies (Fig. 16.10). Medicaroid’s unique history and vision into the future will further revolutionize the field of surgery where ­healthcare providers worldwide will be empowered with viable surgical robotic choices they can trust through Japanese craftsmanship and obsession on quality and reliability.

Mazor Core Robots in Spine Surgery

17

Faissal Zahrawi

17.1 Introduction In the past 30 years, there has been a dramatic increase in the number of spine operations in Western countries [1–8]. This increase was attributed to several factors, including significant developments of spinal fixation devices, the availability of new biological materials (e.g., bone-grafting materials, bone morphogenetic protein), the increasing size of the aging population, the greater number of fellowship-trained spine specialists, the improved understanding of the pathophysiology of the human spine, and the development of minimally invasive surgical (MIS) techniques [1]. Between 1998 and 2008, the annual number of spinal fusion discharges in the USA alone significantly increased 2.4-fold (+137%)—from 174,223 to 413,171 [1]. During this period, the use of lumbar spine fusion for adult lumbar isthmic spondylolisthesis in the USA increased fourfold [2], and an increase in the number of cervical spine surgical procedures and other complex procedures was also noted [3, 4, 6]. It is estimated that in 2018, a total of 1,052,900 spine surgeries with significant implants were performed in the USA (i.e., excluding laminectomies and discectomies) [8]. The increase in spinal operations in the USA and Europe was accompanied by increased patient age, comorbidity, and increased costs, but patient mortality and hospital stays did not change significantly and have even decreased [1, 3, 5].

17.1.1 Implant Placement in Spinal Surgery The growth in spine procedure volume and complexity, together with the increased awareness of their benefit, as well as greater utilization of MIS techniques, has prompted the development of guidance systems for spinal surgeries.

F. Zahrawi (*) Department of Orthopedics, University of Central Florida, Florida Hospital, Orlando, FL, USA

Precise implant placement during spinal surgery is crucial in order to avoid neurologic and vascular damage, while providing proper fixation to support the formation of bone fusion [9]. The insertion of pedicle screws is a demanding procedure, which requires optimizing the screw’s dimensions to the anatomy, locating the entry point in the vertebra, maintaining the desired trajectory, and positioning the implant correctly. The process relies on the surgeon’s fine motor skills and eye–hand coordination. Additionally, procedures may be long and laborious, predisposing the surgeon to both mental and physical fatigue. Due to the complex three-­dimensional (3D) anatomy of the spine and the sensitivity of the neurovascular structures surrounding the spine, inaccurate instrumentation carries the risk of vascular, neurologic, and mechanical complications [10]. This procedure is particularly challenging in an MIS approach because surgeons must rely on indirect visualization of the 3D anatomy mainly by two-dimensional (2D) imaging systems. Traditionally, pedicle screws have been placed without guidance by relying on exposed anatomical landmarks, with or without the use of 2D fluoroscopic control [11]. However, the traditional freehand technique is prone to varying degrees of placement inaccuracy and pedicle violation [12–14]. To improve the accuracy and safety of pedicle screw placement, computer-based navigation systems were developed and first introduced to spine surgery in the mid-1990s [15]. These systems operate by optically tracking the surgical tool location relative to the patient’s spine [16]. Robot-assisted surgery technology was pioneered by Mazor Robotics Ltd. (Caesarea, Israel) and developed in order to improve patient outcomes, to make spine surgery more predictable, to enable procedures that are more complex, especially in a less- or minimally invasive approach, as well as to improve surgical ergonomics [17]. Robotic guidance for spinal instrumentation was first introduced in 2006 with Mazor Robotics’ SpineAssist system [18]. SpineAssist and its successors, Renaissance and Mazor X, are semiactive robotic systems that allow accurate screw placement with less than 1.5 mm deviation of the actual implant placement from the preoperative plan.

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_17

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a

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Fig. 17.2  Mazor X

control panel. Mazor X also includes an integrated 3D camera for spatial tracking of surgical tools. All three systems have six degrees of freedom of motion for positioning surgical instruments and are powered by Mazor Core, which consists of four key technologies that operate together:

Fig. 17.1 (a) SpineAssist and (b) Renaissance

The systems consist of a workstation, a guidance system comprising a spinous process-mounted miniature parallel robot (in the case of the SpineAssist and Renaissance systems; Fig. 17.1) or a patient-connected serial robotic arm (in the case of the Mazor X system; Fig. 17.2), and a surgeon

• A precise surgical planning suite comprising 3D analytics and virtual tools developed to determine procedure goals and surgical plan. The planning suite allows surgeons to increase their familiarity with the anatomical details, to select the ideal trajectory, and to optimize implant dimensions, separating the surgeon’s analytical planning process from the actual surgical execution process (Fig. 17.3). • An anatomy recognition engine that reads images and recognizes anatomical features based on advanced and proprietary algorithms. The engine is fundamental for planning and serves as the underlying technology for features such as spinal segmentation into individual vertebras, image registration, and alignment calculations (Fig. 17.4). • Patient connection platforms are biocompatible devices that rigidly affix the robotic system/arm to the patient’s skeletal anatomy during surgery to create a physical connection between the system and the patient (Fig.  17.5).

17  Mazor Core Robots in Spine Surgery

Fig. 17.3  Mazor X planning screen, axial view of L4 pedicle screws

Fig. 17.4  Mazor X auto-segmentation by the software of L2 to L4

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This connection limits the movement of the operated segments, enabling stable drilling and tool positioning during surgery [19, 20]. • Cross-modality image registration provides the ability to automatically match images from different imaging modalities and fuse them together. For example, preoperative computed tomography (CT) images taken of a supine patient are matched with intraoperative fluoroscopy while the patient lies prone or in the lateral decubi-

Fig. 17.5  Renaissance Hover-T platform with robotic guidance unit on Station 3

F. Zahrawi

tus position. Each vertebra is registered independently of the other vertebras and irrespective of modality or patient position.

17.2 S  pinal Instrumentation with Mazor Core Systems 17.2.1 Preoperative Planning Prior to surgery, the patient’s CT scan is analyzed by the software’s algorithms to recognize anatomical landmarks. The planning software allows 3D visualization of the patient’s anatomy. The surgeon uses the software to plan the instrumentation, optimizing implant dimensions to the anatomy while taking into consideration the overall implant construct, insertion angles, and docking surfaces to verify successful instrumentation without slipping or skiving of the tools during surgery. The plan can be reviewed as a slice-by-slice video in all three anatomical planes and may be modified until the surgeon is fully satisfied with it (Fig. 17.6). The spinal alignment plan can be created using standing and bending X-ray images of the patient, which are fused with the CT scan. Planning may also be done using intraoperative systems, such as O-arm (Medtronic PLC, Louisville, CO).

Fig. 17.6  Mazor X summary details screen showing the full construct plan

17  Mazor Core Robots in Spine Surgery

17.2.2 Intraoperative Setup

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The intraoperative setup consists of (1) attachment of a patient connection platform to the patient’s spine and (2) image acquisition and registration. The robotic guidance unit of the Mazor Core systems is connected to the patient through a patient connection platform. There are a variety of platform configurations for rigid mounting directly to the patient’s spine or pelvis, according to the clinical needs. The bone-mounting feature was designed to improve procedure accuracy by ensuring that patient breathing or motion does not alter the relative position of the robot with respect to the vertebras [20]. The Mazor X system is attached to the patient’s spine as well as to the operating bed in order to support the robotic system’s weight. The patient is placed prone (or in lateral decubitus) on a radiolucent table with a Mazor bedframe adapter (Mazor

Robotics Ltd.) secured to the caudal aspect of the bed where the robotic arm is attached. Once the robot is draped and the patient is prepared, the robotic arm is connected to the patient (Fig.  17.7). A surgical towel is placed over the region of interest (providing a uniform surface without glare) [21] and the robotic arm arcs above it, mapping the surface beneath with a built-in linear 3D optic camera. Subsequently, a 3D image of the entire surgical field is produced, which defines the robot’s work volume to prevent collisions during its movement. The intraoperative registration process uses anteroposterior and oblique fluoroscopic images that are taken of the region of interest in the spine with a 3D fiducial marker attached to the patient connection platform (in the case of SpineAssist and Renaissance; Fig. 17.8) or to the robotic arm which moves into position to optimize the marker’s alignment relative to the spine (in the case of Mazor X; Fig. 17.9). These images are used by

Fig. 17.7  Mazor X bone mount bridge connected to the patient’s illac crest percutaneously with surgeon drilling through robotic arm directly above it

Fig. 17.9  Mazor X robotic arm guiding 3D marker above the region of interest and C-arm positioned above it

Fig. 17.8  Patient positioned in lateral decubitus, with the Hover-T patient connection platform. The 3D marker is placed on the Hover-T and the image adapter array is mounted on the C-arm, used to take AP and oblique images to register

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Fig. 17.10  Intraoperative fluoroscopy images of a deformed spine with the green marking of the software’s auto-segmentation of the vertebras

the software to automatically fuse the 3D images (which also include the preoperative surgical plan) with the intraoperative patient anatomy and the robot’s relative position to it. Using Mazor Core’s “CT to fluoro” registration process, each vertebral body is registered independently of its adjacent vertebras by the software, thereby overcoming changes in intervertebral relationships caused by the patient’s position in the operating room vs. the preoperative CT (e.g., changes due to interbody cage insertion, supine position vs. prone; Fig. 17.10). The Renaissance and Mazor X systems also have a “scan-­ and-­plan” option, whereby an intraoperative 3D scan can be taken with the fiducial marker attached to the mounting platform or robotic arm, respectively. Although this option obviates the need for a preoperative CT scan, the patient is already anesthetized while planning is performed and more than one scan might be required due to the field of view. Therefore, this method is best suited for short constructs and trauma cases [21]. Completion of the setup, i.e., attachment of the patient connection platform and registration process, requires only a few minutes.

17.2.3 Intraoperative Guidance The Mazor Core software translates the surgical plan into precision guidance in the surgical field. In the SpineAssist and Renaissance systems, the robot is attached to the mount-

Fig. 17.11  Surgeon drilling through the Renaissance’s robotic guidance unit into the sacroillac joint

ing frame, and then moves and locks into position, so the surgical tools are aligned with the planned trajectory (Fig. 17.11). The software prompts the surgeon on the surgical tools that are required to instrument the specific trajectory. In MIS surgeries, a scalpel is inserted through the robot’s arm and advanced percutaneously through the soft tissues to the spine. The scalpel is replaced by a drill guide that is pushed in until the tines on its leading edge reach the bone. (In an open approach, rather than MIS, this would be the first step of instrumentation.) The drill guide is then malleted until it is securely docked in bone, to prevent its movement while drilling. The docking of the drill guide is the step

17  Mazor Core Robots in Spine Surgery

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Fig. 17.12  Mazor X pedicle screw planning

susceptible to skiving; therefore, to avoid its occurrence, care should be taken while planning (by selecting the slope/angulation of the trajectory’s docking area) as well as during instrumentation (by preparing the docking area). Drilling is performed manually utilizing a 30 × 3 mm drill bit through the drill guide, creating a pilot hole at the desired entry point (pedicle probing can be performed by the surgeon at this stage) [20, 22]. A hollow (reduction) tube is then placed in the pilot hole. A Kirschner wire (K-wire) is threaded through the tube, the tube is removed, and this procedure is repeated until all trajectories are drilled and K-wires are placed at all planned levels (confirmatory images can be taken). The mounting system remains attached to allow a repeat robot-guided approach in case a trajectory is lost [20, 22]. The robotic arm of the Mazor X system further increases the work volume of the system by eliminating the need for its extension tools and is robust enough to handle instrumentation, which obviates the need for guidewires, eliminating their risk and increasing the surgical efficiency [21].

17.3 Advantages of Mazor Core Systems The Mazor Core robotic guidance systems have several advantages over navigation-based systems for spinal instrumentation. First, due to the prerequisite preoperative plan-

ning, the surgeon can template implant sizes and select the tools’ entry points and trajectories (Fig. 17.12). This process enables the surgeon to plan a personalized and optimized procedure in advance, eliminating surprise findings during surgery (Fig. 17.13). Second, the system recognizes anatomical features in each vertebra and automatically segments the CT image of the spine into separate vertebras. This is an essential step in the registration process based on a preoperative CT that is merged with intraoperative fluoroscopy images. It also saves time when planning as each vertebra is automatically corrected to the midline, facilitating the planning process on virtually de-rotated anatomy. Third, the Mazor Core systems lack the drawbacks of surgeon interference with the optical tracking cameras [23]. Fourth, compared to navigation systems, in which the patient’s anatomy is tracked, in the Mazor Core systems, the rigid frame is physically attached to the patient in order to create a physical connection with the patient and to limit the movement of the operated segments. Beyond synchronization, this provides for stable drilling and tool positioning during surgery. Fifth, preoperative planning allows planning the screw angles and tulip cadence such that the rod will be inserted smoothly through them. This is particularly important when instrumenting three or more vertebras and when utilizing an MIS approach because of the lack of line of sight and the potential difficulties in threading the rods through misaligned screws. Finally, by providing mechanical guidance, which physically

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Fig. 17.13  Screw planning of a scoliosis surgery on Mazor X

holds the surgical tools in the desired trajectory, the surgeon looks at the tools and patient rather than at a screen, without the need to manually align the surgical tools in space based on 2D images. In this manner the robotic system offers both greater efficiency and reproducibility of the preoperative plan [24]. The systems also have inherent advantages compared to freehand surgery, including precise repetition and elimination of tremor and fatigue [25].

17.4 Clinical Evidence Since the Mazor Core systems were first cleared by the FDA, tens of thousands of patient procedures have been performed across a wide spectrum of clinical needs and procedure types. To date, the only systems that have been the subject of extensive clinical review and evidence-based medicine are Mazor Core–based systems. The sections below summarizes the findings of these studies.

17.5 Screw Placement Accuracy Despite the advancement of technology, successful placement of pedicle screws still requires surgical skill and experience, as no existing technique or device can guarantee 100% accurate implant placement. The application of the

Mazor Core systems has been reported in over 70 studies. Many of the studies have evaluated the accuracy of pedicle screw placement utilizing this technology and have reported accuracy rates ranging from 83.4% to 100% [18–20, 22, 24–37]. Furthermore, screws placed with Mazor Core systems were associated with fewer proximal facet joint violations and better convergence orientations [26–29]. A retrospective chart review of 20 patients with degeneration of the spine and operated with the Mazor X system showed screw placement accuracy of 98.7% following placement of 75 screws at 24 levels [21]. Several studies have compared Mazor Core systems with the conventional freehand technique, with or without fluoroscopic assistance. Keric et al. reported that accurate screw placement was higher in the robot-assisted surgery (90%) compared to freehandplaced screws (73.5%) [30], while Kim et al. [29] reported that robot-assisted pedicle screw placement using the Renaissance guidance system was associated with similar intrapedicular accuracy to the freehand technique, fewer proximal facet joint violations, higher screw-positioning accuracy for the proximal facet joint, and less hazardous orientations [29]. Archavlis et  al. [26] reported a significantly lower rate of facet violation grade III in robot-­ assisted percutaneous surgery compared with percutaneous fluoroscopy-guided surgery, but a similar rate to that of open surgery [26]. Zahrawi et  al. reported 100% screw placement accuracy using the Renaissance system com-

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pared with 97.4% accuracy with fluoroscopy-guided surgery (p = 0.005) [31]. A systematic review and meta-analysis that assessed the evidence regarding the efficiency, safety, and accuracy of robot-assisted spinal instrumentation compared with freehand techniques found similar rates of pedicle screw accuracy between robot-assisted spinal instrumentation and freehand technique (95.5% vs. 92.9%) [32]. The implant-to-­anatomy optimization and the “singlepass” drilling of the pilot hole may provide stronger bone purchase, reducing stress increments at proximal adjacent segments and improving construct biomechanics [33].

revision rates between Mazor Core guidance and fluoroscopy-guided freehand surgery in MIS instrumentation of degenerative lumbar or lumbosacral spine disease. During the first year after surgery there was a 5.5-fold decrease in the complication rate and a 9.0-fold decrease in the revision rate of the robotic cases when compared to fluoroscopy guidance [36]. Moreover, the lower complication rate was consistent when restricting the comparison to single-level cases.

17.6 Complication and Revision Rate

Exposure to intraoperative radiation is concerning to patients and is an occupational hazard to surgeons and operating room staff, particularly in minimally invasive procedures, in which fluoroscopy is required to compensate for the lack of direct visualization. Robot-assisted surgery allows minimizing this reliance on intraoperative fluoroscopy. The Renaissance guidance system was associated with reduced intraoperative radiation, as compared to conventional methods [28, 30, 37–39]. In the MIS ReFRESH study mentioned above, there was a 76% reduction in intraoperative radiation exposure per screw during instrumentation with robotics compared to fluoroscopy guidance [36].

Several studies reported no perioperative complications with the use of the Mazor Core systems. Keric et al. [30] reported that implant revision due to misplacement was necessary in 4.95% of the freehand group compared to 0.58% in the robot-assisted group. Intraoperative adverse events were observed in 12.5% of freehand-placed pedicle screws and 6.1% of robot-assisted screw placements. A single revision following robotic guidance was reported by Zahrawi et  al. in a retrospective study that compared the accuracy of percutaneous pedicle screw placement and postoperative course of robotic guidance (n = 99 patients) versus fluoroscopy guidance (99 patients); no other complications were reported for either arm [31]. In a study comparing guidance technologies, the Renaissance guidance system showed a significantly lower complication rate of 5.1% compared with spine surgery using navigation template (17.9%), 3D navigation (13.7%), and fluoroscopy guidance (19.4%); only the Renaissance guidance system utilized a percutaneous screw insertion technique [34]. In a multivariate regression analysis of 403 patients who were operated with Mazor Core systems and 224 patients who were operated with fluoroscopy guidance—all in the MIS approach—the odds ratio for complications in fluoroscopy guidance was 3.0 (95% CI, 1.2–7.1; p = 0.014) and the odds ratio for revision surgery was 3.8 (95% CI, 1.5–10.0; p = 0.006) [35]. A meta-analysis that compared the incidence of clinically relevant pedicle screw revisions among robot-guided, navigated, and freehand spinal instrumentation has demonstrated that computer assistance in the form of robot guidance or navigation has the potential to reduce the incidence of costly and clinically relevant postoperative revisions for screw malposition. However, evidence was insufficient to conclude that either robot guidance or navigation was superior to freehand spinal instrumentation in terms of pedicle screw revision events [16]. The MIS ReFRESH study prospectively evaluated surgical outcomes by comparing the surgical complication and

17.7 Intraoperative Radiation

17.8 Patient-Reported Outcomes Patient-reported outcome measures (PROM) report the outcomes from the patients’ perspective, providing a subjective, yet extremely important, measure for the success or failure of the treatment. The use of PROM in clinical studies, and specifically for reporting the results of spine surgery, is increasing. A few studies that evaluated the Renaissance guidance system reported improved functional outcomes in visual analog scale (VAS) scores for back and leg pain and the Oswestry Disability Index (ODI) at follow-up [28, 31, 40–42]. This improvement was similar after robotic surgery as compared to conventional surgery [28, 31, 42] and was noted for up to 2 years after surgery [42].

17.9 Learning Curve As with any new surgical technology, a learning curve is required to improve time for case completion and increase efficiency. Several studies have reported a learning curve with the SpineAssist [24, 43, 44], Renaissance [28, 29, 45– 47], and Mazor X [21] systems, each focusing on a different parameter, such as instrumentation time, accuracy, ­fluoroscopy use, surgeon experience, etc., with the number of cases required ranging from 0 [21, 44] to 30 [46].

F. Zahrawi

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17.10 Surgical Efficiency There is paucity of data in the literature on surgical efficiencies when utilizing robotic guidance. Four randomized studies compared Mazor Core-based systems in the MIS approach with freehand in an open approach; three reported that the Mazor Core systems took about 2 minutes longer per screw [29, 44, 49], while the fourth reported identical operative times for both techniques [38]. In MIS ReFRESH no difference in surgery time between arms was seen, even when normalizing the skin-to-skin time per screw, or limiting the analysis to single-level cases [36].

17.11 System Limitations In its current form, robotic guidance is an assistive tool that relies on the surgeon’s skill and experience. As seen in the literature, the surgical technique using robotic guidance is user dependent with accuracy ranging between 83.4% and 100% [18–20, 22, 24–37]. Inaccuracy is usually the result of surgical tool deviation, which can be addressed by proper planning of the implants, avoiding external pressures on the tools, and preparing the docking area on the vertebra for the surgical tools to avoid their skiving or skidding off [29]. Proper labeling of the anatomy and validating the accuracy of the automated registration process are also critical to reaping the benefits of this guidance technology. While the detailed planning of the instrumentation construct impacts the whole case, the systems are currently used only for drilling pilot holes. Although this feature greatly facilitates this portion of the surgery, enabling the surgeon to concentrate on surgical strategy rather than on the technical aspect of drilling, it is only one of several stages in the surgery. Finally, robotic systems are expensive. Modeling of the potential cost benefit of adding robotic technology in spine surgery to an active neurosurgical practice at a major academic center resulted in an estimated $608,546 of savings in one academic year [48]; however, the cost-effectiveness of using Mazor Core robotic assistance in a clinical setting (rather than based on a model) is yet to be determined [17, 48].

17.12 Summary and Future Directions As mentioned above, robot-assisted surgery using Mazor Core systems offers many advantages over freehand surgery, such as enabling MIS techniques, improving instrumentation accuracy, reducing exposure to intraoperative fluoroscopy, and reducing surgical complications and revision surgeries even in short fusion cases [36]. Other modalities for spinal instrumentation include clinical patient-specific templates, intraoperative image-guidance navigation systems (either based on paired-point matching or relying on intraoperative 3D imaging), or robotic guidance arms

based on such navigation systems. These systems are fundamentally different from Mazor Core–based robots because they do not offer some of Mazor systems’ key features, including (1) automated anatomy recognition capabilities; (2) detailed preoperative planning of the full instrumentation construct, which increases the surgeon’s familiarity with the patient’s anatomy, reduces the chances of surprise findings during surgery, and allows optimization of implant size and trajectory to the patients’ anatomy; (3) direct connection of the surgical system to the patient (rather than relying on optical tracking); and (4) automated inter-­imaging modality registration capabilities of individual vertebras. In the operating room, these features are translated into accurate and reliable reproduction of the preoperative plan, despite changes in patient positioning. While the body of evidence on the clinical value of robot-assisted surgery is growing, it is yet unknown if this greater clinical efficiency offsets its high costs. Further development of robotic guidance technology holds promise for robotic-powered insertion of pedicle screws, disc preparation and decompression procedures (including laminectomies, laminotomies, foraminotomies, facetectomies, osteophytectomies, and decompression of the ligamentum flavum), as well as more extensive planning, such as cage selection and alignment. Robotic systems for automatically bending surgical rods to desired curvature are also being developed. Advanced software-based capabilities will support surgical decision making, such as assessment of alignment, surgical approach, and optimization of implant placements. By increasing their role during surgery and venturing into automation, robotic-guided spine surgeries will eventually become the standard of care.

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Intelligence and Autonomy in Future Robotic Surgery

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John Oberlin, Vasiliy E. Buharin, Hossein Dehghani, and Peter C. W. Kim

18.1 W  hat Does Future Surgery Look Like with Intelligent Collaborative Autonomy?

because it profoundly affects the fundamental role of the human. What is different about this transformation stems from how it is simply outpacing human capacity to interface fully in the digital realm beyond the technology per se. A Future surgery must create disruptive value for all stakehold- total of 2.5 quintillion bytes of data are created each day. On ers, namely, patients, surgeons, and healthcare systems. We average, Google now processes more than 40,000 searches envision that a significant part of future surgeries will be per- every second (3.5 billion searches per day) [1]. We passed formed using intelligent, supervised, or fully autonomous the 50 million mark in terms of the total number of science technologies working collaboratively with human surgeons. papers published since 1665 in 2009, and approximately 2.5 The intelligence encompasses computer vision extending million new scientific papers are published each year [2]. beyond the human visual spectrum, functional and physio- There are more than two million lifestyle apps and over logic tissue information beyond anatomy, connectivity to rel- 300,000 healthcare apps available on our mobile devices. evant surgical knowledge, and access to technical and clinical There is more technology and computational power in a sincompetence and proficiency at the point of care. Hence, the gle smart phone than was used to send the first man to the future of surgery delivers the best outcomes with minimal or moon and back. no complications to everyone whenever and wherever surIn surgery, there is an increasing gap between the ever gery is needed. Is this a mere pipe dream, or can future sur- more complex surgical technologies being developed to gery be democratized in such a way that the best surgical improve care and the individual practitioner’s capacity to outcomes and better safety are accessible in real time to all master the technologies. Recent efforts strive to improve the patients at the point of care? abilities of individual surgeons through education and Modern surgery has been enabled by the introduction of enhanced training, with the goal of bridging the human– three key technologic changes and paradigm shifts over the technology gap and elevating the standardization of surgical last two centuries: antisepsis, anesthesia, and endoscopic competence and proficiency. However, these endeavors have surgery (Fig. 18.1). Over the last three decades, surgery has made only incremental impacts on patient outcomes, both been undergoing a quiet transformation from a 2000 -year-­ qualitatively and quantitatively. This human–technology long human-centered analog era into a digital realm where chasm or gap is further accelerated by the pervasive presthe standardization of best practice and intelligent function, ence of “The Internet of Things,” which demands increasing beyond current morphology-based surgery, is starting to be transparency and accessibility to the latest and broadest sets realized. This change is qualitatively and quantitatively dif- of information created by the overwhelming digitalization ferent from the recent industrial and information revolutions of our world [3, 4]. Regardless of the rate of change and we experienced, not only in how it impacts our lives but also volume of data and information generated and available, humans can absorb, process, analyze, and make decisions based on an exceptionally narrow sleeve of available and J. Oberlin · V. E. Buharin · H. Dehghani accessible information at a given moment. It is increasingly Activ Surgical Inc., Boston, MA, USA evident that technology has surpassed the human capacity to P. C. W. Kim (*) process and manage data in this new paradigm. Thus, Activ Surgical Inc., Boston, MA, USA machine-aided data processing, analysis, and decision supDepartment of Bioengineering, Department of Surgery, port are necessary and inevitable and will become indisBrown University, Providence, RI, USA pensable in our daily lives. e-mail: [email protected] © Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_18

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Fig. 18.1  Four key technologic changes and paradigm shifts over the last two centuries, from antisepsis, anesthesia, minimally invasive surgery, and most recently information/connectivity

Modern surgery Antisepsis

MIS

Intelligence connectivity Anaesthesia RAS

-2500

-200

-100

-10

0

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Today, surgery remains entirely in the human-based domain, in no small part due to the patient–surgeon covenant and the prima facie objective of patient safety. Although significant perioperative multimodality imaging and monitoring information from CT, MR, and ultrasound is now routinely used to permit better surgical planning and execution, the workflow of how these imaging technologies are used remains traditional, serial mental abstractions of preoperative imaging and memory recall. Very little machine- or algorithm-­supported decisions are made from these imaging data; the ultimate information processing, analysis, and application rests entirely on an individual surgeon at the point of care. Similarly, on the therapeutic side, while endoscope-­based minimally invasive laparoscopic and robot-­ assisted surgeries (RAS) have transformed modern surgery by minimizing collateral tissue trauma associated with surgical access, both the surgical vision and the instruments used remain a simple extension of human vision and dexterity, without harnessing the potential of digitalized surgical data and information. We are now beginning to recognize the potential of digitalization of surgery, and how both hardware- and softwareaided data and information acquisition, processing, analysis, planning, and decision support, and eventually human– machine collaboration and execution of tasks can result not just in non-inferior results but also in superior clinical outcomes for patients. Here the paradigm is not simply to develop and use surgical technologies that permit surgeons to directly translate their human intellectual and manual skill sets but also to geometrically and collaboratively leverage computer vision, intelligence, and dexterity. This paradigm shift in future surgery is similar to current trends in driverless cars. A great parallel can be drawn between surgery and driving cars when one considers the anatomy of

errors in both; for example, 94% of motor vehicle accidents (MVA) are caused by human error [5, 6]. Similarly, most surgical errors occur intraoperatively and are most associated with a lack of situational awareness and subsequently compromised clinical decision-making [7, 8]. For example, although the incidence of ureteric complication is 1–2% at most, 85% is caused by human error, and 75% of surgeons do not recognize the ureteric injury at the time of infliction [9, 10]. The goals of collaborative intelligence and autonomy reach beyond the obvious and often-cited safety benefits in surgery and driving. For example, saving over 35,000 lives per year and preventing 2.6 million injuries are usually recognized as the a priori reasons for autonomous functionalities in driving [5, 6]. The true benefit of machine-aided intelligence and collaborative autonomy, however, stems from repurposing of data. Observations of and information about outcomes of similar tasks performed by various teams transcend each individual driver’s capabilities and experiences. This “collective memory” of tasks will be autonomously searched and made available to the driver in real time, enhancing each driver’s capacity and ability for consistent optimal functional outcomes. In other words, beyond today’s advanced driver assistance systems (ADAS), which offer lane keeping, active cruise control, and emergency braking, future level 4 driverless cars would shadow each driver at all times for superior performance, enhancing user experience by training on the collected data and, of course, improving safety by predicting outcomes [11]. Well, this sounds logical enough, but what is the compelling unmet need for machine- and algorithm-aided intelligence and collaborative autonomy in future surgery? Here are at least four key critical unmet needs to consider for intelligent autonomous capabilities in surgery.

18  Intelligence and Autonomy in Future Robotic Surgery

18.2 W  hat Is the Critical Unmet Need for Intelligence and Autonomy in Surgery? First, over 234 million major surgeries are performed each year globally, and this is estimated to be a third of the global burden of illness for mankind [12–14]. This, however, is estimated to be short of an additional 140 million procedures needed but not performed. Regardless of the current disparity in access to care, resources, and technology, no feasible increase in redistribution, education, or training will produce enough competent surgeons to bridge the unmet gap [12–14]. Second, the critical unmet need stems from the fact that only incremental progress has been made from our efforts to improve each individual surgeon’s technical and clinical judgment from the current model of education and training, including continuing medical education and simulation [15–18]. Significant improvements have been made from systems’ quality improvement and assurance perspective, such as preop checklists and National Surgical Quality Improvement Projects [16–18]. However, recent publication estimates that the medical error rate has not significantly changed over the past two decades and that, if anything (regardless of the lack or absence of comprehensive reporting), it has been underestimated [15]. Overall, medical error may be the third highest cause of death in the United States after the usual suspects like cardiovascular disease and cancer, bigger than motor vehicle and firearm fatalities [19]. The vast majority of surgical errors occurs in operating rooms, and most (greater than 85%) are attributable to human factors. This human error is specifically due to the lack of situational awareness and subsequent compromised decision-making at the point of care [7, 8]. However, efforts to mitigate variables contributing to individual surgeon errors such as checklists, to objectify educational processes where competence and knowledge are demonstrated in simulated clinically relevant training scenarios, and to improve individual human factors have been slow that impact surgical outcomes. The current training paradigm and clinical outcomes continue to depend predominantly on each surgeon’s individual capability, experience level, prior training, and clinical volume. The human factors contributing to performance and outcome variance and disparity affect all aspects of surgery, from relatively simple to highly complex minimally invasive surgery (MIS) [20–25]. For example, no appreciable improvement in outcomes of laparoscopic cholecystectomies performed by novice trainees measured in several outcome metrics (including intraoperative complications, surgery length, and the need for conversion to open cholecystectomy) was noted following the use of the recommended simulated training platform and guidelines using the Fundamentals of Laparoscopic Surgery (FLS) training for trainees [20]. The demonstration of differences in scores between novices and experts did little to confirm the content

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validity of FLS simulation [20]. Counterintuitively, FLScertified surgeons had a higher rate of bile duct injury (BDI) compared with non-FLS-certified surgeons, highlighting additional challenges and disparity in adopting the minimally invasive technologies [21]. These individual surgeon variance and disparity in competence and proficiency based on human factors are further accentuated in more complex surgeries. Recent report on bariatric surgery clearly stipulates the discordance and variance between desired proficiency and accepted competency in peer-evaluated bariatric surgical performance metrics among licensed practicing surgeons and their outcomes [22]. In other words, although all surgeons aspire to be proficient and to be recognized for their technical mastery in the eyes of their peers, not all surgeons perform the same, and their performance is linked to patient outcomes. From a patient’s perspective, it would be ideal not just to have care given by a competent surgeon but also to receive the best care whenever and wherever needed at the point of care. The variance in human factor impacts significantly on the adoption rates and learning curves for any complex laparoscopic or RAS procedure, which remain low and steep despite significant efforts made over the past several decades [23–25]. Some complex MIS may not be feasible at all given the current state of practice. For example, the number of completed procedures needed to attain proficiency and efficiency for robotic pancreaticoduodenectomy (RPD) was estimated to be approximately 80 cases [23–25]. In 2013, surgeons, however, performed a median of 12 pancreaticoduodenectomies (PDs) per year, with a median career volume of 80 PDs and only 53.8% of highly selected respondents surpassing the number of PDs considered necessary to surmount the learning curve [23–25]. The only realistic solution to address the human factor issue and increasing complexity of minimally invasive technologies may be an intelligent, collaborative autonomous technology that supplements or complements variance and disparity in human factors. Thirdly, despite the benefits of a minimally invasive approach, the current endoscopic technology poses additional challenges to surgeons in all three domains of surgery (vision, dexterity, and cognition) as compared to open techniques. This resulted in low adoption rates of the technologies over the last two to four decades for robotic and laparoscopic surgery, despite maximal efforts by device manufacturers. The endoscopic approach in laparoscopic and robotic surgery constrains both tool and endoscopic vision to pivot around insertion points, with smaller visual field, limited peripheral vision, and time-consuming repetitious movements to execute surgical tasks, such as suturing [26]. Visual cues are required to adjust for the lack of tactile feedback [27–29]. The ergonomic challenges in laparoscopic approach, from unintuitive hand motions to cumbersome instrument designs, create significant variations in the surgeons’ proficiency and may also reduce the operative life span of surgeons [30–33]. Although the cur-

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rent RAS is superior to MIS in ergonomics, motion scaling, hand tremor filtering, and inline image display with tool motion, any complex surgeries, such as coronary artery anastomosis and cardiac valvular repair, can be performed by only a limited number of experts following a steep learning curve and high practice volume [30–33]. Inefficiencies of the currently adopted direct transduction teleoperation robotic control paradigm (known as the master–slave paradigm), with its steep learning curves and variable intra- and inter-surgeon experience/proficiency, pose a formidable obstacle to improving the results of complex surgical procedures and tasks, such as anastomotic outcomes [20, 30, 34, 35]. A significantly longer surgeon learning curve is required to master these endoscopic techniques, and the validated metrics of anastomosis, such as accuracy and burst strength, are inferior with current RAS and MIS compared to an open approach [30, 31, 33, 35]. The fourth critical unmet need arises from the medical device approval process and current standards. The global standard bearer for medical device approval remains the FDA. Most, if not all, MIS and RAS devices are currently approved as Class 2 devices through the 510 k process [36]. However, the current and next generations of MIS and RAS devices that are being assessed and approved only require that there is a predicate device in the marketplace for clinical use, and the standards required for the approval of new MIS and RAS devices are equivalent safety and non-inferior efficacy to the current standard. Therefore, the current and next generations of MIS and RAS devices that are being assessed and approved for clinical use do not fundamentally address the technical, technological, or clinical shortcomings of endoscope-based MIS and RAS discussed above. Most of the new RAS products being developed or coming on line over the next 2 years are variations of the current devices in

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Fig. 18.2  Robot-assisted orthopedic surgery by Mako and Mazor

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the marketplace mechanically, vision- and intelligence-wise, and the only differentiating emphasis has been on the route of access, such as single-port or natural orifice devices [37, 38]. These next-gen devices fail to take full advantage of digital potential in surgery and only mitigate the unmet needs in incremental ways. Only by taking full advantage of digitalization by incorporating computer vision and intelligent collaborative autonomy can the next generation of RAS yield devices that are superior to the current generation in function, outcome, and safety while meeting the unmet need for patients, surgeons, device manufacturers, and the healthcare system.

18.3 C  urrent Applications of Intelligence and Autonomy in Hard and Soft Tissue Surgery The distinct advantages of robotic functionality, including potential autonomy, have already been demonstrated in autonomous robotic applications outside of medicine, ranging from manufacturing to self-driving cars [37–40]. Hard tissue surgery, such as in orthopedics, where the intraoperative surgical region and target tissues of interests can be immobilized and remain invariant from high-resolution CT or MR imaging, is a natural environment for the potential application of supervised intelligent autonomous robotic functionality. A limited form of autonomous RAS with a preplanned function based on tissue information and visual servoing has already been introduced in “hard tissue” orthopedic procedures (e.g., ROBODOC, Caspar, and CRIGOS), radiotherapy, and cochlear implants [41–51]. In orthopedic surgery (Fig. 18.2), due to the presumed invariability in tissue

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18  Intelligence and Autonomy in Future Robotic Surgery

deformability and potentially in positioning between preand intraoperative planning and execution, limited forms of autonomous functionalities were introduced as early as 2005 [41–51]. Such functionality as active constraint surgery (ACS), a form of geofencing, is applied to aid surgeons in purposefully executing their intended tasks [52]. More recent results are starting to demonstrate that intelligent preoperative analytics, combined with intraoperative guidance and real-time verification, result in superior outcomes with lower complication and revision rates in clinical trials [53, 54]. A prospective, multicenter study comparing robotic guidance vs fluoro-guidance in MIS lumbar fusion demonstrates a superior outcome with an odds ratio of 12.2 for a clinically significant complication in fluoro-guided surgeries compared to robot-guided cases [53, 54]. Another prospective, multicenter, comparative study of MIS lumbar fusions performed with robotic guidance in 250 patients vs fluoro-­ guidance in 79 controls demonstrated that robotic guidance reduced fluoroscopy exposure time per case by almost a minute, helping offset the patients’ exposure during the preoperative CT scan required for planning the robotic procedure. There was a sixfold higher rate of surgical revision rates for fluoro-guided cases in the first year of follow-up than in RAS cases. In contrast, demonstrations of the feasibility of intelligence and autonomy in complex soft tissue surgery have been limited to elemental tasks, such as isolated individual knot tying, needle insertion, and execution of predefined motions, due to the challenges of tracking and executing a complex surgical task on a deformable mobile soft tissue target of interest in an unstructured dynamic surgical environment [55–57]. Recently, our team has demonstrated the Smart Tissue Autonomous Robot (STAR) system (Fig. 18.3), an in  vivo supervised autonomous soft tissue surgery platform enabled by a plenoptic three-dimensional and near-­ infrared fluorescent (NIRF) imaging system, executing a suturing algorithm [57]. Inspired by the best human surgical practices, a computer program generates a plan to complete complex surgical tasks on deformable soft tissue, such as suturing and intestinal anastomosis. The outcome of the autonomous functionality was validated by measuring the consistency of suturing informed by the average suture spacing, the pressure at which the anastomosis leaked, the number of mistakes that required removing the needle from the tissue, completion time, and lumen reduction in intestinal anastomoses, and by comparing between the supervised autonomous system, manual laparoscopic surgery, and clinically applied RAS approaches. Surprisingly, the outcome of supervised autonomous procedures was superior to surgery performed by expert surgeons, RAS techniques in ex  vivo porcine tissues, and in live pig survival study, despite dynamic scene changes and tissue movement during surgery [57]. The objective of this demonstration was to show that a

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Fig. 18.3  Picture of the STAR system combining intelligent multispectral imaging, tracking of deformable tissue, and supervised autonomy robotic control (STM 2016)

complex surgical task was feasible using an intelligent autonomous robot in soft tissue surgery. Although an immediate inference was drawn in lay press that a surgeon could be replaced in the future, these results promise that an intelligent, collaborative autonomous robot could expand human capacity and capability through enhanced vision, dexterity, and complementary machine intelligence for improved surgical outcomes, safety, and patient access. The real benefit of machine-aided intelligence and collaborative autonomy, however, stems from repurposing the data, observations, and information about outcomes of similar procedures performed by various teams, which extend beyond each individual surgeon’s capabilities and experiences. This “collective memory” of procedures will be autonomously searched and made available to surgeons in real time, enhancing their capacity and ability for consistent optimal functional outcomes.

18.4 C  urrent State of Technologies in Vision, Intelligence, and Dexterity for Complex Soft Tissue Surgery 18.4.1 Computer Vision Precise and accurate real-time vision of the surgical environment and tissues of interest is foundational to effective and efficient planning and execution of any surgical task. In the current clinical paradigm, a human operator (the surgeon) perceives, plans, and executes every facet of a surgical task. However, for a robot to carry out a similar surgical task collaboratively or independently, a computer vision system needs to generate a visual representation of the environment expressed in x,y,z coordinates that enables real-time tracking of deformable and mobile soft tissues in unstructured surgi-

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cal environments and situational awareness of changing surgical anatomy and pathology in the context of the intended procedure. An intelligence algorithm then plans safe, effective, and efficient clinical decisions for the intended tasks, which would have been normally carried out by the surgeon using a serial mental abstraction of images and memory recall. Finally, the robot invokes a dexterity algorithm to control the end effectors, executing the plan and the task in a tight feedback loop, possibly invoking the intelligence algorithm to update the overall plan. For computer vision to detect, segment, classify, and track in x,y,z coordinates in real time, three-dimensional geometric information, in the form of depth maps or point clouds, can be obtained directly from special 3D cameras or estimated from monocular images using shape-from-shading or structure-from-motion techniques. Today, the most basic 3D camera is a stereo camera. More resolute geometric information can also be derived from light field images using plenoptic cameras. In contrast, a comparable x,y,z coordinate can be generated by a structured light system projecting a known pattern of light onto a scene and using a 2D camera to image it [58–64]. The three-dimensional geometry can be inferred by analyzing the way in which the known patterns of light are distorted. Multiple frames must usually be taken in order to gather depth information for every pixel in the scene. A time-of-flight system works much like RADAR except with infrared light instead of radio: a pulse of light is sent into the scene, and the return time for the pulse is measured for each pixel. Time-of-flight systems work well on a room scale, but full-field systems, which return a 2D array of measurements, are not yet small enough to fit inside the body. Anatomical information, such as organ classification, tissue segmentation, or duct detection, can be obtained from standard computer vision algorithms that interpret geometric and color information. Standard methods may suffice for tasks that are straightforward, like discriminating among liver, bowel, and lung tissue. Harder tasks, such as locating a bile duct or a ureter, may benefit from additional information, such as that furnished by multi- and hyperspectral imaging systems, which analyze images with tens or hundreds of color channels from the ultraviolet to the infrared, rather than the ordinary three-color channels of an RGB image. Deformable tissue tracking is still a very difficult task. Sometimes there is very little visual information for an algorithm to work with. In order to track a specific piece of tissue amid a uniform field of similar tissue, it may be advantageous to apply a marker or fiducial to the tissue to aid an algorithm. More precise quantitative depth perception with clearer tissue target-to-background contrast and optimized suture positions based on tissue health and subsurface tissue information would significantly improve the surgeon’s operative decisions and the functional outcome of a surgical task.

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Enhancing the tissue target’s contrast with the background and improving depth perception have been shown to improve proficiency and the functional outcome in surgical tasks [65– 68]. The use of nonvisible light imaging, such as NIRF technology, has been previously applied to improve tissue target-to-background information for tumor detection, including during manual surgery and in RAS [65–68]. NIRF imaging with indocyanine green (ICG) has been shown to be very effective in detecting subsurface ( inserting 1 inserting

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23.5.7  Control Architecture

23.5.8  Human Interface

The control architecture of the I-SUR system is shown in Fig. 23.15, which is a very schematic graphical representation of the main blocks of the system and of their data exchange. At the center of the picture there is the Finite State Machine representing the needle insertion task. The four states represented are those described in Sect. 23.5.3, and each state is associated with a robot controller and a reasoning process. The robot controller is the box at the bottom of the picture, where the torque commands to the motors are generated and the joints are moved to the desired positions, as measured by the robot sensors. Data collected by the sensors are used in this control function, but also integrated with the processing of the ultrasound images (not shown in the picture) to determine the semantics of the state, i.e., whether the needle insertion task has completed one phase and can move to the next. This semantic processing is carried out by the block on the right of Fig. 23.15. Finally, the box on top of Fig. 23.15 represents the interaction of the system with the human operators: the surgeon who should intervene if the needle insertion is not successful and the technician who may need to adjust the robot parameters.

As mentioned above, the clinician must always be aware of the task evolution and be ready to intervene, in case of failure or of unexpected events. The most immediate way to communicate with a semiautonomous system like I-SUR is by means of a visual interface, such as the one shown in Fig.  23.16. This figure shows an example of the information provided to the surgeons and dialogue options available. The left of the screen shows the preoperative images used for diagnosis, and the center image is the graphical rendering of the target on the patient skin and the approach vector of the needle. The left part of the screen shows the current phase “Entry target selection,” the force profile when the needle will enter the patient skin, and the buttons showing the task phases. However, in case of necessity, the surgeon has to intervene and complete, or terminate, manually the task. Therefore, a second type of human interface available in the I-SUR system is the manual control to safely command the needle extraction. The manual interface used in I-SUR is the master device indicated in Fig.  23.2, and, in this situation, the autonomous robot becomes a standard teleoperated surgical

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Fig. 23.15  The control architecture of the I-SUR system

23  Automation and Autonomy in Robotic Surgery

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Fig. 23.16  A screenshot of the I-SUR operator interface Fig. 23.17  The haptic interface of the I-SUR system

robot to allow the surgeon to extract the needle. Figure 23.17 shows the surgeon teleoperating the needle extraction. However, since the master device and the needle have different spatial orientation, the surgeon cannot immediately command the motion of the needle, but she/he must wait until the two are aligned, to avoid brisk motions that could harm the patient [38]. To force the surgeon to move slowly to reach the alignment, we equipped the joystick with force feedback

that limits the velocity and guides the motion direction of the surgeon hand.

23.5.9  Formal Verification An interesting aspect of the analytical approach taken in the development of the I-SUR project is the ability to carry out

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a formal verification of the correctness of the task plan, by simulating the task using verification tools, such as Ariadne [39]. This phase can prove that the design model preserves the properties expressed by the goal model described in Sect. 23.5.2. Although this step requires a knowledge of all the task

elements that is rarely available, it can show where the main uncertainties of the task are, i.e., what parameters are mostly affecting the successful outcome of the task, and therefore can also be used to improve the design robustness. Figure 23.18 shows an example of the outcome of the formal verification

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Fig. 23.18  Example of formal verification of the needle insertion task. The yellow stripes indicate the safe tolerance of the variables and the black areas their uncertainty values as a function of two patient posi-

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tions. Plots (a) and (b) show the uncertainty of X coordinate of the needle entry point; plots (c) and (d) show the uncertainty of the Z coordinate; and plots (e) and (f) show the orientation of the cryo needle

23  Automation and Autonomy in Robotic Surgery

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of the needle insertion task, in which one the safety property of the system is checked as a function of the uncertainty in the measurement of the patient position. The yellow stripes on the top boxes show the safe tolerance on the approach direction of the needle. The black areas indicate the uncertainty on the needle tip position as a function of two different values of the patient position uncertainty.

23.5.10  L  esson Learned from the I-SUR Project The results of the I-SUR project showed that many technologies for autonomous surgical robots are available and can be used to develop a working system, if they are combined in a structured and robust framework. Among the technologies used, standard control, sensing, and estimation algorithms are well established and can be included in a future cognitive system without problems. However the project showed also two major limitations that would hamper further development of an autonomous surgical robot. The first limitation is the hardware setup, since a laboratory prototype, although sophisticated and well manufactured, has not enough credibility with the medical community and it is not reliable enough to carry out long and complex experiments. The second limitation is in the methods used for knowledge representation, which are not general enough to address the full spectrum of surgical procedures. In particular, I-SUR followed a “top-down” approach to knowledge representation, starting from textbook models and interviews with surgeons and representing the task with the domain-goal-operation models that may not reflect the reality of actual surgical interventions. Thus it would be worth exploring different approaches to surgical knowledge representation and to integrate them with models learned in a “bottom-up” mode, by examining data collected during real interventions. Thus we need true clinical data and a more reliable hardware platform to make progresses in the development of autonomous surgical robots.

23.6 C  urrent Steps in the Design of an Autonomous Surgical Robot

Fig. 23.19  The da Vinci Research Kit installed at the University of Verona

University and Worcester Polytechnic Institute to form the da Vinci Research Kit (dVRK) [40]. The dVRK at the University of Verona is shown in Fig. 23.19, and it proved to be an invaluable tool for research. The dVRK software is ROS (Robot Operating System) [41] based and can count on a very large library of functions, some of them have been expressly designed for robotic surgery. The dVRK system is the solid foundation to develop new hardware and software components for surgical robots, both teleoperated and autonomous. In particular, new hardware is needed to collect more information about the interaction of surgical instruments and tissues and on the biomechanical properties of pathological tissues. This new hardware can be developed and tested using the dVRK platform, and its validation using this realistic setting will make it a credible candidate for the future generation of robotic surgical instruments.

23.6.1  Methods of Knowledge Representations

There are many other methods for the formal representation of action knowledge besides the approach described The limitation about the hardware platform on which to in the previous sections. In fact, in [42] the following main develop novel algorithms and architectures for autonomous ­categories are described: situation calculus, ontologies, temsurgical robots has been solved thanks to the kind donations poral and dynamic logic, action sequence representation, by Intuitive Surgical. In fact, many models of the first ver- state machines, Petri nets, and system flowcharts. These catsion of the da Vinci Surgical System that has now reached egories are briefly summarized below. the end of its clinical life have been donated to laboratories In situational calculus [43], actions represent a change worldwide. To be used for research, i.e., changing the robot in the belief about the world in the form of first-order logic hardware and software and avoiding breaking patent and and represent an entity that changes, whereas a situation repcopyright rules, these robots must be enhanced with open-­ resents a sequence of actions. A constant S0 represents the source hardware and software developed by John Hopkins initial situation, and an action sequence follows the situation

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from right to left. Actions are represented with functional symbols such as put(A;B) and situations are represented as first-order terms such as do(put (A;B);s). In this representation, there is the qualification problem [44], where an axiom could not infer a possibility of an action. The predicates whose values become different from situation to situation are called fluents [45]. To represent the world dynamics, action precondition and action effects are used. The former has to be true to execute the action and action effects represent the fluents, which change because of the action. With the evolution of knowledge-based systems, ontologies have been used to separate action sequences from the logical assertions, where real-world instances are specified in action libraries [46]. Action libraries contain a set of actions that are frequently used within a given domain and can be represented based on the logical inference steps, which were implemented in Description Logic (DL) and Web Ontology Language (OWL) [47]. Abstract structure for an action in a task is specified using class restrictions in OWL.  Three knowledge levels were defined for a class called action knowledge, i.e., (1) primitive behavior level, which includes motion as preconditions and action effects as well as feature extraction algorithms for perception; (2) task level, which defines long-term goals for the symbolic preconditions and action effects; and (3) the subtask level, which defines functions. Temporal and dynamic logic are used to translate the robot instructions into action goals and action sequences [48]. When applied together, temporal logic translates robot instructions into action goal, and then dynamic logic is used to detect the action sequence, which is used in execution planning. Here, instead of translating instructions into actions, the instructions are transformed into propositions and then an action sequence is derived. Recently, temporal logic of robot actions has been used for motion and task planning and for generating robot controllers [49]. Various action representations have been used for task planning in robotics. For example, the classical STRIPS plan language attempts to find a sequence of operators, which proves the given goal. STRIPS is a declarative description of actions, or operations, pre- and post-conditions, and effects, where the description of the world is specified in first-order predicate calculus [50]. An action applies to any state that specifies the precondition. Otherwise, the action does not have effect. However, representations with STRIPS were found to be insufficient to represent real-world action sequences and complex predicates. As an advancement to STRIPS, Action Description Language (ADL) was developed, laying between STRIPS and situational calculus [48]. State machines, Petri nets, and system flowcharts are other frameworks for programming robots to perform tasks in unknown environments, such as an anatomical environment. For simple systems and with a low autonomy level,

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task scripting is enough. However, the programmer must ensure that the robot can evolve from failure modes without depending excessively on human intervention. When an increase of robot autonomy is needed, the robot must be capable to plan, execute, and replan the tasks that need to be done. Task planning is the answer to the previous issues, also allowing to scale for more complex scenarios. ROS (Robot Operative System) [41] is currently the standard choice for development of robotic applications since it embeds a set of functionality for task plan execution, e.g., SMACH (“State MACHines”) [51] (that implements state machines) and Petri Net Plans (PNP)-ROS [52] (that implements Petri nets). Other frameworks do exist, e.g., the system flowchart (SFC) framework [53]. SMACH is a Python library that allows designing complex robot tasks and changing the robot behavior. It is based on hierarchical state machines. PNP comprises basic structures that can represent the execution phases of actions, needed to perform a given task, e.g., initiation, execution, termination, and transitions. The latter are very important because it represents the events that have conditions to control state triggering. In [54] a three-layered Petri net model is proposed, which comprises the environment, action executor, and finally the action coordination layers. The environment layer represents the environment discrete-­state event-driven dynamics that results from the human-­ robot actions and the physical environment. The action executor layer represents the actions, e.g., changes in the environment and the conditions that they can occur. The action coordination layer is the one where the task plans, composition of actions, are defined. This brief summary of techniques shows some of the answers the scientific community has given to the growing need for autonomy in robotic systems, to plan actions and their sequences. Research studies have also been performed for optimizing, understanding, and managing the action sequences. The current focus is on modeling action sequences for task planning and execution based on a topdown approach. Several options do exist to represent and deploy such action representations and frameworks in real robots. In particular, if there exists an ROS implementation, it should be preferred to other alternatives, because of the large availability of tools and modules. However, these methods do not account for the actual execution of the same task by a human agent, and autonomous action sequences have never been compared to action sequences by expert surgeons. From a regulatory point of view, it is not clear whether ROS-based architectures can be medically certified; thus, a laboratory prototype could not be directly converted into a medical product. Furthermore, from a liability point of view, an autonomous surgical robot must reach the same level of performance of its human counterpart. However, we do not have proofs that an action sequence built using the methods above is comparable to the same task carried out by a human.

