An evaluation of emerging technologies in ENT- Virtual reality simulation & Robotic surgery Asit Arora Imperial College London Department of ENT & Cancer and Surgery Thesis submitted for the degree of Doctor of Philosophy 1 Declaration of originality I, Asit Arora, hereby declare that the work presented in this thesis is my own. Where information has been derived from other sources, I confirm that this has been indicated in the thesis. 2 Declaration of copyright I confirm that the copyright of this thesis rests with the author and is made available under a Creative Commons Attribution Non-Commercial No Derivatives licence. Researchers are free to copy, distribute or transmit the thesis on the condition that they attribute it, that they do not use it for commercial purposes and they do not alter, transform or build upon it. For any reuse or redistribution, researchers must make clear to others the licence terms of this work. Permission to republish all the third party copyrighted works arising from this thesis has been sought via email. 3 Abstract Virtual reality (VR) simulation and robotic surgery represent two focus areas for research and development in Otolaryngology-Head & Neck Surgery. This thesis was driven by a desire to deliver improvements in surgical training and patient care. The development and long-term prospective clinical evaluation of three novel robotic applications in Head & Neck surgery were investigated. The results suggest that robotic assisted thyroidectomy and robotic assisted parathyroidectomy are safe, feasible alternatives to conventional surgery. The primary advantage is the avoidance of a neck scar. The approach occupies a niche role that is justified in patients who have cultural or biological drivers to avoid a neck scar. Improvement in surgical exposure was necessary. A novel soft-tissue retractor was designed and manufactured to address this issue. Transoral robotic surgery represents a promising treatment option for patients with obstructive sleep apnoea who cannot tolerate or fail all the other treatment modalities. Biometric measures represent an important tool when assessing patient suitability for TORS. Only those who have undergone appropriate training, proctoring and licensure should perform robotic surgery. Safe implementation is essential. The studies of VR temporal bone simulation served as a preparatory to introducing VR simulation for robotic head and neck surgery. The face, content and construct validation of a novel temporal bone simulator was demonstrated. Further studies were conducted to benchmark and pilot a VR skills curriculum and assess the role of case specific surgical rehearsal. Simulation training represented a useful adjunct. This body work demonstrates that both technologies can be integrated to deliver effective robotic surgical training to enhance surgical performance and improve patient care. 4 Acknowledgement First and foremost, I would like to thank Neil Tolley, my mentor and primary research supervisor for his unwavering support, guidance and the faith he has shown in me. His energy and enthusiasm has been a constant source of encouragement over the past 4-5 years. I also wish to acknowledge the role of my secondary supervisor, Dr Eddie Edwards, and Professor Ara Darzi for their support, guidance and inspiration. I was fortunate to receive grants from several awarding bodies and am indebted to them. Without this financial support and their belief, the work would not have been possible within the timeframe. I am most grateful to the St Mary’s Charitable Trust, the Imperial College Healthcare Charity, the Medical Engineering research kick-start scheme, Imperial College London and the Rhinology & Laryngology research fund. Several individuals have been an ever-present support and played an important collaborative and/or supervisory role. I am hugely appreciative to the following people: Prof David Howard, Prof Ceri Davies, Dr Ferdinando Rodriguez Y Baena, Mr Arvind Singh, Mr Bhik Kotecha and Prof Greg Weinstein. I am also grateful to my research successors, Zaid Awad and Konstantinos Chaidas for maintaining the momentum and the clinical databases. Regarding the latter, a special thanks to Keerthini Muthuswamy and Ashik Amlani, final year Imperial medical students. I wish to thank my other co-authors of the publications emerging from this body of work (11 and counting!); George Garas, Sam Khemani, Lorreta Lau, Chloe Swords, Andrew Hall and Amish Acharya. I am particularly indebted to James Budge and Jalpa Kotecha for their statistical input in several of the studies presented here. 5 This body of work has allowed me to establish some fantastic collaborative links, which form the platform for on going and future work. I am indebted to Mathew Oldfield from the Department of Mechanical Engineering, Philip Pratt from The Hamlyn Centre and Danail Stoyanav from the Centre for Medical Image Computing & Department of Computer Science University College London. I look forward to further fruitful collaboration. The logistics of some of these studies were challenging and certain individuals went out of their way to help. A special note of thanks goes to Karen Kerr, Sejal Jiwan, Ken Miller, Stephen Marchington and Kate Miles. Several studies involved cadavers and this would not have been possible without the guidance of Prof Ceri Davies and the help of Rachel Waddington and Lee Dennis from Imperial College London and Dr Matt Szarko from St George’s University of London, Human Anatomy Unit. Regarding the simulation work, certain individuals have played important roles. Raj Aggarwal was a great source of inspiration and I must also acknowledge ENT consultants who came from around the country to benchmark the VR curriculum; Simon Lloyd, Elliot Benjamin, Gareth Rowlands, Chris Aldren, David Alderson and Prof Shak Saeed. A special thanks goes to Nasir Bhatti from John Hopkins, with whom we collaborated on the first validation study. These study days would not have been possible without the logistical support from key individuals from Zeiss (Philip Peacock), Storz (Ben Pattinson) and Medtronics (Derek Gautery). We are also grateful to the VOXEL-MAN group for supplying additional simulators. Regarding the robotic training programme, we are grateful to Todd Larson from Mimic for his assistance developing the VR curriculum in TORS. I am extremely grateful to Selvy Renju and Richard Abbott from the Joint Research Office at St Mary’s Hospital for their guidance and encouragement with the ethics 6 submission process for robotic surgery. Establishing the UK’s 1st robotic clinical programme in ENT took a leap of faith from the rest of the surgical team to whom we are indebted. I wish to acknowledge all members of the operating team at St Mary’s Hospital with a special mention to Shirley Martin and Dr David Lomax. It also took a leap of faith from our endocrine and radiology colleagues. Sincere thanks goes to Dr Jeremy Cox, Prof Stephen Robinson, Mr Fausto Palazzo and Dr Ranju Dhawan. A special thanks to Neil Tolley, George Garas, Prof David Howard and Prof Ceri Davies for taking the time out of their busy schedules to read some of this work and for their honest feedback. Finally, I am hugely grateful to my wife and family for their support, patience and understanding. It has taken a huge leap of faith from our patients and above all else, I wish to acknowledge their courage, honesty and thank them all for their willingness to participate in the clinical studies presented in this thesis. 7 Table of content Declaration of originality.......................................................................................................2 Declaration of copyright.........................................................................................................3 Abstract...............................................................................................................................................4 Acknowledgement.......................................................................................................................5 List of figures................................................................................................................................16 List of tables...................................................................................................................................20 Abbreviations................................................................................................................................22 Chapter 1 Introduction........................................................................................................25 1.1 Motivation for the thesis...........................................................................................26 1.2 Innovation in head & neck surgery.........................................................................28 1.3 Need for innovation in temporal bone surgery training………………………...30 1.4 Evidence based review of robotic surgery in Otolaryngology-Head & Neck Surgery……………………………………………………………………….33 1.4.1 Method……………………………………………………………………..33 1.4.2 Results……………………………………………………………………...34 1.4.3