23  Automation and Autonomy in Robotic Surgery

Initial comparisons are reported in the literature, for example [19], describing an autonomous robotic suture, but the environment is not realistic and the autonomy is rather limited. Thus an in-depth analysis of data from real robot-assisted interventions must be performed to identify the task model followed by the surgeon and compare it with the models built by an artificial reasoning system, to ensure the equivalence between autonomous and human tasks.

23.7 Conclusions The goal of describing automation actions and autonomy functions in a surgical robot is very ambitious, and this chapter barely scratches the surface of the very large body of work addressing different aspects of automation and autonomy. However, this section briefly presents some of the key issues of automation and autonomy in robotic surgery. Initially, after defining in Sect. 23.2 the main concepts and terminology of robotic surgery, this chapter addresses the differences between automation and autonomy in Sect. 23.3. This distinction is very often forgotten, encompassing everything under the general term of “autonomy” (or artificial intelligence). Instead, the two fields are conceptually very different, and they complement each other and interact with each other in ways that have not yet been fully studied. Furthermore, a surgical robot is a teleoperated device with architecture of the type described in Sect. 23.4; thus, autonomous functions can only be added to certain points of the architecture to avoid disrupting the flow of controls and data. The technologies necessary to build an autonomous robot are presented by describing the I-SUR project, funded by the EU FP7 Programme, which addressed the autonomous execution of puncturing and suturing tasks. For the sake of brevity, only the puncturing task is described in some detail. The approach to autonomously execute a puncturing task was to develop a model of the task from which the programs controlling the surgical robot could be directly generated. The goal model used in I-SUR is described in Sect. 23.5 making a distinction between the components that are standard elements of every robotic system, e.g., sensor data processing and user interface, and those that are specific to an autonomous system. In particular, the knowledge representation is described in some detail in Sect. 23.5.2 together with the UML model that permits to generate the code of the state machine described in Sect. 23.5.3. The key part of this section is the description of the I-SUR control architecture, presented in Sect. 23.5.7. Figure 23.15 shows the main elements of the architecture, the data flowing among them, and the interactions between all the elements. The integration of the autonomous functions in the structure of a teleoperation system for surgery is described in Sect. 23.5.8 addressing the haptic part of the human interface, an important function still

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missing in most surgical robots. The main lessons learned during the I-SUR project are summarized in Sect. 23.5.10 to introduce two of the current research directions in autonomous robotic surgery. Section 23.6 of this Chapter describes the major hardware improvement achieved by a few laboratories worldwide thanks to the donation by Intuitive Surgical of their da Vinci first-generation systems. These laboratories, together with those using the RAVEN II [55] surgical robot, have formed a research and development network that supports common research projects and exchange of ideas and people. Furthermore, Sect. 23.6 surveys the main methods that are available to represent in a formal way the knowledge necessary to carry out a surgical task. Several models, spanning a few decades of research, are briefly described in this section, since the cognitive model of the task, with all its uncertainties and bifurcation points, is the main challenge in developing autonomous surgical robots. As mentioned previously, there are many challenges facing the addition of autonomy to surgical robots and it is worth mentioning at least the most significant ones. The technical challenges still refer to knowledge representation, since all the approaches described above are “top-down” models, i.e., formalization of textbook knowledge. These models should be validated by comparing them, in some way, to the execution of the same task/procedure by an expert surgeon. To do this, it is necessary to acquire data of clinical procedure, which is not a simple task, and either compare the real data to those generated by the autonomous robot or directly compare the top-down model to a task/procedure model extracted from the data. Since it is not possible to perform an autonomous intervention on a human, a direct data comparison may not be very meaningful, and therefore the best approach is to extract a task model from the clinical data and compare the two mathematical representations. This is a very challenging task, since there is no advance knowledge of how the surgery actually evolved, on how the surgeon interpreted the data, and how she/he reacted to the different situations raising during the intervention. Unsupervised learning method could be used to address this inverse problem, which will try to develop a mathematical model that closely approximates the unknown mental model followed by the surgeon during the intervention. The nontechnical challenges of autonomy in robotic surgery refer to the certification process that, at the moment, forbids the use of medical devices with some degree of autonomy and to the legal implications of using an autonomous robot in a safety critical activity such as surgery. Both regulatory and legal aspects are not described yet in any national or international document, but many organizations are developing guidelines to start addressing these issues. International standards are being developed to regulate medical devices endowed with one or more degrees

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of autonomy. The central issue is the learning capability of these devices, which will change their behavior by adapting it to different cases from those considered during the design and at deployment in a hospital. This capability violates the strict deterministic nature of a medical device and cannot be predicted nor tested by the device designers. Thus some form of supervisory control that checks the correctness of the adaptation will have to be developed to allow the commercialization of these devices. Ongoing studies by the European Commission seem to indicate that no modifications to the current liability laws are required to protect citizens from mistakes made by autonomous systems, since current laws are probably adequate. The key element in this case is to demonstrate that an autonomous system performs as its human counterpart, i.e., in the case of robotic surgery that an autonomous surgical robot is capable to carry out an intervention with the same quality a human surgeon will do. Mistakes made by an autonomous robot could be compared to those made by a human surgeon, who is liable, together with his/her employer, of errors made during the practice of surgery. In the case of an autonomous robot, the burden of demonstrating the robot capability will be on the robot manufacturer, which will have to establish the level of surgical competence of the autonomous robot. Thus, new and more sophisticated benchmarks need to be developed to test the capabilities of autonomous surgical robots in increasingly complex scenarios. Benchmarks will be the key to build a solid confidence on the robots’ capabilities to understand and react to clinical situations as a human surgeon would do, and the process of medical certification for surgical robots will need to be developed.

References 1. Shah J, Vyas A, Vyas D. The history of robotics in surgical specialties. Am J Robot Surg. 2014;1(1):12–20. 2. Robot Assisted Surgery. Updated 11 July 2019, cited 24 July 2019. Available from: https://en.wikipedia.org/wiki/ Robot-assisted_surgery. 3. Intuitive Surgical Corp. cited 24 July 2019. Available from: https:// www.intuitive.com. 4. Fong Y, Woo Y, Hyung WJ, Lau C, Strong VE. The SAGES atlas of robotic surgery. Cham: Springer International Publishing; 2018. 5. Lang JE, Mannava S, Floyd AJ, Goddard MS, Smith BP, Mofidi A, Seyler TM, Jinnah RH.  Robotic systems in orthopaedic surgery. J Bone Joint Surg Br. 2011;93(10):1296–9. https://doi. org/10.1302/0301-620X.93B10.27418. 6. Davies B. A review of the state-of-the-art of ‘smart’ systems in surgery. Int J Intelligent Syst Technol and Appl. 2010;8:423–33, ISSN: 1740-8865. 7. Bagga V, Bhattacharyya D. Robotics in neurosurgery. Ann R Coll Surg Engl. 2018;100(6_suppl):23–6. https://doi.org/10.1308/ rcsann.supp1.19. Published online: 2 May 2018. 8. Accuray Corp. Cited 24 July 2019. Available from: https://www. accuray.com.

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23  Automation and Autonomy in Robotic Surgery 29. van Lamsweerde A. Requirements engineering: from system goals to UML models to software specifications. Chichester: Wiley; 2009. 30. “FLAGS Graphical Designer,” http://code.google.com/p/flags/. 31. Jackson D. Alloy. 2012. Available at: http://alloy.mit.edu/. 32. Baier C, Katoen J-P.  Principles of model checking. Cumberland: MIT Press; 2008. 33. Preda N, Ferraguti F, De Rossi G, et al. A cognitive robot control architecture for autonomous execution of surgical tasks. J Med Robot Res. 2016;1(4):1650008; (19 pages). 34. Baresi L, Pasquale L. Live goals for adaptive service compositions. In: Conference SEMS’10, 2010, May 2–8, Cape Town. 35. Baresi L, Pasquale L.  Adaptation goals for adaptive service-­ oriented architectures. In: Conference SEMS’10, May 2–8, 2010, Cape Town. 36. Object Management Group. UML v. 2.2 superstructure specification document N. formal/2009–02–02. 2009. Available at http:// www.omg.org/spec/UML/2.2/. 37. Mathiassen K, DallAlba D, Muradore R, Fiorini P, Elle OJ. Robust real-time needle tracking in 2D ultrasound images using statistical filtering. IEEE Trans Control Syst Technol. 2017;25:1. 38. Ferraguti F, Preda N, Manurung A, Bonfe M, Lambercy O, Gassert R, Muradore R, Fiorini P, Secchi C. An energy tankbased interactive control architecture for autonomous and teleoperated robotic surgery. IEEE Trans Robot. 2015;31:1073–88. 39. Muradore R, Bresolin D, Geretti L, Fiorini P, Villa T.  Robotic surgery—formal verification of plans. IEEE Robot Autom Mag. 2011;18:24–32. 40. da Vinci Research Kit wiki community. Updated 30 Sept 2018, cited 24 July 2019. Available from: https://research.intusurg.com/ index.php/Main_Page. 41. Robot Operating System. Cited 24 July 2019. Available from: https://www.ros.org. 42. Nakawala H, Goncalves P, Fiorini P, Ferrigno G, De Momi E.  Approaches for action sequence representation in robotics: a review. In: International Conference on Intelligent Robots and Systems, 2018, Madrid.

255 43. Levesque H, Pirri F, Reiter R. Foundations for the situation calculus. Electron Trans Artif Intell. 1998;2(3–4):159–78. 44. McCarthy J.  Human-level AI: the logical road. 2018. Available from http://jmc.stanford.edu/articles/logicalai.html. 45. Thielscher M.  Introduction to the fluent calculus. Electron Trans Artif Intell. 1998;2(3–4):179–92. 46. Baader F, Horrocks I, Sattler U. Chapter 3. Description logics. In: van Harmelen F, Lifschitz V, Porter B, editors. Handbook of knowledge representation. Amsterdam: Elsevier; 2007. 47. Tenorth M, Beetz M. A unified representation for reasoning about robot actions, processes, and their effects on objects. Presented at IEEE/RSJ International Conference on Intelligent Robots and Systems; 2012, Vilamoura, Algarve. 48. Dzifcak J, Scheutz M, Baral C, Schermerhorn P. What to do and how to do it: translating natural language directives into temporal and dynamic logic representation for goal management and action execution. Presented at IEEE International Conference on Robotics and Automation; 2009, pp. 41634168. 49. Kress-Gazit H, Fainekos G, Pappas G.  Temporal-logic-based reactive mission and motion planning. IEEE Trans Robot. 2009;25(6):1370–81. 50. Fikes RO, Nilsson NJ. STRIPS: a new approach to the application of theorem proving to problem solving. Presented at IJCAI, 1971, Sept 1–3, London. 51. Bohren J, Cousins S.  The SMACH high-level executive [ROS news]. IEEE Robot Autom Mag. 2010;17(4):18–20. 52. Ziparo VA, Iocchi L, Lima P, Nardi D, Palamara P. Petri net plans— a framework for collaboration and coordination in multi-robot systems. Auton Agent Multi-Agent Syst. 2011;23(3):344. 53. Haage M, Malec J, Nilsson A, Stenmark M, Topp EA.  Semantic modelling of hybrid controllers for robotic cells. Procedia Manuf. 2017;11:292–9. 54. Costelha H, Lima P. Robot task plan representation by petri nets: modelling, identification, analysis and execution. Auton Robot. 2012;33:337. 55. Applied Dexterity Corp. Cited 24 July 2019. Available from: http:// applieddexterity.com.

Will Hydrogel Models Fabricated Using 3D Printing Technology Replace Cadavers as the Ideal Simulation Platform for Robotic Surgery Training?

24

Ahmed Ghazi

24.1 Introduction There is a serious need to improve the expertise of surgeons prior to performing procedures on live patients [1]. Training of surgeons outside of the operating room (OR) is becoming imperative given the well-defined financial, medicolegal, and ethical considerations of intraoperative training [2]. Simulation has provided opportunities for trainee and expert operators to practice basic surgical skills [3]. However, the current practice to elucidate the significant benefits of surgical simulation is limited due to the lack of a realistic, simulation platform that can impart advanced procedural knowledge required to perform an operation in its entirety. Although cadaveric and animal models may allow more realistic procedural instruction, their implementation is hindered by high cost, availability, transferable diseases, and potential ethical concerns [4]. Even with these limitations put aside, they still do not allow operative practice with specific pathology or anatomic variability that is required to achieve proficiency in higher-­level competencies including complex psychomotor, and cognitive proficiency [5]. Formal rehearsal that incorporates all aspects of full procedural learning, including relevant anatomy and pathology directly applicable to the impending intervention, is conspicuously absent, and hands-on operative training remains the vanguard of surgical training, exposing the patients to unnecessary risks. The implementation of procedural surgical simulation will only be possible with the availability of a platform that not only realistically replicates a complete procedure but is also equipped with individual characteristics that permit preoperative practice of complex procedures in an accurate and cost-effective manner [6]. With advances in 3D printing technology, coupled with software that digitalizes patient

A. Ghazi (*) Department of Urology, University of Rochester, Rochester, NY, USA e-mail: [email protected]

Digital Imaging and Communications in Medicine (DICOM) imaging data into stereolithography (STL) files, morphological features of human anatomy can be easily duplicated into procedural models. However, hard plastics remain the most widely used materials in 3D printing, and thus their applications are limited to the fabrication of hard tactile models. With a tangible copy of an organ or system, surgeons are able to make better determinations, enrich planning, and enhance the stereognosis of surgeons [7–10]. While the current practice is adequate for surgical planning, models for surgical rehearsal must advance beyond simply a visual aid to provide an interactive element with haptic feedback required to conduct an operation. Currently, none of the commercially available printing polymers can reproduce human tissue properties, and available polymers that can be easily adapted to mimic human tissue properties are challenging to constitute into printing material. Our efforts in combining 3D printing technology with polymer research have provided a platform for producing procedural hydrogel models that have the ability to accurately portray anatomical characteristics including pathological variations. We have developed the capacity to reproduce a range of tissue characteristics and replicate the entire gestalt of the operative experience [11–14]. One surgical procedure that may benefit significantly from an enhanced simulation platform is minimally invasive partial nephrectomy (MIPN). Renal cell carcinoma was associated with 63,990 newly diagnosed kidney cancer cases and 14,400 cancer-related deaths in 2017 in the United States [15]. The broad acceptance of minimally invasive techniques has made MIPN the standard of care for all individuals whenever technically feasible, independent of tumor size [16, 17]. MIPN procedures are more technically demanding with steep learning curves where the experience of the operator seems to be closely related to outcome [18–20]. Kidney phantoms that accurately represent surgically applicable anatomical, physical, functional, and acoustic properties of human tissue seem especially appropriate for training of this high-risk procedure.

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24.2 Methods 24.2.1 Construction of the Kidney Phantoms One area of simulation that has proven to be difficult is the creation of a high-fidelity process that accurately and reproducibly simulates a human anatomy and pathology. To achieve this, our group at the University of Rochester Medical Center has combined 3D printing with the hydrogel polyvinyl alcohol (PVA) to develop such simulation platforms for MIPN.  PVA is a biocompatible and inexpensive hydrogel that can be adapted to mimic human tissue properties was utilized [21]. PVA can be altered to replicate the variable mechanical properties of different tissues such as tissue parenchyma, blood vessels, tumors, and fat by varying PVA concentration and number of processing (freeze/thaw) cycles that form polymeric bonds. The desired concentration is obtained by heating commercially available PVA powder and varying amounts of water. The result is a relatively vicious gel that is shelf stable and costs under $1 per liter. The freezing process is completed at −20 ºC, and thawing is completed at 23 ºC for varying times depending on the object’s size. PVA’s phase change property is also critical a

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Fig. 24.1 (a) Segmentation of patient’s DICOM images, (b) 3D mesh, (c) soothing of the mesh in 3-matic to generate a CAD, (d) Boolean subtraction of the CAD, (e) Kidney injection mold printed in PLA with

for our fabrication process, and the induction of cross-links through successive freeze/thaw cycles polymerizes it from an injectable gel into a progressively stiffer solid texture that upholds its shape. To configure this PVA hydrogel into the geometry of a patient’s specific anatomy, a combination of additive and subtractive methods is utilized. To incorporate patient anatomy and pathology, DICOM files from a CT scan of a patient with single renal artery and moderate tumor complexity (4.2  cm in size, partially exophytic, close proximity of the PCS, and a RENAL nephrometry score of 7×) scheduled for a RAPN were imported into Mimics 20.0 (Mimics, Materialise, Belgium). Segmentation was completed for each component of the patient’s kidney including parenchyma, tumor, inferior vena cava and renal vein, abdominal aorta and renal artery, and urinary drainage system (Fig.  24.1a). Most structures were able to be isolated with the thresholding and region growing tools. Multiple slide edit was used to increase the accuracy of the segmentation for non-contrasted structures. Each component was then converted to a 3D mesh (Fig. 24.1b) and imported into 3-matic 12.0 (Mimics, Materialise, Belgium) to form a computer-­ aided design (CAD) model of the patient’s anatomy. Each structure was wrapped and corrections were b

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24  Will Hydrogel Models Fabricated Using 3D Printing Technology Replace Cadavers as the Ideal Simulation Platform for Robotic…

applied following recommendations from the fix wizard. The parts were smoothed using a combination applying a first-­order Laplacian function and local smoothing tool to remove artifacts from segmentation (Fig.  24.1c). To recreate the functional aspects of the patient’s kidney using PVA hydrogel, the CAD is then converted into an injection mold. An injection mold in its simplest form is designed by surrounding each CAD structure with a box, and using Boolean difference operation, a cavity of the same shape is formed that is converted into an injection mold by adding a parting line, injection, and air ports (Fig. 24.1d). PVA injected into these molds would retain the cavity geometry representative of the patient’s anatomy. The three main injection molds are of the tumor, kidney, and renal hilum (Fig. 24.1e, f). Once all injection molds are designed, they are printed in a hard plastic (PLA) on a Fusion3 F400-S 3D printer (Fusion). To incorporate the functionality of the model in terms of bleeding and urine leakage, the hilar structures (arterial, a

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Fig. 24.2 (a) Hilar structures (arterial, venous, and calyx urinary systems) printed in dissolvable PVA filament, (b) hallow, watertight hilar structures, (c) kidney injection mold housing hilar plug and tumor pre-

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venous, and calyx urinary systems) were printed using dissolvable PVA filament using a FlashForge Creator Pro and coated with processed PVA (Fig.  24.2a). Once the layers are solidified, the inner PVA filament is dissolved in water to create a hollow, watertight vascular, and urinary system (Fig. 24.2b). All these structures are then registered into the hilar mold and surrounded by fat, which will form the hilar plug. Simultaneously, the tumor mold is also injected with PVA hydrogel mixed with silica powder or iodinated contrast to mimic the acoustic appearance of these tissues under ultrasonography and X-ray imaging. The kidney injection mold will form the kidney, encasing the preformed tumor and hilar plug to form a single entity (Fig. 24.2c). This mold will be injected with PVA previously tested to duplicate the mechanical properties of human kidneys as described below. The result is a simulated kidney that matches the patient anatomy (Fig. 24.2d). b

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24.2.2 Validation of Model’s Mechanical Properties 24.2.2.1 Mechanical Validation Guided by studies demonstrating that porcine kidneys can be utilized as human surrogates [22, 23], we tested fresh porcine kidney specimens to model the mechanical properties desired in our PVA kidney models. By varying PVA concentration and the number of F/TC, we identified fabricating conditions to create a kidney phantom that most closely replicates the mechanical properties of a porcine kidney [24].

Norwood, MA) with a 1000 N load cell was used and data acquisition and testing protocol was handled by Bluehill software (Instron Corp; Norwood, MA). Porcine and PVA samples were compressed along their heights, corresponding with the radial vector, at a rate of 10 mm/minute and continued until failure. Strain was calculated as a percent change in height (mm/mm). Stress was calculated as force measured (N) over initial area (mm^2). The root-mean-square error (RMSE) for each plot representing the average data from each PVA kidney version was compared with the average kidney data from all porcine specimens.

24.2.2.2 Uniaxial Compression Testing Five porcine kidneys were obtained within 24  hours after death and kept at 4°C until testing. Ten uniform specimens (50 total specimens) were carefully cut out from the cortex, using an 8  mm punch with a height of 5  mm. Six experimental conditions (7% and 10% PVA solutions at two, three, or four FT cycles) were created, 200 mL blocks, the approximate volume of an average kidney. Ten uniform samples of each condition were cut from the blocks (60 total specimens). Samples were placed on sandpaper-covered test plates in order to create a no-slip boundary, and excess fluids were removed between tests as suggested by Miller K [25] (Fig.  24.3). An Instron ElectroPuls™ E10000 LinearTorsion All-Electric Dynamic Test Instrument (Instron Corp;

24.2.2.3 Suture Pull Through Test The suturing mechanics of the ex vivo PVA and fresh porcine kidneys were compared by measuring suture tension force and displacement across a parenchymal defect. A uniaxial suture tension test was performed in accordance with a published preclinical model of sliding-clip renorrhaphy [26]. For each of the six PVA and fresh porcine kidneys, a 3-inch long, 2-inches deep longitudinal incision was made along the length of the lateral kidney surface. Three, 6-inch, 0-Vicryl, CT-1 sutures with Hem-o-lok (Teleflex Medical, Research Triangle Park, NC) clips were then placed deep and equally across the incision using the sliding-clip technique [27] (Fig.  24.4). Tension was placed on the sutures in the same manner as in the sliding-clip renorrhaphy closure using

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Fig. 24.3 (a) Fresh porcine kidneys, (b) uniaxial compression testing of PVA or porcine cubes

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24  Will Hydrogel Models Fabricated Using 3D Printing Technology Replace Cadavers as the Ideal Simulation Platform for Robotic…

Fig. 24.4  Porcine kidney placed in a specifically designed 3D printed support tray with vertical slits to allow passage of the sutures. The tension was continued till the visual closure of the defect and continued till sutures rip through parenchyma

a customized mechanical testing device. The force needed to achieve closure of the defect continued up to the maximum force necessary to tear the clip through the kidney in six PVA and fresh porcine kidneys.

24.2.3 Determining the Model’s Anatomical Accuracy To validate that our process of fabrication is anatomically accurate, three, 7% PVA kidney models (each containing tumor, artery, vein, and calyx) were created from the same patient’s anatomy. To replicate and determine enhancement of tissue on CT imaging, tumors in each model had varying concentrations of silica powder (0%, 1%, and 2%) (Fig. 24.5). To replicate triphasic CT scanning, 20% contrast was backfilled into the calyx, artery, and vein within the kidney. The phantoms were scanned at a spatial resolution of 0.3  mm (CT scanner, Somatom; Siemens Healthcare) and DICOM images exported. A similar process of segmentation and surface reconstruction was performed using the models’ DICOM images. The separate CAD files from patient’s original imaging and matching PVA kidney phantom were overlaid. The PVA kidney was aligned with the patient’s kidney using N points registration and global registration tools with the tumor, vessels, and calyx defined as move along entities. Several iterations of the global registration tool were completed using input from a subset of 50% of the data points and continued until the error level stabilized. A detailed

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Fig. 24.5 (a) CT imaging of synthetic PVA kidney specimens with three versions of silica powder (top down 0%, 1%, 2%), (b) corresponding PVA models with tumors

quantitative error analysis performed using the part comparison tool in the analysis module of 3-matic (Mimics 3-matic; Materialise, Belgium). The entity is selected from the model and the target entity is selected from the corresponding patient’s structure. A visual representation of the discrepancies between the model and patient is displayed over the surface of the CAD of the model in millimeters guided by a distribution of error bar. A visual representation of this distance is overlaid on the original patient’s CAD derived from the original imaging for each separate component of the kidney as demonstrated in Fig. 24.6. Further metrics obtained from this analysis include mean, standard deviations, and quartile distributions.

24.2.3.1 Development of Procedural Simulation Platform To recreate the entire operative experience, a full procedural rehearsal platform containing the hydrogel kidney, surrounding musculature, peritoneum, fat, and any other pertinent organs defined by patient anatomy was fabricated. The rest of the relevant structures of the abdomen are constructed via the same process described to form the kidney. Correct anatomic layers were recreated starting with the posterior abdominal musculature, and then the kidney, peritoneum,

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fat, mesentery, bowel, and liver or spleen were added one at a time within a custom pelvic trainer (Fig. 24.7a). A final FT creates organ cohesion (Fig. 24.7b). The trainer is covered in a simulated abdominal wall and rehearsal occurred using the da Vinci surgical robot (Intuitive Surgical, Sunnyvale, CA) in a simulated OR environment (Fig. 24.7c). The emphasis was placed on a model incorporating all steps of the procedure including (a) exposure of the tumor-bearing kidney, (b) vascular control of the renal hilum, (c) identification and exposure of the renal mass under ultrasound guidance (Fig. 24.7d), (d) excision of the tumor with negative margins, and (e) reconstruction by closure of medullary vascular and collecting system structures avoiding postoperative bleeding and urine leakage (Fig. 24.7e, f). The fabrication process also includes reproducing genuine operative metrics of performance (blood loss, tumor margins, ischemia time, and the potential for complications).

24.2.3.2 V  alidation of Procedural Simulation Platform Preliminary surgical verification was performed on this model using the da Vinci Surgical System (Intuitive Surgical, CA, USA). Following institutional IRB approval, 20 participants with varying levels of experience [28] at Urology Department at the University of Rochester were recruited. Six experts with >150 upper-tract robotic cases and 14 novices with  = 72 vs. 90%) with a cervical rib are asymptomatic [77– 79]. However, in a small number of patients the presence of cervical ribs may be associated with a diminished or absent radial pulse, which is further reduced with abduction of the arm, reduced sensation, or a painful and weakened hand. Patients may also complain of tingling and numbness of the ulnar part of the forearm and hand. Cervical ribs may mimic a palpable mass in the supraclavicular fossa that at times may be pulsatile due to displacement of the subclavian artery. In symptomatic patients, symptoms can be classified as neurologic or vascular.

41.3.1 Neurologic Symptoms Most patients with cervical ribs suffer due to compression of the brachial plexus [79, 80]. Neurological symptoms are associated with small cervical ribs that articulate with a fibrous band with the first rib or other adjacent transverse processes. In these patients, the brachial plexus is compressed under the fibrous band. Patients with a neurological manifestation may complain of intermittent, migrating pain in the affected upper limb and paresthesia and numbness in the affected ulnar side of the forearm. A cervical rib may distort the lower part of the brachial plexus, especially the eighth cervical and first thoracic nerve roots. Cervical ribs may compress the nerves of the brachial plexus and slightly weaken motor strength of the muscles of the forearm and hand. Compression of the nerves may be especially manifested at the forearm, thenar, hypothenar, and interosseus muscles, or clawing of the little, ring, and middle fingers. It has been noted that cervical ribs may also induce subclinical nerve damage [81]. A correct diagnosis of compression of the brachial plexus elicited by the cervical rib should include the exclusion of carpal tunnel syndrome, neuritis of ulnar nerve, or entrapment syndromes of the prolapsed ulnar or cervical disc.

41.3.2 Vascular Symptoms Vascular manifestations of cervical ribs are associated with compression of the subclavian artery by the rib. Usually longer and more complete ribs are associated with arterial com-

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pression. Patients with vascular manifestation of cervical ribs may present with discoloration of the hand, claudication, diminished distal pulses at wrist, prolongation of capillary refill, and even distal embolization and gangrenous changes at the fingertips. The systolic blood pressure may be decreased, and bruits may be heard in the neck. The Adson test may be positive during hyperabduction of the upper extremity. Depending on the degree and location of compression of the subclavian artery, cervical ribs may be associated with cerebral embolism, recurrent stroke in the young, cerebellar infarction, a subclavian aneurysm, and thrombosis of the subclavian artery. Cervical rib syndrome (CRS) has to be differentiated from other conditions that result in neurovascular symptoms of the upper extremity. Cervical syndrome is a distinct pathophysiologic entity and, therefore, it should not be included under thoracic outlet syndrome. The treatment of CRS depends on symptoms. Conservative treatment includes the use of anti-inflammatory analgesics (NSAIDs), muscle relaxant drugs, physiotherapy, and lifestyle changes. Physical therapy is used to strengthen the muscle of the shoulder girdle [82]. In the event of failure of conservative therapy or the presence of acute vascular or neurological manifestations, resection of the cervical rib, the associated bands, and neurovascular decompression is advised. Historically, cervical ribs have been excised using the supraclavicular or the transaxillary approach. Supraclavicular excision is preferred due to safety and good exposure of cervical rib [82].

41.4 Thoracic Outlet Syndrome (TOS) 41.4.1 Conventional Thinking about TOS Since Peet’s classification of TOS in 1956, conventionally TOS has been thought to represent a group of diverse disorders that result in compression of the neurovascular bundle exiting the thoracic outlet. The thoracic outlet has been defined as the triangular anatomical area between the clavicle and the first rib and the neck muscles which allows for the passage of the brachial plexus, subclavian artery, and ­subclavian vein. Compression of this area has been thought to result in a constellation of distinct symptoms, which can include upper extremity pallor, paresthesia, weakness, muscle atrophy, pain, and swelling [83, 84]. Until recently, TOS classification has been based on symptoms, rather than the underlying pathology, with the subgroups consisting of neurogenic (NTOS), venous (VTOS or PSS), and arterial (ATOS) [85]. Neurogenic TOS (NTOS) can be further divided into true and disputed NTOS, with disputed reportedly representing 95–99% of all neurogenic cases [86]. The symptoms of true and disputed NTOS are

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largely the same, though objective findings from motor nerve conduction studies and needle electromyography are notably absent in the disputed NTOS. The true incidence of TOS is difficult to discern. However, depending on the definition and diagnostic modality, the incidence of TOS has been reported to range from 3/1000 to 80/1000 [4]. Neurogenic TOS accounts for over 95% of the cases, followed by venous (3–5%) and arterial (1–2%) [85]. Historically, TOS presents with symptom onset between the ages of 20 and 50 years (Tables 41.1 and 41.2). The demographics are different for the three types of TOS.  It has been reported that NTOS is more prevalent in women with a female to male ratio of 4:1 [87]. True NTOS most commonly affects a younger woman in their teenage years and is usually unilateral. Disputed NTOS is most commonly seen in women ranging from their 20s to 60s and is often bilateral [86]. Table 41.1  Thoracic outlet syndrome demographics Highly underdiagnosed Up to 8% of the population Majority in third to fifth decade of life Female: Male 4:1 Neurologic symptoms (neurogenic?) 95% Vein symptoms (venous) 3–4% Artery symptoms (arterial) 1%

Table 41.2  Symptoms of thoracic outlet syndrome Pain Numbness Tingling Weakness Fatigue Swelling Fig. 41.2  The interscalene triangle is created by the anterior scalene muscle anteriorly, middle scalene muscle posteriorly, and first rib inferiorly. The costoclavicular space is a “>” shaped space on the right and “” shaped space on the right and “5 cm) • Closure under tension • Observed tearing of the R crus

b

Fig. 49.7  Bioabsorbable mesh is cut to size to reinforce the closure of the diaphragmatic defect; (a) “U-shaped”mesh; (b) “reverse C”-shaped mesh. The mesh is placed onlay and secured in place with interrupted stitches at 1, 4, 8, and 11 o’clock around the circumference of the hiatus

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• Redo operations • Relaxing incisions • Obese patients with large hiatal hernias

49.10.1  Note The idea of the “reverse C”-shaped mesh is to provide reinforcement to the anterior and left lateral aspect of the hiatus, since these are known site for recurrences.

49.11 Antireflux Procedure We routinely perform a fundoplication following a paraesophageal hernia repair. The majority of patients undergo a floppy Nissen fundoplication gauged over a 56 Fr bougie. The bougie is not inserted for the first stitch of the fundoplication. Three 2–0 silk stitches are used to create the wrap, and the most distal stitch is used to attach the wrap to the esophagus. The fundus of the stomach is exposed with two graspers, then the posterior fundus is pulled behind the esophagus. A “shoe shine” maneuver is performed to make sure the right and left sides of the fundoplication are symmetric. The right and left graspers then bring the fundus together on the anterior esophagus (Fig. 49.8). At this time, Arm# 4 holds both sides of the fundus in place while swapping for placement of the first stitch of the fundoplication.

Fig. 49.8 Nissen fundoplication: The fundus of the stomach is exposed with two graspers, then the posterior fundus is pulled behind the esophagus. The right and left graspers then bring the fundus together on the anterior esophagus. Three 2-0 silk stitches are used to create the wrap, and the most distal stitch is used to attach the wrap to the esophagus

C. A. Galvani and M. R. Youssef

Two additional stitches are placed about 1 cm apart. At the completion of the procedure, the bougie is carefully removed. Upper endoscopy is routinely performed at the completion of the case to check the indemnity of the esophagus, stomach, and the adequacy and patency of the fundoplication (Fig. 49.9)

49.11.1  Note The fundoplication not only prevents reflux but also anchors the stomach in the abdomen. Our preferred approach is to tailor the fundoplication to preoperative motility; however, in older patients where the manometry was not technically feasible a partial fundoplication is routinely used. Insertion of the bougie by the anesthesia team should be closely monitored by the operating surgeon. Frequent verbal communication is a must. Gently anterior traction of the Penrose drain by the surgeon straightens up the esophagus to facilitate the entrance of the bougie into the esophagus. We routinely use 56 F bougie; however, in smaller patients, a smaller bougie size is used to prevent mucosal tearing. Construction of the fundoplication should be with the fundus of the stomach and not with the body of the stomach to avoid redundant gastric tissue posterior to the esophagus. An adequate fundoplication decreases the incidence of postoperative dysphagia.

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Fig. 49.9 Postoperative upper endoscopy: Upper endoscopy is routinely performed at the completion of the case to check the indemnity of the esophagus, stomach, and the adequacy and patency of the fundoplication

49.12 R  obotic-Assisted Reoperative Foregut Surgery Special consideration must be given to patients who have persistent, recurrent, or new foregut symptoms (heartburn, dysphagia, chest pain, regurgitation, asthma, hoarseness, chronic cough, or laryngitis) after antireflux surgery, patients that have confirmed physiologic abnormalities (objective evidence of failure) or patients that have a recurrent hiatal hernia. It is well known that revisional foregut surgery is complex and has increased morbidity. A systematic review reported that only 36.3% of cases were done laparoscopic, and 34.7% were with an open laparotomy and 22.7% had a thoracotomy [11]. This review also reported 21.4% of intraoperative complications, 15.6% postoperative complications, 0.9% incidence of death, and a conversion rate of 8.7%. The authors reported that morbidity was most frequently caused by direct injury of the esophagus and stomach during reoperation. For those reasons, we believe that robotic surgery is specialized suited for reoperative foregut surgery since it offers enhanced exposure and visualization of the tissue planes that may be complicated by adhesions and the postoperative anatomy of the index procedure. Lysing of the adhesions between the left lobe of the liver and the anterior wall of the stomach, taking down the previous fundoplication and the mediastinal dissection using robotic scissors are particularly advantageous with the use of the robotic system.

Robotic surgery is also beneficial while considering the options for revision. The appropriate revisional procedure should be decided based upon patient’s symptoms, preoperative workup (e.g., gastroparesis), patterns of failure (intrathoracic wrap migration, wrap disruption, slipped fundoplication, tight wrap, misplaced wrap), patient’s body habitus at the time of the reoperation (obesity vs morbid obesity), and intraoperative findings. Our preferred revisional procedures are: • Redo fundoplication (partial or total) with or without hiatal hernia repair if present –– With or without Pyloroplasty • Conversion to Roux-en-Y (RNY) anatomy

49.13 O  perative Principles for Robotic Revisional Foregut Surgery 1. Adhesiolysis • Detach the fundoplication, the GE junction, and the esophagus from the liver and the crura 2. Perform crural dissection and circumferential dissection of the esophagus in the mediastinum 3. Take down the prior fundoplication (Fig. 49.10) 4. Perform crural closure (mesh vs no mesh) 5. Step 5. • Redo fundoplication • Conversion to Roux-en-Y (RNY) anatomy

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C. A. Galvani and M. R. Youssef

Fig. 49.10 Revisional foregut surgery: take down the prior fundoplication

49.14 Postoperative Instructions It has been documented that the majority of patients experience transient gastrointestinal symptoms after antireflux surgery. [12] Nonetheless, the symptomatology subsides in the majority of patients within 3 months of the initial operation. Some of the most common side effects of the surgery are: • • • • •

Subcutaneous emphysema Postoperative shoulder pain Postoperative nausea and vomiting Postoperative dysphagia Flatulence and gas bloating syndrome

49.15 Outcomes The gold standard for repairing PEHs is the laparoscopic approach. Numerous studies have demonstrated that a laparoscopic repair is just as safe and effective as an open repair, with significant advantages in regard to postoperative pain and length of stay. However, the nature of paraesophageal hernias poses a distinctive challenge for the surgeon due to its morbid anatomy and the many procedural steps described to obtain optimal results. In addition, patient factors such as age >70, obesity, comorbidities, play a significant role in the incidence of postoperative complications and must be taken into account preoperatively. It is also recognized that complications after paraesophageal hernia repair are significantly greater than those

observed with laparoscopic Nissen fundoplication for reflux disease [13]. Our early experience with robotic paraesophageal hernia repair demonstrated that outcomes are comparable to those achieved by the conventional laparoscopic technique [14] However, distinctive features of the robotic platform have enhanced our patient care by increasing efficiency and improving perioperative outcomes. Worth noting are surgeon-­controlled camera and the ability to flip the camera upside down that offers better exposure and visualization of the surgical field, the use of the fourth arm to facilitate practically “solo surgery”, the increased length and wristed movements of the instruments improved the transhiatal dissection of the hernia sac from the mediastinum and the circumferential dissection of the esophagus. The aforementioned benefits along with standardization of operative steps have allowed us to minimize variability and intraoperative complications. Finally, the steadiness of the crural repair using running barbed sutures has allowed us to approximate the hiatus primarily in every case with minimal use of relaxing incisions. We believe that with increase in experience and standardization of the operative steps we continue to improve our technique and observe a steady decrease in operative times without compromising the key surgical principles. Although our experience demonstrates that robotic paraesophageal hernia repair is safe, it is still a technically difficult procedure. Therefore, we recommend that before embarking on robotic paraesophageal hernia repair, extensive experience in foregut and robotic surgery and careful patient selection are critical, since these may help reduce the slope of the learning curve.

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References 1. Hutter MM, Rattner DW. Paraesophageal and other complex diaphragmatic hernias. In: Yeo CJ (ed) Shackelford’s surgery of the alimentary tract. Philadelphia: Saunders Elsevier; 2007. p. 549–62. 2. Kohn GP, Price RR, DeMeester SR, et  al. Surg Endosc. 2013;27:4409. 3. Schlottmann F, Strassle PD, Farrell TM, et al. J Gastrointest Surg. 2017;21:778. 4. Neo EL, Zingg U, Devitt PG, Jamieson GG, Watson DI. Learning curve for laparoscopic repair of very large hiatal hernia. Surg Endosc. 2011;25:1775–82. 5. Okrainec A, Ferri LE, Feldman LS, Fried GM. Defining the learning curve in laparoscopic paraesophageal hernia repair: a CUSUM analysis. Surg Endosc. 2011;25:1083–7. 6. Hill LD. Am J Surg. 1973;126:286–91. 7. Skinner DB, Belsey RHR, Russell PS. J Thorac Cardiovas- Cular Surg. 1967;53:33–54.

619 8. Stylopoulos N, et al. Paraesophageal hernias: operation or observation? Ann Surg. 2002;236:492–500. 9. Carrott PW, et al. Ann Thorac Surg. 2012;94(2):421–6. 10. Dupont FW.  Anesthesia for esophageal surgery. Seminars Cardiothor Vascul Anesth. 2000;4(1):2–17. 11. Furnée EJ, Draaisma WA, Broeders IA, Gooszen HG. Surgical reintervention after failed antireflux surgery: a systematic review of the literature. J Gastrointest Surg. 2009;13(8):1539–49. 12. Dhanabalsamy N, Carton MM, Galvani CA. Management of complications: after paraesophageal hernia repair. In: Failed anti-reflux therapy: analysis of causes and principles of treatment: Springer; 2017. p. 61–72. 13. Carlson MA, Frantzides CT.  Complications and results of primary minimally invasive antireflux procedures: a review of 10,735 reported cases. J Am Coll Surg. 2001;193:428–39. 14. Galvani CA, Loebl H, Osuchukwu O, Samamé J, Apel ME, Ghaderi I.  Robotic-assisted paraesophageal hernia repair: initial experience at a single institution. J Laparoendosc Adv Surg Tech A. 2016;26(4):290–5.

Robotic Anatomic and Physiologic Reconstruction of Paraesophageal Hiatal Hernias: Combining Lessons from a Century of Discovery and Controversy

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Farid Gharagozloo, Mark Meyer, Basher Atiquzzaman, Khalid Maqsood, Rajab Abukhadrah, Fadi Rahal, Soundarapandian Baskar, Barbara Tempesta, Hannah Hallman-Quirk, Amendha Ware, Fortune Alabi, Fred Umeh, Jay Redan, and Stephan Gruessner

50.1 Introduction For the first half of the twentieth century, hiatal hernias (HHs) were repaired “anatomically.” Since the 1950s until recently, hiatal hernia surgery has evolved from “anatomic repair” to “physiologic restoration.” The anatomic repair of hiatal hernias was not successful in relieving the symptoms in patients with hiatal hernias and reflux disease. Therefore, with greater understanding of gastroesophageal reflux disease (GERD), the pendulum moved toward purely physiologic procedures, which, to a large extent, ignored the complex anatomy of the esophageal hiatus and its role in the natural antireflux mechanism. In fact, at one time in the 1970s, investigators proposed F. Gharagozloo (*) Professor of Surgery, University of Central Florida, Surgeon-in-Chief, Center for Advanced Thoracic Surgery, Director of Cardiothoracic Surgery, Global Robotics Institute, Director of Cardiothoracic Surgery, Advent Health Celebration, President, Society of Robotic Surgery, Director, International Society of Minimally Invasive Cardiothoracic Surgery, Celebration, FL, USA e-mail: [email protected] M. Meyer Department of Surgery, Wellington Regional Medical Center, Wellington, FL, USA B. Atiquzzaman Center for Advanced Thoracic Surgery, Advent Health Celebration, Celebration, FL, USA K. Maqsood · R. Abukhadrah · F. Rahal Southlake Gastroenterology, Center for Advanced Thoracic Surgery, Celebration Health, Clermon, FL, USA S. Baskar Center for Advanced Thoracic Surgery, Lake Gastroenterology Associates, Advent Health Celebration, Celebration, FL, USA B. Tempesta Center for Advanced Thoracic Surgery, Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA

that hiatal hernias were irrelevant, and the answer was in the relief of GERD. Today, it is clear that in order to obtain the best results in symptomatic patients, both the anatomic and physiologic aspects of the complex structure at the esophageal hiatus need to be addressed. The era which was characterized by the anatomic repair of hiatal hernias was hampered by a lack of understanding of the actual anatomy of the hiatus and the gastroesophageal junction, as well as the shortcomings of the open surgical techniques. It is now clear that the antireflux mechanism is created by the complex anatomy at the esophageal hiatus. Therefore, restoring the complex anatomy of the esophageal hiatus also restores the antireflux mechanism.

H. Hallman-Quirk Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA A. Ware Center for Advanced Thoracic Surgery, Celebration Health, Celebration, FL, USA F. Alabi University of Central Florida, Department of Pulmonary and Critical Care Medicine, Florida Lung and Asthma Specialists, Advent Health Celebration, Celebration, FL, USA F. Umeh Department of Pulmonary and Critical Care Medicine, Florida Lung and Asthma Specialists, Advent Health Celebration, Celebration, FL, USA J. Redan Advent Health Celebration, Celebration, FL, USA S. Gruessner Department of Surgery, University of Illinois at Chicago, Chicago, IL, USA Formerly of Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA

© Springer Nature Switzerland AG 2021 F. Gharagozloo et al. (eds.), Robotic Surgery, https://doi.org/10.1007/978-3-030-53594-0_50

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In the past few years, a number of factors have been responsible for a slow but methodical shift back to the correct anatomic repair. These factors have included:

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presence of a hiatal hernia (HH) [6]. They believed that the cause of the hernia was the failure of the muscle of the diaphragm to closely encircle the esophagus. In 1926, Akerlund in Stockholm reported 30 more cases of esophageal hiatal • Greater understanding of the complex three-dimensional diaphragmatic defect and for the first time proposed the term anatomy of the esophageal hiatus “hiatus hernia” and classified hiatal hernias into three types • The relationship of the esophageal hiatus to the gastro- [7]. Curiously this is the same classification that is used esophageal antireflux mechanism today! He also noted that patients with HH complained of • The importance of the esophageal hiatus in providing the pain immediately after ingestion of food, sometimes “skeletal” structure onto which the gastroesophageal described “heartburn,” and sometimes complained of dysvalve is suspended phagia. He noted that “a diaphragmatic hernia through the • The non-gastrointestinal complications such as cardiac, esophageal hiatus may properly be termed a Hiatus Hernia. respiratory, and hematologic complications that are asso- They are most often true nontraumatic hernias and can be ciated with hiatal hernias classified in 3 groups: a) hiatus hernias with congenitally • Change in the definition of symptomatic hiatal hernias shortened esophagus (thoracic stomach), b) paraesophageal • Possibility of complex anatomic reconstruction using hernias, c) hernias not included in a and b.” In 1930, Max minimally invasive techniques which have been brought Ritvo, a Boston radiologist, published a series of 60 cases about from the advances in intraoperative three-­ with hiatal hernias [8]. Ritvo stated that the cause of the dimensional visualization and greater instrument dexter- “acquired esophageal orifice hernia” is the increased intra-­ ity provided by the robotic platform abdominal tension, which can be caused by conditions such as constipation, pregnancy, and obesity. He also reported epigastric pain, heartburn, nausea, vomiting, and regurgitation 50.2 Historic Perspective as clinical correlates of hiatal hernia. Despite these reports, the acceptance of hiatal hernia (HH) as a distinct entity was 50.2.1 Anatomic Approach to the Repair not universal, with such giants as Kirklin and Sauerbruch of Hiatal Hernias: An Erroneous considering the presence of hiatal hernias on radiographic Extrapolation from the Experience studies as an artifact [9, 10]. with Abdominal Wall Hernias With the use of the term, “hernia,” and the importance of inguinal hernia repair techniques in the surgical practice of Although congenital and posttraumatic diaphragmatic her- the early twentieth century, surgeons began treating esophanias were described as far back as the sixteenth century by geal hiatal defects as they would “an abdominal wall hernia.” Ambroise Pare (1579), Rivierius Lazari (1689), Giovanni In 1919, Angelo Soresi reported the first surgical approach to Battista Morgagni (1761), and Vincent Alexander Bochdalek the repair of hiatal hernias which consisted of reduction of (1848), a hiatal hernia (HH) was not recognized as a signifi- the hernia and closure of the opening of the diaphragm. cant clinical entity until the first half of the twentieth century Interestingly, he wrote: “patients suffering from this condi[1, 2]. tion are not properly treated.... This lack of interest is not The first report of a hiatal hernia was by Henry Ingersoll easily explained, because diaphragmatic hernias give rise to Bowditch, who in 1853, in a review of 88 cases with a dia- so many complicated and serious symptoms, which if not phragmatic hernia which were reported between 1610 and properly attended to, will lead the patient to an unfortunate 1846, characterized the postmortem findings in three cases life and premature death” [11]. In 1928, Stuart Harrington where “esophagus presented a very abrupt change of its published the Mayo Clinic experience treating 27 patients course. In all, it descended through the diaphragm as usual using the technique of the closure of the esophageal hiatus as but turned back toward the left to enter the abnormal aperture described by Soresi [12, 13]. Harrington emphasized that: caused by the hernia and to join the stomach in the chest” [3]. “closure of the hernia opening is essential for the relief of The advent of radiography allowed for the antemortem symptoms.” When he was not able to close the diaphragm, he visualization of the hiatal hernias. In 1900, Hirsch diagnosed sutured the herniated viscera to the edges of the hiatus (gasa hiatal hernia by means of X-rays and a mercury-filled bal- tropexy), a procedure that he called “palliative.” He recogloon prior to autopsy [1]. Eppinger diagnosed a hiatal hernia nized that such a procedure would not correct the problem, in a living patient 4 years later [4]. In 1911, in a summary of but it was the only possible action given the techniques of the the literature for diaphragmatic hernias, Eppinger identified time. It is curious that many modern surgeons continue to 635 cases, of which only 11 involved the esophageal hiatus perform “gastropexy.” He also introduced “phrenic neurec[5]. In 1925, Julius Friedenwald and Maurice Feldman tomy” via a cervical incision as an adjunct in cases of large described the symptom of heartburn and related it to the hiatal hernias where the hiatus was difficult to close. The

50  Robotic Anatomic and Physiologic Reconstruction of Paraesophageal Hiatal Hernias: Combining Lessons from a Century…

transection of the phrenic nerve was designed to result in a flaccid hemidiaphragm and allow for a tension-free closure of the hiatus. Unfortunately, the surgeons of this era did not appreciate the importance of freeing the esophagus and complete dissection of the gastroesophageal junction. Using the rudimentary X-ray imagining modalities of the 1930s, they reported the recurrence rate with this technique to be 12.5%. Paralyzing the left hemidiaphragm was a technique which was rooted in the treatment of inguinal hernias, where tension-­free repair was obtained by various “relaxing” procedures and was meant as a procedure to decrease the tension on the suture line. After two decades, the technique of phrenic neurectomy was abandoned due to the unpredictable results, complications from unilateral diaphragmatic paralysis, and the shift from anatomic repair to functional repair of hiatal hernias in the 1950s. Richard Sweet from Massachusetts General Hospital first reported the application of this technique to a transthoracic versus transabdominal repair of the esophageal hiatal hernias [14, 15]. He too applied the principles developed in the treatment of inguinal hernias, by reducing the hernia, crushing the phrenic nerve, and plicating the hernia sac. He then narrowed the hiatus with heavy silk sutures until he could get his index finger between the esophagus and the rim of the hiatus. Furthermore, Sweet suggested that, in some cases, fascia lata obtained from the left thigh would be used to reinforce the repair. Interestingly, in cases where the stomach could not be reduced under the diaphragm, he suggested that no attempt to alter the location of the cardia and stomach need be made. This erroneous concept has been carried until the modern age, as many surgeons still believe that an incomplete reduction of the entire hernia sac is acceptable. It is important to note that the inguinal and other abdominal wall hernias were a significant subject of surgical research and practice in the first half of the twentieth century. Therefore, it is not surprising that a defect in the diaphragm at the esophageal hiatus was called a “hiatal hernia” instead of a “hiatal defect,” and by extension, surgical repair was to follow the, albeit erroneous, concepts which were developed for other abdominal wall hernias. Consequently, at this time, surgeons focused on correcting an anatomic defect. Many surgeons believed that symptoms in patients with hiatal hernias emanated from pinching of the stomach as it traversed the hiatus. To their dismay, many patients had successful restoration of anatomy, but the symptoms continued to persist. In turn, in the face of persistent symptoms, surgeons were inclined to blame the original repair. This approach had two shortcomings: (1) Until the 1950s, there was not an appreciation for the link between hiatal hernias and gastroesophageal reflux disease, and (2) the technology of the time did not allow for a clear understanding of the complex three-­ dimensional anatomy of the esophageal hiatus, its relationship with the gastroesophageal junction, and the varied

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pathologic anatomic changes that encompass the diagnosis of a hiatal hernia.

50.2.2 Functional Repair of Hiatal Defects and the Concept of Gastroesophageal Reflux The 1950s witnessed a shift from the focus on the anatomy of hiatal defects as a “hernia” to the functional physiologically based disorder of reflux esophagitis. In 1951, Allison of Leeds attributed reflux esophagitis to incompetence of the gastroesophageal junction, and he stated that “the cause of the incompetence is a sliding hernia of the stomach through the esophageal hiatus of the diaphragm into the posterior mediastinum” [16]. Most importantly, although it has not been recognized widely, Allison classified hiatal hernias (HHs) into two types, the sliding hernia and the paraesophageal or rolling, and he observed that these two types give rise to different symptoms and had a different prognosis. Allison focused on the crural sling as the key factor in preventing reflux. He believed that these crural fibers functioned as a “pinchcock” to prevent reflux. The Allison procedure consisted of a transthoracic reduction of the herniated cardia back into the abdomen, approximation of the crural fibers posterior to the esophagus, and retention of the cardia to that position by suturing the phrenoesophageal ligament and peritoneum to the abdominal aspect of the diaphragm. At that time there was no knowledge of the gastroesophageal valve. Therefore, the “Allison operation” repaired the gastroesophageal junction without creating an antireflux mechanism. It is not surprising that after a long-term follow-up, he reported a 49% gastroesophageal reflux disease in 421 operated patients [17]. Although Norman Barrett became more known for the condition of intestinal metaplasia that carries his name, he was the first investigator to postulate that there was a fold of mucosa at the gastroesophageal junction that acted as a functional flap valve [18]. This is especially remarkable as it predates the advent of endoscopy or any other means of intraluminal visualization of the gastroesophageal junction. As a result, he concentrated on restoring the cardio-phrenic angle. Barrett’s surgical approach can be summarized in his own words: “I believe that the hernia should be reduced because its presence permits reflux; the esophageal hiatus may sometimes require diminishing in size in the hopes that this maneuver will help to prevent a recurrence of the hernia; the esophagogastric angle should be reconstituted by fixing the cardia below the diaphragm and so allowing the fundus of the stomach to balloon up under the dome.” Although instead of focusing on the reduction of the hiatal hernia and the crural sling as with the Allison procedure, Barrett’s procedure emphasized the esophagogastric junction, he was still

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unable to recreate the hypothesized valve by simply fixing the cardia below the diaphragm. During this period, there was great controversy as to the presence or absence of a physical barrier to gastroesophageal reflux at the gastroesophageal (GE) GE junction. As far back as 1902, the radiologist Walter B. Cannon had observed two physiological phenomena during radiographic examination of the GE junction with barium: first, that there is a mechanism that prevents occurrence of reflux across the gastroesophageal junction and, second, that this mechanism allows brief episodes of reflux [19]. Since he could see a negative shadow at the GE junction on the radiographs, Cannon concluded, albeit erroneously, that the “cardiac sphincter” (later called the lower esophageal sphincter, LES) was a thickened band of circular smooth muscle, which he interpreted as being the mechanism that prevented reflux of gastric material back into the esophagus. However, anatomic studies of the GE junction failed to show the existence of a muscular sphincter similar to what was seen and described at the upper esophageal sphincter. Amazingly, long before a “physiologic” antireflux mechanism was recognized, Norman Barrett denied the presence of a sphincter and supported the concept that the anatomic relationships at the esophageal hiatus accounted for the antireflux mechanism. The controversy became more complex when in the late 1950s, Charles Code of the Mayo Clinic used an intraluminal pressure transducer and miniature balloon manometry to demonstrate that there was an intraluminal high-pressure zone (HPZ) interposed between the stomach and the esophagus in humans [20–22]. The results of these findings were unfortunately erroneously interpreted as evidence for the presence of intrinsic muscles of the distal esophagus which were responsible for maintaining this pressure [23–31]. To the present day, many assume that the presence of a high-­ pressure zone (HPZ) is synonymous with the presence of a lower esophageal sphincter (LES), and unfortunately, and erroneously, these terms are used interchangeably. The discovery of a high-pressure zone at the GE junction gave rise to an “alternate” approach to hiatal hernias. This approach emphasized a physiologic approach to the repair of hiatal hernias. In December 1955, Rudolf Nissen of Switzerland reported an operation on a 49-year-old woman with a long history of gastroesophageal reflux disease where he enveloped the lower esophagus with the gastric fundus by suture approximation of the anterior and posterior fundal folds anterior to the esophagus [32]. This technique had been born from a technique which he had used 20  years earlier to manage a distal esophageal ulcer [33]. The history of the events that led to this landmark procedure is significant. Rudolf Nissen was a student of Professor Sauerbruch in Munich and later his assistant in Berlin. In 1933, Nissen was appointed as the professor and chief of the Department of Surgery at the

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University of Istanbul in Turkey. While in Istanbul, in 1936, he had treated a 28-year-old man with a distal esophageal ulcer which had penetrated into the pericardium. In order to protect the anastomotic suture line between the esophagus and the stomach, he folded over the stomach wrapped the anastomosis with the stomach as a “Witzel” gastric tube in order to get serosal apposition [34]. Nissen left Istanbul in 1939 and after spending 13 years in the United States became the professor of surgery at the University of Basel in Switzerland in 1952. Sixteen years after he has performed the procedure on the Turkish patient with the esophageal ulcer, Nissen reexamined the patient, and although he expected the patient to have reflux resulting from the original procedure, to his great surprise, there was no evidence of esophagitis and the patient had no symptoms of reflux. Nissen, who was a firm proponent of Allison’s concepts of gastroesophageal reflux disease but was unhappy with the results of the Allison operation, applied the concept of a fundal wrap in 1955 to the treatment of gastroesophageal reflux disease. On that day in December 1955 when confronted by a 49-year-old woman with a 3-year history of reflux esophagitis, through a transabdominal approach, Nissen divided the phrenoesophageal ligament and mobilized the esophagus. He did not divide the short gastric vessels. Using his right hand, he then passed the gastric fundus behind the stomach through an opening provided by the divided gastro-hepatic ligament and wrapped the distal 6 cm of the esophagus with the gastric fundus. During this procedure, the short gastric vessels were not divided, and the stomach was wrapped around the esophagus which had a large indwelling stent. He used four interrupted sutures, one of which also incorporated part of the anterior wall of the esophagus. The wrap was performed around a large-bore indwelling intra-esophageal stent. A gastropexy was added. The concept of adding a gastropexy emanated from a single case that Nissen had performed while in the United States. In 1946, Nissen performed a laparotomy and anterior gastropexy on his colleague Gustav Bucky to reduce a hiatal hernia. Bucky remained symptom-free throughout his 15-year follow-up, and Nissen attributed the success of the gastropexy to the accentuation of the esophagogastric angle achieved by anchoring of the stomach to the hiatus. The clinical outcome of the first Nissen fundoplication in 1955 was excellent and was reproduced in a subsequent patient. These two cases were published in 1956, and Nissen named the operation “gastroplication” [35–37]. The original Nissen procedure subsequently underwent modifications by Nissen and other investigators. Consequently, the “Nissen fundoplication” refers to many different procedures with the unifying theme of a full gastric fundal wrap. By 1962, gastropexy portion of the operation was omitted. In a modification described by Rossetti, only the anterior wall of the stomach was used to encircle the dis-

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tal esophagus. Later, in an attempt to decrease the complications from a tight wrap and the resultant dysphagia, “gas bloat” syndrome, and wrap disruption, a number of modifications were made. These have included the placement of intra-esophageal stents varying from 46 Fr. to 60 Fr., division of short gastric vessels in order to obtain a floppy wrap, closing the esophageal hiatus posteriorly, anchoring the fundoplication to the preaortic fascia, decreasing the length of the wrap to 1–2 cm, concomitant highly selective vagotomy, and design of wraps that encompass less than 360 degrees of the circumference of the esophagus [38–45]. By contrast to the serendipitous observations resulting in the Nissen fundoplication, Mr. Ronald Belsey’s approach to the treatment of GERD was the culmination of years of careful observation and follow-up in the clinic. Mr. Belsey, a British surgeon at Frenchay Hospital, has been quoted as saying “The battlefields of surgery are strewn with the remains of promising new operations which perished in the follow-up clinic” [46]. His skepticism stemmed from the failures of the anatomic repairs of hiatal hernias. In 1942, Belsey set out to develop a physiologic rather than an anatomic repair. His procedures were based on endoscopic observations using a 50  cm rigid esophagoscope. Patients underwent endoscopy under sedation in a seated position. He observed that the competence of the esophagogastric junction depended on its position below the diaphragm. If the gastroesophageal junction was displaced above the hiatus, the esophagogastric opening was seen to gape and allow a tide of gastric contents to flow out of the stomach. He referred to this condition as a “patulous cardia.” The goal of his surgical procedure was to reposition the esophagogastric junction several centimeters below the diaphragmatic esophageal hiatus. The “Belsey Mark I” operation was essentially a variant of the Allison procedure. During this procedure, Belsey observed that the “naked” esophagus which lacked a serosal cover was difficult to anchor to the underside of the diaphragm. Consequently, the “Belsey Mark II” and “Mark III” procedures represented attempts at providing the esophagus with a serosal covered muscular collar of the stomach which would enable the placement of anchoring sutures to the underside of the diaphragm. Furthermore, these procedures were designed to restrain the intra-abdominal segment of the esophagus from dilating. It is important to note that at no time was Belsey trying to fashion a gastroesophageal valve. However, through the application of the “scientific method” with intervention, observation, and close follow-up, the “Belsey Mark IV” procedure serendipitously created a partial gastroesophageal valve. Importantly, although today we appreciate that the “Mark IV” procedure produces a partial gastroesophageal valve by intussuscepting the esophagus anteriorly into the stomach for the span of 240 degrees of the esophageal circumference, Belsey’s creation of the intussus-

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ception was designed to allow for the secure placement of sutures from the gastroesophageal junction to the underside of the diaphragm. Belsey studied the original group of 71 patients for 6 years before publishing the results of his procedure. Belsey held that a good antireflux procedure met the following criteria: • It would achieve relief of reflux. • It would preserve swallowing, venting of gas, and the ability to regurgitate. • It would be easy to teach to other surgeons. Between 1955 and 1962, 632 patients underwent the Belsey Mark IV procedure at his clinic. He reported an overall good to excellent result of 85%. Skinner showed similar long-term results with the “Belsey Mark IV” repair in over 1000 patients [47]. Another pioneer in the surgical repair of HHs, Lucius Hill, concentrated on studying the antireflux mechanism by the use of manometry and pH testing and applied these tests to a cadaver model of HH and gastroesophageal reflux disease (GERD) [48–51]. He famously proclaimed that “current repair of hiatal hernia is in about the same state as repair of inguinal hernia at the time of Bassini and Halsted in 1888. Their recurrence rates for inguinal hernia were lower in 1888 than they are for hiatal hernia in current documented reports” [48]. Hill’s studies led to the discovery of the flap valve mechanism, “the gastroesophageal valve” (GEV) as opposed to a “sphincter” at the GE junction. Furthermore, he proposed a grading system of the GEV that correlated with the patient’s reflux status better than the measurement of the lower esophageal sphincter pressure alone [50, 51]. Finally, he concentrated on fixing the GE junction to the esophageal crus which became the cornerstone of the posterior gastropexy or the “Hill repair” [49]. For the next 30  years, the open transabdominal Nissen fundoplication and the transthoracic Belsey repair were the mainstay of surgical therapy for HHs and gastroesophageal reflux disease. However, during the 1980s with the advent of better medical therapy, surgery was no longer the primary therapy for GERD, and in time surgery was less commonly advised. Throughout the twentieth century, the relationship between HHs and GERD remained an enigma and subject of great controversy. As the result of the development of the Nissen and Belsey procedures, greater emphasis on gastroesophageal reflux disease, and the high recurrence rates for purely anatomic repairs of the esophageal hiatus, repair of HHs became an afterthought to the fundoplication. In the latter part of the twentieth century, the key to the repair of hiatal hernias was thought to be the fundoplication and not the hiatal reconstruction.

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50.3 T  he Role of the Esophageal Hiatus in the Gastroesophageal Antireflux In larger hiatal hernias, there was the problem of the inability Mechanism 50.2.3 The Concept of Short Esophagus

to reduce the hernia sac below the diaphragm. Surgeons had the option of a left transthoracic approach, an open abdominal approach, and in later years a laparoscopic approach. Each one of these approaches had specific shortcoming when it came to the complete dissection of the hernia and reduction of the contents below the diaphragm. The left transthoracic approach was hampered by the morbidity of a thoracotomy. The abdominal approaches, although a­ ssociated with lesser morbidity, did not allow for full visualization and accurate dissection in the posterior mediastinum above the diaphragm. The final outcome was that surgeons settled for the procedure with lower morbidity and resolved themselves to settle for a less than optimal dissection and reconstruction of the hiatus. In 1957, in order to overcome the problem of an irreducible hiatal hernia, which was erroneously attributed to a “short esophagus,” J. Leigh Collis reported a procedure for lengthening the esophagus by forming a tube out of the proximal stomach [52]. Using this technique, many surgeons reported significant early and late complications, some resulting from the creation of an iatrogenic Barrett’s esophagus. Later, the Collis gastroplasty was combined with a Belsey procedure or a Nissen fundoplication in patients in whom the hiatal hernia could not be completely reduced and the GE junction could not be placed below the diaphragm. When combined with an antireflux procedure, the Collis gastroplasty had excellent results [53, 54]. A variant of the Collis gastroplasty, wedge gastroplasty, has found its way into the modern laparoscopic surgical repair of hiatal hernias. As with the Collis gastroplasty, this procedure represents an indirect measure designed to compensate for the inability to fully dissect the hernia sac and mobilize the esophagus by laparoscopic techniques. It is important to note that the condition of an esophagus shortened by severe inflammatory changes from wide open reflux is rare and is even more rarely seen in the era of medical acid suppression therapy. Furthermore, in patients with giant hiatal hernias in whom the hiatal sac cannot be fully reduced and the GE junction be placed under the diaphragm, endoscopic measurement of the esophageal length and the distance of the GE junction from the incisors is similar to normal individuals. These observations have led to the conclusion that a “short esophagus” is the result of the inability to fully reduce the hiatal hernia and place the GE below the diaphragm. A more direct approach to an irreducible hiatal hernia is a more extensive dissection of the mediastinal extension of the hiatal hernia which has been the shortcoming of the conventional surgical approaches.

What is the anatomic counterpart to the high-pressure zone (HPZ) seen on manometry? Is there an anatomic sphincter or a functional valve at the gastroesophageal junction? What is the relationship of the gastroesophageal valve to the esophageal hiatus? After the description of the distal esophageal high-­ pressure zone (HPZ) on manometry by Fyke in 1956, all attention was focused on the HPZ. Since there was a high-­ pressure zone in the upper esophagus corresponding to the cricopharyngeus muscle or the upper esophageal sphincter, the distal HPZ was referred to as a lower esophageal sphincter (LES). This resulted in the erroneous conclusion that there was a circular sphincter muscle at the distal esophagus which was comparable to that of an upper esophageal sphincter. However, anatomic dissections of the gastroesophageal junction failed to reveal such a sphincter. A study in 1987 by Thor et al. clarified the presence of a functional valve at the gastroesophageal junction [55]. In this study, the stomachs of 33 cadavers without an antemortem history of reflux were distended with water. Reflux of the water from the stomach only occurred when intragastric pressure reached a pressure of 15 cm of water. Clearly a sphincter mechanism would not be functional in the postmortem state. These authors concluded that there is a functional valve which is created by the three-dimensional relationship which exists between the esophagus, the stomach, and the diaphragmatic crural sling at the level of the esophageal hiatus. The three-dimensional relationship accounts for the HPZ on manometry and represents a significant part of the antireflux barrier. In a porcine model of gastroesophageal reflux disease, Gharagozloo et al. replicated the findings of Thor [56]. Furthermore, they showed that the creation of a hiatal hernia resulted in free reflux of gastric content at much lower intragastric pressures. In cadaver and clinical experiments, Hill and associates have identified a gastroesophageal valve which is a musculo-­ mucosal fold created by the intussusception of the esophagus into the stomach spanning from the right limb of the crus to the left limb of the crus anteriorly spanning 240 degrees of the circumference of the gastroesophageal junction [57]. The valve can be visualized by the retroflexion of the gastroscope and cephalad visualization of the gastroesophageal junction during endoscopy. Furthermore, these investigators have described a grading system for the gastroesophageal valve: • Grade I: The gastroesophageal valve (GEV) is normal, where the musculo-mucosal fold that hugs the scope through all phases of respiration opens during swallowing

50  Robotic Anatomic and Physiologic Reconstruction of Paraesophageal Hiatal Hernias: Combining Lessons from a Century…

Fig. 50.1  Retroflexed endoscopic view of the GE junction. Grade I valve: The gastroesophageal valve (GEV) is normal, where the musculo-­mucosal fold that hugs the scope through all phases of respiration opens during swallowing and then closes promptly without allowing reflux

Fig. 50.2  Retroflexed endoscopic view of the GE junction. Grade II valve: GEV is a less defined fold, slightly shorter, which opens during swallowing and thereafter closes promptly

and then closes promptly without allowing reflux (Fig. 50.1). • Grade II: GEV is a less defined fold and slightly shorter, which opens during swallowing and thereafter closes promptly (Fig. 50.2). • Grade III: GEV opens frequently, remains open for varying lengths of time, and may be associated with an intermittent hiatal hernia (Fig. 50.3). • Grade IV: No GEV is evidenced. Gastroesophageal junction is wide open and is always associated with a hiatal hernia (Fig. 50.4). Hansdotter and coworkers have used this grading system as a useful predictor of the presence of gastroesophageal reflux disease [58]. Based on these studies and observations, the antireflux barrier appears to be the result of the intussusception of the esophagus into the stomach by 2 cm anteriorly spanning 240 degrees of the circumference of the gastroesophageal junction. The intussusception of the esophagus enters at an acute

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Fig. 50.3  Retroflexed endoscopic view of the GE junction. Grade III valve: GEV opens frequently, remains open for varying lengths of time, and may be associated with an intermittent hiatal hernia

Fig. 50.4  Retroflexed endoscopic view of the GE junction. Grade IV valve: No GEV is evidenced. Gastroesophageal junction is wide open and is always associated with a hiatal hernia

Fig. 50.5  Lateral view of the GEV. The antireflux barrier appears to be the result of the intussusception of the esophagus into the stomach by 2 cm anteriorly spanning 240 degrees of the circumference of the gastroesophageal junction. The intussusception of the esophagus enters at an acute angle and is posteriorly angulated. This complex three-­ dimensional relationship is held in place and is suspended onto the esophageal hiatus

angle and is posteriorly angulated. This complex three-­ dimensional relationship is held in place and is suspended onto the esophageal hiatus (Fig. 50.5). GERD would occur

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continuously without an antireflux barrier. Mittal and Balaban have described two major elements in the normal antireflux barrier [59]:

50.4.1 Classification

• The lower esophageal high-pressure zone which corresponds to the gastroesophageal valve • The diaphragmatic crural arch

50.4.1.1 T  ypes I–IV: Akerlund Classification from 1926 This classification is based on the position of the gastroesophageal junction relative to the diaphragm. Type I, commonly but erroneously known exclusively as a sliding hiatal hernia, is the most common and occurs when the phrenoesophageal ligament or peritoneum is displaced superiorly into the thoracic cavity. This anatomic configuration was originally called a “sliding” hiatal hernia in the early part of the twentieth century, as the esophagus, a viscous, occupied the posterior aspect of the hernia sac, and the hernia sac was confined to the anterior aspect of the defect. In the original description and classification of hiatal hernias, this type of HH was thought to be analogous to a “sliding” inguinal hernia where the posterior aspect of the hernia sac is occupied by the cecum. Contrary to the popular misunderstanding which has continued to the present, a “sliding” HH does not mean that the GE junction slides or moves up and down through the diaphragmatic hiatus. Type II, also called “rolling” PEH, occurs when the stomach migrates into the chest and “rolls” over the esophagus with the gastroesophageal junction still laying down into the abdomen. Type III occurs when the stomach migrates into the chest and “rolls” over the esophagus with a concomitant migration of the gastroesophageal junction into the chest. Type IV occurs when, together with the stomach, there is herniation of other intra-abdominal contents through the hiatus (e.g., small bowel, colon, duodenum, or pancreas) [60–66]. This classification dates back to 1927 and does not have a relevance in terms of clinical decision-making in patients with HHs.

It appears that the relationship of the GE valve to the esophageal hiatus is similar to the relationship of the mitral valve to the mitral annulus. Dysfunction of the mitral valve and dilation of the annulus result in mitral regurgitation which is analogous to the regurgitation at the GE junction which is commonly referred to as reflux. The mitral valve is suspended onto the framework which is represented by the mitral annulus. The mitral valve cannot function appropriately with a dilated annulus. A dilated mitral annulus results in valvular regurgitation. Furthermore, treatment of mitral regurgitation by repairing the mitral valve needs to be accompanied by mitral annuloplasty and suspension of the valve onto the annulus. By extrapolation, our present understanding of the antireflux mechanism at the GE junction leads to the conclusion that treatment of GE regurgitation or reflux needs to encompass two components: (1) repair of the GE valve and (2) suspension of the GE valve onto a repaired esophageal hiatus. These two components, in turn, would recreate the normal antireflux mechanism. The complex three-dimensional relationship of the entry of the esophagus into the stomach is disrupted by widening of the external crural arch and the occurrence of a hiatal hernia. It is postulated that with a hiatal hernia, there is progressive enlargement of the crural arch anteriorly with stretching and redundancy of the phrenoesophageal ligament. As a result, first, the acute angulation of the gastroesophageal junction is straightened. Subsequently, with further enlargement of the crural arch and the hiatal hernia, there is greater outward traction which results in the reduction of the esophageal intussusception out of the stomach. With a reduction of the esophagogastric intussusception, the functional gastroesophageal valve is disrupted, thereby resulting in gastroesophageal reflux.

50.4 Hiatal Hernias It is estimated that hiatal hernias (HHs) affect approximately 20% of the population. The incidence of HHs is 37% in patients with morbid obesity, defined by BMI  >  43  kg/m2. Furthermore, 37% of HHs are defined as “large” or > 4 cm on endoscopy.

Hiatal hernias have been classified in two ways:

50.4.1.2 C  lassification Based on Clinical Presentation and Intended for Surgical Decision-Making Gharagozloo et  al. have proposed a classification of hiatal hernias based on the clinical stages, stage I and stage II. This classification proposes that hiatal hernias represent a spectrum of disease and therefore all hiatal hernias are sliding hernias with different amounts of intra-abdominal structures which have migrated into the hernia sac. This classification is more relevant in terms of surgical decision-making. Based on this classification, HH represents a spectrum from a patulous cardia to increasingly enlarging hernias which culminate with an intrathoracic “upside-down” stomach and incarceration (Figs. 50.6, 50.7, 50.8, 50.9, 50.10, and 50.11).

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Fig. 50.6  Intraoperative photograph of a sliding hiatal hernia (red arrow). This historic designation stems from the understanding of a type of inguinal hernia where the posterior wall of the sac is a viscous. This term was used to describe sliding hiatal hernias as the posterior wall of the hernia is a viscous, the esophagus

Fig. 50.7  A larger sliding hiatal hernia. Note that the anterior and lateral aspect of the hernia is comprised of peritoneum and the posterior aspect of the defect is comprised by a viscous or esophagus. The erroneous concept of a “sliding hernia” meaning that the GE junction slides up and down in the hiatus has been carried throughout medical textbooks and created a general misunderstanding about the important anatomic and surgical principles in repairing hiatal hernias

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Fig. 50.9  A large sliding hiatal hernia containing colon (red arrow)

Fig. 50.10  The hiatal hernia from Fig. 50.9 after the colon has been reduced into the peritoneal cavity. Even though the anterolateral aspect of the hernia sac extends into the pleural space, this is still a large “sliding” hiatal hernia

a

b

Fig. 50.8  All hiatal hernias are sliding hiatal hernias. The different sizes of hernias represent a spectrum which starts with a small anterior peritoneal sac and extends to large sliding hernias with very large peritoneal sac which at times contains portions of the stomach and other intraperitoneal structures. This clarifies that the approach to repairing hiatal hernias needs to be the same approach to repairing any other “sliding” hernia. (a) Small sliding hiatal hernia. (b) Large sliding hiatal hernia

Fig. 50.11  Even though the hiatal hernia extends anterolaterally up into the posterior mediastinum, it is still a large variant of a “sliding” hiatal hernia (S spine)

The first classification has emphasized the content of the hiatal hernia, and the latter classification focuses on the spectrum of changes which occur at the esophageal hiatus. The advent of laparoscopy has facilitated a greater understanding of the complex three-dimensional anatomy of the esophageal hiatus. The classification proposed by Gharagozloo et al. is based on in situ endoscopic clinical observations in over 700 operated patients with hiatal hernias. Different hiatal hernias

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represent a spectrum of defects that are associated with enlargement of the esophageal hiatus and attenuation of the diaphragmatic muscle. The right and left attachments of the right diaphragmatic crus originate from the vertebral bodies and form a crural sling around the esophagus. The enlargement of the esophageal hiatus is characterized by enlargement anteriorly of the crural sling and the preservation of the posterior portion of the esophageal hiatus. It is due to this phenomenon that the anterior phrenoesophageal ligament (peritoneal reflection) is stretched only on the anterior portion of the gastroesophageal junction from the right side to the left side of the crural sling (270 degrees). As a result, the anterior portion of the stomach and the gastroesophageal junction is displaced above the diaphragm, thereby giving rise to a sliding hiatal hernia. Once again, a sliding hiatal hernia refers to the fact that the anterior portion of the hernia had a peritoneal sac and the posterior portion of the hernia is made up of the esophagus. As the hernia enlarges, progressively more and more of the stomach is displaced only anteriorly into the hernia sac (comparable to type II and III hiatal hernias). Finally, significant enlargement of the crural arch results in attenuation of the crural muscle fibers, stretching of the diaphragmatic hiatus, and, once again, anterior migration of the stomach and other abdominal contents above the hiatus (comparable to type IV hiatal hernia). All hiatal hernias represent a spectrum from a small sliding hiatal hernia to a large hernia. All hiatal hernias result from the enlargement of the crural sling. Finally, with the present understanding of the pathophysiology of HHs in the twenty-first century, it may be more accurate to refer to this condition as a “hiatal defect.”

50.4.2 Pathophysiology and Clinical Presentation Clinical presentation of hiatal hernias represents a continuum which correlates with whether the stomach or other intra-abdominal tissues (a paraesophageal component) have entered into the hernia sac. The classification of HHs into stage I and II clinical presentation based on the anatomic and physiologic changes which occur in the hiatus is more relevant for clinical decision-making and indications for surgical intervention.

50.4.2.1 C  linical Stage I: Gastroesophageal Reflux Disease GERD Patients with small hiatal defects typically present with GERD symptoms. To reiterate, the antireflux barrier is the result of the intussusception of the esophagus into the stomach by 2 cm anteriorly spanning 240 degrees of the circumference of the gastroesophageal junction. This intussusception creates a three-dimensional 2 cm horseshoe-shaped fold, or

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the GE valve, which functions like a “trapdoor.” This complex three-dimensional relationship is held in place and is suspended onto the esophageal hiatus. The pathophysiology of a small HH is such that the anterior aspect of the hiatus enlarges or stretches, and the phrenoesophageal ligament migrates superiorly through the hiatus. As the phrenoesophageal ligament inserts onto the esophagus, its migration gradually pulls the esophagus out of its intussusception in the stomach. Once 2 cm of the esophagus has been pulled out, the GE valve becomes incompetent, resulting in reflux (Fig. 50.6). Therefore, GERD requires a hiatal defect of at least 2 cm. This finding was described by Gharagozloo et al. in a prospective double-blind study of laparoscopic diagnosis of radiologically and endoscopically undiagnosed small HHs in patients with symptomatic GERD [67].

50.4.2.2 S  tage II: Gastrointestinal, Aerodigestive, Pulmonary, Cardiovascular, Gastric, and Hematologic Symptoms With an enlarging HH, the stomach begins to migrate through the hiatus and into the chest. While this is still a “sliding” HH, the migration of the stomach through the hiatus results in varying degree of distal esophageal obstruction. The greater migration of the stomach through the hiatus correlates with a greater degree of obstruction (Figs.  50.7 and 50.9). The anteriorly herniated fundus predisposes the stomach to twist onto itself. In addition, depending on the patient’s BMI and the amount of intraperitoneal and retroperitoneal fatty tissue, varying amounts of fat will also migrate through the hiatus. The fat within the hernia sac is usually omentum on the greater curve and the left lateral aspect of the esophagus, and the fatty tissue of the gastro-hepatic ligament on the lesser curve or the right lateral aspect of the esophagus. The fatty tissue in the retroperitoneum will migrate through the hiatus outside the hernia sac in a retroperitoneal and paraesophageal configuration. Consequently, the gastrointestinal symptoms in stage II which result with a paraesophageal component in the HH are predominantly mechanical, including esophageal and gastric obstruction, strangulation, incarceration, and ulceration [64, 68–70]. 50.4.2.3 Esophageal Symptoms Obstruction at the distal esophagus results in a feeling of early satiety after oral intake and dysphagia which is described by the patients as the feeling that the “food is sticking or getting hung up at the lower esophagus or even the throat.” The stagnation of the food is associated with bacterial decomposition of the food in the moist and dark environment that is presented by the esophagus. With bacterial degradation of the food, over a period of time, the food ­softens, liquifies, and passes into the stomach. The bacterial fluid in the esophagus has been shown to result in esophagitis

50  Robotic Anatomic and Physiologic Reconstruction of Paraesophageal Hiatal Hernias: Combining Lessons from a Century…

and a sensation of “heartburn.” Although culture-based studies have suggested that the esophagus is either sterile or contains only few transient bacteria, in situ staining revealed association of bacteria with the esophageal epithelial cell surfaces, suggesting the presence of residential bacteria in the distal esophagus [71–73]. In addition, it has been demonstrated that esophageal bacterial composition differs under conditions of normal esophagus, reflux esophagitis, and Barrett’s esophagus. Consequently, diverse bacterial communities may be associated with obstructive esophageal disease [74, 75]. As the patient moves from stage I to stage II of the disease, pharmacologic acid suppression therapy becomes more ineffective. The patient continues to report a feeling of “heartburn”; however, in stage II, heartburn and esophagitis are no longer caused by GERD and acid reflux. In the absence of the appropriate testing to document the progression from stage I to stage II of the disease, historically patients have been treated with increasing stronger acid suppression therapy with very little clinical effect.

50.4.2.4 Upper Aerodigestive Symptoms Aside from a feeling of “heartburn,” in stage II, patients report symptoms that in the past have been attributed to “laryngopharyngeal reflux” or LPR. LPR is associated with symptoms of laryngeal irritation such as throat clearing, coughing, and hoarseness. In addition, patients may complain of sinus infections and other conditions affecting the upper aerodigestive system. Studies have failed to show acid reflux as the cause of LPR [76]. On the other hand, impedance monitoring has detected episodes of nonacid or weakly acid gastric reflux in symptomatic patients, suggesting that nonacid components of the esophageal refluxate are responsible for the mucosal damage [77]. It is hypothesized that LPR is the result of the repeated reflux of the infected esophageal fluid into the upper aerodigestive tract in patients in stage II of HH. The “esophageal reflux” is exacerbated when the patient assumes a supine position. 50.4.2.5 Pulmonary Symptoms The pulmonary symptoms include shortness of breath, wheezing, and aspiration pneumonia. Wheezing and aspiration pneumonia result from aspiration of the esophageal fluid into the airway and the lungs. Historically, shortness of breath in patients with large HHs has been attributed to “thoracic displacement.” It has been erroneously suggested that dyspnea in HHs is predominantly due to a mechanical respiratory effect of a large space-occupying intrathoracic mass. Furthermore, historically, and erroneously, explanations for dyspnea in patients with large hiatal hernias have included disturbances of respiratory function, diaphragmatic dysmotility, disturbances of ventilation and perfusion, and asthma caused by esophageal reflux [78]. However, in these patients, spirometry has not correlated with the level of func-

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tional compromise [79, 80]. Low and Simchuk showed only mild abnormalities of spirometry were identified (FEV1 [percentage predicted] and FVC [percentage predicted], 76% and 79%, respectively), despite moderately severe symptoms. In addition, after surgical repair of the HH, even though dyspnea completely resolved in most of their patients, there was only a mild improvement in spirometric values (absolute increase in both FEV1 [percentage predicted] and FVC [percentage predicted] of 13%) [81]. Greater experience and direct in situ observation of the effect of the contents of the hiatal hernia have also refuted the concept that the pulmonary symptoms in patients with HHs are the result of lung compression. The hiatal hernia extends into the posterior mediastinum and has very little direct displacement effect on the lungs. “Asthma” in patients with large HHs appears to be the result of inflammation of the airway from aspiration of esophageal refluxate. Shortness of breath and other pulmonary symptoms appear to be more related to the effect of the hiatal hernia on the cardiovascular system.

50.4.2.6 Cardiovascular Symptoms In stage II, large hiatal hernias can lead to chest pain and dyspnea and at times result in pulmonary edema and cardiac failure (Figs.  50.12, 50.13, 50.14, and 50.15). Siu et  al. reported that a large hiatal hernia caused cardiac failure by the compression to the left atrium in a case presenting with recurrent acute heart failure [81]. Chau et al. demonstrated a large hiatal hernia as the cause of chest pain in patients that presented to emergency department with acute angina [82]. A hiatal hernia can cause pulmonary edema and cardiac failure through pulmonary venous obstruction [83, 84]. Noam et al. prospectively studied patients using resting and stress echocardiography, cardiac computed tomography, and respiratory function testing before and after repair of large hiatal hernias. Preoperatively, despite the presence of normal pulmonary function, 83% of these patients had exertional dys-

Fig. 50.12  An anterior posterior chest radiograph showing a large hiatal hernia (red arrows). Left atrial compression by a large hiatal hernia (HH) with flattening of the LA contour is demonstrated

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Fig. 50.13  A contrast esophagogram showing the migration of the stomach into the chest

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Fig. 50.14  Transverse section of a computed tomogram (CT) showing the migration of the contact of the hiatal hernia behind the heart with compression of the left atrium (arrow)

Fig. 50.15  Apical four-­ chamber echocardiographic view showing left atrial compression by an HH (yellow arrow heads). * Hiatal hernia, LA left atrium, Ao aorta, LV left ventricle

pnea, and this problem improved after surgery. Moderate to severe left atrial compression was present in 77%, and this correlated with the degree of functional impairment. The improvement of functional class and exercise capacity after surgery was associated with resolution of cardiac compression. Indeed, the change of left atrial diameter on echocardiography was the only independent correlate of the improvement in exercise capacity after surgery [85]. In addition, the results of this study provide evidence of left atrial, pulmonary venous, and coronary sinus compression by large hiatal hernias. Surgical repair of the HH results in improvement of left ventricular and left atrial dimensions, as well as a normalization of atrial inflow velocities. Left atrial (LA) compression may cause dyspnea by increasing the pulmonary venous pressure, producing interstitial edema, and reducing pulmonary compliance. Previous case reports describing cardiac failure and dyspnea attributable to LA compression by HHs support this hypothesis [86,

87]. In patients with large HHs, echocardiography demonstrates pulmonary vein compression and increased systolic and diastolic components of the pulse-wave Doppler signal at the pulmonary vein ostium. In addition, in patients with a large HH, there are increased velocities at the LA inflow, which resolve after surgery. Extrinsic cardiac compression also appears to have an effect on left ventricular filling because patients with severe LA compression demonstrate improved ventricular volumes after HH repair. Case reports of HH causing hemodynamic instability including hypotension requiring inotropic therapy or resulting in syncope are consistent with these findings [88–91]. Impaired ventricular filling due to LA compression may also contribute to exercise intolerance by preventing the necessary increase in cardiac output that normally occurs with exercise. Naoum et al. demonstrated compression of the coronary sinus (CS) in 87% of patients [85]. The anatomic course of

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the CS in the posterior atrioventricular groove makes it particularly susceptible to compression. CS compression can lead to diastolic dysfunction and dyspnea [92]. Previous animal studies have confirmed a relationship among CS compression and impaired myocardial blood flow, increased ventricular blood volume, decreased ventricular distensibility, and diastolic dysfunction [93–95]. These may represent further mechanisms of impaired exercise capacity due to cardiac compression by HH. In summary, dyspnea and fatigue are underappreciated but very important complications of stage II symptoms with HHs. Patients with large HHs have significant dyspnea and exercise impairment despite normal baseline respiratory function [96]. Significant cardiac abnormalities including compression of the left atrium, inferior pulmonary veins, and CS are commonly seen in these patients. In addition to dyspnea, diastolic cardiac dysfunction leads to a sense of chronic fatigue. The recovery of exercise capacity with HH repair is independently predicted by recovery of the LA diameter, suggesting a significant causal role for cardiac compression in the pathogenesis of HH-associated dyspnea and fatigability. Assessment of LA compression severity preoperatively is a useful noninvasive clinical tool for identifying those patients who will benefit most from HH repair. Another manifestation of extrinsic compression of the left atrium is syncope. Syncope and dyspnea are provoked by lying down, typically after a large meal. In cases of large HHs which extend posteriorly into the right chest, the inferior vena cava (IVC) and the hepatic veins are compressed (Fig. 50.16). The IVC lies very close to the right limb of the esophageal crus and undergoes external compression by the large HH.  Normally, there is no measurable pressure gradient between the IVC and the right atrium. HHs have been reported to increase the pressure gradient between the IVC and right atrium [97]. This results in poor right atrial filling and a “tamponade” physiology and lower extremity edema. This is yet another cause of dia-

Fig. 50.16 Intraoperative photograph of a large hiatal defect. Extension into the right chest results in compression (red arrows) of the inferior vena cava

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stolic ­dysfunction in patients with large HHs. Furthermore, with pressure on the hepatic veins, the patients can present with ascites [98]. Hiatal hernia appears to be associated with increased frequency of atrial fibrillation (AF) in both men and women of all age groups. In a large study from Mayo Clinic, Roy et  al. showed that the occurrence of AF was 17.5-fold higher in men with HH and 19-fold higher in women with HH compared to the frequency of AF reported in the general population [99]. Atrial arrhythmias in patients with large HHs result from pressure and stretching of the inferior pulmonary veins by the large retrocardiac mass created by the HH.  In addition, this and other studies have shown that patients with AF associated with HH might have a better prognosis than patients with AF without HH. One possibility may be that patients with AF and HH represent a unique subgroup of patients with AF that are actually less likely to develop AF-related complications due to a different mechanism for the AF. These patients may be more likely to have lone AF and less structural heart disease but still develop AF due to the mechanical/neural factors from the effect of the HH on the atria and, consequently, have a lower complication rate. Many studies have suggested that the natural history of AF in patients with HH may be different from AF associated with structural heart disease. Normally, there is no measurable pressure gradient between the inferior vena cava and the right atrium. The finding of an external pressure on the right atrium combined with a pressure gradient between the inferior vena cava and the right atrium led to the conclusion that the clinical findings are due to external compression by the huge hiatal hernia.

50.4.2.7 Gastric Symptoms The strangulation of the stomach in the esophageal hiatus results in discomfort and pain in the subxiphoid region. Rarely with large HHs, the patient may present with gastric volvulus. Chronic venous congestion of the herniated gastric mucosa along with ulceration (Cameron’s ulcers) can also result in occult bleeding leading to iron deficiency anemia [100–103]. Typically, this anemia resolves in more than 90% of patients following the hernia repair [104, 105]. It has been shown that there is a high correlation between delayed gastric emptying and “gastroparesis” and the size of the HH. This may be due to compressive effects on the vagus nerves or stretching of the gastric muscle. Delayed gastric emptying is rarely the result of vagal nerve injury at the time of the repair. Delayed gastric emptying improves after repair of HHs. Therefore, patients with large HHs should be expected to manifest the effects of delayed gastric emptying in the postoperative period. These patients need close monitoring and symptomatic treatment until the delayed gastric emptying resolves.

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50.4.3 Diagnosis Although most patients with HHs are symptomatic, there is still a significant group of patients whose symptoms are not recognized as being caused by an HH and who are diagnosed incidentally during tests performed for other conditions. The evaluation of these patients usually includes a complete history and physical examination. Standard workup typically begins with a barium swallow, followed by upper endoscopy and esophageal manometry [106]. Barium swallow is probably the best diagnostic study and gives information about the amount of the herniated stomach and the direction of herniation [107, 108]. A computed tomography scan of the chest and the abdomen may provide additional information on the type and location of the hernia [100]. Upper endoscopy is useful for visualization of the esophageal and gastric mucosa and detection of Barrett’s esophagus, erosive esophagitis, and Cameron’s ulcers. Furthermore, it can also determine if there are any lesions suspicious for malignancy. The role of manometry in patients with HHs is evolving. In patients with an HH in the range of 2–4 cm who would undergo antireflux surgery for stage I symptoms, manometry is useful in (a) determining the pre-intervention esophageal motility and (b) the type of fundoplication if the surgeon plans on performing a fundoplication. At our institution, our approach to the repair of hiatal hernias does not include a fundoplication. We believe that fundoplication is a nonphysiological procedure from a different era in the understanding of hiatal hernias and GERD. Our patients who have a small hiatal hernia and GERD undergo repair of the hiatal hernia and gastroesophageal valvuloplasty, which is an attempt to repair and recreate the normal antireflux mechanism. In these patients, the surgical procedure is not dictated by the findings of manometry. Rather, the manometry data is used to determine the prognosis and to follow the improvement in esophageal motility after the surgical intervention. In patients with stage II symptoms, it is believed the esophageal dysmotility may be secondary to the distal esophageal obstruction resulting from the hiatal defect. Therefore, preoperative manometry is helpful in following the progression and possible improvement in esophageal motility. Furthermore, esophageal manometry dictates the postoperative use of promotility agents which are used as a “bridge” therapy for the esophagus as it recovers its function following the correction of obstruction, the anatomic and physiologic repair of the hiatal defect, and reconstitution of the normal antireflux mechanism. In patients with small hiatal hernias (2–4 cm) and stage I symptoms, 24-hour pH monitoring may provide a quantitative analysis of reflux episodes and correlate them with

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patient’s symptoms. However, in patients with stage II disease, 24-hour pH monitoring is not required [109, 110]. In fact, preliminary studies from our institution have shown that in patients with stage II symptoms, 24-hour pH monitoring will be falsely positive. Patients who are fully acid suppressed by pharmacologic therapy but continue to have symptoms of “heartburn” have been shown to have positive pH studies. In the face of full acid suppression, it is hypothesized that in these patients, esophageal obstruction leads to bacterial overgrowth and a change in esophageal flora resulting in a low pH environment due to bacterial acid production and not gastric acid reflux.

50.4.4 Indications for Surgery Gastric volvulus is an absolute indication for emergent surgical intervention and is classically described by the Borchardt triad, which includes the inability to pass a nasogastric tube, retching without actual food regurgitation, and chest or epigastric pain [111, 112]. The surgical treatment strategy in patients with stage I symptoms with HHs in the range of 0–2 cm is based on failure of medical therapy, young age, or contraindications for the use of pharmacologic acid suppression. In patients with stage II symptoms with HHs greater than 2 cm, referred to as paraesophageal hiatal hernias, the surgical therapy has been debated extensively. Historically, due to the risks of complications and the mortality associated with emergent surgery, most surgeons opted to repair these HHs regardless of the patient’s symptoms [113]. Afterward, the strategy moved away from this attitude to a more conservative one because some studies showed that elective and emergent hernia repairs were equally effective [114, 115]. These studies were performed at a time when the symptoms associated with HHs were poorly understood. It is important to note that the end point for these studies was not quality of life or symptom relief but survival. In addition, there was greater appreciation that repair of large HHs could be a difficult operation and was rarely accomplished with the use of laparoscopic techniques. These procedures were associated with high rate of recurrence and complications. The laparoscopic techniques had shortcomings in terms of two-­ dimensional visualization and the somewhat rudimentary instrument maneuverability which did not allow for complete dissection of the hernia sac and mobilization of the esophagus. These shortcomings were exacerbated when the HH extended significantly above the diaphragmatic hiatus. Consequently, surgeons “settled” for incomplete mobilization of the hernia sac and relied on the “fundoplication” to keep the stomach below the diaphragm. In turn, fundoplication represented an indirect solution for the anatomic and

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physiologic problem which was created by the hiatal defect. The shortcomings of the laparoscopic technology ­contributed to poor surgical results. These issues were particularly important in patients with larger HHs that required extensive mobilization of the esophagus in the posterior mediastinum [116, 117]. In 2002, Stylopoulos and colleagues examined the hypothesis that elective laparoscopic repair should be routinely performed on patients with asymptomatic or minimally symptomatic paraesophageal HHs [118]. A Markov Monte Carlo decision analytic model was developed to track a hypothetical cohort of patients with asymptomatic or minimally symptomatic paraesophageal hernias and reflect the possible clinical outcomes associated with two treatment strategies: elective laparoscopic paraesophageal hernia repair (ELHR) or watchful waiting (WW). The input variables for ELHR were estimated from a pooled analysis of 20 published studies, while those for WW and emergency surgery were derived from the surgical literature published from 1964 to 2000. Outcomes for the two strategies were expressed in quality-adjusted life-years (QALYs). The mortality rate of ELHR was 1.4%. The annual probability of developing acute symptoms requiring emergency surgery with the WW strategy was 1.1%. ELHR resulted in reduction of 0.13 QALYs (10.78 vs. 10.65) compared with WW. The model predicted that “watchful waiting” (WW) was the optimal treatment strategy in 83% of patients and ELHR in the remaining 17%. Based on this evaluation, they concluded that WW is a reasonable alternative for the initial management of patients with asymptomatic or minimally symptomatic paraesophageal HHs. As a result of this study which reflected the shortcomings of the laparoscopic surgical approaches to the repair of HHs, many practitioners advised WW for patients with HHs. A more recent study from 2018, by Morrow and colleagues, has shown that surgical repair of HHs is superior to WW in terms of quality of life [119]. Clearly, the indications for surgical repair of HHs have evolved over the years. This evolution has been a function of: • Greater understanding of the complex three-dimensional anatomy of the esophageal hiatus • The relationship of the esophageal hiatus to the gastroesophageal antireflux mechanism • The importance of the esophageal hiatus in providing the “skeletal” structure onto which the gastroesophageal valve is suspended • The non-gastrointestinal complications such as cardiac, respiratory, and hematologic complications that are associated with hiatal hernias • Change in the definition of symptomatic hiatal hernias • Possibility of complex anatomic reconstruction using minimally invasive techniques

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• Advances in intraoperative visualization and greater instrument dexterity provided by the robotic platform Historically, the only symptoms considered for elective repair included severe regurgitation, aspiration, cough, anemia, or dysphagia. However, recent literature suggests that symptoms associated with HHs are much broader than just gastrointestinal issues and, due to the slow progression of disease, are present in a subtle form for a long time. Furthermore, several quality of life studies have shown that patients are severely debilitated by the extra-gastrointestinal symptoms, but due to a lack of broad appreciation among medical professionals, they are driven to attribute the symptoms to other causes. Finally, many studies have shown that the “heartburn” and other gastrointestinal symptoms which are associated with stage II of the disease are erroneously attributed to GERD by medical professionals. Therefore, based on our present understanding of HHs, truly asymptomatic patients are rare. Carrott et al. found that symptoms are wide ranging and patients with HHs are often labeled as asymptomatic or minimally symptomatic because the hernia has been present for years in an older patient, and the gradual alterations in eating and postprandial symptoms had been attributed to aging [120, 121]. In addition, symptoms such as dysphagia, early satiety, and postprandial dyspnea are often insidious and increase over the course of many years. While, historically, gastrointestinal symptoms of HHs have been the main focus of the indications for repair, pulmonary, upper aerodigestive, cardiovascular, hematologic, and functional symptoms have been severely underappreciated. In fact, many HH repair series in the literature do not assess patients for such symptoms as dyspnea or easy fatigability, likely because in the elderly population these symptoms are often assumed to arise from other comorbidities [121]. On the other hand, patients who are younger (  2–3  cm, surgical repair is indicated barring any physiologic contraindications.

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The principles of the surgical repair are: • Complete dissection of the hernia sac. • Preservation of the hernia sac as opposed to resection. In larger HHs, the anterior (left) vagus nerve is elevated and displaced with the phrenoesophageal ligament or the anterior sac. One of the common mistakes is to resect the sac. The hernia sac represents an extension of the peritoneum in the anterolateral aspect of the HH. It is important to recall that an HH represents a “sliding” HH where the posterior aspect of the hernia is made up of the esophagus as opposed to a peritoneal sac. HHs need to be approached like a “sliding” inguinal hernia where the hernia is reduced but the sac is not resected as it would result in damage to the cecum in the case of a “sliding” inguinal hernia. In the case of an HH, all tissues should be dissected and replaced into the abdomen. Attempts at resecting the sac result in injury to the anterior vagus or the esophagus. • Complete mobilization of the esophagus to the level of the inferior pulmonary vein. • Dissection of all periesophageal fatty tissue, the so-called mediastinal fat pad away from the esophagus. • Identification and preservation of both vagus nerves. • Dissection and removal of the fatty tissue at the esophagogastric junction (GE fat pad). • Posterior closure of the hiatal “V” by crural reapproximation in a primary fashion using absorbable buttresses (pledgets) for the sutures, without the use of nonabsorbable buttressing material or mesh. • Suspension of the esophagus onto the right and left limb of the crus. • Recreation of the esophagogastric intussusception and creation of the gastroesophageal (GE) valve. • Anterior closure of the hiatus in a primary fashion over a 60 French esophageal bougie. • Suspension of the GE valve onto the anterior crural closure. Traditionally, these steps have been accomplished using a left thoracotomy, direct visualization of the hernia, mobilization of the esophagus to the aortic arch, and dissection of the hernia sac. The main advantage of the transthoracic approach is the direct visualization and accessibility of the esophagus, which is essential in this procedure. Proper mobilization of the esophagus is highly correlated to the success rate of the procedure in terms of recurrence, as it ensures a tension-free repair [124, 125]. The advent of laparoscopy introduced an alternative to open procedures. However, laparoscopy has been hampered by the shortcomings of two-dimensional visualization and unwristed instruments that pivot at the level of the trocars on the abdominal wall. Although in experienced hands, these

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shortcomings have been largely overcome, in common practice, the essential steps of the procedure have not been adequately accomplished. In general practice of laparoscopic repair, surgeons have used various techniques to overcome the shortcomings relating to inadequate hiatal dissection and esophageal mobilization. These techniques have included relaxation of the diaphragmatic crura and the use of mesh. The goal of mesh repair has been to oppose the radial tension by strengthening the hiatal orifice. While many surgeons continue to use mesh, this issue continues to be debated, as many studies have shown that mesh does not improve the success of the procedure but it can cause severe complications, such as dislodgement and erosions requiring gastric resection [128]. In fact, a randomized controlled trial from Watson et al. demonstrated similar outcomes between suture and mesh repair [129]. Another area of controversy where the shortcomings of the laparo-endoscopic techniques have dictated the surgical approach to HHs has been in morbidly obese patients. The connection between obesity and HH is well established. Wilson et al. found that individuals with a body mass index (BMI) exceeding 30 kg/m2 were 4.2 times more likely to have a hiatal hernia than those with a BMI lower than 25 kg/ m2.83 [130]. However, a 10-year retrospective review of laparoscopic repair of HHs identified obesity as a risk factor for long-term adverse outcomes [131]. In other studies, obesity has also been shown to increase the failure rate of antireflux surgery [132]. Because of the increased risk of surgical failure in this challenging population, a sleeve gastrectomy or gastric bypass has been recommended [133–135]. However, aside from the many potential physiologic shortcomings of this indirect approach to the repair of HHs in patients with high BMIs, there are still several sociologic obstacles, such as patient preference and lack of insurance coverage. Many patients with a hiatal hernia do not meet Medicare requirements for bariatric surgery (BMI >40  kg/m2, alone, or 2 35–40 kg/m , with significant comorbidities). Other patients may meet these requirements but may prefer not to undergo gastric bypass or are unwilling to comply with postoperative lifestyle modifications. The advent of robotic technology, which provides enhanced minimally invasive capabilities such as three-­ dimensional high-definition visualization and greater and more precise instrument maneuverability in a confined space, has facilitated more extensive mediastinal dissection, full mobilization of the HH and the esophagus, and an accurate anatomic primary reconstruction of the esophageal hiatus. Robotic repair of HHs provides for an equivalent procedure which has been heretofore performed by a thoracotomy using laparoscopic trans-hiatal techniques. With the results of robotic repair of hiatal hernias, elective repair may be a

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more appropriate solution in all patients (including patients with high BMIs) with HHs. The concept of the robotic anatomic and physiologic repair of HHs (RAPR) represents an evolution in the understanding of the anatomy of the esophageal hiatus and its role in the normal physiologic functioning of the gastroesophageal antireflux mechanism. This is somewhat analogous to the evolution of the treatment of mitral regurgitation which for the purpose of this argument can be seen as “reflux” of blood through an abnormal mitral valve. Treatment of mitral regurgitation began with medical therapy until prosthetic valves became available in the 1950s and 1960s. During this era, the valve was the focus of attention, and it was thought that valve replacement would be an adequate treatment. In the 1970s, 1980s, and 1990s, it became clear that the mitral annulus played a significant role in the competence of the mitral valve and that annular dilation could lead to regurgitation and valve dysfunction. Furthermore, it was discovered that the mitral valve mechanism played a significant role in left ventricular function. As a direct result of the evolution in the understanding of the anatomy and physiology of the mitral annulus and the mitral valve, and their interrelated role in preventing mitral regurgitation and preserving left ventricular and left atrial function, the modern treatment of mitral regurgitation focuses on reconstruction of the mitral annulus and the mitral valve. There are some important parallels in understanding the role of the HH (the “annulus”) and the gastroesophageal antireflux mechanism (the “valve”) in the normal physiologic function of the esophagus and the stomach. To use the mitral valve analogy, the treatment of HHs has evolved from concentrating on creating an obstruction to regurgitation as with fundoplication to a reconstruction of the complex anatomic and physiologic relationship that is present at the esophageal hiatus. Robotic anatomic and physiologic repair of HHs “stands on the shoulder of giants.” In that, the procedure represents an evolution in the understanding of the very complex anatomic and physiologic relationship at the esophageal hiatus. Furthermore, RAPR incorporates many of the concepts in previous surgical approaches to HHs in coming closer to seeing the “whole elephant.”

50.5 Technique 50.5.1 Preoperative Evaluation It has become clear that HHs affect the pulmonary, cardiovascular, and GI systems. Therefore, in addition to routine blood testing and anesthesia evaluation, preoperatively we obtain: • PFTs and evaluation by the pulmonary critical care team. • Nuclear stress test.

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• Echocardiography and diastolic function assessment is used selectively in patients who present with a history of atrial arrhythmias. • Venous Dopplers of the lower extremities.

50.5.2 Anesthesia Management In patients with large HHs, many times the pleural space is entered during the robotic dissection. This is especially true in elderly female patients. In order to perform a complete dissection of the hernia sac, and return all the peritoneal contents into the abdomen, it is imperative to have full exposure of the entire mediastinum. Entry into the pleural space results in loss of pneumoperitoneum, a tension pneumothorax, downward pressure on the diaphragm, and loss of exposure at the hiatus. Consequently, in order to have full control of the exposure and to complete a perfect robotic dissection, it is important to have a mitigation plan in place. We prefer to use a double lumen endotracheal tube in patients with large hiatal defects. In case of pleural entry, the lumen of the tube to the ipsilateral lung is clamped, thereby isolating the ipsilateral lung. This maneuver creates a large space in the chest, thereby “buying” more time before the CO2 pressure can result in “tension” and tamponade physiology. The pleural entry is closed with robotically applied clips, and a member of the surgical team places a small chest tube through the ninth interspace anteriorly. After placement of the chest tube thoracostomy and evacuation of the CO2, the ipsilateral lung is reinflated. This strategy allows the surgeon to continue with the dissection with perfect exposure and without interruption. In cases where the pleural space must be entered and closure of the pleura is not possible, the tube thoracostomy evacuates the CO2 and facilitates an excellent exposure of the surgical field. We use two laparoscopic insufflators in order to maintain the pneumoperitoneum at a pressure of 15 mmHg.

50.5.3 Port Placement The patient is placed in the lithotomy position. The surgeon stands between the legs. Two laparoscopic CO2 insufflators are used. We prefer to accurately place laparoscopic ports and introduce the robotic arms through these ports. This strategy diversifies the options for the surgeon in the event of adhesions, unexpected complications, and if the surgeon elects to use conventional laparoscopy for the repair and reconstruction phase of the procedure. We prefer to use the Visiport instrument (Medtronic, Norwalk Conn., USA) for initial port entry into the peritoneum (Fig.  50.17). Port #1 (camera port) is placed inferior to the umbilicus. A small curvilinear incision is made under the umbilicus. A Kocher clamp is used to grasp the frenulum of the umbilicus and to

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Fig. 50.17  Port placement

elevate the anterior abdominal wall. Upward traction on the clamp provides the countertraction which is necessary for safe peritoneal entry under direction videoendoscopic guidance using the Visiport instrument. Alternatively, a Veress needle is introduced inferior to the umbilical frenulum, and upon entry into the peritoneum, a characteristic popping sensation is felt. Saline is introduced through the needle, and an unobstructed free peritoneal position of the needle is verified by the “hanging drop method” where the saline flows freely into the peritoneal cavity with elevation of the abdominal wall. A 10–12 Versaport trocar (Covidien/Medtronic Inc., Norwalk, Conn.) is introduced using the Veress needle. A 0 degree Endoeye videoendoscope (Olympus Inc.) is used. Pneumoperitoneum is created using CO2 gas to a maximum pressure of 15 mmHg. The table is placed in a steep reverse Trendelenburg position. Under direct videoendoscopic guidance, five to six other ports are placed. We prefer to use the 10–12 Versaport trocar (Medtronic Inc., Norwalk, Conn.) for all ports. These ports do not require reducer caps. An additional design advantage of these ports is that the port sites do not have to be closed. The peritoneal entry site is only 4 mm and is virtually pain-free. The use of the Versaport allows for the placement of extra ports as needed, especially in patients with a high BMI or very large hiatal defects which may extend far above the diaphragm. Furthermore, the capless design of these ports enables rapid instrument change without loss of pneumoperitoneum. Port #2 is placed in the right paraumbilical region at the mammary line. An Endo-Paddle Retract retractor (Medtronic Inc., Norwalk, Conn.) is placed through Port #2 and fixed to the table using a self-retaining system (Mediflex, Velmed Inc., Wexford, Penn). The advantage of the Endo-Paddle Retract device is that it is used to exert constant fixed upward traction onto the apex of the esophageal hiatus, thereby facilitating visualization and instrument maneuverability within the hiatal opening. Port #3 is placed halfway between the costal arch and the umbilicus as laterally on the right side of the abdomen as possible. This port will carry the left robotic arm. Using the videoendoscope, the left and right limbs of the right crus are identi-

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fied. Port #4 is placed in the subcostal region halfway between the umbilicus and the xiphoid just to the left of the midline. This port is aligned with the right limb of the right crus of the diaphragm. Port #5 is placed in the subcostal region two fingerbreadths to the left and caudad to Port #4. Port #5 is aligned with the left limb of the right crus of the diaphragm. The laparoscopic insufflator is disconnected from Port #1 and attached to Port #4. A second insufflator is attached to Port #5. The use of two high flow insufflators facilitates rapid extracorporeal knot placement while preserving pneumoperitoneum and exposure of the esophageal hiatus. Port #6 is placed halfway between the costal arch and the umbilicus as laterally on the left side of the abdomen as possible. This port will carry the right robotic arm. At times a seventh port is needed to retract the contents of the hiatal defect. In such an instance, Port #7 is placed in the mammary line halfway between Ports #1 and #6.

50.5.4 Positioning and Introduction of the Robot The surgical robot (da Vinci, Intuitive Surgical, Sunnyvale, Ca.) is docked using “side docking” technique (Fig. 50.18). A 30-degree down-viewing robotic binocular camera is used, and it is introduced through Port #1. The right robotic arm with a hook cautery instrument is introduced through Port #3. The left robotic arm with a Debakey grasper instrument is introduced through Port #2. The entire dissection uses electrocautery and meticulous hemostasis. It is important not to use vessel sealing or other dissecting devices. The use of the hook cautery allows the surgeon to dissect along anatomic planes. Two assistants are used. A paddle retractor (Endo-Paddle Retract, Medtronic, Norwalk, Conn USA) is introduced by Assistant #1 through Port #6. This is used to retract the tissues in a caudal direction at different points in the dissection. Assistant #2 introduces two Endo-Kittner instruments through Ports # 4 and #5. The Endo-Kittner instruments are used to place lateral and upward traction on

Fig. 50.18  Side docking of the robot

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the limbs of the esophageal crus. This maneuver opens the space inside the hiatus further and allows the surgeon to have optimal exposure.

50.5.5 The Operation Is Divided into Seven Steps 50.5.5.1 S  tep 1: Dissection of the Right Side of the Hiatal Defect The lesser omentum overlying the caudate lobe of the liver is opened (Fig. 50.19). This allows for entry into the lesser sac and visualization of the right limb of the esophageal crus Fig. 50.21  The vessels that cross over the caudate lobe (CL) and the right limb of the esophageal crus (RL) are divided (RL). The vessels that cross over the caudate lobe and RL are dissected and elevated by the surgeon, clipped using Hem-o-­ lok clips (Teleflex Inc., Morrisville, NC, USA) which are introduced through Port #4 by Assistant #2, and divided (Figs.  50.20 and 50.21). This gives full visualization of RL. It is imperative to open the peritoneum overlying the RL (Fig. 50.22). The space between the peritoneum and the muscle of RL needs to be entered (Fig. 50.23). This is a natural and relatively avascular plane. Dissection in this plane allows for mobilization of the peritoneal sack and the contents of

Fig. 50.22  The peritoneum overlying the right limb of the esophageal crus (RL) is entered

Fig. 50.19  The lesser omentum overlying the caudate lobe of the liver (CL) is opened

Fig. 50.23  The space between the peritoneum (P) and the muscle of the right limb of the esophageal crus (RL) is entered

Fig. 50.20  The vessels that cross over the caudate lobe (CL) and the right limb of the esophageal crus (RL) are dissected

the hiatal defect with virtually no blood loss and perfect exposure. The Endo-Kittner which is introduced through Port # 5 and manned by Assistant #2 is placed at the 11 o’clock position of RL and used to retract RL laterally (Fig.  50.24). Next, the Endo-Paddle retractor manned by Assistant #1 and introduced through Port #6 is placed at the 7 o’clock position of the esophageal crus and used to sweep the tissues in a caudal and leftward direction (Fig.  50.25). These maneuvers allow the surgeon to grasp the peritoneum

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Fig. 50.24  The Endo-Kittner which is introduced through Port # 5 and manned by Assistant #2 is placed at the 11 o’clock position of the right limb of the esophageal crus (RL) and used to retract RL laterally

Fig. 50.26  Intraoperative photograph showing the right limb of the esophageal crus (RL). The hiatal sac (HS), the pleura (PL), and the retro-esophageal fat pad (FP)

Fig. 50.25  The surgeon dissects in the avascular plane between the pleura (PL) and the hiatal sac (HS)

Fig. 50.27  Intraoperative photograph showing the right limb of the esophageal crus (RL), the aorta (AO), and the retro-esophageal fat pad (FP)

and dissect in the avascular plane between the pleura and the hiatal sac. If the pleura is entered, the anesthesiologist clamps the ipsilateral lung (right), clips are placed to close the pleural opening, and after the completion of the dissection, a 24 French chest tube is placed through an anterior thoracostomy. It is important to dissect the right side of the hiatal defect first. The dissection is then carried inferiorly until the posterior “V” formation between the RL and the left limb of the esophageal crus (LL) is identified. The LL is deeper than RL and is covered with fatty tissue. It is important to dissect the fatty tissue which overlies the LL until the muscle fibers are visualized. At this point, the esophagus is elevated with the grasper in the left robotic hand, and the posterior aspect of the esophagus is separated from the crural “V” and the aorta. This maneuver allows for the identification and preservation of the right (posterior) vagal nerve (Figs. 50.26, 50.27, 50.28, 50.29, and 50.30).

50.5.5.2 S  tep 2: Dissection of the Arch of the Esophageal Hiatus Assistant #2 introduces an Endo-Kittner through Port #4. This Endo-Kittner is used to retract the right limb of the

Fig. 50.28  Intraoperative photograph showing the esophagus (E) being elevated away from the aorta (AO) by the robotic grasper

esophageal crus (RL) laterally. The surgeon uses a sweeping maneuver with the hook cautery to separate the adventitial tissue and some blood vessels from the 11 o’clock to 2 o’clock position of the hiatus. The anterior vagus nerve is deep to these tissues and is not in danger of injury (Figs. 50.31, 50.32, and 50.33).

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Fig. 50.29  Intraoperative photograph showing the esophagus (E) being elevated away from the aorta (AO) and the right limb of the esophageal crus (RL) by the robotic grasper

Fig. 50.30  Intraoperative photograph showing the esophagus (E) being elevated away from the aorta (AO) and the right limb of the esophageal crus (RL) by the robotic grasper

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Fig. 50.32  Endo-Kittner is used to retract the right limb of the esophageal crus (RL) laterally. The surgeon uses a sweeping maneuver with the hook cautery to separate the adventitial tissue and some blood vessels from the 11 o’clock to 2 o’clock position of the hiatus

Fig. 50.33  Dissection is carried into the right posterior mediastinum. PL pleura, E esophagus

Fig. 50.31  Endo-Kittner is used to retract the right limb of the esophageal crus (RL) laterally. The surgeon uses a sweeping maneuver with the hook cautery to separate the adventitial tissue and some blood vessels from the 11 o’clock to 2 o’clock position of the hiatus. E esophagus

Fig. 50.34  The Endo-Paddle retractor is positioned at the 3 o’clock position and used to retract the tissues at the hiatus laterally to the right of the patient and in a caudal direction, thereby exposing the left limb of the esophageal crus (LL)

50.5.5.3 S  tep 3: Dissection of the Left Side of the Hiatal Defect The Endo-Paddle retractor is placed at the 3 o’clock position and used to retract the tissues at the hiatus laterally to the right of the patient and in a caudal direction (Fig. 50.34).

The LL is identified and the tissues overlying the LL are dissected away until the muscle is visualized. The key to the hiatal dissection is to use the limbs of diaphragmatic crus as a landmark. The dissection of the LL is then carried inferiorly and laterally to the right of the patient until the “V”

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with the RL is identified (Figs. 50.35, 50.36, 50.37, 50.38, 50.39, 50.40, and 50.41). If the left pleura is entered, the same strategy as with the right pleural entry is utilized: the left lung is deflated, the pleural defect is closed with clips, a chest tube is placed through an anterior thoracostomy, and the exposure of the hiatus and pneumoperitoneum is maintained.

Fig. 50.38  The left side of the hiatal sac (HS) is dissected away from the left pleura (PL). S stomach

Fig. 50.35  The left side of the hiatal sac (HS) is dissected away from the left pleura (PL)

Fig. 50.39  Dissection is carried to the pleural reflection (PL) on the aorta (AO). LL = left limb of the diaphragmatic crus

Fig. 50.36  The adventitial space between the hernia sac (HS) and the left limb of the diaphragmatic crus (LL) is opened

Fig. 50.40  The hernia sac (HS) is dissected away from the left limb of the esophageal crus (LL) and mobilized toward the abdominal cavity

Fig. 50.37  Dissection is carried to the level of the left inferior pulmonary vein (IPV)

50.5.5.4 Step 4: Encircling the Esophagus It is important to resist the temptation of encircling the esophagus above the crural opening. In patients with large hiatal hernias, the only constant anatomic landmark is the muscle of the crus. Therefore, in order to prevent injury to the aorta or the esophagus, the esophagus must be encircled at the crus. The Endo-Paddle retractor is used to sweep the

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Fig. 50.41  The left limb of the esophageal crus (LL) is identified and the tissues overlying the LL are dissected away until the muscle is visualized. The key to the hiatal dissection is to use the limbs of diaphragmatic crus as a landmark

Fig. 50.43  The grasper in the left robotic arm is placed behind the esophagus and used to follow the muscle of the left limb of the esophageal crus (LL) in an oblique sweeping motion from a caudad to cephalad direction and toward the patient’s left shoulder

Fig. 50.42  The dissection of the left limb of the esophageal crus (LL) is then carried inferiorly and laterally to the right of the patient until the “V” with the right limb of the esophageal crus (RL) is identified. S spine

Fig. 50.44  Assistant #2 passes a vessel loop through Port # 4

tissues at the hiatus to the left of the patient and caudally, and the “V” formation between the RL and LL is identified. The grasper in the left robotic arm is placed behind the esophagus and used to follow the muscle of LL in an oblique sweeping motion from a caudad to cephalad direction and toward the patient’s left shoulder (Fig. 50.42). Assistant #2 passes a vessel loop through Port # 4, the vessel loop is retracted around the esophagus, and a Hem-o-lok clip is used to attach the two limbs of the vessel loop together. The excess vessel loop is cut and removed (Figs.  50.43, 50.44, 50.45, and 50.46). Next, Assistant #2 introduces a laparoscopic grasper through Port #4, the vessel loop just above the Hem-o-lok clip is grasped, and the esophagus is retracted laterally to the left of the patient.

50.5.5.5 S  tep 5: Completion of the Mediastinal Dissection In order to repair the hiatus in an anatomic fashion at a later point in the procedure, the esophagus needs to be dissected free from the mediastinal tissues. This dissection should be

Fig. 50.45  The vessel loop is retracted around the esophagus (E)

carried posterior to the pericardium, to the level of the inferior pulmonary vein. Complete dissection and mobilization of the esophagus facilitates a tension-free primary repair and places at least 2  cm of esophagus below the hiatal reconstruction. Assistant #2 retracts the esophagus laterally to the left and then to the right, thereby facilitating exposure of the periesophageal mediastinal tissues. Esophageal dissection is continued laterally and superiorly at least to the level of the

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Fig. 50.46  A Hem-o-lok clip is used to attach the two limbs of the vessel loop together

Fig. 50.47  Assistant #2 introduces a laparoscopic grasper through Port #4, the vessel loop just above the Hem-o-lok clip is grasped, and the esophagus (E) is retracted laterally to the left of the patient

Fig. 50.48  The esophagus (E) is elevated with the grasper in the left hand and dissected away from the aorta (AO)

inferior pulmonary vein. All vascular and adventitial connections to the esophagus are divided such that the vessel loop can be moved freely up onto the distal esophagus (Figs. 50.47, 50.48, 50.49, 50.50, 50.51, 50.52, 50.53, and 50.54). In addition, the periesophageal fat pad and migrated retroperitoneal fatty tissue is dissected away from the esophagus. Frequently, retroperitoneal fat, and at times lesser sac fatty tissue, migrates between the posterior vagus nerve and the esopha-

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Fig. 50.49  The esophagus (E) is elevated with the grasper in the left hand and dissected away from the aorta (AO) using the hook cautery in the right hand in a “back-handed” fashion

Fig. 50.50  The esophagus (E) is elevated with the grasper in the left hand and dissected away from the aorta (AO) using the hook cautery in the right hand in a “back-handed” fashion

Fig. 50.51  From a right to left direction, the space posterior to the esophagus and anterior to the aorta is dissected to the level of the inferior pulmonary vein. AO aorta

gus on the right side of the hiatal defect or the lesser curve aspect of the GE junction. In addition, fatty tissue from the retroperitoneum can migrate behind and to the left of the esophagus at the greater curve aspect of the GE junction. The retroperitoneal fatty herniation results in kinking and twisting of the esophagus and will need to be dissected away. At

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Fig. 50.52  The space posterior to the esophagus and anterior to the aorta is dissected to the level of the inferior pulmonary vein

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Fig. 50.55  Frequently, retroperitoneal fat, and at times lesser sac fatty tissue, migrates between the posterior vagus nerve and the esophagus on the right side of the hiatal defect or the lesser curve aspect of the GE junction. The fat pad (FP) and all retroperitoneal fatty tissue is dissected away from the esophagus and the posterior vagus nerve (PVN) is freed. E esophagus

Fig. 50.53  The space anterior to the esophagus is dissected away from the pericardium to the level of the inferior pulmonary vein. This allows for full mobilization of the esophagus Fig. 50.56  At the end of the dissection, the esophagus (E) and the vagus nerve should be the only tissues that remain within the encircling vessel loop. PL pleura

Fig. 50.54  The anterior vagus nerve (AVN) is identified and preserved. E esophagus

the end of the dissection, the esophagus and the vagus nerve should be the only tissues that remain within the encircling vessel loop (Figs. 50.55, 50.56, 50.57, 50.58, and 50.59).

Fig. 50.57  View of the mediastinal dissection from the left. The esophagus (E) is encircled by the vessel loop and the left limb of the esophageal crus (LL) can be seen

50.5.5.6 S  tep 6: Anatomic and Physiologic Repair of the Esophageal Hiatus The strategy is to recreate the normal anatomy of the hiatus and therefore recreate the normal gastroesophageal antire-

flux barrier. This step can be carried out with the use of the robot or by conventional laparoscopy. We prefer ­conventional laparoscopy for this step. In our experience, laparoscopic suturing with extracorporeal knot-tying technique is more

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Fig. 50.58  View of the mediastinal dissection from the right. The esophagus (E) is encircled by the vessel loop and the right limb of the esophageal crus (RL), and the thoracic spine (S) can be seen

Fig. 50.59  View of the dissected hiatus. E esophagus, RL right limb of the esophageal crus, LL left limb of the esophageal crus

rapid and facilitates more accurate knot placement under tension. The crucial role of the robot and its significant differential advantage to laparoscopy is in the dissection of the hernia sac and full mobilization of the esophagus. In order to accomplish full esophageal mobilization to the level of the inferior pulmonary veins, many times the pleura needs to be entered and the esophagus needs to be dissected away from the inferior pulmonary ligament. This level of accurate and extensive dissection cannot be accomplished by laparoscopy. However, as the repair phase of the procedure is confined to the hiatus, laparoscopic or robotic repair is equivalent and is dictated by the surgeon’s preference. The antireflux mechanism is the result of the intussusception of the esophagus into the stomach by 2  cm anteriorly spanning approximately 240 degrees of the circumference of the gastroesophageal junction from the 8 0’clock position on RL to 4 0’clock position on LL. The intussusception forms a horseshoe-shaped valve which opens and closes like a trapdoor. The intussusception of the esophagus enters at an acute angle, and the esophagogastric junction is angulated posteriorly. This complex three-dimensional relationship is held in place and is suspended onto the esophageal hiatus.

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Step 6a: Posterior Crural Closure. Posterior crural closure is accomplished by reapproximating the RL and LL with two or three sutures. We prefer the Endostitch instrument (Medtronic Inc. Norwalk, Conn., USA) with 0 Ethibond suture. The Endostitch instrument is an ideal suturing device for laparoscopy as it facilitates one-handed suturing, thereby allowing the surgeon’s left hand to provide appropriate exposure. Furthermore, when approximating the RL and LL of the right crus posteriorly, the straight needle of the Endostitch instrument passes in a tangential plain anterior to the aorta and carries a lower risk of inadvertent aortic injury which usually is the result of deep suture placement with a curved needle. The curved needle used with a laparoscopic needle driver can pass deeper than intended and can engage the anterior wall of the aorta. The Endo-Paddle retractor is placed on the medial aspect of the esophagus and used to retract the esophagus laterally and to the left. The maneuver exposes the “V”-shaped posterior junction of the RL and LL of the right crus (Fig. 50.60). A 1  cm squared absorbable pledget cut from Vicryl mesh (Ethicon, Inc., Somerville, NJ, USA) is passed through Port #5. The Endostitch with 0 Ethibond is passed through Port #4. Intracorporeally the pledget is loaded onto the needle. The needle is passed through LL, a second pledget is loaded intracorporeally onto the needle, and the needle is passed through RL.  Next, intracorporeally the needle is passed through a third Vicryl pledget which is introduced with the grasper in the surgeon’s left hand. The Endostitch carrying the suture is withdrawn out of the entry Port #4, and extracorporeal knots are placed using a long external knot pusher. The suture is cut above the knot. This technique is repeated for all the posterior crural sutures (Figs. 50.61, 50.62, 50.63, and 50.64). Step 6b: Suspension of the Esophagus onto the Esophageal Crus. The camera is moved to Port #7. In a similar manner, an

Fig. 50.60  The Endo-Paddle retractor is placed on the medial aspect of the esophagus and used to retract the esophagus laterally and to the left. The maneuver exposes the “V”-shaped posterior junction of the right limb of the esophageal crus (RL) and left limb of the esophageal crus (LL)

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Fig. 50.61  Step 6a: posterior crural closure. The Endostitch instrument passes an 0 Ethibond suture through left limb of the esophageal crus (LL). AO aorta, PVN posterior vagus nerve

Fig. 50.64  Step 6a: posterior crural closure. Completed posterior crural closure. RL right limb of the esophageal crus, LL left limb of the esophageal crus, PVN posterior vagus nerve, E esophagus

Fig. 50.62  Step 6a: posterior crural closure. 1 cm squared absorbable pledgets cut from Vicryl mesh are used to buttress the posterior crural closure

Fig. 50.65  Step 6b: suspension of the esophagus onto the esophageal crus – left side. The needle is passed through left limb of the esophageal crus at the 4 o’clock position and then through the lateral wall of the esophagus just above the gastroesophageal (GE) junction at the greater curve. RL right limb of the esophageal crus, LL left limb of the esophageal crus

Fig. 50.63  Step 6a: posterior crural closure. RL right limb of the esophageal crus, LL left limb of the esophageal crus, PVN posterior vagus nerve, E esophagus

0 Ethibond suture on the Endostitch device is introduced through Port #4. Intracorporeally the pledget is loaded onto the needle; the needle is passed through LL at the 4 o’clock position; then through the lateral wall of the esophagus just above the GE junction at the greater curve, a second Vicryl pledget is loaded as described; and the suture is tied using extracorporeal technique. This fixes the left lateral aspect of

Fig. 50.66  Step 6b: suspension of the esophagus onto the esophageal crus – left side. The suture is tied using extracorporeal technique. This fixes the left lateral aspect of the esophagus to the esophageal hiatus and recreates the normal attachment of the phrenoesophageal ligament. RL right limb of the esophageal crus, LL left limb of the esophageal crus

the esophagus to the esophageal hiatus and recreates the normal attachment of the phrenoesophageal ligament (Figs. 50.65 and 50.66). Next, an 0 Ethibond suture on the Endostitch

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device is introduced through Port #4. Intracorporeally the pledget is loaded onto the needle; the needle is passed through the medial wall of the esophagus just above the GE junction at the lesser curve, through RL at the 8 o’clock position; then, a second Vicryl pledget is loaded as described; and the suture is tied using extracorporeal technique. This fixes the right medial aspect of the esophagus to the esophageal hiatus and recreates the normal attachment of the phrenoesophageal ligament (Figs. 50.67, 50.68, 50.69, and 50.70). Step 6c: Anterior Crural Closure. In a similar manner to the posterior crural closure, 0 Ethibond sutures on the Endostitch instrument with intracorporeally loaded pledgets of Vicryl mesh are used to reapproximate the anterior portion of the crural arch. The anterior crural closure allows for the formation of an acute angle at the gastroesophageal junction and recreates one of the important features of the normal antireflux barrier. The sutures are passed through Port #4, a Vicryl pledget is loaded on the suture intracorporeally, the suture is passed through the LL, a second pledget is loaded intracorporeally onto the needle, and the needle is passed

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Fig. 50.69  Step 6b: suspension of the esophagus onto the esophageal crus – right side. The suture is tied using extracorporeal technique. RL right limb of the esophageal crus

Fig. 50.70  Right side. The suture is tied using extracorporeal technique. This fixes the right medial aspect of the esophagus to the esophageal hiatus and recreates the normal attachment of the phrenoesophageal ligament. RL right limb of the esophageal crus

Fig. 50.67  Step 6b: suspension of the esophagus onto the esophageal crus – right side. The needle is passed through the medial wall of the esophagus (E) just above the GE junction at the lesser curve. RL right limb of the esophageal crus

Fig. 50.71  Step 6c: anterior crural closure. The crural closure is sized based on the passage of a 60 French bougie into the distal esophagus

Fig. 50.68  Step 6b: suspension of the esophagus onto the esophageal crus – right side. The needle is passed through the medial wall of the esophagus (E) just above the GE junction at the lesser curve and through RL at the 8 o’clock position. RL right limb of the esophageal crus

through LL at the crural arch. A third Vicryl pledget is loaded intracorporeally onto the suture, and the suture is tied using extracorporeal technique as outlined previously. Usually one to two anteriorly placed sutures are required (Fig.  50.71). The crural closure is sized based on the passage of a 60 French bougie into the distal esophagus.

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Fig. 50.72  Step 6d: creation of the normal gastroesophageal valve. The intussusception of the esophagus into the stomach is accomplished for the anterior 240 degrees (from RL to LL of the right crus) of the 360-degree circumference of the esophagogastric junction. The esophagus is marked 2 cm above the esophagogastric junction (EG) at the 4 o’clock position lateral to left vagus nerve (E1), at the 8 o’clock position just anterior to the right (posterior) vagus nerve (E3), and halfway in between at approximately the 11 o’clock position (E2). The stomach is marked 2 cm below the GE junction at the greater curvature (G1), the lesser curvature (G3), and at a point halfway between G1 and G3 (G2)

Step 6d: Creation of the Normal Gastroesophageal Valve. Following crural closure, the normal gastroesophageal valve is recreated. The intussusception of the esophagus into the stomach is accomplished for the anterior 240 degrees (from RL to LL of the right crus) of the 360-degree circumference of the esophagogastric junction. The esophagus is marked 2  cm above the esophagogastric junction (EG) at the 4 o’clock position lateral to left vagus nerve (E1), at the 8 o’clock position just anterior to the right vagus nerve (E3), and halfway in between at approximately the 11 o’clock position (E2). The stomach is marked 2  cm below the GE junction at the greater curvature (G1), the lesser curvature (G3), and at a point halfway between G1 and G3 (G2) (Fig. 50.72). The Endostitch instrument with 0 Ethibond is introduced through Port #4. The first suture (G3 to E3, lesser curve) passes from G3 to E3 and through the diaphragm at the right crural limb, RL, at 8 o’clock position. A Vicryl pledget is introduced with a grasper through Port #5, and the suture is passed through the pledget. The suture is withdrawn through Port #4. The suture is tied using extracorporeal knot-tying technique (Figs. 50.73, 50.74, 50.75, and 50.76). The second suture (G1 to E1, greater curve) is passed in a similar manner from G1 to E1 and through the diaphragm at the left crural limb, LL, at 4 o’clock position. A Vicryl pledget is introduced with a grasper through Port #5, and the suture is passed through the pledget. This suture is withdrawn from Port #4 and tied using a knot pusher and extracorporeal knots (Figs. 50.77, 50.78, and 50.79). The third suture (G2 to E2, midpoint) is introduced in the same manner from G2 to E2 and through the diaphragm at

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Fig. 50.73  Step 6d: creation of the normal gastroesophageal valve. The first suture (G3 to E3, lesser curve) passes from G3 to E3 and through the diaphragm at the right crural limb, RL at 8 o’clock position

Fig. 50.74  Step 6d: creation of the normal gastroesophageal valve. The first suture (G3 to E3, lesser curve) passes from G3 to E3 and through the diaphragm at the right crural limb, RL at 8 o’clock position

Fig. 50.75  Step 6d: creation of the normal gastroesophageal valve. The first suture (G3 to E3, lesser curve) passes from G3 to E3 and through the diaphragm at the right crural limb, RL at 8 o’clock position

the midpoint of the crural arch. This suture is withdrawn from Port #4 and tied using a knot pusher and extracorporeal knots (Fig. 50.80).

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Fig. 50.76  Step 6d: creation of the normal gastroesophageal valve. The first suture (G3 to E3, lesser curve) passes from G3 to E3 and through the diaphragm at the right crural limb, RL at 8 o’clock position

Fig. 50.79  Step 6d: creation of the normal gastroesophageal valve. The second suture (G1 to E1, lesser curve) is passed in a similar manner from G1 to E1 and through the diaphragm at the left crural limb, LL at 4 o’clock position

Fig. 50.77  Step 6d: creation of the normal gastroesophageal valve: The second suture (G1 to E1, lesser curve) is passed in a similar manner from G1 to E1 and through the diaphragm at the left crural limb, LL at 4 o’clock position

Fig. 50.80  Step 6d: creation of the normal gastroesophageal valve. The third suture (G2 to E2, midpoint) is introduced in the same manner from G2 to E2 and through the diaphragm at the midpoint of the crural arch

Fig. 50.78  Step 6d: creation of the normal gastroesophageal valve. The second suture (G1 to E1, lesser curve) is passed in a similar manner from G1 to E1 and through the diaphragm at the left crural limb, LL at 4 o’clock position

Fig. 50.81  Intraoperative view of the completed repair

Placement of the valvuloplasty sutures results in the intussusception of the esophagus into the stomach by 2  cm for approximately 240 degrees and recreates the normal gastroesophageal valve (Figs. 50.81 and 50.82).

At this point, the newly created gastroesophageal valve is graded based on the Hill I–IV grading system using intraoperative endoscopy. Only a grade I valve is acceptable. Any deviations which would necessitate a grade less than grade I need to be corrected at this time and before removal of the ports.

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Fig. 50.82  Retroflexed endoscopic view of the newly created gastroesophageal valve. Placement of the valvuloplasty sutures results in the intussusception of the esophagus into the stomach by 2 cm for approximately 240 degrees and recreates the normal gastroesophageal valve

50.5.5.7 S  tep 7: Evacuation of CO2 and Port Closure Only the camera port needs to be closed. This trocar site is closed using a laparoscopic suture passer and 0 Vicryl (Ethicon Endo-Surgery). CO2 is evacuated from the highest trocar by placing the patient in a steep reverse Trendelenburg position. The other Versaport trocars are removed, and the tissues are allowed to close around the introducer sheath. Subcutaneous tissues are closed with 00 Vicryl and the skin is closed with staples. Videos 50.1 and 50.2 demonstrate this procedure.

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prolonged period inflow obstruction to the heart. The changes in the hemodynamics and the fluid shifts demand positive pressure ventilation. Without control of the airway and positive pressure ventilation, these patients are at a high risk for lung collapse and pleural effusions (Figs.  50.83, 50.84, 50.85, and 50.86). Lung collapse and pleural effusions are determinants of significant postoperative morbidity and mortality in this population. Furthermore, positive pressure ventilation decreases the risk of pulmonary edema during the period when the hemodynamics are changing after a long period of diastolic dysfunction. In addition, positive pressure ventilation is required to force the lungs and the pleura to gradually close the large dead space in the mediastinum that is created as the result of extensive intrathoracic esophageal mobilization. Consequently, the patient needs to remain ventilated and receive positive pressure ventilation in the immediate postoperative period. The purpose of ventilation is not

50.5.6 Postoperative Management

Fig. 50.83  Computed axial tomographic images of the chest just above the diaphragm in a patient who did not receive positive pressure ventilation during the immediate postoperative period following robotic Patients who undergo repair of large HHs present specific repair of an HH.  There are bilateral pleural effusions (yellow arrow) challenges in the postoperative period. These issues can be and bilateral lung collapse (red arrow) necessitating bronchoscopy and divided into (1) immediate postoperative care and (2) long-­ drainage of the pleural spaces

term care.

50.5.6.1 Immediate Postoperative Care To reiterate, in these patients, the presence of the HH results in changes in the circulatory, pulmonary, gastrointestinal, and hematologic systems. In the immediate postoperative period, the patients need to be treated as patients who undergo a thoracic surgical procedure with pleural entry and extensive mediastinal dissection. In the operating room, the anesthesiologist replaces the double lumen tube with a single lumen endotracheal tube. The patient needs to undergo bronchoscopy and re-expansion of the lungs. In patients with larger HHs, the first 24 after the repair coincides with gradual re-expansion of the lungs, significant fluid shifts due to the relief of extrinsic left atrial and IVC compression, and progressive improvement in diastolic dysfunction. Lung re-­ expansion is facilitated by positive pressure ventilation. The patients many times require fluid resuscitation due to the

Fig. 50.84  Computed axial tomographic images of the chest at the level of the left atrium in a patient who did not receive positive pressure ventilation during the immediate postoperative period following robotic repair of an HH. There is a collection of fluid within the posterior mediastinal space with extrinsic compression of the atrium (red arrow). Left atrial compression has resulted in bilateral pleural effusions

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Fig. 50.85  Computed axial tomographic images of the chest at the level of the carina in a patient who did not receive positive pressure ventilation during the immediate postoperative period following robotic repair of an HH. There are bilateral pleural effusions (yellow arrows)

Fig. 50.86  Computed axial tomographic images of the chest at the level of the carina in a patient who did not receive positive pressure ventilation during the immediate postoperative period following robotic repair of an HH. There are bilateral pleural effusions (yellow arrows) which require drainage and can significantly increase the postoperative morbidity

respiratory compromise but control of the patient’s ventilation and fluid shifts during the immediate postoperative period. In the majority of patients after approximately 10–12  hours of positive pressure ventilation and hemodynamic support, if the hemodynamics and ventilatory parameters allow, the patient can be weaned from the ventilator, undergoes bronchoscopy with removal of secretions, and is extubated. It is imperative that in these patients the level of sedation be maintained until the time of weaning. Another important consideration in patients who undergo robotic anatomic and physiologic reconstruction of the hiatus with primary repair of large HHs is to prevent disruption of the hiatal and at times the diaphragmatic repair. Respiratory distress which results in large diaphragmatic excursion and increased tension at the suture line has been shown to result in disruption of the suture line, strangulation of the stomach in the hiatal repair, and an increase in the recurrence rate. Furthermore, as the esophagus is suspended onto the diaphragmatic crura, sudden or forceful excursion of the dia-

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phragm will result in an esophageal tear and disastrous complications from mediastinitis. All measures need to be taken to decrease the tension on the diaphragm in the immediate postoperative period. These measures include ­ intraoperative strategies as well as postoperative ventilatory strategies which are all designed to prevent respiratory distress, patient agitation, labored breathing, and ultimately disruption of the repair. In order to meet the requirements that have been outlined above, the patient needs to remain intubated, sedated, and ventilated immediately after the robotic repair of the HH.  The patient’s hemodynamics and pulmonary status need to be assessed in 12-hour intervals. In the event that the hemodynamic parameters and pulmonary parameters are satisfactory, sedation should be withdrawn, and the patient should be assessed for extubation. It is imperative that all personnel who are entrusted with the care of patients who undergo a robotic repair of a large HH be familiar with the complexities of the surgical procedure and not be misled by the minimally invasive nature of the procedure. Robotic repair of large HHs is a true “wolf in sheep’s clothing” and should be viewed as a complex thoracic and esophageal operation that, although is performed minimally invasively due to advances in robotic technology, still presents significant physiologic, technical, and surgical changes in the postoperative period. The role of a comprehensive specially trained “team” of professionals who are acutely aware of the complex challenges in these patients and are involved in all aspects of the patient’s care from the time of admission to discharge cannot be overemphasized. Following extubation, the patients need to undergo an esophagogram with water-soluble contrast in order to rule out an esophageal or gastric “leak.” In these patients, the extensive dissection of the esophagus results in a large potential space in the posterior mediastinum. This fact is important for two reasons: (1) Immediately after surgery, positive pressure ventilation is required to expand the pleura bilaterally and to eliminate this space in order to prevent fluid accumulation in the space during the period when the patient experiences fluid shifts. Fluid accumulation in this space will result in extrinsic compression of the left atrium and the IVC and cause diastolic dysfunction. (2) In this setting, an esophageal or gastric “leak” will quickly result in severe mediastinitis and sepsis. Even after ruling out an esophageal or gastric “leak,” the patient cannot resume oral intake until full bowel function returns. Although the vagus nerves are identified and protected during the surgical repair, manipulation of the ­ nerves may result in an ileus in the immediate postoperative period. In addition, the extensive dissection of the hiatus and the use of Vicryl pledgets result in an inflammatory reaction in the area of repair. The vagus nerve becomes encased in the inflammatory process, thereby affecting gastric emptying and overall bowel function. In turn, the patients may experi-

50  Robotic Anatomic and Physiologic Reconstruction of Paraesophageal Hiatal Hernias: Combining Lessons from a Century…

ence a bloated feeling for varying periods after surgery. Each patient needs to be monitored, and the strategy for oral intake needs to be individualized for each patient. Typically, the patients remain on a liquid to a soft diet for at least 2 weeks. Starting the third week postoperatively, the diet is advanced as tolerated under the direction of a nurse practitioner. After starting oral intake, in patients with a dilated esophagus or esophageal dysmotility, we prefer to use oral erythromycin (erythromycin lactobionate [1  mg/kg] every 8 hours) as a promotility agent. Erythromycin is continued for 6–12 months.

50.5.6.2 Long-Term Care Recovery in patients who undergo robotic anatomic and physiologic reconstruction of the hiatus is in two phases: Phase 1  – the first phase of recovery is within the first 2 weeks during which the patient typically recovers from the surgical incision. During this time, due to the relief of extrinsic compression of the cardiovascular system and gastric strangulation, the patient experiences improvement in pulmonary and cardiovascular symptoms. These include improvement in dyspnea on exertion, tachypnea, atrial arrhythmias, and palpitation. In addition, there is relief of epigastric pain and cessation of blood loss from the Cameron’s ulcer. Phase 2 – the second phase of recovery is more protracted and can last for many months. During this phase, as a direct result of the relief of esophageal obstruction, there is resolution of the inflammatory process affecting the esophagus, the airway, and the aerodigestive tract. Therefore, the patient will experience gradual resolution of “heartburn,” cough, and other symptoms which relate to the inflammatory process. The duration of this phase is variable and can last up to 1 year. It is imperative that during this phase the patient remain under the care of a “team” comprised of the surgical team and the patient’s gastroenterologist. At our institution, experience with over 400 consecutive cases has shown that this strategy is absolutely necessary in order to appropriately and accurately assess the results of the surgical intervention.

50.6 Results Evaluating the success of robotic anatomic and physiologic repair of large HHs (RRHH) requires long-term follow-up. In a prospective cohort study, we evaluated patients undergoing RRHH with at least a 2-year follow-up. All patients undergoing elective (RRHH) were identified preoperatively and enrolled prospectively in this study. Exclusion criteria included previous repair of HH, previous fundoplication, esophageal surgery for a malignant disease process, any subject unwilling to provide informed consent, or any individual who was unwilling to undergo the required follow-up studies.

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Preoperative characteristics, medical comorbidities, and clinical information were all recorded prospectively by trained research personnel and recorded into a secure surgical outcomes database. Postoperatively, patients typically were started on a full liquid diet and advanced quickly to a soft diet for 2 weeks postoperatively. A registered dietitian assisted with teaching in all patients before discharge. The patients were followed by surgical clinic visits, clinic visits with their gastroenterologist, and telephone consultation by specially trained nurse practitioners. In addition, the patients were followed by their local gastroenterologist by at least semiannual clinic visits and endoscopy. All patients received the previously validated Gastroesophageal Reflux Disease−Health-Related Quality of Life (GERD-HRQL) questionnaire preoperatively and at postoperative time points of 1 month and 1 year and 2 years. The questionnaire consists of ten questions with a maximum score of 50 (six questions relate to gastroesophageal reflux disease, two questions relate to swallowing, one question relates to bloating, and one question relates to medication use). A greater score indicates a worse symptom severity. Patient satisfaction with their current condition was determined at each time point. These questionnaires were administered by trained personnel during scheduled clinic visits. Patients routinely had a barium swallow postoperatively before discharge but did not undergo a barium swallow, an endoscopy, or a CT scan study at the 1-month time point unless indicated by symptoms. At 6  months, 1  year, and yearly intervals thereafter, all patients received an endoscopy study to ascertain the presence of a recurrence, regardless of symptoms. Recurrence was defined as over 2  cm or 10% of the stomach above the diaphragm detected by either CT, esophagogram, or endoscopy. It is important to point out that due to the intussusception of the esophagus into the stomach by 2 cm in the process of creating the GE valve, there will always be 2 cm of stomach above the GE junction for 240 degrees of the circumference. Any stomach above the diaphragm, however, represents a recurrence. In order to decrease the chance of bias, the studies were interpreted by the referring gastroenterologists and independent radiologists who were reminded of the study parameters and definitions but were blinded to the rest of the clinical data. 423 patients underwent RRHH. With a long-term follow­up, there was a significant decrease in the median symptom severity score from 42 preoperatively to 3 postoperatively. Recurrence was seen in five patients (5/423) for a recurrence rate of 1.1%. To the best of our knowledge, this experience represents the largest single center consecutive experience and the lowest reported recurrence rate for the surgical repair of large hiatal hernias.

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50.7 Conclusion The robotic approach to the repair of hiatal hernias which not only incorporates the technology of robotics but is designed to return the anatomy and physiology of the hiatus to its n­ ormal function is the culmination of the work of many surgical giants who independently identified specific parts of the “elephant” that is represented by the entity of a hiatal hernia. The robotic anatomic and physiologic repair of the hiatal hernia is also the result of a greater understanding of the very complex normal and pathologic physiology of the esophageal hiatus. Investigators from five specialties (cardiology, gastroenterology, pulmonary medicine, surgery, and radiology), using multiple modalities such as echocardiography, computed tomography, exercise testing, and respiratory function testing, have shed new light into the pathophysiology and surgical indications for the repair of hiatal hernias. The culmination of a century of investigation has clarified that (1) hiatal hernias are a gastrointestinal pathologic process that is more than GERD (gastroesophageal reflux disease) and (2) a hiatal hernia is identified as a common condition which by virtue of its anatomic location affects the gastrointestinal, pulmonary, cardiovascular, and aerodigestive systems. Finally, the borders between specialty “silos” have been erased, and new treatments for this important condition have been designed based on new insights and greater understanding of the complex anatomic and physiologic properties of the esophageal hiatus.

Appendix Video 50.1 Robotic anatomic reconstruction of the hiatus (https://youtu.be/7lM7Nvr6URY) Video 50.2 Robotic dissection with anatomic and physiologic repair of a giant hiatal hernia (https://youtu.be/ oMSr9ItiW0s)

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50  Robotic Anatomic and Physiologic Reconstruction of Paraesophageal Hiatal Hernias: Combining Lessons from a Century… 123. Hawasli A, Zonca S. Laparoscopic repair of paraesophageal hiatal hernia. Am Surg. 1998;64:703–10. 124. Fullum TM, Oyetunji TA, Ortega G, et  al. Open versus laparoscopic hiatal hernia repair. JSLS. 2013;17:23–9. 125. Zehetner J, Demeester SR, Ayazi S, et  al. Laparoscopic versus open repair of paraesophageal hernia: the second decade. J Am Coll Surg. 2011;212:813–20. 126. Hashemi M, Sillin LF, Peters JH.  Current concepts in the management of paraesophageal hiatal hernia. J Clin Gasroenterol. 1999;187:227–30. 127. Oddsdottir M.  Paraesophageal hernia. Surg Clin North Am. 2000;80:1243–52. 128. Tam V, Winger DG, Nason KS.  A systematic review and meta-­ analysis of mesh vs suture cruroplasty in laparoscopic large hiatal hernia repair. Am J Surg. 2016;211:226–38. 129. Watson DI, Thompson SK, Devitt PG, et al. Laparoscopic repair of very large hiatus hernia with sutures versus absorbable mesh versus nonabsorbable mesh: A randomized controlled trial. Ann Surg. 2015;261:282–28.

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130. Wilson LJ, Ma W, Hirschowitz BI. Association of obesity with hiatal hernia and esophagitis. Am J Gastroenterol. 1999;94:2840–4. 131. Luketich JD, Nason KS, Christie NA, et  al. Outcomes after a decade of laparoscopic giant paraesophageal hernia repair. J Thorac Cardiovasc Surg. 2010;139:395–404. 132. Anvari M, Allen C, Marshall J, et al. Randomized controlled trial of laparoscopic Nissen fundoplication versus proton pump inhibitors for treatment of patients with chronic gastroesophageal reflux disease: one-year follow-up. Surg Innov. 2006;13:238–49. 133. Merchant AM, Cook MW, Srinivasan J, et  al. Comparison between laparoscopic paraesophageal hernia repair with sleeve gastrectomy and paraesophageal hernia repair alone in morbidly obese patients. Am Surg. 2009;75:620–5. 134. Davis M, Rodriguez J, El-Hayek K, et al. Paraesophageal hernia repair with partial longitudinal gastrectomy in obese patients. JSLS. 2015;19:e2015.00060. 135. Patel AD, Lin E, Lytle NW, et al. Combining laparoscopic giant paraesophageal hernia repair with sleeve gastrectomy in obese patients. Surg Endosc. 2015;29:1115–22.

Redo Hiatal Hernia Surgery: Robotic Laparoscopic Approach

51

Alexander Christiaan Mertens and Ivo A. M. J. Broeders

51.1 Introduction In the first decades of hiatal hernia repair, surgical outcomes were unsatisfactory and patients were generally counseled to refrain from searching surgical repair. This was especially true for reoperations. Given the increasing success rates, low morbidity, and low mortality seen in recent publications, surgical treatment is becoming more accepted. This is welcome, given the perspective that recurrence of hiatal hernias is seen in up to 40% of patients and redo surgery is indicated in some 10% [1–4]. It is important to discuss these facts at the time of preoperative counseling, as recurrence is the major cause of dissatisfaction after surgery for reflux disease or hiatal hernia. Publications showing high recurrence rates often base these rates on radiology findings. However, counseling for redo surgery should not be based on radiologic studies but rather on the symptomatology of the patient, as slipped fundoplications may still provide good reflux control without dysphagia [5, 6]. Symptoms of a recurrent hiatal hernia vary greatly, and it is of the utmost importance to differentiate between a symptomatic recurrent hernia and, for example, abdominal complaints caused by delayed gastric emptying due to vagal nerve damage. The latter will not benefit from a redo hiatal hernia repair, as the symptoms of vagal nerve damage leading to the consultation will not be treated.

A. C. Mertens Department of Robotics and Mechanatronics, University of Twente, Enschede, The Netherlands I. A. M. J. Broeders (*) Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands Faculty of Electrical Engineering, Mathematics & Computer Science, Department of Robotics and Mechatronics, University of Twente, Enschede, The Netherlands e-mail: [email protected]

51.2 Diagnostic Tools: When to Consider Surgical Repair Due to the large number of patients with an asymptomatic recurrence, it is of great importance to ascertain the relation between the recurrent hiatal hernia and the patients’ symptoms. Each presentation requires a tailored approach. As is often the case in medicine, the first step in the diagnostic process is taking a detailed medical history. If the symptoms match with the profile of a recurrent hernia, one should proceed to obtaining imaging studies. A plain CT scan of the thorax and upper abdomen combined with exclusively oral contrast is an easy, fast, and affordable method to acquire the required anatomical information. This type of imaging allows for an optimal visualization of all types of (recurrent) hernias and can be used in the workup of all patients considering surgical treatment of a (recurrent) hernia or antireflux surgery. When in doubt, an esophageal barium swallow X-ray series may reveal additional detailed information, especially in the case of dysphagia. Upper gastrointestinal endoscopy may be of value to show a limited shift of the gastroesophageal junction and rule out esophagitis, Barrett’s metaplasia, or malignant disorders. If no evidence of a recurrent hernia is found, the next step depends on the patient history. If the main complaint is reflux, high-resolution manometry combined with 24-hour pH measurement is required to objectively diagnose esophageal reflux as the cause of the symptomatology. Gastric emptying studies can be of value in case of serious dyspeptic symptoms if no anatomical substrate for the symptoms can be found. After objectively confirming delayed gastric emptying, both surgical and conservative treatments can be considered. The treatment of delayed gastric emptying, however, is outside of the scope of this chapter. If a CT scan does indicate wrap disruption, migration, or a newly developed paraesophageal hernia, these anatomic recurrences can be classified using the Hinder classification. Surgical therapy can be indicated when the symptomatology outweighs the risks of surgery [7, 8].

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51.3 Categorizing Failed Repairs Most failed repairs are diagnosed within 5 years of primary surgery [9, 10]. Immediate failure is usually diagnosed by persistent dysphagia, although partial or complete recurrent herniation can be seen within the days or weeks after surgery. These early recurrences may be caused by excessive strain on the crus, caused by physical activity, coughing, or vomiting, often combined with a frail diaphragm. Technical failures may also lead to early recurrent herniation. Some of these early failures can be caused by incomplete hernia sac resection, inadequate esophageal mobilization, suturing under excessive tension, or inadequate hiatal closure. When an early recurrence is diagnosed, minimally invasive repair should be attempted as soon as possible. A delay can give the body opportunity to form dense adhesions, impeding gastric and esophageal mobilization from the thoracic cavity. This in turn increases chances for conversion to open surgery and the risk of serious morbidity. Early dysphagia is a common symptom after surgery, and spontaneous resolution can be awaited when a diet of fluids is enough to provide sufficient nutrients and fluids. Complete or near-complete esophageal or gastric blockage of fluids requires further investigation. An esophageal barium swallow X-ray series or CT scan with oral contrast may reveal the cause, but upper gastrointestinal endoscopy is usually indicated to exclude fungal infection or blockage by solid food. The endoscopy can be combined with therapeutic balloon dilatation and/or placement of a feeding catheter when required. In severe cases, a multi-lumen tube can be inserted to allow gastric drainage while, at the same time, delivering sustenance distal from the pylorus. If no improvement in dysphagia is seen in the first 3 months and dilatation does not help, surgical intervention can be considered. The preoperative workup should include imaging to exclude or diagnose any recurrent herniation, combined with an upper gastrointestinal endoscopy to ascertain the condition of the esophageal mucosa. Persistent early dysphagia without recurrence of a hiatal hernia is often caused by an overly tight hiatal closure. Other examples of causes for early dysphagia include technical failures in 360-degree fundoplications and severe motility disorders of the esophagus. In case of a prior anterior fundoplication, treatment consists of breakdown of the fundoplication, if it is still (partly) intact. This is then followed by widening the hiatus anteriorly to the esophagus by cutdown of one or more sutures or incision of the hiatal rim until a clear passage into the mediastinum is seen. Following this, a fundoplication can be recreated. In case of a 360° fundoplication, the Nissen sutures are cut, the hiatus is widened as described, and the fundoplication is restored in a 270° fashion. Dissection has to be per-

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formed with great caution to avoid damage of the anterior trunk of the vagal nerve as much as possible. Early redo surgery for recurrence or persistent dysphagia is relatively uncommon and usually entails less than 2% of surgical cases. The majority of redo surgery is performed for recurrence of hiatal hernias or failed reflux control of the fundoplication. Redo surgery is performed in up to 10% of all initial procedures. This percentage is even higher in type 3 and 4 hiatal hernias. The majority of revisions are performed in the first 5 years after the initial procedure. The types of failed fundoplications have been classified by Hinder, based on radiologic findings on barium swallow studies or CT scans. Hinder distinguished four types of failed fundoplication [8]. In Hinder type 1, a complete or almost complete disruption of the fundoplication wrap is seen, usually with recurrence of the hiatal hernia. This may be caused by insufficient thoracic esophageal dissection and incomplete hernia sac dissection. Any suture from stomach to esophagus may fail in time due to persistent traction, and sutures including the hiatal rim will fail in the end when upward forces due to tension on the esophagus persist. Hinder type 2 failure regards slippage of part of the stomach above the diaphragm, often caused by placing the fundoplication around the upper stomach instead of the esophagus. Hinder type 2 recurrence is usually seen after repair of type 3 and 4 hiatal hernias. In Hinder type 3 failure, one sees slippage of the stomach through a fundoplication while the gastroesophageal junction is still at, or below, the level of the hiatus. This type of failure usually relates to technical failures when creating a 360° Nissen fundoplication. Slippage through a 360 fundoplication might indicate insufficient esophageal dissection or lengthening. In Hinder type 4 failure, the complete and intact wrap has moved upward into the chest, usually just above the diaphragm. This type of failure is encountered frequently after surgery for reflux or type 1 hiatal hernias, certainly when performing radiologic investigation at long term. Wrap migration as seen on radiologic investigation is certainly no reason for intervention by itself, because many patients still encounter good reflux control without dysphagia [5, 6]. Other failed repairs may be caused by crural disruption or adhesions.

51.4 Indications for Redo Surgery Patients usually encounter a gradual return of symptoms over a period of months or years. Some patients will report a sudden episode of severe pain or the sensation of a snap, with immediate recurrence of symptoms. When recurrence has been diagnosed as described earlier in this chapter, counseling the patient is the next step. The choice between redo surgery, on the one hand, and no intervention supported by

51  Redo Hiatal Hernia Surgery: Robotic Laparoscopic Approach

medication and dietary advice, on the other hand, should be based on severity of symptoms and the risk profile of redo surgery. In general, redo surgery has a lower satisfaction rate of about 70% and a higher percentage of perioperative morbidity and mortality [11–13]. When symptoms are mild or well controlled by medication, one should defer intervention due to the surgical risks and a suboptimal expected outcome. It is important to mention the increased risk of vagal nerve damage in redo surgical interventions, especially to branches of the anterior vagal trunk. These branches are often embedded in the scar tissue at the upper hiatal rim and can be very difficult to identify. Damage may result in severe and lasting dyspeptic complaints. At this point in time, recurrence of hiatal hernias is unavoidable even for the most experienced surgeons. It should not be regarded as personal failure, and such feelings should not play any role in the decision to proceed to repair. When the decision is made to proceed with redo surgery, the surgeon has the choice between an abdominal and transthoracic approach through either open or endoscopic surgery. Endoscopic surgery has definite advantages over open surgery due to the reduced tissue damage but may be very challenging due to dense adhesions and altered anatomy. Robotic assistance can be of explicit value in these less common and more complex cases of recurrent hiatal hernias. For gastrointestinal surgeons, the abdominal laparoscopic route to redo surgery is a well-known approach. Open surgery should be reserved for patients with excessive adhesions. Evidence of these adhesions can usually be found in earlier operating reports and often predict increased difficulty in redo surgery. The thoracic approach can be regarded as an alternative, when the previous report demonstrates that the abdominal route is no longer feasible. Arguments advocating for a thoracic approach include extensive earlier damage to the esophagus or stomach during dissection or dense adhesions of the esophagus or stomach to the thoracic aorta. A thoracic approach is less commonly performed, and there is limited modern literature on the outcomes in redo hiatal hernia surgery by this approach. It may be a viable alternative in those patients where abdominal access is no longer deemed possible or has a very unattractive risk profile. The technique for the transthoracic approach with robotic assistance is published in Chap. 52.

51.5 R  obotic Approach to Redo Hiatal Hernia Surgery Due to the fact that redo surgery is not often performed by the surgeon responsible for the primary repair, one of the most important steps in the preparation for surgery is studying prior operating reports. Planning ahead for what to expect

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during surgery can prevent attempts to gain access through infeasible routes or major surgical complications. Previous surgery outside of the upper abdomen rarely leads to intraoperative difficulties in hiatal repair. Upper abdominal surgery such as an open cholecystectomy, however, may induce adhesions in the area of envisioned trocar placement and should be planned for accordingly. A Veress needle approach at Palmer’s point or an open approach is advised, placing the first trocar in the left upper abdomen to perform adhesiolysis prior to safely placing the remaining trocars. Adhesions after previous open gastric or hiatal hernia surgery may be severe, with the omentum and transverse colon adhering to the upper abdominal wall and liver. A careful open introduction in the left flank is advised in these cases, after which laparoscopic adhesiolysis can be performed. Care should be taken not to perforate the omentum, leading to a view on the lower border of the colon transversum. For dissection, scissors and bipolar energy devices are the preferred tools, with as little heat production as possible, in order to avoid late perforation of the colon or small bowel. Once the route from the upper abdomen to mid-stomach is cleared, one may progress to docking of the robotic system and subsequently continue the procedure with the robotic system. The operating room setup for redo surgery is equal to the setup for primary surgery. The surgical principles are similar to the primary repair, with modifications made to accommodate for the previously constructed fundoplication and accompanying scar tissue. We advise placing a nasogastric tube prior to surgery in all patients. This serves multiple purposes: besides avoiding aspiration of gastric contents during anesthesia, it enables decompression of the stomach, making manipulation of the stomach during surgery significantly easier. We remove the tube before suturing of the fundoplications, but positioning of a large-bore tube can be an option, based on the surgeon’s personal experience and preference. Trocar placement is performed over a slender “smiling” line with the camera trocar some 5  cm (approximately 2 inches) above the umbilicus, followed by two trocars in a symmetrical fashion on either side (Fig. 51.1). The position of the assistant trocar can be in between camera and flank port on the patient left side or in the left flank. The legs of the patient may be spread with the assistant positioned between them, or they can be positioned in a straight line with the assistant on the patient’s left side. It is advisable to experiment with these two setups to find the preferred scenario (Fig. 51.2). The positioning depends on the position of the assistant trocar and the dominant hand of the assistant. The patient is positioned on a mattress that blocks slippage, allowing for steep anti-Trendelenburg or a beach chair table

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Fig. 51.1  Trocar positioning for robotic redo hiatal hernia surgery Fig. 51.3  Curved tip grasper as a dynamic liver retractor

Fig. 51.2  Docked XI system for robotic redo hiatal hernia surgery

position. The liver retractor is then placed in the flank port on the patient’s right side. We use a blunt da Vinci instrument for this purpose, for example, a curved tip grasper. This allows step-by-step retraction of the liver toward the hiatus (Fig. 51.3). A fixed liver retractor can be used, as long as the fixator is low and positioned on the chest. When using such a retractor, one should be certain that collision with robotic arms is avoided. The fourth arm can then be left unused or applied as an extra retractor through a sixth trocar. The first step in redo surgery is to perform adhesiolysis of the omentum, sac remnants, and stomach from the liver and diaphragm. Blood loss should be avoided in this phase because it will severely hamper insight in the complex anatomy. Robotic dissection strongly supports step-by-step bloodless dissection. It is achievable in most cases, and conversion to open surgery can generally be avoided with the use of a robotic system. We experienced a dramatic fall in

Fig. 51.4  Takedown of an anterior fundoplication in a patient with retro-esophageal gastric herniation

conversion rates using robotics in redo hiatal hernia surgery [13, 14]. One should, however, be aware of the risk of serious bleeding. The most common cause for this is bleeding from an aberrant left liver lobe artery, which was spared during the primary repair. The presence of such arteries can often be found in prior operating reports. The left gastric artery can sometimes be found in unexpected locations, and the inferior caval vein may be much closer to the hiatus than expected due to retraction caused by scarring from the initial repair. Any aberrant left liver lobe arteries usually have to be ligated to allow proper visualization. One should preferably use clips or a sealing device. The difficulty of the dissection of the stomach and esophagus from the hiatal rim can vary from easy to difficult (Fig. 51.4). Dissection can be very challenging due to the formation of scar tissue, especially when arti-

51  Redo Hiatal Hernia Surgery: Robotic Laparoscopic Approach

ficial material has been used at the primary repair or when the first surgery was performed through a laparotomy. There is a definite risk of perforation of the stomach or fundoplication in this phase. Serosal tears of the stomach surface or superficial muscular tissue do not warrant repair. Gastric perforations, however, should be closed immediately to avoid spillage or further tearing of the defect. Closure of the defect can be performed with standard absorbable sutures, but a barbed suture wire makes the task easier and faster. It is advisable to inspect the repair at the end of the procedure to make sure no dehiscence occurred due to the manipulation during the remainder of the procedure. Removing any sutures from the prior fundoplication can lead to microscopic perforations, and this area should be covered by the new fundoplication or diaphragm to protect the vulnerable tissue. Antibiotic treatment other than the regular perioperative prophylaxis is not required. If repetitive gastric perforations occur without true progression in the procedure, this should be interpreted as a sign to abort the procedure and seek other treatment modalities. Gastric perforations that are closed properly seldom give rise to postoperative problems. The opposite is true for esophageal perforations, which are difficult to close due to vulnerability of the tissue and low healing capacity. Direct repair is warranted, and the repaired area should be covered by a fundoplication at all times. A contrast swallow X-ray or CT scan should be performed at the slightest suspicion of leakage because any delay will lead to fulminant mediastinitis with serious consequences. Postoperative leakage can be treated by esophageal stenting in combination with mediastinal drainage. The latter can be performed through a percutaneous approach, thoracoscopy, thoracotomy, or sometimes by a laparoscopic transhiatal approach. Hernia sac dissection can be very difficult in redo surgery, especially when the hernia sac dissection was not completely dissected during the primary procedure. Adhesions to the pleura and aorta may be very dense. Remnants of the hernia sac may be left in the mediastinum, as long as adequate mobilization of the esophagus is performed and the hiatal rims are cleared of the peritoneal sac. Dissection at the gastroesophageal junction should be performed with great care because patients are much more prone to vagal nerve damage in redo surgery. The main vagal trunks may be difficult to recognize in the scar tissue, and they may be positioned further away from the esophageal tube than usual. The reported incidence of accidental vagal nerve injury in primary hiatal hernia repair in the available literature is around 2%, although publications primarily describe the incidence in open surgery [15–18]. We suspect the incidence in redo surgery is significantly higher. Vagal nerve injury can lead to delayed gastric emptying, which is one of the feared complications of hiatal hernia repair. The pleura is often damaged in redo surgery, even though damage to the actual pulmonary parenchyma hardly ever

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occurs. If pleural defects occur, it is generally sufficient for the anesthesiologist to raise the end expiratory pressure to 15 mmHg and lower the abdominal pressure to 10 mmHg. Closure of the defect is seldom necessary, but careful release of residual CO2 is advised at the end of the procedure, using suction if needed. There is no need for routine thoracic drainage, although a chest X-ray should be performed at the recovery to rule out any significant pneumothorax. Drainage with a small-bore percutaneous drain can be performed in the case of pulmonary collapse, but this is encountered very rarely when taking measures as described. Besides damage to the pulmonary tissue, adhesions to vascular structures in the mediastinum can greatly complicate the procedure. Especially when little is known about the primary repair, one should pay close attention to the location of the aorta, vena cava, and aorto-esophageal branches. These structures can become encased in scar tissue, and careful step-by-step dissection is needed. Accidental damage to these structures can quickly limit the visibility of the surgical field. The visualization and dissection capacities of the robotic system provide support in this phase. After the intra-­ thoracic contents of the hernia sac have been removed from the mediastinum and a tension-free position of the esophagus has been achieved, hiatal closure is performed. We advise using interrupted, nonabsorbable braided 2-0 sutures for this. Sutures are placed both anteriorly and posteriorly of the esophagus in order to spread the tension on the hiatus and to avoid kinking of the esophagus at the level of the hiatal opening. Mesh can be used at the surgeon’s discretion. We have moved from a V-shaped mesh to polypropylene pledgets and use these only when the patient has a frail diaphragm (Fig.  51.5). Since evidence for the long-term efficacy of mesh [19] is lacking, we tend to use less mesh, currently in under 10% of redo cases [13]. In rare cases, the crus cannot

Fig. 51.5  Hiatal repair with polypropylene pledgets

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be approximated with sutures due to frailness or excessive tension with the risk of tearing. In these cases, a lateral diaphragmatic incision can be made to relieve some of this ­tension. The incision can be made the left or right side, depending on the circumstances. After hiatal closure, both the hiatal crura and the defect are covered with mesh. The mesh is preferably secured by sutures, although tackers may be used in the lower part, taking care not to use these near the cardiac protrusion in order to prevent damage to the pericardium. Suturing with barbed running sutures is the easiest way to secure mesh over long distances. The choice of the type of fundoplication differs on a patient-to-patient basis. In the case of large hiatal hernias, we prefer an anterior partial fundoplication in order to mimic the normal anatomy as much as possible. In patients who predominantly suffer from reflux, with normal anatomy or a type 1 hiatal hernia at the initial procedure, we create a posterior partial 270-degree fundoplication. The 360-degree fundoplication should be reserved for severe reflux when other types of fundoplications have failed. There is no evidence for long-term superiority of 360-degree fundoplications, while the incidence of comorbidity is significantly higher, especially bloating and dysphagia [20–24].

51.6 Summary/Conclusion Redo hiatal hernia surgery can be challenging, especially after prior upper abdominal laparotomy or the use of artificial material at the initial hiatal repair. Robotic assistance greatly provides support in the careful dissection of the hiatus and during hiatal repair. The use of robotics has proven to lower conversion rates. Principles and technical approaches are described in this chapter.

References 1. Oelschlager BK, Pellegrini CA, Hunter J, Soper N, Brunt M, Sheppard B, et al. Biologic prosthesis reduces recurrence after laparoscopic paraesophageal hernia repair. Trans Meet Am Surg Assoc. 2006;124:146–55. 2. Sathasivam R, Bussa G, Viswanath Y, Obuobi R-B, Gill T, Reddy A, et al. ‘Mesh hiatal hernioplasty’ versus ‘suture cruroplasty’ in laparoscopic para-oesophageal hernia surgery; a systematic review and meta-analysis. Asian J Surg. 2019;42(1):53–60. 3. Asti E, Lovece A, Bonavina L, Milito P, Sironi A, Bonitta G, et al. Laparoscopic management of large hiatus hernia: five-year cohort study and comparison of mesh-augmented versus standard crura repair. Surg Endosc. 2016;30(12):5404–9. 4. Zhang C, Liu D, Li F, Watson DI, Gao X, Koetje JH, et  al. Systematic review and meta-analysis of laparoscopic mesh versus suture repair of hiatus hernia: objective and subjective outcomes. Surg Endosc. 2017;31(12):4913–22. 5. Dunne N, Stratford J, Jones L, Sohampal J, Robertson R, Booth MI, et  al. Anatomical failure following laparoscopic antireflux

A. C. Mertens and I. A. M. Broeders surgery (LARS): does it really matter? Ann R Coll Surg Engl. 2010;92(2):131–5. 6. Donkervoort SC, Bais JE, Rijnhart-de Jong H, Gooszen HG. Impact of anatomical wrap position on the outcome of Nissen fundoplication. Br J Surg. 2003;90(7):854–9. 7. Fundoplication F, Kim RH, Gates T, Agostino HRD. Imaging findings of successful. Radiographics. 2014;34(7):1873–85. 8. Hinder RA, Klingler PJ, Perdikis G, Smith SL.  Management of the failed antireflux operation. Surg Clin North Am. 1997;77(5):1083–98. 9. Stefanidis D, Hope WW, Kohn GP, Reardon PR, Richardson WS, Fanelli RD. Guidelines for surgical treatment of gastroesophageal reflux disease. Surg Endosc. 2010;24(11):2647–69. 10. Mittal SK, Bikhchandani J, Gurney O, Yano F, Lee T.  Outcomes after repair of the intrathoracic stomach: objective follow-up of up to 5 years. Surg Endosc. 2011;25(2):556–66. 11. Chen Z, Zhao H, Sun X, Wang Z.  Laparoscopic repair of large hiatal hernias: clinical outcomes of 10 years. ANZ J Surg. 2018;88(10):E703–7. 12. Zahiri HR, Weltz AS, Sibia US, Paranji N, Leydorf SD, Fantry GT, et  al. Primary versus redo paraesophageal hiatal hernia repair: a comparative analysis of operative and quality of life outcomes. Surg Endosc. 2017;31(12):5166–74. 13. Mertens AC, Tolboom RC, Zavrtanik H, Draaisma WA, Broeders IAMJ.  Morbidity and mortality in complex robot-assisted hiatal hernia surgery: 7-year experience in a high-volume center. Surg Endosc. 2019;33(7):2152–61. 14. Tolboom R, Broeders I, Draaisma W.  Robot-assisted lapa roscopic hiatal hernia and antireflux surgery. J Surg Oncol. 2015;112(3):266–70. 15. Low DE, Mercer CD, James EC, Hill LD. Post Nissen syndrome. Surg Gynecol Obstet. 1988;167(1):1–5. 16. Watson DI, de Beaux AC. Complications of laparoscopic antireflux surgery. Surg Endosc. 2001;15(4):344–52. 17. Watson I, de Beaux AC. Complications of laparoscopic antireflux surgery. Surg Endosc. 2001;15:131. 18. Lindeboom MYA, Ringers J, van Rijn PJJ, Neijenhuis P, Stokkel MPM, Masclee AAM.  Gastric emptying and vagus nerve function after laparoscopic partial fundoplication. Ann Surg. 2004;240(5):785–90. 19. Tam V, Winger DG, Nason KS.  A systematic review and meta-­ analysis of mesh vs suture cruroplasty in laparoscopic large hiatal hernia repair. Am J Surg. 2016;211(1):226–38. 20. Du X, Wu J-M, Hu Z-W, Wang F, Wang Z-G, Zhang C, et  al. Laparoscopic Nissen (total) versus anterior 180° fundoplication for gastro-esophageal reflux disease: a meta-analysis and systematic review. Medicine (Baltimore). 2017;96(37):e8085. 21. Du X, Hu Z, Yan C, Zhang C, Wang Z, Wu J. A meta-analysis of long follow-up outcomes of laparoscopic Nissen (total) versus Toupet (270°) fundoplication for gastro-esophageal reflux disease based on randomized controlled trials in adults. BMC Gastroenterol. 2016;16(1):88. 22. Broeders JAJL, Mauritz FA, Ahmed Ali U, Draaisma WA, Ruurda JP, Gooszen HG, et al. Systematic review and meta-analysis of laparoscopic Nissen (posterior total) versus Toupet (posterior partial) fundoplication for gastro-oesophageal reflux disease. Br J Surg. 2010;97(9):1318–30. 23. Roks DJ, Broeders JA, Baigrie RJ.  Long-term symptom control of gastro-oesophageal reflux disease 12 years after laparoscopic Nissen or 180° anterior partial fundoplication in a randomized clinical trial. Br J Surg. 2017;104(7):852–6. 24. Broeders JA, Roks DJ, Ahmed Ali U, Watson DI, Baigrie RJ, Cao Z, et  al. Laparoscopic anterior 180-degree versus nissen fundoplication for gastroesophageal reflux disease: systematic review and meta-analysis of randomized clinical trials. Ann Surg. 2013;257(5):850–9.

Redo Hiatal Hernia Surgeries: Robotic Thoracoscopic Approach

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Paul J. M. Wijsman, Robert C. Tolboom, Werner Draaisma, and Ivo A. M. J. Broeders

52.1 Introduction Surgical treatment of gastroesophageal reflux disease (GERD) is generally performed by laparoscopy or laparotomy. A minimally invasive approach is currently treatment of choice. The hernia sac is removed from the thorax, the hiatal hernia is repaired, and the GE-junction reinforced by total (Nissen) or partial (Toupet or Dor) fundoplication. The majority (85–96%) of patients are relieved of complaints after surgical intervention [1–4]. A minority (10–15%) suffers from dyspeptic symptoms or dysphagia. Recurrence of a hiatal hernia is seen in 5% to more than 40% of patients, with redo surgery in up to 10%. Indications for reoperation are not unambiguous and show wide variations [5]. Diagnostic tools such as manometry, 24-hour pH measurement, gastroscopy CT imaging, gastric emptying studies, and swallow x-rays can help objectify symptoms and give insight in the etiology of the complaints. This will aid in decision-making, because symptomatology alone does not justify reintervention. The most important task of the surgeon is to determine the pathology of the recurrent symptoms, with a consecutive risk assessment of potential benefits versus morbidity and mortality for every individual patient. This tailored approach will

P. J. M. Wijsman Department of Surgery, Meander Medical Centre/Jeroen Bosch Hospital, Amersfoort/’s-Hertogenbosch, The Netherlands R. C. Tolboom Department of Surgery, Meander Medical Centre, Amersfoort, The Netherlands W. Draaisma Department of Surgery, Jeroen Bosch Hospital, ‘s Hertogenbosch, The Netherlands I. A. M. J. Broeders (*) Department of Surgery, Meander Medical Center, Amersfoort, The Netherlands Faculty of Electrical Engineering, Mathematics & Computer Science, Department of Robotics and Mechatronics, University of Twente, Enschede, The Netherlands e-mail: [email protected]

help identify individuals who may potentially benefit from yet another operation. Redo surgery mostly take place in the first few years after initial surgery with 1, 5, and 10-year cumulative reoperation rates of 1.7%, 5.2%, and 6.9%, respectively [4, 6, 7]. Currently, most redo surgeries are performed via laparotomy (35%) or thoracotomy (23%), followed by more minimal-­invasive approaches such as laparoscopy (37%)— with or without robotic assistance [8–11]. Morbidity and mortality of redo surgery is higher than after primary surgery, and symptomatic and objective outcomes are less satisfactory [11]. In literature, 18.6–21.4% intraoperative complications are described when performing redo surgeries and are more frequently seen in laparoscopy compared to laparotomy (19.5% versus 5.4%). The most common complication is perforation of the esophagus or stomach (13.1–14.2%), followed by pneumothorax (2.3–3.4%), hemorrhage (1.4–1.9%), and other complications (2.3%). Postoperative complications are described in 15.6–16.9% of the cases and have various etiologies. Pulmonary complications occur most frequently (3.6%), followed by wound infection (1.8%), incisional hernia (1.6%), other infectious complications (1.4%), urinary tract infection (0.3–1.1%), cardiac complications (0.9%), and lastly other complications (3.9–12.2%) [5, 11]. Every subsequent abdominal approach to the diaphragm increases in difficulty due to abundant adhesions and altered anatomy, hindering the surgeons’ ability to properly recognize anatomical structures. Due to these technical difficulties, redo surgery is known for its higher reported mortality of up to 1%. Moreover, decreased objective and subjective surgical outcomes compared to initial surgery is reported with 70% good results in redo surgery versus 85–95% in primary surgery. Compared to primary surgery, operative times are notably increased from 103 minutes to 172 minutes. This is primary due to extensive adhesiolysis and taking down the previously created wrap. Open surgery is known to create more adhesions than laparoscopy [6, 11–16].

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After several operations of the diaphragm, the anatomy can be unrecognizable and risk of complications will rise. The operative reports will give good insight of the difficulty of the previous operations. Predictors for a difficult procedure with risk of complications are intraoperative perforations, conversion to open surgery, extensive adhesions, and difficulty to access and recognize the hiatus. Therefore, another abdominal approach is sometimes too risky and alternatives have to be discussed with the patient.

52.2 A  lternative Surgical Approaches in Redo Hiatal Hernia Repair As the abdominal approach is not a possibility anymore after several procedures or in the case of an inaccessible abdomen, the only option remaining is a thoracic approach. There are currently three possibilities: a thoracoscopic approach, thoraco-­laparoscopic approach, or a thoracotomy. All these modalities will be discussed and a newly developed robotic thoracoscopic approach will be described as an alternative last resort option. Champion et  al. previously attempted a thoracoscopic Belsey fundoplication in a cohort of 21 patients, resulting in relatively high mortality and morbidity rates. Surgery was converted in two patients due to pulmonary complications during anesthesia and excessive bleeding, respectively. Short term follow-up showed two leaks requiring open surgical therapy. Long-term results mention three patients with persisting dysphagia and five with recurrent GERD. The authors concluded that the thoracoscopic approach is more technically involved than the laparoscopic approach and that instrument mobility is severely hampered by the rigid rib cage. Intracorporeal suturing and adequate surgical dissection was considered difficult and further use of the thoracoscopic approach was discouraged [17]. Thoraco-laparoscopic repair (simultaneous or consecutively) is described for selected cases with type IV hernias or recurrence of hiatal hernia [18, 19]. The patient is in supine position for the simultaneous approach and a total of five abdominal and three thoracic trocars are used. The operation is performed with two experienced surgeons; a thoracic surgeon and a laparoscopic surgeon. The consecutive approach requires the patient to be in lateral decubitus position for the first (thoracic) phase of the surgery and in supine position for the abdominal phase. Four trocars are used for the VATS portion of the procedure and five trocars for the abdominal part. Depending on the side of the hernia, a left or right thoracic approach is used. During the thoracic phase mobilization of the intra-thoracic organs, reduction of the hernia sac and mobilization of the esophagus is performed. Crural closure and the creation of the fundoplication take place in the abdominal part of the procedure. Starting by thoracoscopic means allows good visualization of the hernia sac, vagal

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nerves, and esophageal length and tension making the abdominal part of the procedure much easier. However, when a patient has a so-called hostile abdomen and the abdomen is inaccessible, a complete thoracic approach is warranted. A well-known open thoracic approach fundoplication using techniques described by Belsey could be used when the abdomen proves inaccessible after multiple antireflux or hiatal hernia procedures. The Belsey Mark IV technique consists of a 270° anterior fundoplication with creation of a posterior buttress of the right crus through a left-sided thoracotomy in the sixth intercostal space [20]. The goal of this procedure is to return the high pressure zone, also known as the lower esophageal sphincter (LES), to its normal anatomical position below the diaphragm and thereby recreating a patent gastroesophageal junction (GEJ) [21]. During the 10 –year-long period 1942–1952, Belsey and colleagues developed various techniques for the control of reflux disease which were named Mark I–IV. The results of these trials were assessed thoroughly by regular clinical, radiological, and endoscopic examinations resulting in the formulation of the technical principles. Returning the LES to its anatomical position in the abdomen proved to be the most successful principle. Belsey describes multiple advantages of a thoracic approach. First of all, due to good exposure a more adequate mobilization of the esophagus that enables the LES to be positioned tension-free in the high pressure zone. Secondly, mobilization of the cardia is easier than the abdominal approach in case of recurrent hernia in the presence of postoperative adhesions. Moreover, improved exposure reduces the risk of vagal nerve injury. The main disadvantage of the thoracic approach are thoracotomy-­ related complications and especially post-thoracotomy pain, which can be reduced by certain technical maneuvers as published by Belsey [22]. The long-term 5-year results of the Belsey Mark IV have been recorded and are satisfactory with a success rate of around 90% [23, 24]. The technique for primary transthoracic hiatal hernia surgery has been described in detail. The patient is placed in right lateral decubitus position for the Belsey Mark IV. Double-lumen intubation can be used to improve exposure but is not necessary if the patient cannot tolerate single lung ventilation. A shoulder roll is placed one arm’s length under the axilla to prevent damage to the plexus brachialis. The table is flexed just above hip level to widen the intercostal spaces. A left posterolateral thoracotomy through the sixth intercostal space is then made to access the thoracic cavity. Once entered, the lung is retracted and the mediastinal pleura overlying the esophagus is incised from the hiatus up to the aortic arch. Afterwards the inferior pulmonary ligament is divided to the level of the inferior pulmonary vein. The lower esophagus and vagal nerves are mobilized together and a penrose drain that encircles the esophagus is used for easy manipulation. In case of a hiatal hernia, the herniated peritoneum (hernia sac) is opened and removed if needed. Any

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additional phrenoesophageal attachments and peritoneum including the phrenocardial fat pad are divided and removed using upward traction and cautery. Next the fundus is grasped and 4–6 short gastric vessels also called the vasa brevia are divided. After complete mobilization of the cardia and fundus, three untied sutures are placed 1 cm apart posterior of the esophagus from the medial to lateral crus of the diaphragm to reapproximate the hiatus at the end of the procedure. A 50–56 Fr dilator is orally placed across the GEJ to prevent a too tight closure of the hiatus in order to reduce postoperative dysphagia. The fundoplication is created by placing three mattress sutures, starting 2 cm below the GEJ from the fundus to the esophagus 2 cm above the GEJ and reverse, 1 cm apart in a semi-circumferential manner to form a 240° incomplete anterior wrap. A second row of three mattress sutures are then placed first passing the diaphragm, then the stomach 2  cm below the first row of sutures and the esophagus 2 cm above the first row and reverse. Afterwards the three posterior crural sutures are tied completing the procedure [21]. In redo surgery, the same technical principles are employed, although mobilization of the cardia can be cumbersome due to intra-abdominal adhesions and bleeding or perforation outside reach needs to be avoided at any time. As already mentioned, the Belsey Mk IV fundoplication is executed through a large thoracotomy and not without risks. Airway complications such as atelectasis, bronchospasm, and pneumonia are more prone to develop (15–20%) with thoracic surgery and account for the majority of expected surgical mortality (3–4%) [25]. Another frequent more long-term complication is the postthoracotomy pain syndrome (PTPS) which occurs in approximately 50% of all patients. PTPS is a chronic condition where patients suffer various degrees of pain. These complaints may have a substantial impact on quality of life [26]. In pulmonary surgery, lung resections by video-assisted thoracoscopic surgery (VATS) have proven to decrease morbidity and incidence rates of PTPS [27, 28]. We believe that a more minimal invasive approach for redo transthoracic hiatal hernia surgery via robot-assisted thoracoscopic surgery (RATS) might similarly reduce postoperative complications. We therefore aimed to develop a safe and effective robotic procedure that uses concepts of Belsey’s technique [29]. Such a technique would complete the minimally invasive palette of treatment options for patients with complex (recurrent) hiatal hernias.

First, two embalmed human cadavers were used to examine the exterior and interior anatomy of the left hemithorax. Possible trocar placement sites were considered, and if present, pitfalls were documented. Next, three fresh-frozen human cadavers were used to review the feasibility of these trocar placement options while performing the redo procedure by VATS. Surgical steps, potential pitfalls, safety issues, and the technical feasibility of a minimal invasive thoracoscopic hernia repair were evaluated (Fig. 52.1). This study was conducted with two experienced upper-GI surgeons executing the new minimal-invasive procedure on two fresh-frozen cadavers with the da Vinci Si robotics system. Optimal docking of the robot was determined to minimize the risk of arm-collisions, while enabling the assisting surgeon sufficient access to the assistant port. Observers’ and surgeons’ findings were noted in journals and all procedures were photographed and recorded for analysis. We considered our procedure to be successful when we were able to successfully reduce the hernia and create a robot-assisted modified Belsey fundoplication.

52.3 Development of the Robotic Thoracoscopic Redo Hiatal Hernia Procedure (RATAS) To develop a new robot-assisted thoracoscopic antireflux procedure based on Belsey’s principles, we started at the beginning and assessed every surgical step thoroughly.

52.3.1 Positioning Initially, a right lateral decubitus position with varied degrees of additional ventral rotation was evaluated. The thoracic cavity of human cadavers that were positioned without any additional rotation ventrally were sufficiently accessible. However, adequate visibility of the crural region was obstructed by the lower lobe of the left lung. When positioned in a right lateral decubitus position with an additional 45-degree rotation ventrally, we found that the left lung was naturally retracted by gravity away from the surgical field. This provided an optimal view at the posterior mediastinum during surgery. Additional rotation beyond 45-degrees showed no benefits.

52.3.2 Trocar Placement In the beginning of the experiments, the camera port (C) was placed in the mid-axillary line of the 6th intercostal space. With this placement, excellent view of the hiatus, aorta, and esophagus was achieved. However, later in the experiments this port was adjusted to the 7th or 8th intercostal space in the mid-axillary line due to collision with the second robotic arm (R2). The working ports were initially introduced 5  cm left paravertebral in the 7th intercostal space (R3) and 2 cm ventrally of the anterior axillary line of the 7th intercostal space (R2). The assistant port (A) was placed in between the camera and the second working port in the 6th intercostal space. An additional working port (R1) was introduced to retract the diaphragm in the 8th intercostal space in-line with the

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Fig. 52.1  Assessment of port position for RATAS

second working port 2 cm ventrally of the anterior axillary line. This setup was chosen to explore the possibility to reduce the odds of chronic postoperative pain by placing trocars in the same intercostal space and away from the nerves (e.g. long thoracic and thoracodorsal nerve) in the axillary region between the anterior and posterior axillary line. This concept was abandoned when we found this limiting our range of motion. Also, docking the robot would have been impossible, as it would not have reached the trocars when docked at the feet of the patient. Sufficient range of motion of all instruments without collisions was achieved when we introduced the camera port (C) in the 6th or 7th intercostal space in the mid-axillary line and the working port (R2) 2 cm dorsal to the posterior axillary line in the 5th intercostal space. The working port (R1) introduced in the mid- to anterior -axillary line in the 9th intercostal space was required to retract the diaphragm in the cadavers. During the final stage of the experiment, the third robotic arm was omitted by placing the assistant ports in the 6th or 7th intercostal space anterior of the mid-axillary line in between the camera port and R2. This placement enabled the assistant to retract the diaphragm or esophagus when needed, making the third robotic arm obsolete. Determining optimal trocar placement remains patient tailored; we have not been able to determine a trocar placement that fits all patients. We advise to first introduce the camera port in the middle of the thorax, several centimeters posterior to the mid-axillary line. This will often be the 7th or 8th intercostal space. Next the second robotic arm (R2) can be introduced laterally to the tip of the scapula, several centimeters posterior to the posterior axillary line. The first robotic arm (R1) can then be introduced in the posterior axil-

lary line, just above the diaphragm. Special care should be taken to introduce R1 supra-diaphragmatic without perforating the diaphragm. Nonetheless, as much distance as possible between the three robotic arms remains the key goal in trocar placement. The assistant port is placed anteriorly to the camera port in the mid-axillary line to enable the assistant excellent access to the surgical plane while seated on a surgical stool and avoid any collisions with all robotic arms due to its low position. This trocar configuration resembles the Y-figure, as shown in Fig. 52.2, before and after docking of the da Vinci XI system. Docking the robot was possible with this setup of trocars and the da Vinci Si robot was docked from the dorso-caudal direction. Recent use of the XI system did not give considerations to change this approach.

52.3.3 Surgical Procedure After docking a da Vinci system from posterior -in a 45-degrees angle in case on an SI or X system- the procedure starts with ligating the pulmonary ligament up to the left inferior pulmonary vein to optimize access to the surgical plane. In order to avoid damage to the thoracic duct, the mediastinal pleura is opened anteriorly to the aorta in order to locate the esophagus. This is done by first identifying the crus by following the dome of the diaphragm to the deepest point near the spine, then opening the pleura at the beginning of the esophageal hiatus to uncover the esophagus (Fig. 52.3). This incision is extended up to the aortic arch. The esophagus is then mobilized while preserving the vagal nerves. This may be challenging at the level of the GE junction due to severe scarring or damage resulting from earlier transabdom-

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Fig. 52.2 (a) Trocar position in RATAS clinical cases. (b) Da Vinci XI system docked for RATAS procedure

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Fig. 52.3 (a) Overview of the crural area. (b) The esophagus was revealed by opening the pleura and after dissection is pulled laterally. Legend: D = diaphragm, LL = tip of the lower lobe of the lung, OE = esophagus

inal approaches. Unnamed perforation arteries running from the descending aorta to the junction of the middle and lower thirds of the esophagus are divided. The blood supply of the esophagus will not be impaired if the ascending branch of the left gastric artery is conserved. After full mobilization, the esophagus is encircled with a vessel loop for easy manipulation. Next, the hernia sac is dissected from the crura circumferentially. This dissection can be quite troublesome, as previous cruroplasty can cause dense adhesion and previous sutures have to be cut and sometimes removed. Caution not to cause perforations to the esophagus and stomach is warranted. Entrance to the abdominal cavity is obtained when the hernia sac is opened. The objective is to perform adhesiolysis at the abdominal surface of the diaphragm as much as possible and considered safe. It will allow better positioning of the GE junction below the diaphragm. This step may vary from relatively easy to

extremely difficult, based on the amount of scarring resulting from abdominal surgery. It is important to expose the crura circumferentially at the thoracic side by incising the whole hernia sac to reduce the GE junction completely into the abdomen. Exposing the posterior crura is the most difficult part as the dissection happens just millimeters from i­ mportant structures such as the descending aorta, the pleura parietalis of the right lung, the esophagus, and the stomach, and vision is hampered by the overlying esophagus. Mobilization of the esophagus with the Penrose drain is helpful in this phase. The normal anatomy is restored by redressing the gastroesophageal (GE) junction below the level of the diaphragm and re-approximation of both legs of the crus. This is done by first placing sutures to accommodate the hiatal opening to the right size. These sutures may be left untied till the end of the procedure to allow optimal view during creation of the fundoplication. Horizontal mattress sutures (“Belsey

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sutures”) are then placed behind esophagus at the right side, at the dorsal aspect and two or three on the left side of the esophagus. All nonresorbable woven sutures were placed through the crus, the stomach 2 cm distal to the GE-junction and at the rim of the GE-junction on the esophagus. Initially we positioned the top of this mattress suture through the muscular wall of the esophagus 2 cm above the GE junction. In recurrent redo surgery, this may create too much tension on the esophagus, which resulted in late perforation in one of our patients. When the mattress sutures are tied the GE-junction is forced below the level of the diaphragm by tensioning the sutures and creating an intussusception of the esophagus into the stomach. After reduction of the hiatal hernia the posterior buttress sutures are tied from behind forwards. By tying these sutures one may decide to remove any of these to avoid tightening the hiatus too much [22]. A concession we made was to omit the first row of Belsey’s sutures and just use the second row to anchor the fundoplication to the crus. This was done in consideration of the patient category in whom one may expect extensive adhesions and limited mobility of the stomach. Moreover, these patients already have a fundoplication in situ and breaking down the fundoplication thoracoscopic after one or two redo-operations is challenging to nearly impossible. The risk of a perforation or vagal nerve injury does not outweigh the expected benefit for such a maneuver. Therefore, we only try to reduce the hernia and restore the GE junction to its normal anatomical position in the abdomen while expecting support from previously created fundoplications. Preliminary results show that the robotic thoracoscopic hiatal hernia repair procedure is feasible using four ports. A total of 25 patients were operated at the time of writing this chapter. The average operative time is 105 minutes (skin-to-­ skin surgical time). None of the procedures were converted to open surgery. The median hospital stay was 3.8  days. Peroperative complications occurred in two patients; bleeding from an aorta-esophageal artery and a pneumothorax which did not need further drainage. Postoperative complications occurred in three patients. One patient needed pneumodilations due to dysphagia, one patient had a myasthenia crisis due to not receiving perioperative glucocorticoids, and one patient had an esophagus perforation probably due to late perforation caused by one of the mattress sutures resulting in mediastinitis. Overall, one-third of the patients experienced complete success, one-third improvement, and one-third had the same complaints as before the operation. With these results we use robot thoracic approach in a highly selected patient group when the abdominal cavity is inaccessible. Success rates may increase with growing experience but expectations should be realistic after repetitive antireflux procedures.

P. J. M. Wijsman et al.

References 1. Pizza F, Rossetti G, Limongelli P, Del Genio G, Maffettone V, Napolitano V, Brusciano L, Russo G, Tolone S, Di Martino M, Del Genio A. Influence of age on outcome of total laparoscopic fundoplication for gastroesophageal reflux disease. World J Gastroenterol. 2007;13:740–7. 2. Draaisma WA, Rijnhart-de Jong HG, Broeders IAMJ, Smout AJPM, Furnee EJB, Gooszen HG. Five-year subjective and objective results of laparoscopic and conventional Nissen fundoplication: a randomized trial. Ann Surg. 2006;244:34–41. https://doi. org/10.1097/01.sla.0000217667.55939.64. 3. Anvari M, Allen C. Five-year comprehensive outcomes evaluation in 181 patients after laparoscopic Nissen fundoplication. J Am Coll Surg. 2003;196:51–7; discussion 57–8; author reply 58–9. 4. Hunter JG, Smith CD, Branum GD, Waring JP, Trus TL, Cornwell M, Galloway K.  Laparoscopic fundoplication failures: patterns of failure and response to fundoplication revision. Ann Surg. 1999;230:595–604; discussion 604–6. 5. van Beek DB, Auyang ED, Soper NJ. A comprehensive review of laparoscopic redo fundoplication. Surg Endosc. 2011;25:706–12. https://doi.org/10.1007/s00464-010-1254-0. 6. Richter JE. Gastroesophageal reflux disease treatment: side effects and complications of fundoplication. Clin Gastroenterol Hepatol. 2013;11:465–71. https://doi.org/10.1016/j.cgh.2012.12.006. 7. Zhou T, Harnsberger C, Broderick R, Fuchs H, Talamini M, Jacobsen G, Horgan S, Chang D, Sandler B. Reoperation rates after laparoscopic fundoplication. Surg Endosc. 2015;29:510–4. https:// doi.org/10.1007/s00464-014-3660-1. 8. Furnée EJ, Draaisma WA, Broeders IA, Smout AJ, Gooszen H. Surgical reintervention after antireflux surgery for gastroesophageal reflux disease: a prospective cohort study in 130 patients. Arch Surg. 2008;143:267–74. https://doi.org/10.1001/archsurg.2007.50. 9. Tolboom RC, Draaisma WA, Broeders IAMJ.  Evaluation of conventional laparoscopic versus robot-assisted laparoscopic redo hiatal hernia and antireflux surgery: a cohort study. J Robot Surg. 2016;10:33–9. https://doi.org/10.1007/s11701-016-0558-z. 10. Tolboom RCC, Broeders IAMJAMJ, Draaisma WAA.  Robot-­ assisted laparoscopic hiatal hernia and antireflux surgery. J Surg Oncol. 2015;112:266–70. https://doi.org/10.1002/js0.23912. 11. Furnee EJ, Draaisma WA, Broeders IA, Gooszen HG.  Surgical reintervention after failed antireflux surgery: a systematic review of the literature. J Gastrointest Surg. 2009;13:1539–49. https://doi. org/10.1007/s11605-009-0873-z. 12. Furnee EJB, Broeders JAJL, Draaisma WA, Schwartz MP, Hazebroek EJ, Smout AJPM, Broeders IAMJ, Furnée EJ, Broeders JAJL, Draaisma WA, Schwartz MP, Hazebroek EJ, Smout AJPM, Broeders IAMJ. Symptomatic and objective results of laparoscopic Nissen fundoplication after failed EndoCinch gastroplication for gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol. 2010;22:1118–23. https://doi.org/10.1097/ MEG.0b013e328338c1f8. 13. Yamamoto SR, Hoshino M, Nandipati KC, Lee TH, Mittal SK. Long-term outcomes of reintervention for failed fundoplication: redo fundoplication versus Roux-en-Y reconstruction. Surg Endosc. 2014;28:42–8. https://doi.org/10.1007/s00464-013-3154-6. 14. Awais O, Luketich JD, Schuchert MJ, Morse CR, Wilson J, Gooding WE, Landreneau RJ, Pennathur A. Reoperative antireflux surgery for failed fundoplication: an analysis of outcomes in 275 patients. Ann Thorac Surg. 2011;92:1083–9; discussion 1089–90. https://doi.org/10.1016/j.athoracsur.2011.02.088. 15. Dutta S, Bamehriz F, Boghossian T, Pottruff CG, Anvari M.  Outcome of laparoscopic redo fundoplication. Surg Endosc. 2004;18:440–3. https://doi.org/10.1007/s00464-003-8822-5.

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16. Bais JE, Horbach the late JMLM, Masclee AAM, Smout AJPM, Terpstra JL, Gooszen HG.  Surgical treatment for recurrent gastro-oesophageal reflux disease after failed antireflux surgery. Br J Surg. 2000;87:243–49X. https://doi. org/10.1046/j.1365-2168.2000.01299.x. 17. Champion JK.  Thoracoscopic belsey fundoplication with 5-year outcomes. Surg Endosc Other Interv Tech. 2003;17:1212–5. https:// doi.org/10.1007/s00464-002-8564-9. 18. Derksen WJ, Oor JE, Yilmaz A, Hazebroek EJ.  Simultaneous thoraco-laparoscopic repair of giant hiatal hernias: an alternative approach. Dis Esophagus. 2017;30:1–6. https://doi.org/10.1111/ dote.12452. 19. Molena D, Mungo B, Stem M, Lidor AO.  Novel combined VATS/laparoscopic approach for giant and complicated paraesophageal hernia repair: description of technique and early results. Surg Endosc. 2015;29:185–91. https://doi.org/10.1007/ s00464-014-3662-z. 20. Fenton KN, Miller JI, Lee RB, Mansour KA.  Belsey Mark IV antireflux procedure for complicated gastroesophageal reflux disease. Ann Thorac Surg. 1997;64:790–4. https://doi.org/10.1016/ S0003-4975(97)00625-5. 21. Cooke DT.  Belsey Mark IV repair. Oper Tech Thorac Cardiovasc Surg. 2013;18:215–29. https://doi.org/10.1053/j. optechstcvs.2013.10.001. 22. Belsey R.  Mark IV repair of hiatal hernia by the transthoracic approach. World J Surg. 1977;1:475–81.

23. Markakis C, Tomos P, Spartalis ED, Lampropoulos P, Grigorakos L, Dimitroulis D, Lachanas E, Agathos EA.  The Belsey Mark IV: an operation with an enduring role in the management of complicated hiatal hernia. BMC Surg. 2013;13:24. https://doi. org/10.1186/1471-2482-13-24. 24. Gooszen HG. De operatieve behandeling van de gastro-oesofageale refluxziekte | Nederlands Tijdschrift voor Geneeskunde. In: Ned. Tijdschr. Geneeskd. 1998. https://www.ntvg.nl/artikelen/de-operatieve-behandeling-van-de-gastro-oesofageale-refluxziekte/volledig. Accessed 30 Apr 2019. 25. Sengupta S.  Post-operative pulmonary complications after thoracotomy. Indian J Anaesth. 2015;59:618–26. https://doi. org/10.4103/0019-5049.165852. 26. Karmakar MK, Ho AMH.  Postthoracotomy pain syndrome. Thorac Surg Clin. 2004;14:345–52. https://doi.org/10.1016/ S1547-4127(04)00022-2. 27. Dziedzic D, Orlowski T. The role of VATS in lung cancer surgery: current status and prospects for development. Minim Invasive Surg. 2015;2015:938430. https://doi.org/10.1155/2015/938430. 28. Landreneau RJ, Hazelrigg SR, Mack MJ, Dowling RD, Burke D, Gavlick J, Perrino MK, Ritter PS, Bowers CM, DeFino J. Postoperative pain-related morbidity: video-assisted thoracic surgery versus thoracotomy. Ann Thorac Surg. 1993;56:1285–9. 29. Hiebert CA, O’Mara CS. The Belsey operation for hiatal hernia: a twenty year experience. Am J Surg. 1979;137:532–5. https://doi. org/10.1016/0002-9610(79)90126-0.

Robotic Esophageal Myotomy for Achalasia

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Farid Gharagozloo, Amine Bouri, Mark Meyer, Nabiha Atiquzzaman, Stephan Gruessner, and Basher Atiquzzaman

53.1 Introduction Achalasia, originally called “cardiospasm,” was described by Thomas Willis in 1679 [1]. In 1930, Hurst introduced the Greek term for “lack of relaxation” and named this disease achalasia [2]. Achalasia occurs in 0.4–0.6 per 100,000 population. It is most commonly seen in the third decade of life and affects men and woman equally. Achalasia is characterized by abnormal relaxation of the lower esophagus and absence of progressive peristalsis in the body of the esophagus [3]. In patients with achalasia, histopathologic studies of the lower esophagus have shown depletion of the ganglion cells and inflammation of the myenteric plexus [4, 5]. In achalasia, there is preservation of the cholinergic excitatory nerves F. Gharagozloo (*) Professor of Surgery, University of Central Florida, Surgeon-in-Chief, Center for Advanced Thoracic Surgery, Director of Cardiothoracic Surgery, Global Robotics Institute, Director of Cardiothoracic Surgery, Advent Health Celebration, President, Society of Robotic Surgery, Director, International Society of Minimally Invasive Cardiothoracic Surgery, Celebration, FL, USA e-mail: [email protected] A. Bouri Thoracic Robotics Program, Advent Health Celebration, Celebration, FL, USA M. Meyer Department of Surgery, Wellington Regional Medical Center, Wellington, FL, USA N. Atiquzzaman University of Central Florida, Center for Advanced Thoracic Surgery, Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA S. Gruessner Department of Surgery, University of Illinois at Chicago, Chicago, IL, USA Formerly of Global Robotics Institute, Advent Health Celebration, Celebration, FL, USA B. Atiquzzaman Center for Advanced Thoracic Surgery, Advent Health Celebration, Celebration, FL, USA

of the lower esophageal muscle with impairment of the nonadrenergic noncholinergic inhibitory nerves [6]. Although the cause of achalasia is unknown, a number of hypotheses have been proposed. Most authors believe that inflammation is the primary cause for ganglion cell loss [7, 8]. There has been evidence for inflammation of the myenteric plexus with both an infectious as well as an autoimmune etiology [9]. DNA hybridization studies have shown the presence of varicella-zoster virus in the myenteric plexus and increased serum antibodies to the virus in patients with achalasia [7]. Eosinophilic cationic protein (ECP), which is a cytotoxic and neurotoxic protein released by eosinophils, has been detected in the lower esophageal muscle of patients with achalasia [10]. Furthermore, some authors have described eosinophilic infiltrates in the Auerbach plexus of the esophageal muscle in patients with achalasia [11, 12]. Evidence for the autoimmune etiology of achalasia stems from the demonstration of mucosal antibodies in patients with achalasia. Furthermore, class II human leukocyte antigen DQw1, which is seen in other autoimmune disorders, has been seen in patients with achalasia [9]. It is entirely possible that there may be different causes for the destruction of the myenteric plexus in different patients who present with symptoms of achalasia. After all, achalasia represents an esophageal muscle dysfunction which may be caused by different pathophysiologic pathways, all leading to the destruction of the myenteric plexus. Achalasia presents with an indolent course of gradually increasing progressive dysphagia. The natural history of this disease is that of progressive esophageal dilation and “a spiral downward” with the final loss of esophageal function. With increasing dilation, the progressive widening of the esophagus results in lower peristalsis and increased dysfunction. Soon, the esophagus transforms from a conduit to a reservoir. When the dilated dysfunctional esophagus has become an intrathoracic reservoir, the patient experiences more of the complications of repeated aspiration and pulmonary infection, airway obstruction, and even the development of squamous cell carcinoma [13, 14]. As the natural history of this disease is one of increasing symptoms and complications, relief of the distal esophageal obstruction should be the goal as soon as the diagnosis of achalasia has been confirmed.

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53.2 Diagnosis

53.3.3 Pneumatic Dilation

Although contrast upper GI studies and endoscopy are helpful, we believe that esophageal manometry is the “gold standard” in the diagnosis of achalasia. The diagnosis of achalasia is confirmed by the following:

Interestingly, the original patient described by Willis used a whalebone to dilate the distal esophagus every day for 15 years [1]. The experience with the more modern techniques of pneumatic dilation also attest to the transient nature of the relief which is obtained with dilation of the esophagus in patients with achalasia. Although presently most patients undergo balloon dilation initially, it is clear that this technique has a limited role in the long-term management of achalasia. With more successful and minimally invasive surgical options, this technique will be reserved more for patients in whom surgical myotomy is contraindicated [20]. It would seem that if dilating the esophageal muscle has the endpoint of forcibly rupturing the esophageal muscle fibers by nature of dilating across the mucosa, either the muscle will only stretch temporarily leaving the mucosa intact or a more forceful transmucosal tear of the esophageal muscle will result in mucosal rupture. Balloon dilation for achalasia has shown good to excellent transient results in 70% to 85% of patients. Review of the largest series reporting dilation for achalasia have shown the need for repeated dilations in 17% of patients, reflux in 22% of patients, perforation in 1.4% of patients, and a mortality rate of 0.3% [21].

• The presence of high pressure in the distal esophagus (increased pressure at the HPZ). • Lack of relaxation of the lower esophagus to swallowing. • Absence of peristalsis in the body of the esophagus.

53.3 Treatment As the function of the lower esophageal myenteric plexus cannot be restored, the treatment of achalasia is palliative. The therapeutic options include the following: • • • •

Medical therapy Botulinum toxin injections Pneumatic dilation Surgery

Historically, the lack of success with and the invasive nature of surgery has led patients and practitioners to search for other options.

53.3.1 Medical Therapy Beta-agonists, nitrates, anticholinergics, and calcium channel blockers have been used. With these medications, clinical improvement is often limited and the side effects are significant [15–18]. Medical therapy has a very limited role in the care of patients with achalasia.

53.3.2 Botulinum Toxin Injection Transendoscopic injection of botulinum toxin has been shown to be effective in 65% of patients [19]. Although simple, this technique suffers from the need for repeated injections, temporary benefit, and results in more difficult dissection at the time of surgery should a surgical approach be necessary. Most importantly, as in patients with achalasia, the ganglia of the Auerbach plexus are destroyed, it is difficult to understand the effect of either medical therapy or the injection of botulinum toxin on nonexistent ganglia. This reasoning has led some investigators to speculate that the symptom relief seen with botulinum toxin may in part stem from dilation of the esophageal muscle during endoscopy and may occur even without the injection of the toxin.

53.3.4 Surgery The fact remains that achalasia is a mechanical problem which stems from the destruction of the distal esophageal nerve bodies and, therefore, the ideal therapeutic strategy would be a mechanical approach for the relief of obstruction. The history of surgical therapy for achalasia is characterized by increasingly more successful and less invasive procedures which have been developed as a direct result of better understanding of the following: • The pathophysiology of achalasia. • The anatomy of the gastroesophageal junction and the nature of “antireflux barrier.” • Advancement in technology: optics, surgical instrumentation, and robotics. The first surgical procedures for the treatment of achalasia were described by Marwedel and Wendel [22, 23]. These procedures consisted of a transabdominal anastomotic cardioplasty of the gastroesophageal junction and were similar to pyloroplasty which was described by Heinke and Mikulicz. At the end of the nineteenth century and the beginning of the twentieth century, achalasia was thought to represent “cardiospasm,” a term which was proposed by Mikulicz. Therefore, the surgical therapy was designed to be similar to the surgery for pyloric obstruction. Obviously, the poor understanding of the nature of achalasia at the time had resulted in the design of an inadequate surgical procedure

53  Robotic Esophageal Myotomy for Achalasia

which did not address the nature of the disease. Although this technique relieved the esophageal obstruction, it was associated with significant gastroesophageal reflux and was eventually abandoned. In 1913, Heller performed a transabdominal anterior and posterior esophageal myotomy [24]. This procedure was later modified to a single anterior esophageal myotomy by Zaaijer in 1923 [25]. In relation to the Mikulicz cardioplasty, the modified Heller myotomy was similar to performing a pyloromyotomy versus a pyloroplasty. Like the earlier procedure, the complete distal esophageal myotomy as described by Heller and Zaaijer was based on the incomplete understanding of the nature of achalasia and the antireflux barrier at the gastroesophageal junction. Just like the earlier procedure, the modified Heller myotomy relieved the obstruction at the GE junction, but was associated with severe gastroesophageal reflux and esophagitis. Interestingly, in order to decrease post-myotomy reflux, originally Dor and Toupet described their respective techniques for anterior and posterior cardioplasty as modifications of the Heller procedure [26, 27]. During the 1950s, the high rate of reflux associated with this procedure led to the widespread interest in hydrostatic esophageal dilation. Over the years, surgical therapy for achalasia has been controversial. The controversy has centered on the ideal operative approach, the extent of esophageal myotomy, and the need for the addition of an antireflux procedure. With minor changes, presently the same controversies continue. Prior to the advent of laparoscopic or thoracoscopic approaches to achalasia, the most commonly performed procedure for this disease was the transthoracic modified Heller myotomy with or without an antireflux procedure. The transthoracic approach was preferred to the transabdominal approach due to the technical difficulties of exposing the gastroesophageal junction and the distal esophagus by an open abdominal procedure. One group of surgeons felt that with experience and appropriate intraoperative measures, they were able to perform transthoracic esophageal myotomy without an antireflux procedure with very low rates of postoperative reflux [28–30]. Another group of surgeons advocated solving the problem of new postoperative gastroesophageal reflux with Heller’s myotomy by adding a partial fundoplication to the myotomy procedure [31–33]. The proponents of myotomy combined with the antireflux procedure reasoned that: • Residual achalasia occurred as the result of incomplete myotomy which could be obviated by a generous extension of the myotomy onto the stomach cardia. • Without a generous myotomy, the extent of the myotomy and therefore the success of the procedure was difficult to judge at the time of surgery. • Judgment of the appropriate extent of myotomy was associated with a steep learning curve.

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Therefore, to avoid the problem of incomplete myotomy and to prevent severe gastroesophageal reflux following the myotomy, these authors recommended complete lower esophageal myotomy with a long extension onto the cardia of the stomach with the addition of an antireflux procedure. Furthermore, these authors observed that in addition to preventing postopertive reflux, the fundoplasty prevented the formation of a mucosal diverticulum following myotomy, a condition which may have added to the problem of chronic dysphagia in these patients with compromised esophageal motility. Due to the dysphagia associated with the Nissen fundoplication in patients with esophageal dysmotility, most authors have preferred partial wraps such as Dor or Toupet or the Belsey fundoplasty [34]. On the other hand, the surgeons who have advocated myotomy without an antireflux procedure most notably Ellis et al., have emphasized that in their experience, fundoplication recreates the resistance to esophageal emptying and that depending on the degree of resistance, fundoplication can lead to progressive esophageal dilation and ultimately the same sequalae as with untreated achalasia. Furthermore, these authors have asserted that in their experience, if the esophageal myotomy is carried on to the cardia by 5–10  mm, an antireflux procedure is not required [28–30]. The present understanding of the gastroesophageal antireflux barrier has served to explain the different observations and the discrepancy in the experience of the proponents versus the opponents of an added antireflux procedure to the modified Heller myotomy. The antireflux barrier, which corresponds to the high-pressure zone on esophageal manometry, seems to be the result of: • Anterior and lateral intussusception of the esophagus into the stomach, extending 270° from the right limb of the right crus to the left limb of the right crus of the diaphragm. • The crural sling exerts pressure in an anterior to posterior direction onto the GE junction and creates a slight anglation. This anglation at the GE junction serves to hold the intussuscepted esophagus in place and provides a slight resistance to reflux at the GE junction. • The entire “antireflux” mechanism is held in place by the phreno-esophageal ligament and the tissues at the esophageal hiatus. • Disruption of the esophageal hiatus either with a hiatal hernia or at the time of surgical dissection, leads to the straightening of the GE junction, reduction of the anterior esophageal intussusception and the creation of gastroesophageal reflux. In retrospect, it appears that by trial and error and careful surgical observation, surgeons who performed modified esophageal myotomy for achalasia had discovered that in

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patients with an intact antireflux barrier, in whom the esophagus is intussuscepted into the stomach by a few centimeters, the esophageal muscles seemed to extend beyond the perceived GE junction onto the cardia of the stomach. Furthermore, with experience these surgeons had discovered that by grasping the intrathoracic esophagus and pulling in a cephalad direction, one could temporarily reduce the intussusception and carry the myotomy down to the true junction of the esophagus and the stomach. In fact, using esophageal manometry, we have demonstrated that if the last few circular muscle fibers of the distal esophagus are not divided, the elevated HPZ pressure in patients with achalasia does not decrease. As a result of this information, it can be surmised that residual achalasia following surgery is a direct result of an incomplete myotomy. In retrospect, by nature of not disrupting the three-dimensional relationship at the esophageal hiatus and performing a very careful and limited myotomy, the surgeons who did not add an antireflux procedure have been able to preserve the antireflux barrier and accomplish the goal of the myotomy without the need for an antireflux procedure. On the other hand, surgeons who opened the esophageal hiatus and performed an extensive dissection of the gastroesophageal junction thus disrupting the normal antireflux barrier, needed to add an antireflux procedure to the myotomy in order to prevent postoperative reflux. It is important to note that in order to visualize an adequate length of esophagus, a transabdominal approach invariably needs to disrupt the anatomy at the gastroesophageal junction and the antireflux barrier. Consequently, all transabdominal approaches to esophageal myotomy have required the addition of an antireflux procedure. The emergence of video endoscopic techniques changed the approach to the surgical therapy of achalasia. Laparoscopic techniques allowed for better transabdominal visualization and manipulation of the gastroesophageal junction. Until the advent of laparoscopy, visualization of the GE junction by virtue of its location deep under the costal arch required extensive retraction. Even with the use of self-­ retaining retractors, visualization of the GE junction remained suboptimal. As the direct result of the inability to see, open transabdominal myotomy was associated with poor results. The extensive use of laparoscopy for fundoplication in patients with gastroesophageal reflux disease provided greater facility and familiarization with the anatomy of the gastroesophageal junction. It was not difficult to extrapolate the techniques used for fundoplasty to the procedure of esophageal myotomy which, if performed transabdominally, required an antireflux procedure at any rate. Unlike conventional surgery, video endoscopic techniques were associated with lower morbidity and pain, as well as shorter hospital stays. Therefore, these minimally invasive techniques with the promise of better long-term results were more favorable to nonsurgical approaches and found acceptance among patients and medical practitioners.

F. Gharagozloo et al.

In 1991, Shimi et al. reported the first laparoscopic experience for Heller Myotomy, and Pellegrini et al. reported a series of patients who had undergone esophageal myotomy using the thoracoscopic approach [35, 36].

53.3.4.1 Laparoscopic Approach The object of the laparoscopic esophageal myotomy and anterior fundoplication is to perform myotomy of the lower 6 cm of the esophagus and the proximal 2 cm of the stomach. In order to access the intrathoracic esophagus, this procedure requires full dissection of the right crus of the diaphragm and the entire esophageal hiatus. Consequently, following myotomy, a partial anterior gastric fundoplication is performed as an antireflux procedure. Invariably, all series reporting the laparoscopic approach to Heller myotomy have shown excellent relief of dysphagia [37]. In one series of 133 patients who had undergone laparoscopic myotomy with a partial fundoplication, Patti et al. reported 11% persistent dysphagia, 17% new gastroesophageal reflux, and 5% mucosal perforations which were amenable to laparoscopic closure [38]. The majority of difficulties with the laparoscopic approach were related to reflux and the technical aspects of the fundoplication. In a series of 69 patients undergoing laparoscopic myotomy and fundoplication for achalasia, Finley et  al. reported a median operative time of 1.9 hours, one mucosal perforation which was amenable to laparoscopic repair, 96% patient satisfaction for relief of dysphagia, and a 9% rate of new postoperative gastroesophageal reflux [39]. 53.3.4.2 Thoracoscopic Approach During the thoracoscopic approach, the esophagus is approached through the left chest. The myotomy is carried down to the gastroesophageal junction. During this approach, either the gastroesophageal junction is left intact or the left rim of the right crus is opened and subsequently re-­ approximated following the myotomy. With the thoracoscopic approach, an antireflux procedure has not been necessary. Whereas the complications of the laparoscopic approach have been related to reflux and the antireflux procedures, the thoracoscopic approach has suffered from the difficulty of residual achalasia and the steep learning curve associated with obtaining a complete myotomy [40]. The most important complication following the thoracoscopic approach has been incomplete myotomy and persistent dysphagia. Pellegrini et al. have reported that after thoracoscopic myotomy, dysphagia was relieved in 70% of patients, 12% of patients had residual achalasia, and mild reflux was seen in 20% of patients. Stewart et al. reported esophageal perforation in 12% of patients undergoing the thoracoscopic esophageal myotomy and conversion to thoracotomy in 21% of patients [40]. The mean hospitalization for this group of patients was 6 days. In the same group at 42 months, 31% of patients had relief of dysphagia and 23% of patients had new

53  Robotic Esophageal Myotomy for Achalasia

gastroesophageal reflux. Patti et al. reported a 6% conversion to a thoracotomy, a 73% rate of relief of dysphagia, and a 25% rate of incomplete myotomy [38]. The data has shown the laparoscopic procedure to have a lower conversion rate to an open procedure and to be associated with lower morbidity and shorter hospitalization. Most importantly, the laparoscopic Heller myotomy with an anterior fundoplasty has shown excellent relief of dysphagia at the expense of the higher rate of new gastroesophageal reflux. Due to these results at the present time, the laparoscopic approach has become the initial approach of choice for patients undergoing the surgical palliation for achalasia [41]. Our experience with both laparoscopic as well as thoracoscopic approaches to esophageal myotomy has led to the following conclusions: • Although easier, the laparoscopic approach necessitates the disruption of the esophageal hiatus and extensive mobilization of the esophagus. Due to this fact, the antireflux procedure is added to the myotomy. The clinical results reveal an excellent relief of dysphagia. However, the complications associated with this technique relate to the high rate of gastroesophageal reflux disease even with an antireflux procedure and the problems associated with the added antireflux procedure itself. • When performing a thoracoscopic Heller myotomy without disrupting the esophageal hiatus, the thoracoscopic approach is associated with a much lower rate of new postoperative gastroesophageal reflux disease. However, this procedure is hampered by the technical difficulties of performing a complete myotomy. Consequently, this technique has suffered from lower rates of dysphagia relief. We have reasoned that adapting the procedure performed through a left thoracotomy and described by Ellis et  al., where through a transthoracic approach a Heller myotomy was performed without the need for an antireflux procedure, to videoendoscopic techniques, there would be excellent relief of dysphagia with low incidence of new gastroesophageal reflux disease. Our experience with the thoracoscopic approach to esophageal myotomy has been in two phases.

53.3.4.3 P  hase I: VATS with Intraoperative Manometry The first thoracoscopic Heller myotomy by the senior author was performed in 1992. As the result of the initial thoracoscopic experience, it was obvious that with the loss of tactile input during VATS, assessment of the completeness of the esophageal myotomy was very difficult. This problem was resolved by the use of intraoperative esophageal manometry. Online direct intraoperative monitoring of the pressure at the distal esophagus by manometry was invaluable in confirming the completeness of the myotomy. As the last circular

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esophageal muscle fibers responsible for the high distal esophageal pressure were divided, the online esophageal monitoring would record a decrease in the pressure to the normal range. We reasoned that normal pressure reading (8–15  mmHg) at the esophagogastric junction reflected completeness of the myotomy and the intact nature of the antireflux barrier. Using this technique, the results were gratifying. In an 8-year period 32 patients underwent VATS esophageal myotomy with intraoperative manometry. There were 5 intraoperative mucosal injuries which were repaired primarily. Post myotomy the mean esophagogastric junction pressure decreased from 26 ± 3.3 to 9.1 ± 0.9 mmHg. The median hospitalization for patients with and without a mucosal injury was 7 days and 4 days, respectively. Mean follow-up was 38  months. All patients experienced postoperative improvement in dysphagia. Fifty-six percent had no dysphagia, and 44% had mild to moderate dysphagia. The patients with postoperative dysphagia had a dilated esophagus on preoperative esophagography. Of these patients, 9/14 (64%) showed improvement of dysphagia at the time of follow-up. At the time of follow-up 84% of patients had good to excellent relief of dysphagia, and 28% of patients had mild reflux which responded to antacid therapy. Although the results with VATS Heller myotomy were gratifying, this approach represented a technically challenging procedure which required significant experience with video-assisted thoracic surgery. It was obvious that in order for this approach to gain widespread acceptance, the procedure needed to be refined and become more “surgeon friendly.” A number of obstacles remained. • During video-assisted thoracic surgery, thoracoscopic instruments are introduced through a small hole in the chest wall. The instruments pivot at the entry point which makes fine control of the instrument tip, usually located at a remote location, difficult and cumbersome. The “chopstick” nature of the movements of the VATS instruments stems from the fact that the rigid shaft axis of the instruments is fixed at entry site on the chest wall. Consequently, the VATS instruments are limited to maneuvering in four directions (up, down, left side, and right side). Obviously, this technical feature of VATS presents the greatest limitation for complex dissection, especially in a remote confined space. By nature of pivoting at the chest wall, as the tip of the VATS instrument is moved further from the entry site, mobility of the instrument and its maneuverability in relation to the remotely positioned tissue decreases. Indeed it is as though the surgeon is operating at the apex of a pyramid with instruments which are pivoted at the base of that structure. • Another shortcoming of the VATS technique is in the lack of three-dimensional visualization. Although a surgeon with facility and experience with VATS uses the two-­ dimensional information from the video monitor and

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combines the visual input with tactile input in order to form a three-dimensional mental image, the fragile nature of the tissues, the confined space, and the paucity of tactile information when performing an esophageal myotomy results in a very poor mental three-dimensional image. Binocular three-dimensional vision with adequate depth perception is crucial to the task of separating the esophageal mucosa from the muscle and dividing the esophageal muscle fibers. By addressing these shortcomings, the robot represented the ideal tool for the accomplishment of robotic video endoscopic transthoracic Heller myotomy. The beneficial features of the robotic platform are the following: • The endowrists. The endowrist is a cable-driven wrist at the end of the robotic arm. The placement of the robotic arm through the VATS hole is comparable to the chopstick maneuvers of the conventional VATS instruments. The endowrist at the distal end of the robotic arm is then positioned in the confined space and brings four more degrees of freedom and six more directions of movement to the maneuverability already possible by the movement of the robotic arm pivoting at the entry site. The movement of the endowrist allows for movement of the distal instruments much like the movements of the surgeon’s wrist during conventional surgery. • Downscaling. The DaVinci robotic system is designed to provide downscaling from the motion of the surgeon’s hands to that of the robotic arm. This is invaluable in dissecting the fine and fragile tissues of the distal esophagus. Furthermore, a fixed Hz motion filter is used to filter out the tremor in the surgeon’s hand and enhance the accuracy of the surgical dissection. • Binocular vision. The binocular robotic camera provides superb three-dimensional visualization and by nature of being mounted on the central robotic arm, it is manipulated by the surgeon. The result of this is an immobile field of vision with high resolution and magnification and total control of movements by the surgeon. The ability to manipulate the camera and the robotic arms recreates the surgeons own natural head, eye, and wrist motions as used during open procedures and enhances hand-eye coordination.

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blocker. With a double lumen tube, lung collapse is superior and hilar manipulation does not result in movement of the blocker and inadvertent expansion of the lung. As is addressed in a separate chapter in this book, the facility of the anesthesiologist with the robotic techniques is crucial to the conduct of the operation. Following the induction of anesthesia, with the patient in the supine position, upper GI endoscopy is performed. The gastroesophageal junction is identified and a nasogastric tube is positioned under direct vision into the stomach. Decompression of the stomach facilitates retraction of the diaphragm and enhances visualization of the gastroesophageal junction. While the patient is in the supine position, the gastroscope is pulled back to the distal esophagus and secured for patient positioning. As has been described by Pellegrini et al., the gastroscope plays a significant role during the myotomy procedure [36]. First, it allows for identification of the left lateral wall of the esophagus without the need for extensive mobilization of a circumferential dissection of the esophagus. Second, it transilluminates the esophageal mucosa and helps in ­identification of the area of incomplete myotomy. Third, by application of intraluminal suction to the mucosa during the myotomy procedure, the mucosa is pulled toward the lumen of the esophagus thereby exposing the anterior plane between the esophageal mucosa and the muscle of the esophagus.

53.4.2 Patient Positioning The patient is placed in an extended right lateral decubitus position. The table is fully flexed to enlarge the space between the ribs. The surgeon stands behind the patient. A monitor is positioned at the patient’s feet and a second monitor is positioned in front of the patient facing the surgeon. The robot is positioned in front of the patient (Fig.  53.1).

53.4 Operative Technique 53.4.1 Anesthesia Patients undergoing robotic video-assisted thoracic surgical Heller myotomy require single-lung ventilation. We prefer a left-sided double lumen endotracheal tube to a bronchial

Fig. 53.1  Positioning the robot and trocars for the robotic thoracoscopic approach

53  Robotic Esophageal Myotomy for Achalasia

During the robotic portion of the procedure, the robot is brought into the operative field from an anterior to posterior direction facing cephalad at a 30-degree angle to the axis of the patient.

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space. The esophageal hiatus is identified and the left lateral limb of the right crus of the diaphragm is divided using the endosheers with cautery. The dissection is discontinued with the visualization of the phrenoesophageal ligament on the underside of the diaphragm. Using the endostitch instrument with a 0 Ethibond suture, full-thickness retraction sutures are 53.4.3 Myotomy placed on the cut edges of the diaphragm and brought out through the anterior and posterior incisions respectively (#2 After the patient is prepped and draped, a 2 cm incision (#1) and #4). The sutures are fixed to the drapes. This maneuver is made in the seventh intercostal space in the midaxillary allows for the full visualization of the esophagogastric juncline. This incision will serve as a camera port during the tion. At the end of the procedure, the cut edges of the left VATS and robotic portion of the operation. A second 2-cm limb of the right crus of the diaphragm are re-approximated incision (#2) is made in the sixth intercostal space anteriorly using an endostitch instrument with 0 Ethibond suture. in the midclavicular line. A third 2-cm incision (#3) is made Usually, three such sutures are necessary to repair the crus of in the sixth intercostal space posteriorly in the posterior axil- the diaphragm. By avoiding disruption of the anterior crural lary line. A fourth 2-cm incision (#4) is made one interspace arch and by restoring the integrity of the left limb of the right below incision #3 in the seventh intercostals space posteri- crus of the diaphragm, the crural sling is preserved and the orly. It is paramount that incisions #1, #2 and #3 be posi- antireflux barrier remains intact. At this point, the VATS tioned approximately one hand-breath away from one camera is removed and the robot is positioned. The Robot is another in order to prevent interference with the robotic brought in from the posterior aspect of the patient. It is posiarms. As has been described in Chap. 54 of this book, we tioned caudad to cephalad with 30° rotation in the cephalad prefer the Olympus EndoEye Video Endoscopic System. A direction on the patient’s axis. The camera port is positioned 10 mm 0° end viewing scope is positioned initially viewing in the camera incision (#1) and a 30° down viewing scope is cephalad over the diaphragm using conventional video-­ positioned viewing caudally onto the distal esophagus. The assisted thoracic surgical techniques and viewing the moni- right robotic arm with a hook end-effector instrument contor located in front of the patient and facing the surgeon, the nected to a cautery is placed through the anterior incision inferior pulmonary ligament is divided and the lung is (#2) and its endowrist is positioned directly over the distal retracted superiorly. The table is positioned in esophagus. A left robotic arm with a DeBakey forceps as its “Trendelenburg” in order to allow the lung to fall into the distal end-effector instrument is positioned through the posapex of the chest. The camera is then rotated 180° in order to terior incision (#3) and its endowrist is positioned directly view the distal esophagus at the diaphragm. The surgeon and over the distal esophagus. A metal suction with a blunt tip is the surgical team then rotate their field of vision and use the positioned through incision #4. The suction is used by the video monitor at the patient’s feet for the next phase of the assistant to evacuate cautery smoke, control bleeding, and procedure. In order to retain intuitive spatial relationships, it provide downward force on the esophageal mucosa during is imperative that the surgical team view the surgical site in the myotomy. With binocular view and natural depth percepthe same direction and axis as the videoendoscope. The gas- tion and the facility of the endowrist movements, the perfortroscope is rotated towards the patient’s left, its tip is flexed mance of esophageal myotomy is quite accurate and thus allowing the surgeon to visualize the distal esophagus uncomplicated. The muscular wall of the esophagus is without the need for further dissection. An endoscopic fan exposed and the muscle is divided with a hook cautery at the retractor (Ethicon Endosurgery, Inc.) is introduced through midpoint of the exposed esophagus. The anatomic plane incision #2 and used to retract the diaphragm at the gastro- between the mucosa and the muscle is identified. The blunt esophageal junction in a caudad direction. The retractor is metal suction is positioned on the mucosa. Endoluminal sucfixed to the table using a self-retaining holder (Mediflex, tion is also applied using the video gastroscope. The robotic Velmed, Wexford, Pennsylvania). Using conventional forceps are used to elevate the muscle layers. The combinaendosheers (Ethicon Endosurgery, Cincinnati, OH) with cau- tion of these maneuvers allows for the hook cautery (blended tery attachment, the pleura overlying the esophagus is coagulation current set at 30 watts) to be used to divide the divided. An endostitch instrument (Autosuture, US Surgical, muscle fibers of the esophagus. As the distal aspect of the Norwalk, CT) with a 2–0 Ethibond suture is used to place esophagus and the intussuscepted portion of the esophagus retraction sutures on the two edges of the pleura. The sutures into the proximal stomach is approached, the robotic forceps are then brought out through the anterior and posterior inci- are used to reduce the intussusception by pulling the esophasions (incisions #2 and #4) and fixed to the drapes. This gus in a cephalad direction. The hook cautery then completes maneuver creates a pleural sling and elevates the esophagus the myotomy approximately 1  cm onto the cardia of the from its normal mediastinal location into the left pleural stomach. Myotomy is discontinued when the submucosal

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vascular plexus of the stomach wall is visualized. At this point, an assistant positioned at the head of the patient advances the gastroscope past the GE junction into the stomach. The ease of movement of the gastroscope into the stomach and the lack of resistance further confirms the complete division of the esophageal muscles at the GE junction. Furthermore, the gastroscope is retroflexed to view the GE junction from a caudad to cephalad direction. Observation of the transilluminated mucosa of the proximal portion of the gastric cardia from the light of the robotic camera serves as the final confirmation for the completion of the esophageal myotomy. Following the completion of the myotomy, the chest is filled with saline and the gastroscope is used to insufflate air into the stomach and esophagus in order to rule out any mucosal perforation. Any mucosal perforations are easily repaired by the endoscopic techniques and the use of 4–0 Prolene sutures. The robotic arms are retracted and the robot is moved away from the table. At this juncture, the conventional VATS EndoEYE camera is inserted through the camera port and the left limb of the right crus of the diaphragm is re-approximated as described earlier. At this point, a 2  cm square piece of Vicryl mesh (Ethicon, Inc., Somerville, NJ) is positioned at the distal aspect of the mediastinum. This absorbable mesh is attached to the edges of the mediastinal pleura using the endostitch with 2–0 Ethibond sutures. We have found that the Vicryl mesh which is absorbed and replaced by scar tissue approximately 8  weeks following implantation, reestablished the integrity of the pleura on the left lateral aspect of the esophagus and repositions the distal esophagus into the mediastinum. Furthermore, this maneuver with the resultant scarring of the pleura prevents the formation of a mucosal diverticulum at the distal portion of the esophagus. It has been hypothesized that the mucosal diverticulum may be one of the causes of chronic dysphagia even with an adequate myotomy when a fundoplasty is not performed. In fact, some authors have proposed that one of the benefits of the fundoplasty is the prevention of a mucosal diverticulum by placing external pressure on the mucosa. Prior to the employment of this technique, we had observed mucosal outpouching at the distal esophagus and the level of the gastroesophageal junction in a number of patients. This technique seems to have addressed that issue without any negative sequalae. Following pleural closure, the diaphragmatic retractor is removed. The lung is reinflated under direct vision. A 28-French straight chest tube is inserted through incision #1 and positioned posteriorly in the pleural space. ON-Q Pain Buster catheters are positioned in a subpleural tunnel extending from the second to the eighth intercostal spaces as were described in Chap. 54 and the incisions are closed as described in the same chapter for video-assisted surgery. The gastroscope is used to confirm the appropriate position of the nasogastric tube. The patient is extubated in the operating room. Postoperatively, we routinely obtain an

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upper GI contrast study with water-soluble contrast in order to rule out mucosal perforation and to confirm completeness of the distal esophageal myotomy. With a satisfactory study, a soft diet is started, the chest tube is removed, and most patients are discharged on the second postoperative day (Video 53.1). Using the Robotic Transthoracic Approach, 11 patients with achalasia underwent a Left lateral Heller Myotomy without fundoplication. This was the minimally invasive replication of the Left Thoracotomy approach described by Ellis et al. [28]. There were no mucosal injuries, or conversion to thoracotomy. Median hospitalization was 4  days. Relief of dysphagia was seen in 90%. New Reflux was seen in 4% and median PPI use was seen in 12% [41].

53.4.4 Robotic Laparoscopic Approach The next phase was to adapt the robotic thoracoscopic approach to a lateral Heller myotomy without fundoplication to a robotic laparoscopic approach (Video 53.2).

53.4.5 Surgical Technique The procedure is performed on a laparoscopic platform (Fig.  53.2). Preoperative UGI endoscopy is performed and the gastroesophageal junction is examined by the retroflexed endoscope. Two laparoscopic CO2 insufflators are used. Port #1 (Camera Port) is placed inferior to the umbilicus. Pneumoperitoneum is created. The table is placed in a steep reverse Trendelenberg position. Port #2 is placed in the right paraumbilical region at the right mammary line. An Endo-­ Paddle Retract retractor (Medtronic Inc., Norwalk, Conn.) is placed through Port #2 and fixed to the table using a self-­ retaining system (Mediflex, Velmed Inc., Wexford, Penn) The advantage of the Endopladdle retract device is that it is used to exert constant fixed upward traction onto the apex of

Fig. 53.2  Positioning the robot and trocars for the robotic laparoscopic approach

53  Robotic Esophageal Myotomy for Achalasia

the esophageal hiatus, and thereby, facilitates visualization and instrument maneuverability within the hiatal opening. Port #3 is placed halfway between the costal arch and the umbilicus as laterally on the right side of the abdomen as possible. This port will carry the left robotic arm. Using the videoendoscope, the left and right limbs of the right crus are identified. Port #4 is placed in the subcostal region halfway between the umbilicus and the xiphoid just to the left of the midline. This port is aligned with the left limb of the right (esophageal) crus of the diaphragm. Port #5 is placed in the subcostal region two finger-breaths to the right and caudad to port #4. Port #5 is aligned with the right limb of the right crus of the diaphragm. The laparoscopic insufflator is disconnected from port #1 and attached to port #4. A second insufflator is attached to port #5. The use of two high flow insufflators facilitates rapid extra corporeal knot placement while preserving pneumoperitoneum and exposure of the esophageal hiatus. Port #6 is placed halfway between the costal arch and the umbilicus as laterally on the left side of the abdomen as possible. This port will carry the right robotic arm. At times a seventh port is needed to retract the contents of the hiatal defect. In such an instance port #7 is placed in the mammary line halfway between ports #1 and #6. The surgical robot (daVinci, Intuitive Surgical, Sunnyvale, Ca.) is docked using “side docking” technique (Fig. 53.3). A 30° down-viewing robotic binocular camera is used and it is introduced through port #1. The right robotic arm with a hook cautery instrument is introduced through port #3. The left robotic arm with a Debakey grasper instrument is introduced through port #2. The entire dissection uses electrocuatery and meticulous hemostasis. An endo-kittner is introduced through port #5 by the assistant and is used to provide appropriate counter traction and exposure at the esophagogastric junction. A 30° camera is used. The left limb of the esophageal crus is identified, and the muscle is divided for ½ of the thickness of the crus. Care is taken not to enter the pleura which resides just under the crus. The left limb is not transected completely. This allows

Fig. 53.3  Side docking of the robot for the robotic laparoscopic approach

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for partial retraction of the muscle away from the lateral aspect of the gastroesophageal junction while at the same time facilitating repair of the left limb at the end of the procedure. The hook cautery is set at 30 cut/30 coagulation with blend setting. The stomach in retracted inferiorly, thereby straightening the GE junction. Care is taken to stay on the left lateral aspect of the gastroesophageal valve. By preserving the gastroesophageal valve and the phreno-esophageal ligament, the antireflux mechanism is kept intact. The muscle of the esophagus is divided to the level of the mucosa. The hook cautery them completes the myotomy approximately 1 cm onto the cardia of the stomach. Myotomy is discontinued when the submucosal vascular plexus of the stomach wall is visualized (Fig. 53.4). At this point, an assistant positioned at the head of the patient advances the gastroscope past the GE junction into the stomach. The ease of movement of the gastroscope into the stomach and the lack of resistance further confirms the complete division of the esophageal muscles at the GE junction. Furthermore, the gastroscope is retroflexed to view the GE junction from a caudad to cephalad direction (Fig. 53.5). Observation of the transilluminated mucosa of the proximal portion of the ­gastric cardia from the light of the robotic camera serves as the final confirmation for the completion of the esophageal myotomy. The retroflexed view further confirms that the myotomy is lateral to the gastroesopahageal valve. Following the completion of the myotomy, the area is filled with saline and the gastroscope is used to insufflate air into the stomach and esophagus in order to rule out any mucosal perforation. Mucosal perforation is easily repaired by the endoscopic techniques and the use of 4–0 Prolene sutures. Following a satisfactory myotomy, the partially transected left limb of the esophageal crus is reapproximated with two O- Ethibond sutures with 2 cm squared absorbable pledgets cut from vicryl mesh (Ethicon, Inc.Sommerville, NJ). The most common approach to Heller myotomy by either robotics or laparoscopy is an anterior myotomy. With this

Fig. 53.4  Laparoscopic view of the completed lateral esophageal myotomy prior to the re-approximation of the left limb of the esophageal crus

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procedure, there is disruption of the gastroesophageal junction and the phrenoesophageal ligament, thereby requiring a partial fundoplication. Dor fundoplication is most commonly used. As has been noted earlier in this chapter, greater understanding of the gastroesophageal antireflux mechanism and the gastroesophageal valve has led investigators to hypothe-

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size that cutting the esophageal muscle anteriorly at the 12 o’clock position will open the valve at its midpoint and result in significant reflux. Based on this reasoning, cutting the esophageal muscle at the 3 o’clock position or in the left lateral aspect of the gastroesophageal junction just under the left limb of the crus will lead to the preservation of the gastroesophageal valve and thereby obviate the need for an antireflux procedure and attendant complications (Fig. 53.6).

53.5 C  omparison of Robotic Lateral Heller Myotomy Without Fundoplication (RLHM) to Robotic Anterior Heller Myotomy With Dor Fundoplication (RAHM) 53.5.1 Hypothesis

Fig. 53.5  Retroflexed endoscopic view of the gastroesophageal junction from within the gastric lumen. Following a complete myotomy the esophageal mucosa is transilluminated with the light from the laparoscopic robotic camera. The myotomy is lateral to the gastroesophageal valve which remains intact, thereby obviating the need for an additional antireflux procedure

The gastroesophageal valve consists of the anterior and lateral intussusception of the esophagus into the stomach, 270° from right limb to left limb of the right crus. The entire 3-D relationship is held in place by phrenoesophageal ligament and tissues at esophageal hiatus. Therefore, anterior myotomy results in division of the gastroesophageal valve at its midpoint, thereby resulting in an insufficient valve and significant reflux.

Fig. 53.6  Comparison of the gastroesophageal valve (GE) to the mitral valve. Cutting the mitral valve or the GE valve in the middle at the 12 o’clock position results in significant regurgitation or reflux. A lateral

esophageal myotomy at the 3 o’clock position (likened to a mitral commissurotomy) preserves the GE valve and thereby obviates the need for an antireflux procedure

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Lateral myotomy results in division of the esophageal muscle fibers lateral to the gastroesophgaeal valve, thereby resulting in less reflux.

53.5.2 Study Design This was a prospective, randomized, double blind study. Patients with achalasia were assigned to undergo Robotic Laparoscopic Anterior Heller Myotomy with Dor Fundoplication (RAHM) or Robotic Laparoscopic Lateral Heller Myotomy Without Fundoplication (RLHM). Diagnosis of achalasia was made by esophagogram, endoscopy, and manometry. Exclusion criteria included previous myotomy and objective proof of ongoing GERD. An investigator not involved in the surgical procedure used a random numbers table, then prepared, coded, and sealed envelopes with treatment allocation. All recruited patients and investigators involved in the evaluation of the study were blinded to the treatment throughout the study period. All patients underwent manometry, pH testing and subjective dysphagia score at 6 months. Data was presented as median and range.

patients who underwent Robotic Laparoscopic Lateral Heller Myotomy without a Fundoplication (RLHM). On manometry, the Postoperative LES Pressure, was similar in the two groups (Table 53.3). However, the Length of LES Pressure Zone was significantly shorter in patients who underwent RLHM (Table 53.4). On 24-hour pH monitoring the rate of pathologic GERD (Table  53.5), median acid exposure (Table  53.6), and the DeMeester score (Table 53.7) were similar in the two groups. The Postoperartive Dysphagia Score was significantly lower in patients who underwent RLHM (Table  53.8). Postoperative Dysphagia Score is based on Scoring Severity and Frequency of Dysphagia from 0 to 5 each for a total Score of 0–10 [42]. This study showed that Robotic Laparoscopic Lateral Heller Myotomy Without Fundoplication is associated with a similar Rate of Pathologic Reflux as Robotic Laparoscopic Anterior Heller Myotomy with Fundoplication. However, Robotic Laparoscopic Lateral Heller Myotomy Without Fundoplication results in a Shorter Length of LES Zone and Greater Relief of Dysphagia. This procedure should be considered as the first line of therapy in patients with Achalasia. Table 53.3  Postoperative LES pressure on manometry

53.5.3 Results

RAHM 3.7 mm Hg (7.9–17.2)

RLHM 13.2 mmHg (9.8–16.6)

P value 0.74 (NS)

Forty-eight patients were enrolled. Table  53.1 illustrates patient characteristics. The operative and postoperative data are shown in Table 53.2. The median OR time was significantly lower in

Table 53.4  Length of LES pressure zone on manometry

Table 53.1  Patients and methods

Table 53.5  Pathologic GERD on 24-hour PH study

Age Sex M/F Preoperative LES pressure Preoperative dysphagia score

RAHM 46 (27–73) 12/12 38 mm Hg (16–120) 8 (7–10)

RLHM 48 (21–71) 13/11 35 mm Hg (18–120) 9 (8–10)

P value NS NS NS

P value 30 kg/m2. Microsurgical repair may be more difficult in patients with higher body mass index due to difficulty of mobilization and elevation of the uterus for microsurgical repair and limits of magnification with increased depth of the incision. From the largest series of microsurgical tubal anastomosis, 6692 women aged 20–51 years, pregnancy rates ranged from 82% for women under age 30–38% for women over age 40. Pregnancy rates were higher after reversal of tubal ligation via clips/ring (76%) and lowest after coagulation (67%) [19]. A 10-year follow-up of 1898 women ranging from 20–44  years, who underwent tubal anastomosis between 1985 and 2009, observed a first live birth rate of 51% at 5  years with only marginal increase after 10  years. Again, age was the most significant predictor of outcomes. Birth rates for women under 40 (50–56%) were higher than for women over 40 (26%). Women with a sterilization window of at least 8  years had lower live birth rates (44.7%) than women with shorter intervals (52.2%); however, the sterilization window may be a surrogate marker for age at time of tubal reversal. Women who had postpartum tubal ligations had significantly lower live birth rates (39.3%) than women who underwent interval tubal ligation (52.1%); however, the type of interval tubal ligation had no impact on live birth rates [20].

magnification does permit one to apply principles of good surgical technique on a microscopic scale. With open procedures, success rates have been inversely related to the duration of the procedure, likely due to tissue desiccation and adhesion formation with extended procedures. Alternatively, duration may be a reflection of surgical skill [32]. To decrease surgical time, authors have suggested single suture [33] techniques, application of tissue adhesives as an alternative to suture [34], and laser welding [35]. Using biologic glue, Sedbon et  al. described the first laparoscopic tubal anastomosis [36]. None of these techniques have been widely adopted. Minimally invasive techniques have been described in an attempt to decrease patient hospitalization time and minimize the potential for tissue desiccation and adhesion formation [37]. Several authors have since described microscopic technique using a standard laparoscopic approach, mimicking the open procedure [12, 38, 39]. Placing intracorporeal sutures using laparoscopic instrumentation is often cumbersome and time-consuming, leading to surgeon fatigue. Approaches to reduce this challenge included using only one [40] or two [41] sutures, staples [42], and a variety of sealants [31, 43, 44]. Reported pregnancy rates have been similar following all laparoscopic approaches as compared to the open microscopic approach. A large systematic review found no differences in success rates comparing currently used microsurgical techniques; however, macrosurgical approaches had poorer results than any microsurgical techniques [15]. Liu et al., reported an emerging surgical approach using transvaginal natural orifice transluminal endoscopic surgery with single-site incision using a Gelport in the posterior cul-­ de-­sac [45].

118.3 Evolution of Tubal Anastomosis

Robot-assisted laparoscopy offers the advantages of minimally invasive surgery with the ability to replicate the fine tissue handling and precision of an open microscopic procedure. The binocular 3-dimensional vision provides superior image quality compared to the operating microscope due to the degree of magnification possible, and depth perception not limited to a single surgical plane. Laparoscopic surgery reduces adhesive effects of tissue desiccation due to environmental exposure of open procedures [32], and the use of robot assistance eliminates surgeon tremor seen with fine procedures, while minimizing surgeon fatigue from the labor-intensive suturing and intracorporeal knot tying of traditional laparoscopy [46].

The first successful end-to-end tubal anastomosis in an animal model was reported in 1908 [21], and the first human tubal anastomosis in modern literature was reported in 1913 [22]. Macroscopic procedures were described through the late 1970s [23–26] with pregnancy rates ranging from 46 to 85%. The modern microscopic technique was described by Swolin [27] and refined in the 1970s by Gomel [28] and Diamond [29] with pregnancy rates ranging from 63 to 75%. Comparisons of micro- and macro-surgical technique [30] and microsurgery using a microscope or loupes [31] have not shown significant differences in tubal patency, although

118.4 Robot-Assisted Laparoscopic Tubal Anastomosis

118  Robot-Assisted Laparoscopic Microscopic Tubal Anastomosis

118.4.1  Case Reports and Series Margossian et  al. described the first robot-assisted laparoscopic tubal anastomosis in a porcine model in 1998 with 100% intraoperative tubal patency [47]. Utilizing the Zeus Robotic Surgical System, (Computer Motion Inc., Goleta, CA.), which is no longer commercially available, two surgeons performed 3 anastomoses on a single uterine horn in a single female pig. Anastomoses were performed using standard laparoscopic technique, robot-assisted laparoscopy, and finally open microsurgery. Patency was confirmed by chromopertubation after each anastomosis procedure. Anastomosis time was 33 minutes for laparoscopy, 50 minutes for robot-assisted laparoscopy, and 15  minutes for microsurgery. Minimal surgeon fatigue was reported with robot assistance. The surgeons reported increased fatigue and neck, shoulder, and back pain with the conventional laparoscopic procedures. The same group also reported a series of 6 Yorkshire pigs who underwent laparoscopic anastomosis 2  weeks after bilateral uterine horn resection [48]. All steps to prepare the uterine horn were performed under conventional laparoscopic techniques. Using the Zeus Robotic Surgical System, full-thickness micro-suturing of the uterine horns was performed with robot assistance by three surgeons who had prior experience in human microsurgical laparoscopic tubal suturing. Tubal patency was confirmed in all 12 uterine horns at the time of surgery. At 4-week necropsy, 8 horns (67%) remained patent. Mean surgical time was 170 minutes, and surgeons reported only mild fatigue. The following year, Falcone et al. described the first successful human robot-assisted laparoscopic tubal anastomosis [49]. The authors performed a bilateral tubal anastomosis in a 33-year-old woman who had undergone Falope Ring (Gyrus ACMI, Southborough, MA) tubal ligation 8  years earlier, using the voice-activated AESOP robot (Computer Motion Inc., Goleta, CA) attached to the laparoscope, and the Zeus Robotic Surgical System, attached to two robotic instruments. The preparation of the tubes was accomplished using hand-held laparoscopic instruments. Two-layer micro-­ suturing of the muscularis and serosa was performed with robot assistance. Operating time was 5  hours and 20  minutes. Tubal patency was confirmed by chromopertubation. Postoperative tubal patency and/or pregnancy were not reported. The same group subsequently reported 10 similar procedures [50]. The mean total operating time was 284 minutes. In 10 patients, 19 tubes were successfully anastomosed without conversion to laparotomy. Hysterpsalpingography performed 6 weeks postoperatively revealed patency in 17 of the 19 anastomosed tubes (89%). There were 5 pregnancies reported with a mean follow-up time of 5 months. The same year, Deguerlde et al. [51] reported 8 successfully completed robot-assisted laparoscopic tubal anastomo-

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ses using the da Vinci Surgical System (Intuitive Surgical, Mountain View, CA) for tubal preparation and two-layer closure of the muscularis and serosa with 100% intraoperative tubal patency. Mean surgical time was 181  minutes, with 52 minutes required per tube. Of the 5 patients who underwent postoperative hysterosalpingography, 4 had patent tubes bilaterally. Two patients conceived. In 2001, Cadiere et al. [52] reported 28 tubal anastomosis procedures using the da Vinci Surgical System with a mean operative time of 122 minutes and hospitalization of 1 day. Outcomes were not reported. The following year, Schwarzler et al. [53] reported anastomosis of 8 fallopian tubes in 5 women using the da Vinci Surgical System. Mean operating time was 189 minutes, and 6-week postoperative hysterosalpingography confirmed patency in 7 of 8 tubes. Two pregnancies occurred after a mean follow-up period of 5 months. The next report followed 5 years later. Vlahos et al. [54] reported the successful reconstruction of 10 fallopian tubes in 3 overweight and 2 obese patients with the da Vinci Surgical System. Using a single layer closure that incorporated muscularis and serosa, the mean surgical time was 172 minutes and decreased with subsequent procedures. One patient conceived before hysterosalpingogram, and postoperative tubal patency was confirmed in 7 of 8 (87.5%) tubes in the other 4 patients. Caillet et  al. [55] reported the largest series by a group practice evaluating pregnancy and delivery outcomes in 160 patients who underwent robot-assisted laparoscopic tubal anastomosis over an 8-year period. Of these patients, 14 were excluded from analysis due to male factor infertility and tubal pathology, and 49 were lost to follow-up. The authors reported 66 pregnancies and 58 live births in 97 patients with a median time to pregnancy of 8 months.

118.4.2  Comparative Studies No prospective or randomized trials have been reported to date comparing robot-assisted laparoscopic tubal anastomosis to either open microscopic or traditional laparoscopic tubal anastomosis. In 2003, Goldberg and Falcone [56] compared results of 25 women undergoing laparoscopic tubal anastomosis with and without the assistance of the Zeus Robotic Surgical System. The 10 patients who had laparoscopy with robot assistance were younger and lighter than the 15 patients who underwent standard laparoscopic tubal anastomosis procedures. Using standard laparoscopic approach, each surgeon acted as an independent “hand” for intracorporeal knot tying. Tubal patency and pregnancy rates were similar between the groups; however, operative time was 2  hours longer using robot assistance.

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Rodgers et al. [57] reported the first retrospective analysis comparing 26 robot-assisted laparoscopic tubal anastomosis procedures using the da Vinci Surgical System to 41 procedures of the microscopic approach via minilaparotomy over a 5-year period. The authors reported that surgical and anesthesia times were 48 and 78 minutes longer with the robot-­ assisted laparoscopic approach, and procedure costs were $1446 higher; however, patients were able to return to work up to 2 weeks earlier. Time to pregnancy was 2–4 months. The authors reported viable intrauterine pregnancy rates of 74% with robot-assistance and 49% in microscopic cases, which did not reach statistical significance. The incidence of ectopic gestations was not significantly different. The authors concluded the robot offered no advantage over microsurgery, but may be useful in patients who are poor surgical candidates for minilaparotomy (i.e., those with high body mass index). One year later, Patel et al. reported a second retrospective analysis of 18 robot-assisted laparoscopic tubal anastomosis procedures in 1 year compared to 10 microscopic tubal anastomosis procedures performed by the same surgical team the preceding year [58]. The 6-minute longer operative time of the robot-assisted laparoscopic approach was offset by the 30.7-hour reduced hospitalization time and 17-day earlier return to activities of daily living. Although not reaching statistical significance, pregnancy rates were higher for patients undergoing the robot-assisted laparoscopic approach (62.5% vs. 50%); however, ectopic gestation rates were also higher (22% vs. 10%). The direct surgical costs per live birth were only slightly higher ($483) when the robot was used.

118.4.3  Procedure Patients are positioned on the operating table in modified lithotomy position with arms tucked at each side. A Foley catheter is placed in the bladder and an orogastric or nasogastric tube is placed. Patient preparation and draping follow the same guidelines as conventional laparoscopy. Four abdominal trocars are required for the completion of the procedure [57–59]. A trocar is placed in the umblilicus for the 0-degree or 30-degree laparoscope. The laparoscope is near the operating area to maximize the benefit of magnification. Two robot trocars are placed bilaterally between 8 cm and 10  cm from the umbilicus for the operative instruments of the robot. These may be placed in the bilateral lower quadrants approximately 2 cm cephalad and medial to the anterior superior iliac spine, or they may be placed near the level of the umbilicus. An additional 8-mm trocar is placed for the bedside assistant to pass suture and assist as needed. This trocar may be placed at the level of the umbilicus or in the

M. B. Henne

Camera port

Accessory port

Da Vinci port

Fig. 118.1  Laparoscopic port placement. Four 8-mm laparoscopic ports are placed in the lower abdomen. The midline camera port is flanked by two robotic instrument ports. One additional site is required for the bedside assistant and can be placed on the side most convenient for the surgical team

right or left lower quadrant depending on robotic trocar placement (Fig. 118.1). Placement of the robotic trocars in the lower quadrants of the pelvis, and the accessory port higher, permits the bedside assistant greater mobility without requiring reaching under the robotic arms. However, higher placement of the accessory port limits visualization of the trocar site as the assistant is passing small needles into and out of the abdomen. Finding a lost small needle is challenging, if even possible, and the needles used for the micro-­ suturing are too small for identification on X-ray. Additional consideration may be given to placing the assistant trocar eccentrically from the robotic trocars (versus in-line) to allow greater mobility for the assistant, minimizing interference of the robotic arms. The robot may be docked in the midline or on the side. Side docking permits easier access to the vagina for uterine manipulation. A uterine manipulator with a channel for chromopertubation with indigo carmine or methylene blue is valuable for positioning the uterus in the pelvis and confirming tubal patency. The operating table is tilted into steep Trendelenberg position and small and large

118  Robot-Assisted Laparoscopic Microscopic Tubal Anastomosis

bowel is displaced above the sacral promontory prior to docking the robot. The remote workstation and seated position of the surgeon during micro-dissection and micro-suturing reduce surgeon neck and back tension and fatigue during the procedure. However, due to lack of haptic feedback when using robotic assistance, meticulous tissue handling of small anatomic structures is vital to prevent avulsion. For the same reason, ultra-fine suture material is easily broken if the surgeon relies on tactile sensation rather than visual cues while handling suture and securing knots. Additionally, a skilled bedside assistant is needed to assist with irrigation, tubal manipulation, and passage and retrieval of tiny needles. Micro-dissection and anastomosis are performed in the same fashion as in the open microscopic technique. Micro-­ dissection may be performed with standard laparoscopic technique or with robot assistance. Injection of dilute vasopressin (20U in 100–200 mL normal saline) may be injected into the mesosalpinx between and below the proximal and distal segments of fallopian tube. This may aid in maintaining hemostasis as well as hydrodistending the mesosalpinx to aid in dissection. A variety of robotic instruments have been described for microdissection; however, all descriptions include the use of atraumatic graspers, sharp instruments for incising tissue (i.e., scissors or hooks), and electrosurgical instruments for obtaining hemostasis [57– 59]. The mesosalpinx between tubal segments is incised sharply, and clips or bands, if present, are removed. Throughout the procedure, hemostasis is maintained with monopolar and bipolar electro-cautery, and the bedside assistant irrigates the operative area to clear any blood and aids in tissue retraction. The mesosalpinx is dissected from the underlying segments of fallopian tube to generate mobility to reduce subsequent tension on the muscularis at the anastomosis site. The obstructed ends of the proximal and distal segments of fallopian tubes are identified. The serosa may be incised and stripped from the ends with monopolar electrocautery or sharply before the muscularis is transected separately [57–59]. Alternatively, all layers may be transected simultaneously. Transection of the muscularis/mucosal layers exposing the tubal lumina is performed sharply with scissors, and bleeding vessels are cauterized. Electrosurgical energy is not applied to the mucosal or muscularis layers. Tubal patency can be confirmed by the use of a stent and/or chromopertubation of the proximal segment. A stent may also be placed to align the juxtaposed tubal lumina as a guide for approximating the muscularis (Fig.  118.2). Described stents include pediatric feeding tubes, a Novy cannula (Cook Medical Inc., Bloomington, IN), and large caliber sutures. Placement of a short stent across the anastomosis site is simple, but requires removal prior to final suture placement. Although cannulation of a long and tortuous distal segment is challenging, passage of a stent through the

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Fig. 118.2  Stent placement through distal and proximal segments of fallopian tubes

Fig. 118.3  Mesosalpinx suture placement

anastomosis site and fimbria permits retention of the stent as all sutures are placed and may be removed from the fimbria after final patency is confirmed. Using tapered needles, the mesosalpinx is approximated with at least one interrupted absorbable suture, such as polyglactin 910 (Vicryl) or polydioxanone (PDSII) with a diameter of 0.04  mm (8–0) to 0.1  mm (5–0) (Fig.  118.3). This reduces tension at the tubal anastomosis site and aligns the tubal lumina, which are approximated by circumferential interrupted absorbable suture 0.04–0.07  mm (8–0 to 6–0) through the muscularis with knots tied extraluminally (Figs. 118.4, 118.5, 118.6 and 118.7). The knots may be tied as each suture is placed, or after placement of all sutures to allow easy visualization of the lumina during suture placement. This micro-suturing requires practice and a gentle technique. Excess tension may damage the needle or break the suture during suture placement or knot tying. As there are no haptics, the surgeon must rely on visual cues. In general,

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M. B. Henne

Fig. 118.4  Muscularis suture placement at 6 o’clock

Fig. 118.7  Muscularis suture at 12 o’clock

Fig. 118.5  Muscularis suture placement at 9 o’clock

Fig. 118.8  Second layer closure of serosa

Fig. 118.6  Muscularis suture at 3 o’clock

the 6 o’clock suture is placed first, and the subsequent sutures are placed based on difficulty of positioning and visualization, with the simplest sutures placed last. A second layer of similar-sized interrupted or running absorbable suture may be placed approximating the serosa (Fig. 118.8). Easy passage of a stent and/or chromopertubation confirms tubal patency. Chromopertubation has the added advantage of assessing for leaks at the anastomosis site (Fig. 118.9). An adhesion barrier may be placed over the anastomosis to prevent postoperative adhesions. However, there is no data to suggest that this provides greater benefit over the anti-­ adhesive benefits of avoidance of tissue desiccation seen with laparoscopy compared to open procedures. A single suture technique, placing a suture through the serosa, muscularis, and mucosa at the 12 o’clock position, has been described with good results. Tubal patency at

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References

Fig. 118.9  Chromopertubation after bilateral anastomosis

6 months was confirmed in 16/17 patients. Pregnancy was achieved in 10 patients, with one ectopic and 2 early losses [60]. Postoperatively, patients progress toward oral intake and ambulation in the same manner as for conventional laparoscopy and may be discharged on the same day of surgery. They should follow a routine postoperative course with the same instructions and precautions of conventional laparoscopy and follow-up in 2–6 weeks. Patients may attempt conception after any vaginal bleeding or discharge has ceased. Hysterosalpingogram may be performed 6 weeks postoperatively to confirm tubal patency or after 6  months of failed attempts at conception. Patients should be cautioned for close monitoring in early pregnancy to rule out ectopic gestation.

118.5 Conclusion In summary, robot-assisted laparoscopic tubal anastomosis is a highly effective procedure with pregnancy rates comparable to the standard open microscopic and conventional laparoscopic approaches. Minimal tissue handling, decreased environmental exposure, and desiccation may minimize postoperative adhesion formation, which could lower pregnancy rates. The longer surgical time is offset by a shorter hospital stay and more rapid return to daily activities. This technique is especially useful for patients who would otherwise be considered poor surgical candidates due to body habitus or previous pelvic surgery with adhesions. Furthermore, robot-assisted laparoscopy allows the surgeon to practice improved surgical principles, employed on a microscopic scale with high degree of magnification and 3-dimensional view and with reduced surgeon fatigue.

1. Ahlborg J, Cordero C, Cullins V, Jacob M, O’Hanley K. Chapter 6. Female sterilization. In: EngenderHealth, editor. Contraceptive sterilization: global issues and trends. New York City: EngenderHealth; 2002. p. 139–60. 2. Clifton D, Kaneda T, Ashford L.  Family planning worldwide 2008 data sheet. Washington, D.C.: Population Reference Bureau; 2008. 3. Chan LM, Westhoff CL.  Tubal sterilization trends in the United States. Fertil Steril. 2010;94:1–6. 4. Chandra A. Surgical sterilization in the United States: prevalence and characteristics, 1965–95; 1998. 5. Hillis SD, Marchbanks PA, Tylor LR, Peterson HB. Poststerilization regret: findings from the United States Collaborative Review of Sterilization. Obstet Gynecol. 1999;93:889–95. 6. Schmidt JE, Hillis SD, Marchbanks PA, Jeng G, Peterson HB.  Requesting information about and obtaining reversal after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Fertil Steril. 2000;74:892–8. 7. Curtis KM, Mohllajee AP, Peterson HB. Regret following female sterilization at a young age: a systematic review. Contraception. 2006;73:205–10. 8. Boeckxstaens A, Devroey P, Collins J, Tournaye H. Getting pregnant after tubal sterilization: surgical reversal or IVF? Hum Reprod. 2007;22:2660–4. 9. Messinger LB, Alford CE, Csokmay JM, Henne MB, Mumford SL, Segars JH, Armstrong AY. Cost and efficacy comparison of in vitro fertilization and tubal anastomosis for women after tubal ligation. Fertil Steril. 2015;104(1):32–8. 10. Hirshfeld-Cytron J, Winter J.  Laparoscopic tubal reanastomosis versus in  vitro fertilization: cost-based decision analysis. Am J Obstet Gynecol. 2013;209(1):56. 11. Armstrong A, Neithardt AB, Alvero R, Sharara FI, Bush M, Segars J. The role of fallopian tube anastomosis in training fellows: a survey of current reproductive endocrinology fellows and practitioners. Fertil Steril. 2004;82:495–7. 12. Gordts S, Campo R, Puttemans P.  Clinical factors determining pregnancy outcome after microsurgical tubal reanastomosis. Fertil Steril. 2009;92:1198–202. 13. Hanafi MM. Factors affecting the pregnancy rate after microsurgical reversal of tubal ligation. Fertil Steril. 2003;80:434–40. 14. Yoon TK, Sung HR, Kang HG, Cha SH, Lee CN, Cha KY.  Laparoscopic tubal anastomosis: fertility outcome in 202 cases. Fertil Steril. 1999;72:1121–6. 15. van Seeters JAH, Chua SJ, Mol BJ, Koks CAM.  Tubal anastomos after previous sterilization: a systematic review. Hum Reprod Update. 2017;23(3):358–70. 16. Kim SH, Shin CJ, Kim JG, Moon SY, Lee JY, Chang YS. Microsurgical reversal of tubal sterilization: a report on 1,118 cases. Fertil Steril. 1997;68:865–70. 17. Paterson PJ. Factors influencing the success of microsurgical tuboplasty for sterilization reversal. Clin Reprod Fertil. 1985;3:57–64. 18. Deffiux X, Morin Surroca M, Faivre E, Pages F, Fernandez H, Gervaise A.  Tubal anastamosis after tubal sterilization: a review. Arch Gynecol Obstet. 2011;283:1149–58. 19. Berger GS, Thorp JM, Weaver MA. Effectiveness of bilateral tubotubal anastomosis in a large outpatient population. Hum Reprod. 2016;31(5):1120–5. 20. Malacova E, Kemp-Casey A, Bremner A, Hart R, Stewart LM, Preen DM. Live delivery outcome after tubal sterilization reversal: a population-based study. Fertil Steril. 2015;104(4):921–6. 21. Pearl R, Surface FM. Resection and end-to-end anastamosis of the oviduct in the hen without loss of function. Am J Phys. 1908;22:357.

1274 22. Christian SL, Sanaderson EL. A new method of anastomosing the ovarian tube or vas deferens. JAMA. 1913;61:2157. 23. Hodari AA, Vibhasiri S, Isaag AY. Reconstructive tubal surgery for midtubal obstruction. Fertil Steril. 1977;28:620–8. 24. Jones HWJ, Rock JA. On the reanastomosis of the fallopian tubes after surgical sterilization. Fertil Steril. 1978;29:702–4. 25. McCormick WG, Torres J, McCanne LR. Tubal reanastomosis: an update. Fertil Steril. 1979;31:689–90. 26. Siegler AM, Perez RJ. Reconstruction of fallopian tubes in previously sterilized patients. Fertil Steril. 1975;26:383–92. 27. Swolin K. [50 fertility operations]. Acta Obstet Gynecol Scand 1967;46:234–68. 28. Gomel V.  Tubal reanastomosis by microsurgery. Fertil Steril. 1977;28:59–65. 29. Diamond E. Microsurgical reconstruction of the uterin tube in sterilized patients. Fertil Steril. 1977;28:1203–10. 30. Henderson SR.  Reversal of female sterilization: comparison of microsurgical and gross surgical techniques for tubal anastomosis. Am J Obstet Gynecol. 1981;139:73–9. 31. Rock JA, Bergquist CA, Kimball AW Jr, Zacur HA, King TM. Comparison of the operating microscope and loupe for microsurgical tubal anastomosis: a randomized clinical trial. Fertil Steril. 1984;41:229–32. 32. Boeckx W, Gordts S, Buysse K, Brosens I.  Reversibility after female sterilization. Br J Obstet Gynaecol. 1986;93:839–42. 33. Swolin K. Simplified suture technique for isthmical anastomosis of fallopian tubes. Hum Reprod. 1981;55:426–8. 34. Rucker K, Baumann R, Volk M, Taubert HD.  Tubal anastomosis using a tissue adhesive. Hum Reprod. 1988;3:185–6. 35. Kao LW, Giles HR.  Laser-assisted tubal anastomosis. J Reprod Med. 1995;40:585–9. 36. Sedbon E, Delajolinieres JB, Boudouris O, Madelenat P.  Tubal desterilization through exclusive laparoscopy. Hum Reprod. 1989;4:158–9. 37. Kavic SM. Adhesions and adhesiolysis: the role of laparoscopy. J Soc Laparoendosc Surg. 2002;6:99–109. 38. Barjot PJ, Marie G, Von Theobald P. Laparoscopic tubal anastomosis and reversal of sterilization. Hum Reprod. 1999;14:1222–5. 39. Bissonnette F, Lapensee L, Bouzayen R.  Outpatient laparo scopic tubal anastomosis and subsequent fertility. Fertil Steril. 1999;72:549–52. 40. Dubuisson JB, Swolin K.  Laparoscopic tubal anastomosis (the one stitch technique): preliminary results. Hum Reprod. 1995;10:2044–6. 41. Mettler L, Ibrahim M, Lehmann-Willenbrock E, Schmutzler A. Pelviscopic reversal of tubal sterilization with the one- to two-­ stitch technique. J Am Assoc Gynecol Laparosc. 2001;8:353–8. 42. Stadtmauer L, Sauer MV. Reversal of tubal sterilization using laparoscopically placed titanium staples: preliminary experience. Hum Reprod. 1997;12:647–9. 43. Schepens JJ, Mol BW, Wiegerinck MA, Houterman S, Koks CA. Pregnancy outcomes and prognostic factors from tubal steril-

M. B. Henne ization reversal by sutureless laparoscopical re-anastomosis: a retrospective cohort study. Hum Reprod. 2011;26:354–9. 44. Wiegerinck MA, Roukema M, van Kessel PH, Mol BW. Sutureless re-anastomosis by laparoscopy versus microsurgical re-­anastomosis by laparotomy for sterilization reversal: a matched cohort study. Hum Reprod. 2005;20:2355–8. 45. Liu J, Bardawil E, Qiongyan L, Liang B, Wang W.  Transvaginal natural orifice transluminal endoscopic surgery tubal reanastomosis: a novel route for tubal surgery. Fertil Steril. 2018;110(1):182. 46. Nezhat C, Saberi NS, Shahmohamady B, Nezhat F. Robotic-assisted laparoscopy in gynecological surgery. JSLS. 2006;10:317–20. 47. Margossian H, Garcia-Ruiz A, Falcone T, et al. Robotically assisted laparoscopic tubal anastomosis in a porcine model: a pilot study. J Laparoendosc Adv Surg Tech A. 1998;8:69–73. 48. Margossian H, Garcia-Ruiz A, Falcone T, Goldberg JM, Attaran M, Gagner M. Robotically assisted laparoscopic microsurgical uterine horn anastomosis. Fertil Steril. 1998;70:530–4. 49. Falcone T, Goldberg J, Garcia-Ruiz A, Margossian H, Stevens L. Full robotic assistance for laparoscopic tubal anastomosis: a case report. J Laparoendosc Adv Surg Tech A. 1999;9:107–13. 50. Falcone T, Goldberg JM, Margossian H, Stevens L.  Robotic-­ assisted laparoscopic microsurgical tubal anastomosis: a human pilot study. Fertil Steril. 2000;73:1040–2. 51. Degueldre M, Vandromme J, Huong PT, Cadiere GB. Robotically assisted laparoscopic microsurgical tubal reanastomosis: a feasibility study. Fertil Steril. 2000;74:1020–3. 52. Cadiere GB, Himpens J, Germay O, et  al. Feasibility of robotic laparoscopic surgery: 146 cases. World J Surg. 2001;25:1467–77. 53. Schwarzler P, Fessler S, Marth C. Robot-assisted laparoscopic surgery in gynaecology: first experiences and review of the literature. Eur Surg. 2002;34:180–2. 54. Vlahos NF, Bankowski BJ, King JA, Shiller DA.  Laparoscopic tubal reanastomosis using robotics: experience from a teaching institution. J Laparoendosc Adv Surg Tech A. 2007;17:180–5. 55. Caillet M, Vandromme J, Rozenberg S, Paesmans M, Germay O, Degueldre M. Robotically assisted laparoscopic microsurgical tubal reanastomosis: a retrospective study. Fertil Steril. 2010;94:1844–7. 56. Goldberg JM, Falcone T.  Laparoscopic microsurgical tubal anastomosis with and without robotic assistance. Hum Reprod. 2003;18:145–7. 57. Rodgers AK, Goldberg JM, Hammel JP, Falcone T. Tubal anastomosis by robotic compared with outpatient minilaparotomy. Obstet Gynecol. 2007;109:1375–80. 58. Dharia Patel SP, Steinkampf MP, Whitten SJ, Malizia BA. Robotic tubal anastomosis: surgical technique and cost effectiveness. Fertil Steril. 2008;90:1175–9. 59. Bedaiwy M, Barakat E, Falcone T. Robotic tubal anastomosis: technical aspects. J Soc Laparoendosc Surg. 2011;15:10–5. 60. Kavoussi SK, Kavoussi KM, Lebovic DI.  Robotic-assisted tubal anastomosis with one-stitch technique. J Robot Surg. 2013;8(2):133–6.

Robotic-Assisted Laparoscopic Surgery and Pelvic Floor

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Nataliya Vang, Mailinh Vu, Chandhana Paka, M. Ali Parsa, and Camran Nezhat

119.1 Introduction Pelvic organ prolapse (POP) is a major health consideration for women, and as the population ages there is an increased need for effective techniques to address these healthcare demands [1, 2]. The estimated lifetime risk of undergoing surgical intervention for POP is 11% [3]. The origin and progression of pelvic floor dysfunction remains not fully elucidated, though contributing factors include pregnancy, vaginal childbirth, obesity, menopause, and genetics. Proposed causes include denervation of the pelvic floor musculature, direct injury to the pelvic floor musculature, abnormal synthesis or degradation of collagen, and defects in endopelvic fascia [4]. The support for the pelvic viscera, the vagina, and neighboring structures involves a complex interplay among muscles, fascia, nerve supply, and appropriate anatomic orientation, with the endopelvic fascia and pelvic floor muscles providing most of the functional support in the female pelvis [5]. Loss of support of the pelvic organs may involve any or all of the three following areas: anterior, posterior, and apical compartments. Defects in the anterior vaginal compartment result in cystourethrocele formation and occasionally associated with stress urinary incontinence. Posterior compartment defects result in rectocele and enterocele. Apical defects result in uterovaginal prolapse and vaginal vault prolapse [6]. Usually, pelvic floor defects occur in several places resulting in need for multiple procedures to correct. Reconstructive pelvic surgery requires a thorough knowledge of pelvic floor N. Vang · M. Vu · C. Nezhat (*) Camran Nezhat Institute, Center for Special Minimally Invasive and Robotic Surgery, Palo Alto, CA, USA C. Paka Department of Obstetrics/Gynecology, Kahn School of Medicine at Mt. Sinai, New York, NY, USA M. A. Parsa Department of Obstetrics and Gynecology, Mark Twain Medical Center, Angels Camp, CA, USA

anatomy and its supportive components before repair of defective anatomy is attempted. The existence of numerous surgical techniques for treating genitourinary prolapse and incontinence demonstrates that no single method is completely satisfactory. The treatment of pelvic organ prolapse has significantly evolved over the last decade, with increasing understanding of anatomy and development of minimally invasive surgical procedures. The development of video laparoscopic surgery (VL) by Nezhat has revolutionized modern-day gynecologic and general surgery [7–10]. Although VL has now been used for decades, only recently has it gained widespread popularity for major operative procedures. The increasing application of operative laparoscopy is the result of advances in laparoscopic techniques and equipment [10–12]. Multiple studies have established that VL results in lower morbidity, better visualization of areas difficult to access thus allowing for more precise dissection, decreased blood loss, decreased postoperative pain, and faster recovery [13]. Despite these well-established benefits, conversion from laparotomy to laparoscopy has been gradual. This hesitance is explained by the long learning curve, which stems from two-dimensional imaging, counterintuitive movements, and only four degrees of freedom.[14, 15] Thus, partly in response to these obstacles, robot-assisted laparoscopic surgery (RALS) emerged to overcome the inherent complexity of VL, while maintaining the benefits of minimally invasive surgery [14].

119.2 Vaginal Vault Prolapse Vaginal vault prolapse is seen whenever the apex of the vagina descends below the introitus, turning the vagina inside out. Vaginal vault prolapse occurs as a result of damage to the supporting structures of the vaginal apex: the cardinal ligaments or the uterosacral ligaments. The most common cause of this condition is hysterectomy with failure to adequately reattach the cardinal–uterosacral complex to the pubocervical fascia and rectovaginal fascia at the vaginal

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cuff. Other predisposing factors include enterocele, damage to the endopelvic fascia, or pelvic floor ligaments during labor and delivery and postmenopausal atrophy. Vaginal vault prolapse is usually associated with cystocele, rectocele, enterocele, or a combination of these defects [4, 10, 16]. The goal of vaginal vault suspension is to correct anatomic defects, maintain or restore normal bowel and bladder function, and restore a functioning vagina. Transvaginal sacrospinous vault suspension and needle urethropexy may result in a satisfactory outcome in most operations [17]. The vaginal route may be used in women whose preference or medical disorders contraindicate the abdominal approach. However, studies have shown a 33% rate of recurrent prolapse associated with sacrospinous fixation and transvaginal needle suspension. Use of laparoscopic sacrocolpopexy has increased over the past decade, and this minimally invasive option has been adapted to RALS. The first case series of laparoscopic sacrocolpopexy was reported in 1992 and 1994 by Nezhat et  al [12, 18]. The procedure was performed on 15 patients, with one conversion to open. All patients reported relief of symptoms and appropriate vault support. Despite these promising results, due to the technical difficulty of advanced laparoscopic techniques, this technique has not been rapidly adopted. This has been attributed to difficulty with dissection of the presacral and rectovaginal spaces and suturing. RALS provides some methods to thereby overcome these deficiencies. The first RALS sacrocolpopexy was described by Di Marco et al in 2004. Since this, multiple centers have published their experience with the use of RALS sacrocolpopexy [19–21]. It has become a preferred technique of abdominal sacrocolpopexy with improved intraoperative morbidity, decreased convalescence, superior precision and visualization as well as ability to maintain natural vaginal length and depth [22–24].

119.3 Technique A peritoneal incision is made over the sacral promontory. Exposure over this area and the presacral space can be facilitated with the use of an accessory port for retraction, as tilting once the robot is docked is not possible. The incision is made longitudinally and extended to the cul-de-sac. The presacral fat is cleared to expose the sacral promontory. This is done to allow for retroperitonealization of the mesh after the suspension. Anterior dissection is then performed by dissecting the peritoneum off the anterior and posterior aspects of the vaginal vault and the mesh is affixed to both sides of the vaginal vault. The superior aspect of the mesh is then affixed directly to the anterior longitudinal ligament of the sacrum. We recommend closure of the peritoneum over the graft. If a sacrohysteropexy is being performed, the rectovaginal space is dissected off the length of the posterior vaginal

N. Vang et al.

wall. The graft is then affixed to the posterior vaginal wall along the rectovaginal fascia and posterior cervix at the level of the internal os. Once again the peritoneum is closed over the graft.

119.4 Paravaginal/Posterior Defect Repair Prolonged, bothersome vaginal protrusions and pelvic pressure that worsens with ambulation and daily activity are common symptoms in women who have vaginal prolapse. Other symptoms include difficulty walking, voiding, defecating, urinary incontinence, recurrent mucosal irritation, ulceration, and coital difficulty. Improvement of the quality of life is achievable in certain patients with behavioral modification and nonsurgical vaginal devices. The arcus tendineus fascia pelvis is a band of dense regular connective tissue stretched between the pubic bone and the ischial spine. The pubocervical fascia forms a trapezoidal layer spanning the area between the two arcus tendineae [4]. Paravaginal repair is required when cystourethrocele results from a separation of the pubocervical fascia from its lateral attachment to the pelvic sidewall. If this defect is accompanied by genuine urinary stress incontinence (GUSI), the paravaginal repair almost always will correct the problem. Paravaginal repair restores the lateral attachments to the pelvic sidewall at the linea alba. Reported failure rates range from 0% to 20% for anterior colporrhaphy and from 3% to 14% for paravaginal repair [25]. Dissection during anterior colporrhaphy splits the vaginal muscularis. Subsequent repair involves plication of the muscularis and adventitia in the midline and pulling of the lateral attachments farther from the pelvic sidewall. In determining the correct surgical approach, preoperative clinical assessment of the patient is very important. Successful surgical correction of cystocele depends on the type of defect found in the pubocervical fascia. On examination of the anterior vagina, anterolateral support should be confirmed. If one or both anterolateral sulci are absent and vaginal rugae is present, then a detachment of the pubocervical fascia from the fascial white line, a paravaginal defect should be suspected [5]. Four different pubocervical fascial defects could cause cystocele. Distinguishing these defects is important, as each type requires a different operative procedure. • The paravaginal defect results from detachment of the pubocervical fascia from its lateral attachment to the fascia of the obturator internal muscle at the level of the arcus tendineus fascia of the pelvis. This is the most common cause of cystourethrocele. The repair consists of reestablishing the lateral pelvic sidewall attachments of the pubocervical fascia and restoring the stability of this “hammock” by correcting the fundamental anatomic defect.

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• The transverse defect is caused by transverse separation of the pubocervical fascia from the pericervical ring into which the cardinal and uterosacral ligaments insert. The base of the bladder herniates into the anterior vaginal fornix and forms a cystocele without displacing the urethra or urethrovesical junction. • The midline or central defect results from a break in the central portion of the hammock between its lateral, dorsal, or ventral attachments. • With the distal defect, the distal urethra becomes avulsed or separated from its attachment to the urogenital diaphragm as it passes under the pubic symphysis.

119.5 Technique Many operations have been described to correct loss of pelvic support. The abnormalities are identified, and the operation is planned with the intention of correcting each defect to achieve the optimal outcome. The patient should be able to tolerate general anesthesia, increased intra-abdominal pressure, and the Trendelenburg position. The principles of a transabdominal approach used at laparotomy are employed during both VL and RALS.  This minimally invasive technique has evolved as an alternative in reconstructive pelvic operations [26, 27]. After evaluation of the peritoneal cavity and completion of other indicated procedures, the pelvic reconstruction can proceed. The retropubic space is entered and carefully dissected. The pubic symphysis, obturator foramen, and obturator neurovascular bundle are identified. The paravaginal defect (the lateral vaginal sulci) can be seen detached from the arcus tendineus fascia. The bladder is mobilized medially, and the pubocervical fascia is exposed. The ischial spine can be located digitally by placing the operator’s fingers inside the vagina while viewing from above. During mobilization of the bladder, the lateral superior sulcus of the vagina is lifted by the assistant’s fingers in the vagina to facilitate dissection. Separation of the lateral sulcus from the pelvic sidewall can be seen from above. Permanent sutures are used to attach the superior lateral sulcus of the vagina to the arcus tendineus fascia (white line). The superior lateral sulcus of the vagina is elevated with the assistant’s fingers in the vagina. Beneath the prominent paraurethral vascular plexus, the vagina is sutured to the linea alba of the pelvic sidewall. The paraurethral vascular plexus runs longitudinally along the axis of the vagina and is desiccated before the placement of sutures. Otherwise, bleeding may occur if the plexus is penetrated by the needle. Such bleeding invariably stops when the suspension sutures are tied. To avoid bleeding, the first paravaginal suspension stitch should be placed close to the ischial spine. Before this first suture is placed, the gynecologist should identify the ischial spine by vaginal palpation and by viewing through the laparoscope to avoid

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injuring the pudendal vessels and nerve. The initial stitch is placed through the linea alba approximately 1.0 to 1.5  cm ventral to the ischial spine [28]. Figure-of-eight sutures are used for the suspension stitches to obtain good hemostasis and suspension. After placement of the first stitch, additional sutures are placed through the vaginal sulcus with its overlying fascia and the arcus tendineus fascia ventrally toward the pubic symphysis. The last stitch should be as close as possible to the pubic ramus. Frequent vaginal examinations are done while suturing to assist the proper placement of the stitches, assess the adequacy of suspension, and establish anterior support. The procedure is completed by bladder neck suspension. Specifically for rectocele repair, the rectovaginal septum is opened down to the perineal body. The perineal body is then sutured to the rectovaginal septum. The fascial defects are closed, and if the fascia is further separated from the iliococcygeus fascia, it is reattached.

119.6 Conclusions Multiple surgical techniques have been described for treating POP. These techniques include abdominal, vaginal, laparoscopic, and robotic-assisted routes. As the merits of minimally invasive surgery continue to be highlighted, improved surgical techniques, instrumentation, and training become more important.

References 1. Nygaard I, Barber MD, Burgio KL, et al. Prevalence of symptomatic pelvic floor disorders in US women. Jama. 2008;300:1311–6. 2. Wu JM, Hundley AF, Fulton RG, Myers ER. Forecasting the prevalence of pelvic floor disorders in U.S. Women: 2010 to 2050. Obstet Gynecol. 2009;114:1278–83. 3. Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL.  Epidemiology of surgically managed pelvic organ prolapse and urinary incontinence. Obstet Gynecol. 1997;89:501–6. 4. Deval B, Haab F. What’s new in prolapse surgery? Curr Opin Urol. 2003;13:315–23. 5. Miklos JR, Moore RD, Kohli N. Laparoscopic surgery for pelvic support defects. Curr Opin Obstet Gynecol. 2002;14:387–95. 6. Birnbaum SJ.  Rational therapy for the prolapsed vagina. Am J Obstet Gynecol. 1973;115:411–9. 7. Kelley WE Jr. The evolution of laparoscopy and the revolution in surgery in the decade of the 1990s. Jsls. 2008;12:351–7. 8. Nezhat C, Crowgey SR, Garrison CP. Surgical treatment of endometriosis via laser laparoscopy. Fertil Steril. 1986;45:778–83. 9. Page B. Camran Nezhat & the advent of advanced operative video-­ laparoscopy. In: Nezhat C, editor. Nezhat’s history of endoscopy. First ed. Tuttlingen: Endo Press; 2011. p. 159–87. 10. Tadir Y, Fisch B.  Operative laparoscopy: a challenge for general gynecology. Am J Obstet Gynecol. 1993;169:7–12. 11. Margossian H, Walters MD, Falcone T.  Laparoscopic manage ment of pelvic organ prolapse. Eur J Obstet Gynecol Reprod Biol. 1999;85:57–62.

1278 12. Nezhat C, Nezhat F.  Operative laparoscopy (minimally invasive surgery): state of the art. J Gynecol Surg. 1992;8:111–41. 13. Cook AS, Rock JA.  The role of laparoscopy in the treatment of endometriosis. Fertil Steril. 1991;55:663–80. 14. Nezhat C, Saberi NS, Shahmohamady B, Nezhat F. Robotic-assisted laparoscopy in gynecological surgery. Jsls. 2006;10:317–20. 15. Kenngott HG, Muller-Stich BP, Reiter MA, Rassweiler J, Gutt CN.  Robotic suturing: technique and benefit in advanced laparoscopic surgery. Minim Invasive Ther Allied Technol. 2008;17:160–7. 16. Drutz HP, Alnaif B.  Surgical management of pelvic organ prolapse and stress urinary incontinence. Clin Obstet Gynecol. 1998;41:786–93. 17. Sze EH, Miklos JR, Partoll L, Roat TW, Karram MM. Sacrospinous ligament fixation with transvaginal needle suspension for advanced pelvic organ prolapse and stress incontinence. Obstet Gynecol. 1997;89:94–6. 18. Nezhat CH, Nezhat F, Nezhat C. Laparoscopic sacral colpopexy for vaginal vault prolapse. Obstet Gynecol. 1994;84:885–8. 19. Ayav A, Bresler L, Hubert J, Brunaud L, Boissel P. Robotic-assisted pelvic organ prolapse surgery. Surg Endosc. 2005;19:1200–3. 20. Daneshgari F, Kefer JC, Moore C, Kaouk J.  Robotic abdominal sacrocolpopexy/sacrouteropexy repair of advanced female pelvic

N. Vang et al. organ prolapse (POP): utilizing POP-quantification-based staging and outcomes. BJU Int. 2007;100:875–9. 21. Akl MN, Long JB, Giles DL, et  al. Robotic-assisted sacrocolpopexy: technique and learning curve. Surg Endosc. 2009;23:2390–4. 22. Giannini A, Russo E, Malacarne E, Cecchi E, Mannella P, Simoncini T.  Role of robotic surgery on pelvic floor reconstruction. Minerva Ginecol. 2019;71(1):4–17. 23. Marie FR.  Paraiso. Robotic-assisted laparoscopic surgery for hysterectomy and pelvic organ prolapse repair. Fert Ster. 2014;102(4):933–8. 24. Linder BJ, Occhino JA, Habermann EB, Glasgow AE, Bews KA, Gershman A. National contemporary analysis of perioperative outcomes of open versus minimally invasive sacrocolpopexy. J Urol. 2018;200(4):862–7. 25. Weber AM, Walters MD.  Anterior vaginal prolapse: review of anatomy and techniques of surgical repair. Obstet Gynecol. 1997;89:311–8. 26. Daneshgari F, Paraiso MF, Kaouk J, Govier FE, Kozlowski PM, Kobashi KC. Robotic and laparoscopic female pelvic floor reconstruction. BJU Int. 2006;98(Suppl 1):62–8; discussion 9. 27. Rardin CR.  Minimally invasive urogynecology. Obstet Gynecol Clin North Am. 2011;38:639–49. 28. Nezhat F, Nezhat C, Gordon S, Wilkins E.  Laparoscopic versus abdominal hysterectomy. J Reprod Med. 1992;37:247–50.

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Camran Nezhat, Elizabeth Buescher, Mailinh Vu, and Nataliya Vang

120.1 Introduction The only way to never have any kind of complication is to have no surgery. With any surgical procedure or method, complications are bound to arise. In fact, “the only way not to have any complications is not to operate.” The key, though, is to use surgical technique and surgical equipment that minimizes the risk of complications. In addition, a thorough knowledge of the tools being used in the operating room will help to reduce the rate of complications. Prompt recognition of the complication is vital to ensure the best possible patient outcome. Finally, in assessing the complications associated with robotically assisted surgery, one must differentiate between the risks of the surgery itself as compared to the risks related to the use of the robot. Multiple studies have shown that video laparoscopic surgery with or without robotic assistance have similar outcomes overall, and both have better outcomes than laparotomy [1–4]. The conversion to minimally invasive approaches is associated with significant benefits to the patient. These benefits include smaller incisions, shorter hospital stay, faster recovery, less complications, less adhesions, and a faster return to work [2–4]. Originally, obesity was considered a contraindication to minimally invasive surgery; however, now obesity is considered an indication for minimally invasive surgery as obese patients are at much higher risk of wound complications and venothrombotic events from a laparotomy [5]. In fact, with the lack of haptics and the ability of the surgeon to sit at the console during surgery, robotically assisted surgery has many advantages over laparotomy in the obese patient [5]. In this chapter, we look at some complications specific to roboticassisted surgery in comparison to laparotomy and video laparoscopy without robotic assistance. C. Nezhat (*) · M. Vu · N. Vang Camran Nezhat Institute, Center for Special Minimally Invasive and Robotic Surgery, Palo Alto, CA, USA e-mail: [email protected] E. Buescher Department of Obstetrics & Gynecology, Good Samaritan Hospital, Los Gatos, CA, USA

120.2 C  omparing Different Routes of Hysterectomy Gynecologic surgeons now have four methods available to perform a hysterectomy: abdominal, vaginal, video laparoscopic with or without robotic assistance. With each patient that a gynecologic surgeon encounters, the decision must be made regarding the best surgical approach. In order to decide on the safest, most effective route of hysterectomy for a given patient, the surgeon must take into account the potential complications with each modality. In addition, the skill and experience of the surgeon as well as the availability of proper instrumentation should be considered. Arrastia reported the first case series of robotic hysterectomy in 2002 [6]. This was followed in 2006 by another case series by Nezhat et al. [7]. Backes et al. published the largest study on robotic hysterectomy in 2012 [8]. Matthews et al. looked at a two-year period to see how the introduction of the robot affected the hysterectomy route and the complication rate when comparing the first and second years of robotic use [9]. The study included 461 hysterectomies performed abdominally, vaginally, video laparoscopically with or without robotic assistance. During the second year of the study, more robotic-assisted hysterectomies were performed compared to video laparoscopic hysterectomies without robotic assistance. Open hysterectomies had a complication rate of 23%, vaginal hysterectomies 11%, video laparoscopic hysterectomies 7%, and robotic-assisted hysterectomies 4%. Both video laparoscopic hysterectomies with and without robotic assistance had statistically significant fewer wound complications than their counterparts. Robotic-assisted surgery was not associated with a statistically significant increase in complications in any of the areas investigated as compared to the other routes of hysterectomy [9]. In a 2011 study of 124 patients undergoing hysterectomy, total video laparoscopic hysterectomy was compared to robotic-assisted hysterectomy. Of the 77 patients who underwent total video laparoscopic hysterectomy, the mean

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o­ perative time was 111 minutes [4], as compared to 150 minutes [8] for the 47 patients who underwent a robotic procedure. The video laparoscopic arm had a mean estimated blood loss of 207.7 mL compared to 131.5 mL in the robotic arm. Estimated blood loss is notoriously inaccurate, and none of the patients in either arm required a blood transfusion. The only intraoperative complication was a cystotomy in the video laparoscopic group that was repaired at the time of surgery. In addition, the robotic arm had no conversions to laparotomy, while the video laparoscopic cohort had three conversions to laparotomy [10]. In 2011, Tinelli et al. [11] presented data on 99 patients with cervical cancer who underwent either video laparoscopic radical hysterectomy or robotic-assisted video laparoscopic hysterectomy. They looked at operative time, estimated blood loss, hemoglobin decline, postoperative fever, and length of hospital stay. The only significant difference in outcome was operative time, with a mean of 255 minutes for laparoscopic cases and 323  minutes for robotic cases. Both the laparoscopic and robotic groups had two incidental cystotomies and no ureteral, bowel, or vascular injuries. One patient (4.4%) in the robotic group had a vaginal cuff recurrence, compared to four patients (5.4%) in the laparoscopic group, but this difference was not statistically significant [11]. With this data, robotics should be considered a viable platform for hysterectomy and other major gynecologic surgery. The complication rates are similar between robotic and traditional video laparoscopy, both of which are clearly superior to laparotomy.

120.3 Operative Time The most common complaint from surgeons and operating room (OR) staff regarding the use of the robotic arm is the increased operative time. At this point, it is well established that the robot does take longer than both traditional video laparoscopy and laparotomy to complete the case during initial implementation of the robotic platform [1–4, 12]. However, this increase in time for robotic cases decreases as practitioners become more proficient with the robotic platform. Some studies show no significant difference in operative time once the OR staff has completed the learning curve [13, 14]. In addition, the implementation of a dedicated robotic staff may help to minimize the operative time and has proven beneficial at many institutions. The majority of the increased operative time is attributed to docking and undocking the robotic device. As the surgical time becomes more prolonged, the risks of complications from anesthesia increase.

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Different studies have included varying steps in robotic assembly; however, the time taken to switch from laparoscopy to robotics is generally regarded to include moving the robot (which has been previously draped) to the patient’s bedside, changing to the robotic camera, docking the robot, and attaching the robotic instruments. Some studies also include switching from a 5 mm trocar to an 8 mm trocar. One of the early gynecologic studies evaluating the robotic device showed robot docking required approximately 18.9 minutes, and robot undocking averaged 2.1 minutes in a 2006 study. This study did not consider the overall operative time [7]. A similar study from Singapore looked at operative times in endometrial cancer cases after the introduction of the robotic device. The authors compared 34 patients who underwent robotic-assisted surgery for endometrial cancer with 90 patients who underwent traditional laparotomy procedures. They found that the first 20 robotic cases had a mean operative time of 196 minutes. However, the subsequent 14 cases had a mean operative time of 124 minutes. The laparotomy group had a mean operative time of 124 minutes [15]. This study supports the general body of literature that operative times with robotic assistance are initially much longer than video laparoscopy without robotic assistance and laparotomy, but ultimately becomes equivocal with time and experience.

120.4 Herniation The majority of the robotic instruments require the use of 8 mm ports as opposed to 10 mm ports. It is well established that incisions 10 mm or larger require closure of the fascia. There are very few reports of postoperative herniation in the gynecologic robotic literature, but trocar-site herniation occurs in less than 1% of video laparoscopic cases [16–20]. It is likely that this is an under-reported phenomenon. In a 2009 study, 136 robotically assisted gynecology procedures, there was one herniation from an 8 mm port that was recognized on the first postoperative day and repaired video laparoscopically [21]. There is also a report of a patient who underwent robotic-assisted surgery for endometrial cancer who was found to have a small bowel obstruction on the fourth postoperative day. Evaluation revealed a small bowel evisceration through the 8 mm lateral port which was repaired without the need for laparotomy or bowel resection [20]. To avoid trocarsite herniation in robotic-assisted surgery, we recommend closing the fascia on all port sites of 10  mm or greater. In addition, if there is excessive manipulation of a trocar site, such as repeated removal and re-entry, we recommend closure of the fascia. In a large 4-year study of 503 patients, four patients were noted to have port-site herniations [8]. This data supports a herniation frequency of less than 1%.

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120.5 Complications Specific to Oncology

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developed lymphedema, but only 8% had lymphedema severe enough to warrant physical therapy. This finding is significant given that only 2.3% of the patients whose cases were converted to laparotomy developed lymphedema. The authors present a number of possibilities for the increase in lymphedema, including the removal of more lymph nodes via robot-assisted surgery, better visualization of the deep lymph nodes around the obturator and deep circumflex iliac vein, and increased awareness of lymphedema as a potential complication [8]. Regardless, the authors advocate for vigorous screening for lymphedema with early intervention.

Port-site metastasis has been found to be uncommon in robotic-assisted surgery. However, it is likely that this is underreported in the literature. Based on the available literature, it appears that video laparoscopy without robotic assistance has a port-site recurrence of approximately 1% [22–25]. For robotic-assisted surgery to be comparable to video laparoscopy without robotic assistance, it needs to have a similar port-site recurrence rate. A case report from 2010 presented a patient who underwent a robotically assisted video laparoscopic radical hysterectomy, bilateral salpingectomy, and bilateral pelvic lymph node dissection for stage 1B cervical cancer. Eighteen months later, the 120.6 Vaginal Cuff Dehiscence patient developed a recurrence involving the bladder mucosa and parametria. As part of her cancer recurrence evaluation, Vaginal vault dehiscence is a known complication of video the patient underwent an abdominal CT that demonstrated a laparoscopic hysterectomy with or without robotic assisport-site recurrence at one of the 8 mm ports. She was treated tance. Vaginal vault evisceration after total video laparowith chemoradiation [22]. To our knowledge, this is the only scopic hystectomy was first reported in 1996 by Nezhat et al. report of a cervical cancer recurrence after robotic-assisted [27]. It examined the potential for an increased risk of vagisurgery. In their study, the authors reported over 250 robotic-­ nal cuff dehiscence after total video laparoscopic hysterecassisted radical hysterectomies for cervical cancer with a tomy as compared to total abdominal hysterectomy. With the advent of the robot, many researchers have re-addressed this port-site metastasis rate of less than 1% [22]. A retrospective study reviewed 181 patients with pathol- issue. The reasons for cuff dehiscence include intercourse ogy confirming malignancy for information on postoperative too soon after surgery and infection. However, most of these port-site metastasis. Of the patients included in the study, complications occur in the absence of any identifiable cause. only two were found to have metastatic disease at the site of If this complication is not promptly recognized and treated, a robotic port. Interestingly, the first patient was a 47 year-­ it can lead to infection, sepsis, and hemorrhage [28]. A 2011 meta-analysis by Uccella et al. reviewed 13,000 old with a history of gallbladder carcinoma treated with surhysterectomies performed using video-assisted surgical gery and chemotherapy. A follow up CT scan showed a liver techniques and found that transvaginal cuff closure had the lesion and a solid left adnexal mass. She underwent robotic-­ assisted total hysterectomy and bilateral salpingo-­ lowest rate of cuff dehiscence at 0.18%, while those closed oophorectomy. The final pathology of the ovarian mass was video laparoscopically without robotic assistance had an metastatic gall bladder adenocarcinoma. Three weeks post- incidence of 0.64%, and those closed robotically had the operatively, she was noted to have a port-site metastasis in highest incidence at 1.64% [28]. Many authors have attempted to discern the reason for the right lateral port. The second patient was a 50-year-old the cuff dehiscence after total robotic hysterectomy. As who underwent robotic-assisted total hysterectomy and left robot-­ assisted surgery becomes more common, we must be salpingo-oophorectomy (right salpingo-oophorectomy had aware of the reasons for these complications so that they previously been performed) for endometrioid endometrial adenocarcinoma. Postoperatively, she received progesterone can be avoided. The robotic camera enables such a high therapy. Eleven months after her robotic surgery, a CT scan degree of magnification that the surgeon may be placing sutures that are falsely of adequate size. Other proposed noted an umbilical port recurrence [26]. Another consideration with oncology cases is the pres- reasons for this complication include the surgical technique ence of postoperative lymphedema, lymphoceles, and lym- employed by the surgeon, the use of electrocautery, and phocysts. Studies have shown a significant increase in improper tension on the suture during knot-tying [28, 29]. lymphatic complications when the robotic arm (8%) is used Patient characteristics associated with a higher incidence of as compared to both video laparoscopy without robotic assis- vaginal vault dehiscence and evisceration include the prestance and laparotomy (6% and 0.7%, respectively). This ence of pelvic prolapse, the post-menopausal state, obesity, increase is especially present in cases of endometrial cancer smoking, and immuno-suppression [29–38]. A comparison and may be due to an increased number of lymph nodes study of unidirection barbed suture with 2–0 monofilament removed during the initial surgical procedure [4]. In a large absorbable suture found no vaginal cuff dehiscense in study of 503 patients who underwent robotic surgical staging either arm, and the authors concluded that both sutures for endometrial cancer, authors found 13.4% of patients were acceptable [39].

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To avoid a vaginal vault dehiscence, gynecologic surgeons should take care to use minimal electrocautery while amputating the uterus. In addition, the surgeon must ensure the suture has an adequate bite on both sides of the vaginal cuff, without disrupting the integrity of the rectum, bladder, and ureters. Finally, we recommend a vaginal exam on all patients after the closure of the cuff to ensure no additional sutures need to be placed [40]. Any time a surgeon feels that the robot is not providing an adequate closure of the vaginal cuff, we strongly urge the surgeon close the cuff vaginally.

120.7 Injury Due to Electrocautery The risks of injury from electrocautery are well documented, and a discussion of the mechanism of thermal injury is beyond the scope of this chapter. However, the robotic arm does present some special considerations in regard to thermal injury. In 2012, Cormier et al. presented three cases of thermal injury associated with the robotic platform [41]. Two of the three patients presented with cervical cancer and underwent robotically assisted radical hysterectomy, bilateral salpingo-oophorectomy, and lymph node dissection. The third patient had endometrial cancer and underwent robotically assisted total hysterectomy, bilateral salpingo-­ oophorectomy, and surgical staging. All three cases resulted in vascular injury, and it was demonstrated that there was a failure to insulate the sheath on the monopolar scissors. In all cases, the current was set at 35 watts. The endometrial cancer patient had a thermal injury to the external iliac artery; this resulted from monopolar scissor arcing to the metallic suction irrigator that was retracting the external iliac vein. That patient was transfused and underwent emergent laparotomy to repair the vessel. The two cervical cancer patients had injuries to the right external iliac artery that were also attributed to arcing. Both were repaired using the robotic platform with synthetic monofilament non-absorbable suture. The authors emphasized the importance of inspecting all robotic instruments for damage prior to the case. For a prolonged case, the integrity of the sheaths should be inspected during the case as well, especially if there have been a multitude of instrument collisions [41]. In 2011, researchers at Ohio State University presented data on all robotic cases performed at their institution over 1 year. Instrument tip cover failures were recorded during the surgery, as well as whether or not that failure caused an iatrogenic injury to the patient. Four hundred fifty-four cases were included in the study, and twelve cover failures were noted. Three of the twelve failures caused patient injury. Thus, there was an instrument failure rate of 2.6% and a complication rate of 0.6%. All the failures occurred when the desiccate mode was used at a current of 30 watts. The authors report that Intuitive® engineers recommended keeping the power settings below 3 kV to avoid sheath failures, and that

Fig. 120.1  This patient has an obliterated posterior cul de sac. If there is a crack in the sheath of the robotic instruments, arcing can occur and damage the bowel

the implementation of that change along with routine inspection of sheath covers, the use of prepackaged tip covers, and sheath changes after 2 hours of use, resulted in fewer instrument failures as a result of this study (Fig. 120.1) [42]. Regardless of the cause, delayed thermal injury is one of the greatest concerns in minimally invasive gynecologic surgery. As surgeons, we must use utmost care to ensure prevention of these injuries. When robotic electrocautery instruments are used, the entire length of the sheath should be inspected to verify integrity. In addition, the course of the instrument in the pelvic cavity should be checked to ensure that the instrument is not adjacent to bowel or other internal structures. The surgeon should have a low threshold to replace instruments during the course of the case if there is any concern for instrument damage. If thermal injury is suspected, the bowel should be run and thoroughly evaluated for potential damage.

120.8 Gastrointestinal Complications When electrocautery is used, there is a chance of thermal injury as addressed above. However, bowel injury can also occur at the time of abdominal entry. With abdominal entry, the Veress needle or trocar can penetrate the bowel if there are adhesions at the point of entry, which is most commonly the umbilicus. The Hasson entry technique has not been shown to eliminate the risk of bowel injury [43–45]. Prior to entering the abdomen, the surgeon should consider the risk of bowel adhesions at the umbilicus. Patients with prior midline laparotomy, especially patients with a midline incision that extends above the umbilicus, are at high risk of umbilical adhesions, and thus Palmer’s point entry should be considered [46]. We also recommend two techniques, the “mapping” test or preoperative periumbilical ultrasound-guided saline ­infusion (PUGSI) to prevent bowel injury at the time of video laparoscopic entry [47]. For mapping, we use an

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18-gauge spinal needle on a 10 mL syringe with 2–3 mL normal saline. After obtaining pneumoperitoneum, the needle is inserted at the point of entry. If aspiration results in bubbles, the surgeon can be assured that he is in the peritoneal cavity and that the trocar can be inserted safely. If aspiration results in no bubbles or the presence of bowel contents, the surgeon should not consider this a safe point of entry into the abdomen. Once access to the abdomen has been obtained, the surgeon should look at the initial point of access from another port site to ensure that no injury occurred. If injury is suspected, the surgeon should run the bowel [48]. Another common reason for bowel injury is making the incision too small for the trocar. The surgeon may then use excess force to try to advance the trocar, resulting in bowel injury. If the surgeon feels the incision is not large enough for the trocar, the skin incision should be elongated. In addition, the surgeon should push slowly in a twisting motion using the entire arm and shoulder for maximum control [45]. Whatever the cause of bowel injury, early recognition and treatment is essential to ensure patient safety. To aid in the intraoperative diagnosis of bowel injury, we recommend proctoscopy prior to terminating the procedure if surgery was near the rectum [49]. A delay in recognition was attributed to 10% of patient mortalities from video laparoscopic entry [45]. Once recognized, a bowel injury should be repaired immediately, during the initial surgery or at repeat surgery. Postoperatively, the clinical signs of bowel injury include tachycardia, fever, severe pain, and initial leukopenia followed by leukocytosis. Bowel injury does not necessitate conversion to laparotomy. In the hands of an experienced surgeon, the case can be completed robotically. The use of video laparoscopy with or without robotic assistance to complete a bowel repair was first reported by Nezhat [50]. However, if there is not a surgeon readily available to repair the bowel using minimally invasive techniques, the surgeon should proceed with laparotomy. Reports of bowel injury during robotic surgery are limited. In a study about robotic sacrocolpopexy, one out of 80 patients had a small bowel injury that occurred during trocar placement. It was diagnosed and repaired at the time of surgery [51]. In a large study of 506 cases of surgical staging for endometrial cancer, two enterotomies were noted, one recognized and repaired at the time of initial robotic surgery and the other required laparotomy on the second postoperative day [8]. All of these cases highlight the importance of early bowel injury recognition.

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Because the course of the ureter runs near both the infundibulopelvic ligament and the uterine artery, it is at risk in many gynecologic procedures. We routinely perform a cystoscopy after surgeries performed near the bladder and ureters to ensure no injury occurred during surgery. If an injury is diagnosed on cystoscopy, it can be immediately repaired [52]. A thorough knowledge of the course of the ureter is essential for any gynecologic surgeon to avoid damaging it. The ureters traverse inferiorly in the retroperitoneum after coursing from the hyla of the kidneys. At the level of the pelvic brim, the ureters pass in front of the common iliac arteries, just as the iliac vessels divide into interal and external branches. Here, at the pelvic brim, the ureters run just posterior to the infundibulopelvic ligament (Fig. 120.2). The ureters then course deep into the broad ligament to the uterosacral ligaments, posterior to the uterine artery. From there, the ureters enter the bladder posteriorly at the trigone. At times, it may be appropriate to perform robotic ureterolysis to trace the path of the ureter and ensure that it is not damaged intraoperatively (Figs. 120.3 and 120.4). Reports on the incidence of ureteral injury vary, but are generally approximately 1% for video laparoscopic hysterectomy [53, 54]. If recognized intraoperatively, ureteral

Fig. 120.2  The ureter at the level of the pelvic brim

120.9 Urologic Complications Urologic complications are one of the most dreaded complications of gynecologic surgery. They range from mild complications such as transient urinary retention to more serious complications like iatrogenic bladder and ureter injury.

Fig. 120.3  Ureterolyis is initiated by incision of the pelvic peritoneum at the level of the pelvic brim

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a

b

Fig. 120.4  Ureterolysis is completed and the course of the ureter has been completely traced

injury can be repaired using the robotic platform at the time of initial injury [8]. The use of video laparoscopy to repair ureteral injury has been documented since 1992 [55, 56]. In addition, the use of the robotic arm to repair a ureteral injury 9 days after robotic-assisted hysterectomy has been reported [57]. If ureteral injury is suspected, laboratory and imaging tests, such as BUN, creatinine, urinalysis, and an intravenous pyelogram, can help in the diagnosis (Fig. 120.5). As always, we emphasize early recognition of the injury and prompt repair by minimally invasive techniques if possible. Physicians often overlook urinary retention as a postoperative complication, especially if it resolves within 1 or 2 days with bladder rest. However, urinary retention can be alarming for patients. With minimally invasive techniques, more patients are discharged the same day after their surgery; thus, some patients are discharged home with a urinary catheter in place or with instruction to self-catheterize. This can lead to patient discontent if they are not adequately counseled about this possibility prior to surgery. A 2012 study by Smorgick et al. looked at risk factors for urinary retention in 545 women who underwent video laparoscopic hysterectomy either with or without robotic assistance. The authors looked at several factors including age, body mass index, tobacco use, and diabetes. The only factor that was statistically associated with urinary retention was the use of the robotic platform, in which urinary retention occurred in 10% of cases as compared to 4% of video laparoscopic cases. All patients resumed normal voiding by 5 days after initial surgery. The authors theorize that the robot allowed for a more extensive bladder dissection, which resulted in increased urinary retention [58]. Injury to the bladder is less common than injury to the ureter and is often seen in patients with prior laparotomies resulting in a scarred bladder. A 2009 study on 80 robotic

Fig. 120.5 (a) Intravenous pyelogram shows a ureteral stricture with hydroureter. (b) Intraoperatively, the finding of the pyelogram and confirmed with this hydroureter

sacrocolpopexy reported two bladder injuries that were recognized and repaired at the time of the initial surgery, one of which required conversion to laparotomy for repair [51]. Similarly, a 2009 study of 835 patients who underwent gynecologic robotically assisted surgery found one bladder injury to the trigone that required conversion to laparotomy for repair [59]. If the bladder is repaired video laparoscopically, it can be repaired in a single layer with a running suture. If there is a conversion to laparotomy, it should be closed in 2–3 layers with running sutures. The repair should be watertight, and the urinary catheter should be left in place for 7–14 days after surgery [60, 61].

120.10  Major Vessel Complications Like bowel injuries, most vessel injuries in robotic surgery occur either during abdominal entry or as a result of complications from electrocautery. Arcing from monopolar electricity can also injure vessels, similar to the method as previously described. Depending on the vessel injured, the patient may lose a large amount of blood in a small amount

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ment, complications may occur. Education and due caution are the best tools we have to prevent injuries. As more surgeons become aware of the potential complications associated with the robotic platform, we as surgeons must be diligent to avoid some of the pitfalls associated with this technology. If injury does occur, early recognition and treatment are the keys for obtaining the best outcome for the patient. In many cases, it is not the complication that causes problems for the patient and surgeon, but the sequelae of that complication which may result in greater morbidity and mortality [65].

Fig. 120.6  An injury to the aorta has been repaired robotically with interrupted sutures

of time. If an injury to a major vessel is suspected, communication with the anesthesia team and the operating room staff is essential to ensure patient survival. Massive transfusion protocols may need to be initiated, and one should have a low threshold to consult vascular surgery. Sometimes, the vessel can be repaired robotically (Fig.  120.6). The first video laparoscopic vascular injury and repair were reported as early as 1996 by Nezhat et al. [62]. At other times, conversion to laparotomy may be required. When entering the abdomen, the surgeon should ensure that the bed is flat and the abdomen is level. We use towel clamps to elevate the abdominal wall and create distance between the aorta and the abdominal wall. The skin incision must be the appropriate size to avoid excess force, and the trocar should be introduced with a twisting motion of the upper arm and shoulder. If the surgeon applies excessive force during entry, the retroperitoneal space should be inspected for hematoma or other signs of vascular injury. It has also been theorized that the robot, with its lack of haptic feedback, may contribute to vascular injury. It has been suspected that the third arm of the robot may lead to compression injuries [63], but we could not find literature describing this. However, delayed thrombus formation of the common iliac artery has been reported after robotic surgery. The authors attributed the thrombus to blunt trauma at the time of initial trocar placement [64]. Due to the lack of haptics with the robot, there is concern for the potential of inadvertent excessive force being applied on the vessels by the robotic instruments, which can lead to traumatic injury.

120.11  Conclusion The robotic arm has further helped in the revolution of minimally invasive surgery, and allowing it to be more accessible to patients. However, like any surgical technique or instru-

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1286 15. Mok ZW, Yong EL, Low JJ, Ng JS. Clinical outcomes in endometrial cancer care when the standard of care shifts from open surgery to robotics. Int J Gynecol Cancer. 2012;22(5):819–25. 16. Lajer H, Widecrantz S, Heisterberg L. Hernias in trocar ports following abdominal laparoscopy. A review. Acta Obstet Gynecol Scand. 1997;76(5):389–93. 17. Mac Cordick C, Lecuru F, Rizk E, Robin F, Boucaya V, Taurelle R.  Morbidity in laparoscopic gynecological surgery: results of a prospective single-center study. Surg Endosc. 1999;13(1):57–61. 18. Eltabbakh GH.  Small bowel obstruction secondary to herniation through a 5-mm laparoscopic trocar site following laparoscopic lymphadenectomy. Eur J Gynaecol Oncol. 1999;20(4):275–6. 19. Tonouchi H, Ohmori Y, Kobayashi M, Kusunoki M. Trocar site hernia. Arch Surg. 2004;139(11):1248–56. 20. Seamon LG, Backes F, Resnick K, Cohn DE.  Robotic trocar site small bowel evisceration after gynecologic cancer surgery. Obstet Gynecol. 2008;112(2 Pt 2):462–4. 21. Nezhat C, Lavie O, Lemyre M, Unal E, Nezhat CH, Nezhat F.  Robot-assisted laparoscopic surgery in gynecology: scientific dream or reality? Fertil Steril. 2009;91(6):2620–2. 22. Sert B. Robotic port-site and pelvic recurrences after robot-assisted laparoscopic radical hysterectomy for a stage IB1 adenocarcinoma of the cervix with negative lymph nodes. Int J Med Robot. 2010;6(2):132–5. 23. Abu-Rustum NR, Rhee EH, Chi DS, Sonoda Y, Gemignani M, Barakat RR.  Subcutaneous tumor implantation after laparoscopic procedures in women with malignant disease. Obstet Gynecol. 2004;103(3):480–7. 24. Shoup M, Brennan MF, Karpeh MS, Gillern SM, McMahon RL, Conlon KC.  Port site metastasis after diagnostic laparoscopy for upper gastrointestinal tract malignancies: an uncommon entity. Ann Surg Oncol. 2002;9(7):632–6. 25. Childers JM, Aqua KA, Surwit EA, Hallum AV, Hatch KD.  Abdominal-wall tumor implantation after laparoscopy for malignant conditions. Obstet Gynecol. 1994;84(5):765–9. 26. Ndofor BT, Soliman PT, Schmeler KM, Nick AM, Frumovitz M, Ramirez PT. Rate of port-site metastasis is uncommon in patients undergoing robotic surgery for gynecological malignancies. Int J Gynecol Cancer. 2011;21(5):936–40. 27. Nezhat CH, Nezhat F, Seidman DS, Nezhat C. Vaginal vault evisceration after total laparoscopic hysterectomy. Obstet Gynecol. 1996;87(5 Pt 2):868–70. 28. Uccella S, Ghezzi F, Mariani A, et  al. Vaginal cuff closure after minimally invasive hysterectomy: our experience and systematic review of the literature. Am J Obstet Gynecol. 2011;205(2):119 e111–2. 29. Kho RM, Akl MN, Cornella JL, Magtibay PM, Wechter ME, Magrina JF.  Incidence and characteristics of patients with vaginal cuff dehiscence after robotic procedures. Obstet Gynecol. 2009;114(2 Pt 1):231–5. 30. Magrina JF, Kho RM, Weaver AL, Montero RP, Magtibay PM.  Robotic radical hysterectomy: comparison with laparoscopy and laparotomy. Gynecol Oncol. 2008;109(1):86–91. 31. Croak AJ, Gebhart JB, Klingele CJ, Schroeder G, Lee RA, Podratz KC. Characteristics of patients with vaginal rupture and evisceration. Obstet Gynecol. 2004;103(3):572–6. 32. Farquhar CM, Steiner CA. Hysterectomy rates in the United States 1990–1997. Obstet Gynecol. 2002;99(2):229–34. 33. Wu JM, Wechter ME, Geller EJ, Nguyen TV, Visco AG. Hysterectomy rates in the United States, 2003. Obstet Gynecol. 2007;110(5):1091–5. 34. Hur HC, Guido RS, Mansuria SM, Hacker MR, Sanfilippo JS, Lee TT. Incidence and patient characteristics of vaginal cuff dehiscence after different modes of hysterectomies. J Minim Invasive Gynecol. 2007;14(3):311–7.

C. Nezhat et al. 35. Iaco PD, Ceccaroni M, Alboni C, et al. Transvaginal evisceration after hysterectomy: is vaginal cuff closure associated with a reduced risk? Eur J Obstet Gynecol Reprod Biol. 2006;125(1):134–8. 36. Pollinger HS, Mostafa G, Harold KL, Austin CE, Kercher KW, Matthews BD. Comparison of wound-healing characteristics with feedback circuit electrosurgical generators in a porcine model. Am Surg. 2003;69(12):1054–60. 37. Sowa DE, Masterson BJ, Nealon N, von Fraunhofer JA.  Effects of thermal knives on wound healing. Obstet Gynecol. 1985;66(3):436–9. 38. Ramirez PT, Klemer DP. Vaginal evisceration after hysterectomy: a literature review. Obstet Gynecol Surv. 2002;57(7):462–7. 39. Neubauer NL, Schink PJ, Pant A, Singh D, Lurain JR, Schink JC. A comparison of 2 methods of vaginal cuff closure during robotic hysterectomy. Int J Gynaecol Obstet 2012;120(1):99–101. 40. Nezhat C, Kennedy Burns M, Wood M, Nezhat C, Nezhat A, Nezhat F. Vaginal cuff dehiscence and evisceration: a review. Obstet Gynecol 2018;132(4):972–85. 41. Cormier B, Nezhat F, Sternchos J, Sonoda Y, Leitao MM Jr. Electrocautery-associated vascular injury during robotic-assisted surgery. Obstet Gynecol. 2012;120(2 Pt 2):491–3. 42. Mues AC, Box GN, Abaza R.  Robotic instrument insulation failure: initial report of a potential source of patient injury. Urology. 2011;77(1):104–7. 43. Kornfield EA, Sant GR, O’Leary MP. Minilaparotomy for laparoscopy: not a foolproof procedure. J Endourol. 1994;8(5):353–5. 44. Sadeghi-Nejad H, Kavoussi LR, Peters CA.  Bowel injury in open technique laparoscopic cannula placement. Urology. 1994;43(4):559–60. 45. Bhoyrul S, Vierra MA, Nezhat CR, Krummel TM, Way LW.  Trocar injuries in laparoscopic surgery. J Am Coll Surg. 2001;192(6):677–83. 46. Brill AI, Nezhat F, Nezhat CH, Nezhat C. The incidence of adhesions after prior laparotomy: a laparoscopic appraisal. Obstet Gynecol. 1995;85(2):269–72. 47. Nezhat C, Cho J, Morozov V, Yeung P Jr. Preoperative periumbilical ultrasound-guided saline infusion (PUGSI) as a tool in predicting obliterating subumbilical adhesions in laparoscopy. Fertil Steril. 2009;91(6):2714–9. 48. Nezhat C, Li A, Falik R, et al. Bowel endometriosis: diagnosis and management. Am J Obstet Gynecol. 2018;218(6):549–62. 49. Nezhat C, Seidman D, Nezhat F. The role of intraoperative proctosigmoidoscopy in laparoscopic pelvic surgery. J Am Assoc Gynecol Laparosc. 2004;11(1):47–9. 50. Nezhat C, Nezhat F, Ambroze W, Pennington E.  Laparoscopic repair of small bowel and colon. A report of 26 cases. Surg Endosc. 1993;7(2):88–9. 51. Akl MN, Long JB, Giles DL, et  al. Robotic-assisted sacro colpopexy: technique and learning curve. Surg Endosc. 2009;23(10):2390–4. 52. Nezhat C, Falik R, McKinney S, King LP.  Pathophysiology and management of urinary tract endometriosis. Nat Rev Urol. 2017;14(6):359–72. 53. Ibeanu OA, Chesson RR, Echols KT, Nieves M, Busangu F, Nolan TE.  Urinary tract injury during hysterectomy based on universal cystoscopy. Obstet Gynecol. 2009;113(1):6–10. 54. Brummer TH, Seppala TT, Harkki PS. National learning curve for laparoscopic hysterectomy and trends in hysterectomy in Finland 2000–2005. Hum Reprod. 2008;23(4):840–5. 55. Nezhat C, Nezhat F.  Laparoscopic repair of ureter resected during operative laparoscopy. Obstet Gynecol. 1992;80(3 Pt 2):543–4. 56. Nezhat CH, Malik S, Nezhat F, Nezhat C.  Laparoscopic ureteroneocystostomy and vesicopsoas hitch for infiltrative endometriosis. JSLS. 2004;8(1):3–7.

120  Complications in Robotic-Assisted Video Laparoscopic Surgery 57. Kalisvaart JF, Finley DS, Ornstein DK.  Robotic-assisted repair of iatrogenic ureteral ligation following robotic-assisted hysterectomy. JSLS. 2008;12(4):414–6. 58. Smorgick N, Delancey J, Patzkowsky K, Advincula A, Song A, As-Sanie S.  Risk factors for postoperative urinary retention after laparoscopic and robotic hysterectomy for benign indications. Obstet Gynecol. 2012;120(3):581–6. 59. Lowe MP, Chamberlain DH, Kamelle SA, Johnson PR, Tillmanns TD.  A multi-institutional experience with robotic-assisted radical hysterectomy for early stage cervical cancer. Gynecol Oncol. 2009;113(2):191–4. 60. Nezhat C, Grace LA, Razavi GM, Mihailide C, Bamford H. Reverse vesicouterine fold dissection for laparoscopic hysterectomy after prior cesarean deliveries. Obstet Gynecol. 2016;128(3):629–33.

1287 61. Delacroix SE Jr, Winters JC. Urinary tract injuries: recognition and management. Clin Colon Rectal Surg. 2010;23(3):221. 62. Nezhat CR, Childers J, Borhan S.  Major vessel injury during advanced laparoscopic surgery. J Am Assoc Gynecol Laparosc. 1996;3(4 Supplement):S33. 63. Kadiyala S. Blunt vascular trauma can be a consequence of robotic surgeries. J Minim Invasive Gynecol. 2009;16(4):516. 64. McLean K, Dillman JR, McCarthy JD, Strouse PJ, Quint EH, Advincula AP.  Delayed iliac artery thrombosis after blunt trauma during operative laparoscopy. J Minim Invasive Gynecol. 2009;16(1):102–5. 65. Nezha C, Nezhat FR, Nezhat C. Nezhat’s video-assisted and roboticassisted laparoscopy and hysteroscopy. Cambridge, UK: Cambridge University Press. 2013.

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Daniele Geras Fuhrich, Kudrit Riana Kahlon, Jacklyn Locklear, and Aileen Caceres

121.1 Introduction In the past 30 years, there have been increased attention and utilization of minimal invasive surgery (MIS) techniques. Research has proven the advantages of smaller incision sites, fewer wound complications, decreased pain, shorter hospital stays, and improved cosmesis after MIS when compared to laparotomy [1–5]. One of the main contributors to the morbidity of laparoscopic surgeries is the number of incision sites for trocar insertion. These incision sites can lead to pain, hernias, and infection [6, 7]. Increased interest has been placed on how MIS can be further minimized. Laparoendoscopic single-site surgery (LESS), also known as single-port laparoscopic surgery (SPLS) and single-incision laparoscopic surgery (SILS), is an example of a minimally invasive surgery technique that allows a single-incision site to be used to introduce several ports. The central incision can be hidden entirely within the umbilicus and, once healed, leaves a barely noticeable scar [8, 9]. Initial studies established that single-site surgeries were a feasible alternative to multiport laparoscopic gynecologic procedures and had similar safety profiles [2, 10, 11]. Studies comparing patient pain, cosmetic recovery, and morbidity after single-site and multiport surgeries have shown varying results, with some showing better patient outcomes after single-site surgery, while others have shown no significant change from multiport laparoscopic procedures [12–17]. The popularity of MIS techniques has led to the development of robot-assisted surgery. The US Food and Drug Administration first approved robot-assisted surgery for carD. G. Fuhrich University of Central Florida, Orlando, FL, USA K. R. Kahlon · J. Locklear University of Central Florida College of Medicine, Orlando, FL, USA A. Caceres (*) University of Central Florida and Advent Health Celebration, Orlando, FL, USA

diac and urological procedures in 1999. In 2005, the use of da Vinci® robotic surgery system (Intuitive Surgical, Inc., Sunnyvale, California, USA) for gynecologic indications was approved by the US Food and Drug Administration [18, 19]. It is still the only FDA-approved and commercially available robot for gynecologic procedures. Since then, the use of da Vinci® robots has grown tremendously due to the increased mobility of instruments, ability to finely control three surgical arms, increased field of view compared to conventional laparoscopic surgery, and prevention of surgeon hand tremor [18–21]. Although the first LESS was described in 1969, it was limited by its more technically challenging nature due to the close proximity of instruments, increased difficulty triangulating the instruments, and greater surgeon fatigue [18, 22]. Langebrekke et  al. performed the first total laparoscopic single-port hysterectomy in 2009 but reported difficulties such as instrument collisions and limited view [23]. Escobar et  al. reported the first case of robot-assisted laparoendoscopic single-site surgery in gynecology on patient undergoing bilateral salpingo-oophorectomy and total hysterectomy. They reported improvement with triangulation despite still noting difficulties with instrument crowding and structural integrity of the surgical site. Despite these limitations, the authors concluded that further technological development could allow for robot-assisted single-port surgery to be feasible in gynecology [24]. In 2013, the FDA approved the use of da Vinci® robots for single-site surgery, termed robotic LESS (R-LESS), in gynecology; the approval was granted only for hysterectomy and adnexal surgery. The robotic platform offers improved control and field of view, which has allowed it to bridge the inherent limitations of LESS [9, 18, 20, 25]. The da Vinci® surgical system arms have seven degrees of mobility and high-definition cameras that allow for excellent 3D visualization and detailed dissection without trocar collision [26]. Whereas laparoscopic camera control and field of view can change depending on handling and patient behavior, robotic cameras allow for fixed and stable views that are controlled

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by the surgeon [21]. R-LESS may offer greater risk reduction in complicated cases or in obese patients undergoing gynecologic procedures due to better control of visualization and instruments [27]. There are several well-reported challenges with R-LESS as well. Surgeons must go through advanced training to learn the technique and must have access to specialized instruments and robotic platforms [22, 28]. Although robotic devices have excellent three-dimensional acuity, they diminish the surgeon’s perception depth due to lack of haptic or tactile feedback [21]. Additionally, R-LESS is hampered by the limited range of motion within the surgical site due to the multiple large components that make up the robot surgical platform. Research and development into flexible instruments and smaller robot components is ongoing. R-LESS has been used in various procedures such as hysterectomy, myomectomy, sacrocolpopexy, and resection of endometriosis while demonstrating favorable outcomes in regard to efficacy and safety compared to traditional LESS [29–35]. It has also shown to be safe and just as effective as multiport procedures in many cases with the added benefit of enhanced postoperative cosmesis and decreased blood loss [1]. Given the increased cost with traditional multiport robot-­ assisted laparoscopy, single-site procedures come with the additional benefit of decreased overall cost due to shorter hospital stays, faster recovery time, and lower cost of disposable instrumentation [2]. While still in relative infancy, R-LESS is a developing minimally invasive surgery tool that has the potential to further reduce gynecologic procedures requiring laparotomy in the future.

121.2 Technology The da Vinci® (Intuitive Surgical, Inc., Sunnyvale, CA, USA) single-site cannulas have a curved design that triangulates instruments internally and separates arms externally, maximizing range of motion and minimizing collisions. The single-site instruments differ from the existing da Vinci EndoWrist as their entire length is semirigid, which allows the instrument to pass through the curved cannula while providing rigidity to manipulate tissue. One of the limitations of this platform was that the instruments were not wristed. However, with innovations, the current version of the set includes a wristed needle driver, providing surgeons additional dexterity while suturing. The instruments available are Maryland dissector, clip applier, suction irrigator, Cadiere grasper, curved scissors, fundus grasper, crocodile grasper, Maryland bipolar forceps, curved needle driver, permanent cautery hook, fenestrated bipolar forceps, and wristed needle driver. da Vinci system software reconfigures the surgeon’s hand controls so they experience intuitive movement when using

D. G. Fuhrich et al.

single-site instruments. The surgeon’s right hand controls the screen right instrument while the instrument is in the left robotic arm, and the left side follows the same rule. The other advantages of the da Vinci surgical system for single-site surgery are the same ones found with multiport surgery.

121.3 Technique After induction of general anesthesia, the patient is placed in dorsal lithotomy position with stirrups for leg support. Arms are tucked at the sides with foam padding protection bilaterally, and the patient is prepped and draped in the normal sterile fashion. After a Foley catheter is inserted, a uterine manipulator is utilized (VCare/ConMed manipulator or Advincula Arch/Cooper Surgical depending on uterine size). Attention is then turned to abdominal wall and umbilicus where a 2.5-cm horizontal skin incision is made in a semilunar fashion in the superior aspect of the umbilicus. Abdominal access is attained via modified open Hasson technique during which the fascial incision is made to 2.5  cm. Upon abdominal entry, a small Alexis retractor (Applied Medical) is placed intra-abdominally to facilitate placement of a small gel port (mini-Gelpoint/Applied Medical or single-site gel port/Intuitive Surgical) (Fig. 121.1a, b). If the mini-Gelpoint is used, then ports are placed in a triangular fashion through the gel (two single-site instruments, an 8.5-mm 3DHD endoscope, and a 5/10-mm accessory port and insufflation adaptor), and then, the apparatus is inserted in the abdomen (Fig. 121.2a–c). When Intuitive’s single-site gel port is used, then the five-lumen port allows for the simultaneous use of two single-site instruments, an 8.5-mm 3DHD endoscope, and a 5/10-mm accessory port and insufflation adaptor. Pneumoperitoneum is established to an operating pressure of 13–15 mmHg. In order to improve access to uterine manipulation, the robotic patient-side cart is positioned at the patient’s left. At our institution, left-sided docking is preferred for all robotic gynecologic procedures; however, between-leg docking as described by Lewis et al. provides an alternative approach for uterine manipulation by the primary bedside assistant from above [36, 37]. Diagnostic laparoscopy is performed before robotic docking. The robotic camera used for all procedures is an 8.5-mm high-definition camera. The 8.5-mm camera trocar and camera are placed first through the access port, and the camera arm is docked. A 5–8-mm AirSeal® access port (SurgiQuest) is placed through the gel port’s assistant channel, in order to improve smoke evacuation and allow for uterine retraction with a 5-mm tenaculum. After, the 5  ×  250  mm2 curved cannulas are lubricated and inserted through the designated lumen under direct vision so that their entry point into the abdomen via the gel port is noted (Fig. 121.3).

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a

b

Fig. 121.1  Insertion of small Alexis retractor. (a) Small Alexis Retractor. (b) Amall Alexis Retractor in place (Photo courtesy of Robert Huerbsch)

a

b

c

Fig. 121.2  Insertion of mini-Gelpoint. (a, b) Mini-Gelpoint Device. (c) Mini-Gelpoint Device in place (Photo courtesy of Robert Huerbsch)

The operating surgeon then moves to the console. At the console, the surgeon confirms that the robotic arms are swapped such that the screen right instrument is being controlled by the right master and vice versa. The use of a 30° robotic camera is rotated to look downward or upward depending on the procedure. No accessory trocar that is not part of the single-site device is inserted.

121.4 Discussion Single-site surgery has become a popular frontier for minimally invasive surgery, as minimizing the number of incisions is thought to have the potential to improve safety and cosmetic outcomes. Although data on outcomes has been mixed, research on future applications and new techniques

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A 2013 systematic review concluded that no significant difference in complication rates resulted from gynecologic procedures using LESS when compared to multiport laparoscopic procedures. This study included organ injury, bleeding requiring transfusion, and death as end points [10]. A similar metaanalysis on surgery techniques for gynecologic disease found no significant differences between LESS and conventional laparoscopy in terms of perioperative complication rates, conversions to open surgery, and postoperative pain. The authors also noted that there were no differences in operative time, hemoglobin changes, and length of hospital stay [42]. In 2016, Xie et al. published a meta-analysis confirming the safety, feasibility, and effectiveness of LESS compared to multiport laparoscopy, where the only difference observed Fig. 121.3  Single-site robotic system. (Photo courtesy of Robert was total operating time that was slightly longer in the single-­ site group [43]. Sandberg et al. further echoed these results in Huerbsch) 2017 in a systemic review and meta-analysis evaluating the for single-site gynecologic surgery is continuing to gain safety and effectiveness of LESS for hysterectomy [2]. As robotic platforms are incorporated into LESS, a key interest. Wheeless and Wheeless and Thompson were the first to area of research is whether there is any difference in surgical report on single-trocar laparoscopy as early as 1970 [38, 39]. outcomes or complication rates between LESS and R-LESS Although occasional case reports and efforts to utilize single-­ as these platforms seemed very appealing to surgeons since port surgery have been reported since, the difficulties with they allow for better instrument triangulation, surgeon ergotechnique, need for advanced training, and technological nomics, and field of view than conventional non-robotic limitations prevented the popularization of single-site sur- single-site surgery. Also the same way as in LESS, several gery until the past 15 years. Recent advancements in technol- studies have analyzed the safety, feasibility, and effectiveogy have included the development of flexible and curved ness of R-LESS alone and compared to both LESS and mulinstruments for improved triangulation. Robot-assisted tiport robotic surgery [22, 33, 44–49]. Gungor et  al. in 2018 compared R-LESS with LESS single-­site surgery has further improved upon laparoscopic hysterectomies in terms of operative time, conversion to techniques by increasing range of motion, increasing surlaparotomy or multiport laparoscopy/robotic rates, compligeon precision, and steadying the field of view. Professional attitudes toward this new approach have cation rates, and postoperative results and found no differbeen one of the limiting factors for the adoption of mini- ence between the two when performed by experienced mally invasive surgical techniques. A 2016 report looked at surgeons [47]. When comparing R-LESS with multiport robotic surgery, surgical techniques for nonmetastatic endometrial cancer patients undergoing hysterectomy from 2012 to 2013 and Bogliolo et al. found that there was no significant difference found that 47.6% of cases used minimally invasive technol- between the single-site and multiport approach in console ogy. Teaching hospitals, hospitals in urban settings, and time, surgical complication rate, conversion rate, and postophigh-volume hospitals were the most likely to adopt this erative pain. The estimated blood loss and length of hospitalapproach, whereas hospitals in rural settings and those cater- ization were lower in the single-site group [49]. In a published report, Moon et al. compared R-LESS and ing to minority patients used open surgery [40]. Studies evaluating gynecologists’ attitudes toward minimally invasive LESS for advanced-stage endometriosis. The authors found surgery have shown steady increase over the last 15 years, that there was a statistically significant increase in operative suggesting that personal and professional attitudes have times and estimated blood loss that occurred in the R-LESS cohort, although they noted that the R-LESS cohort had a affected the rate of widespread adoption of MIS [41]. As with any new surgical technique, one of the primary larger mean size of endometriosis. The authors of this study concerns to the medical community is the safety and efficacy reported no significant differences in intraoperative or postof the new approach compared to the gold standard that operative complications [50]. Matanes et al. evaluated the data from three retrospective sometimes has been used for years. The safety and efficacy of single-site surgery as compared to multiport laparoscopic studies that compared the outcomes of R-LESS and surgery are well studied. Several meta-analyses have evalu- LESS.  The authors determined that the R-LESS cohorts ated the postoperative outcomes and complication rates fol- showed longer mean operating times, decreased estimated blood loss, and shorter postoperative hospitalizations [18]. lowing LESS.

121  Robotic Single-Site Gyn Surgery

The consensus opinion is that the single-site technique is feasible, safe, and equally as effective as conventional laparoscopy and multiport robotics for gynecologic surgery. Even if single-site surgery is not approved by the FDA for all gynecologic procedures (only approved for hysterectomy), different studies already show safety and effectiveness of R-LESS for myomectomy, endometriosis, and endometrial cancer surgeries [50–55]. Minimally invasive surgery techniques are becoming a mainstay of gynecologic oncology management. Early reports showed that MIS procedures were equivalent to open procedures in patients with early-stage malignancies. Proponents theorize that minimally invasive methods hold particular promise for gynecologic malignancies, which can be infiltrative and anatomically complex. Multiple studies have evaluated the feasibility of LESS and R-LESS in early-stage gynecologic oncology cases for staging and excision. Fagotti et  al. were the first to describe the outcomes of 100 endometrial cancer cases that underwent LESS.  They concluded that LESS could be used to successfully stage and treat endometrial cancer [11]. In 2014, Boruta et al. utilized LESS for cervical cancer excision in 22 patients and reported that all surgical margins were negative, although they did note increased technical difficulty with the technique [56]. Moukarzel et  al. assessed the feasibility of R-LESS on patients with uterine and cervical cancer and found no increase in blood loss, operative time, or postoperative complications over traditional hysterectomy [55]. After you evaluate safety and effectiveness of a new technique, it is also extremely important to study the possible advantages that are associated with it, ones that could possibly favor one approach over the other. One of the main hypothesized benefits of single-site surgery as compared to multiport surgery is reduction in postoperative pain. Corroborating this, Fagotti et  al. found that postoperative pain and need for rescue analgesia were decreased in patients undergoing LESS instead of multiport laparoscopy for benign adnexal disease [57]. Following the same results pattern, Kliethermes et  al. compared postoperative pain ratings after multiport incision surgery, LESS, and R-LESS for benign hysterectomy. The authors found that single-site patients reported reduced pain at an earlier time point when compared to multiport incision patients. They found no significant difference in pain between the LESS and R-LESS patients, although they qualified that the LESS group size was too small for generalization [15]. Leitao et  al. showed that endometrial cancer patients undergoing robot-associated surgery reported lower postoperative pain and pain medication requirements as compared to laparoscopic procedures. Although this study did not specifically investigate single-site surgery, it does suggest that

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future research should compare postoperative pain after LESS and R-LESS [58]. In contrast to these results, several studies have also showed no decrease in pain or difference in postoperative analgesia following single-site surgery as compared to multiport surgery [59, 60]. While, overall, the research seems to suggest that there is decreased postoperative pain after LESS and the potential for further decreased pain after R-LESS, there is no strong consensus about clinical postoperative pain reduction and analgesia use. Patients should be informed about this potential benefit but also counseled on appropriate pain management techniques and offered adequate postoperative analgesia. Another proposed benefit for LESS over conventional multiport laparoscopy is the cosmetic outcome of a single incision. Proponents commonly cite reduced scarring as well as decreased hernia formation as potential advantages. Few studies have evaluated cosmesis and patient satisfaction following single-site gynecologic surgery. A 2012 study evaluated subjective surgeon and patient satisfaction with the cosmetic results following LESS for adnexal disease. The authors reported high mean scores, ranging from 9.0 to 9.5 out of a 10-point scale measured at discharge and 1 month postoperatively [61]. One small randomized study comparing the cosmetic outcomes after LESS and multiport surgery found that patients undergoing LESS reported significantly higher cosmetic satisfaction through 6 months postoperatively [62]. In our institution, we did a comparison of R-LESS with multiport hysterectomies, and the satisfaction scores pertaining to surgical cosmesis were exceptionally high with single-­ site approach (Fig. 121.4).

Fig. 121.4 R-LESS umbilical scar. (Photo courtesy of Robert Huerbsch)

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While the vast majority of LESS procedures use an umbilical incision, there is also potential for single-site vaginal approaches that prevent the need for abdominal incisions. The vaginal fornix has less sensory innervation than the navel, which could lead to reduced postoperative pain [63]. In addition, the vaginal approach allows for removal of larger specimens that would otherwise require larger abdominal incisions or additional ports. This approach would also obviate the risk of hernia development. While initial reports are strongly positive, this approach has not been well studied or popularly adopted in gynecology [64]. Future research will need to evaluate safety outcomes as well as long-term patient satisfaction with quality of life and risk of sexual dysfunction. Cosmetic outcomes are important as they can have a significant impact on patient’s body image and self-esteem postoperatively. The hope with new technology and techniques is to improve patient quality of life and recovery of function more than traditional methods, so ensuring improved cosmesis and patient satisfaction should continue to be a goal with future developments with LESS. It is important to highlight that the majority of currently published literature has shown the feasibility of single-site surgical techniques; it has been unable to reach a consensus on the relevant clinical benefits of LESS over multiport laparoscopy. As previously discussed, proposed benefits include reduced pain, enhanced cosmesis, and fewer complications following LESS as compared to traditional techniques. While establishing the safety and non-inferiority of the single-site technique is a vital step to widespread use, future research and improvements are necessary in order to broadly implement R-LESS for gynecologic disease management. It should be noted that although initial consensus on the use of MIS in gynecology oncology was positive, there has been a paucity of data on long-term survival outcomes following laparoscopic and robotic surgeries. Recent research on this topic has led to conflicting opinions. The Laparoscopic Approach to Cervical Cancer (LACC) study was an international randomized study that showed lower rates of 3-year disease-free survival and overall survival after MIS procedures as compared to open hysterectomy [65]. These results call into question the oncologic opinion that minimally invasive surgery is non-inferior to open surgery. Current instrumentation and robotic platforms can lead to technical issues such as crowding and loss of triangulation, which prevents the use of LESS and R-LESS in advanced disease. Technical innovation is needed to allow surgeons more precision and improved ergonomics for complex cases. So future research in gynecologic oncology MIS is also much needed and must evaluate long-term disease and survival outcomes for the many types of gynecologic cancers and for patients of different tumor staging and risk profiles. The results of this research may affect current gynecologic oncology guidelines and utilization of single-site surgery techniques.

D. G. Fuhrich et al.

Another important factor affecting the adoption of minimally invasive technology is the advanced training required for physicians to master the skill set and technology. One small study evaluated the difficulty of learning LESS skills as compared to multiport laparoscopy. This study randomized 20 novice medical interns into two groups that learned one surgical technique. Both groups improved, and the study authors concluded that both skills could be learned in a similar time frame in a laboratory setting. While this study’s results may not be applicable to an operating room setting, they do suggest that trainees can learn LESS without multiport laparoscopic experience [66]. While the technical skill required for single-site laparoscopy is unique, studies suggest that the learning curve to R-LESS is favorable and has two phases. The proficiency and better outcomes are often achieved after 12–14 cases. It seems to be easier for surgeons that already have experience in robotics [33, 44–46]. Even though a lot of future research and a lot of questions still need to be answered, minimally invasive surgery is fast becoming the surgical standard for gynecologic procedures. As the popularity of this technique continues to grow, the financial cost of this developing technology is another important aspect to consider. Scalici et  al. used the American College of Surgeons National Surgical Quality Improvement Program database to research trends in minimally invasive surgery for endometrial cancer. They projected that each 10% increase in MIS use would equate to $2.8  million in healthcare savings [67]. One of the most important factors guiding the utilization and applicability of minimally invasive surgery techniques is the costs to the patient and the physicians offering these procedures. Minimally invasive surgery tools and training can be expensive investments for hospital systems and individual providers. As minimally invasive surgery techniques become more mainstream, training often becomes the responsibility of graduate medical education programs. Robotic platforms can be cost-prohibitive, and thus, training programs and cases are less widely available. Multiple cost analyses have shown that the cost of robotic surgery is greater than conventional laparoscopic techniques in gynecology. One 2017 meta-analysis calculated that robotic gynecologic procedures were approximately $1750 more than traditional laparoscopic procedures [68]. The major contributor to higher robotic surgery cost is the use of disposable instruments and higher hospital costs for robotic procedures [69, 70]. The increase in cost must be weighed against the clinical benefits of robotic surgery as physicians and hospital systems offer these procedures to patients. Although the higher costs of robotic surgery are well established, Moukarzel et al. reported that robotic single-site surgery is more cost-effective than multiport robotic surgery while having similar perioperative outcomes in patients with endometrial cancer. The authors state that single-site surgery

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requires less disposable components than multiport surgery, allowing for approximately $500  in reduced costs [30]. Notably, no published literature breaks down procedure costs according to different versions of the da Vinci® robot platform. As this technology continues to be studied, future research will need to evaluate both clinical results and surgical costs in order to determine widespread applicability. Despite the advantages of R-LESS over conventional LESS, there are still several limitations of the robotic platform. The large components of the robotic platform still lead to crowding issues, which usually require the assistance of trained operating room assistants. There is the risk of mechanical failure. In addition, the lack of tactile and haptic feedback can impede depth perception. Advanced training with robotic platforms can allow the surgeon to overcome these limitations. However, this also steepens the learning curve of R-LESS and restricts its widespread utilization [71]. A major area of development within robotic surgery is the new da Vinci SP® surgical system, which is specifically designed for single-site surgery. This platform allows three wristed instruments and a wristed camera to emerge from a single cannula, allowing for improved triangulation and fewer instrument collisions. The surgeon console is the same as in the original da Vinci® system. The FDA first approved this new technology for urological procedures in 2014. Since then, it has expanded clearance to include other procedures requiring access from a single small incision, such as single-­ site tonsillectomy [72]. While this platform has not yet been cleared for gynecologic procedures, this does signal a shift in acceptance of R-LESS technology across specialties.

121.5 Conclusion Minimally invasive surgery techniques are transforming gynecologic surgery, offering reduced morbidity and pain, better cosmesis, and quicker healing. The advent of new surgical techniques has led to the development of robot-assisted laparoendoscopic surgery, with multiple approaches that are still being refined and compared to one another. Single-site surgery offers the potential to be even less invasive than the multiport laparoscopic approach. LESS and R-LESS hold particular promise for obese patients and with complex cases. As more surgeons learn these advanced techniques and apply them to their patients, the best way to utilize these technologies is being better understood. However, as new technologies are adopted, they must also be evaluated to ensure that safety outcomes are better or at minimum not worse than traditional methods; it is also hard to predict the long-term outcomes. That is why however repetitive this may sound, future research especially multicenter controlled randomized clinical trials is urgent and much needed to the improvement of medical care.

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1297 66. Fransen SA, Mertens LS, Botden SM, Stassen LP, Bouvy ND.  Performance curve of basic skills in single-incision laparoscopy versus conventional laparoscopy: is it really more difficult for the novice? Surg Endosc. 2012;26(5):1231–7. 67. Scalici J, Laughlin BB, Finan MA, Wang B, Rocconi RP. The trend towards minimally invasive surgery (MIS) for endometrial cancer: an ACS-NSQIP evaluation of surgical outcomes. Gynecol Oncol. 2015;136(3):512–5. 68. Ind T, Laios A, Hacking M, Nobbenhuis M. A comparison of operative outcomes between standard and robotic laparoscopic surgery for endometrial cancer: a systematic review and meta-analysis. Int J Med Robot. 2017;13(4). 69. Barnett JC, Judd JP, Wu JM, Scales CD Jr, Myers ER, Havrilesky LJ.  Cost comparison among robotic, laparoscopic, and open hysterectomy for endometrial cancer. Obstet Gynecol. 2010;116(3):685–93. 70. Holtz DO, Miroshnichenko G, Finnegan MO, Chernick M, Dunton CJ.  Endometrial cancer surgery costs: robot vs laparoscopy. J Minim Invasive Gynecol. 2010;17(4):500–3. 71. Lopez S, Mulla ZD, Hernandez L, Garza DM, Payne TN, Farnam RW. A comparison of outcomes between robotic-assisted, single-­ site laparoscopy versus laparoendoscopic single site for benign hysterectomy. J Minim Invasive Gynecol. 2016;23(1):84–8. 72. Agarwal DK, Sharma V, Toussi A, Viers BR, Tollefson MK, Gettman MT, et al. Initial experience with da Vinci single-port robot-assisted radical prostatectomies. Eur Urol. 2020;77(3):373–9.

Part VIII Gynecology Oncology Section

Robotic Surgery and Physician Wellness in Gynecologic Oncology

122

Martin A. Martino, Andrea Johnson, Joseph E. Patruno, and Pedro F. Escobar

122.1 T  he Introduction of Robotics into the Field of Gynecology As of 2020, there remains little doubt that robotics has played a major impact in the care provided to women worldwide. This, however, has been with significant controversy. Some believe there are significant metrics with improved quality outcomes by the use of a 3D vision platform with articulating instruments [1]. Others, however, believe these are not accurate and do not see a benefit with these novel tools [2]. Regardless of which sides we align, there is no question that with the introduction of robotics, the rates of open surgery for hysterectomy in both benign and malignant gynecology procedures have decreased nationally since 2005 when the FDA approved the da Vinci surgical platform (Intuitive Surgical, Inc., Sunnyvale, CA) for use in gynecologic surgery [3]. After the introduction of the original standard robot by Intuitive Surgical, the S model was introduced, followed by the Si. In 2014, Intuitive Surgical upgrades their surgical platform to fourth-generation technology and developed enhanced energy and stapling devices for use with this platform. Enhanced benefits to this include ergonomics, optics, tele-mentoring, and image-guided surgery with “firefly” technology. Simulation and connectivity have been added to M. A. Martino (*) Division of Gynecologic Oncology, Lehigh Valley Cancer Institute, Allentown, PA, USA Minimally Invasive Robotic Surgery Program, Lehigh Valley Health Network, Allentown, PA, USA e-mail: [email protected] A. Johnson Obstetrics and Gynecology, University of Minnesota, Minneapolis, MN, USA J. E. Patruno Department of Obstetrics and Gynecology, Lehigh Valley Health Network, Allentown, PA, USA P. F. Escobar Department of Gynecologic Surgical Oncology, San Jorge Children and Women’s Hospital, San Juan, Puerto Rico

help standardize education and training in robotic surgery as well. As of this writing in 2019, an additional platform known as the SP was FDA approved for use in urology and ENT [3]. Over the course of this chapter, we will present an update as of 2020, with certainty that this will change in the upcoming decade. What lies ahead is not only exciting but also revolutionary. The future is optimistic, and we are fortunate to be a part of these exciting times to deliver innovative care for patients around the world.

122.2 An Update on Endometrial Cancer Prior to 2006, the standard approach for patients diagnosed with endometrial cancer was a large incision in the midline with a TAH/BSO and complete lymph node dissection— possibly to the renal vessels [4]. With the publication of GOG LAP2 in 2006 and 2009, the management of patients with uterine cancer radically changed for the better [5]. In this randomized clinical trial, women were randomized to open (laparotomy) or laparoscopic surgical resection and staging. Outcomes from this study definitely identified that laparoscopic surgery was associated with fewer complications and decreased length of stay compared to laparotomy [5]. This significant improvement that was identified shifted procedures away from open surgery and toward a minimally invasive approach. These outcomes were validated through large data series which demonstrated improved outcomes when performed by high-volume surgeons who have standardized their workflow [6]. A recent comparative effectiveness study compared robotic hysterectomy to laparoscopic and open hysterectomy. This systematic review compared a total of 48 studies and noted that the robotic hysterectomy (RH) approach appeared to be a safer and better option for patients that have hysterectomy for endometrial cancer [7]. What has significantly changed over the past decade is the extent of lymph node dissections being performed by gyneco-

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logic oncologists who have access to the firefly technology on the new platforms. Controversy had existed as to whether it was necessary to perform a complete lymph node dissection for patients with endometrial cancer or perform a limited LND using either a frozen section approach or image-guided surgery with sentinel LN [8]. In 2014, firefly (image-guided surgery) was added to the Intuitive XI. In addition to this, the SLN algorithm was formally introduced into the NCCN Guidelines, leading to the rapid adoption of this limited LND approach for patients with endometrial cancer. Studies have been performed for patients with both low-risk and high-risk disease, and these have validated the benefit of sentinel LND when performed in experienced and trained hands [9]. Escobar (co-author of this chapter) et  al. recently published a study in The Lancet Oncology showing noninferiority of indocyanine green compared to isosulfan blue for mapping of lymph nodes. Disease status and subsequent treatment planning are determined based on involvement of regional lymph nodes in pelvic cancers. For gynecologic cancers, lymph node mapping is typically done by injecting dye into the cervix at the beginning of surgery. This allows the surgeon to identify lymph nodes that would otherwise be undetectable. This study aimed to show noninferiority of indocyanine green fluorescent dye to isosulfan blue dye; they found that green dye identified approximately 50% more nodes than blue dye (97% identification of lymph nodes with green dye, 47% with blue dye, confirmed on pathology). They also found that green dye was superior to blue dye in identifying sentinel nodes and bilateral nodes and reported no adverse outcomes with injection of green dye [10]. Clinical data has validated the role for minimally invasive surgery (MIS) and robotics in the patient with obesity [11]. Obesity in the United States and other countries remains one of the greatest risk factors that can potentially be modified. Specific to endometrial cancer, obesity is one of the greatest risk factors, as most derivatives of estrogen are converted to estrone, which has a direct stimulatory effect on the estrogen receptors in the endometrial lining. This is believed to be the primary mechanism of action leading to the development of endometrial cancer. When compared to laparoscopy, robotic surgery offers several advantages including decreased blood loss, fewer blood transfusions, decreased operative times, fewer conversions to open surgery, and decreased lengths of stay [12].

122.3 Cervical Cancer Prior to the twentieth century, the standard approach to patients with cervical cancer IA1 with +LVSI to IB1/IB2 was an open radical hysterectomy [13]. With the publication of the Landoni trial, many surgeons limited the application of the radical hysterectomy to patients with tumors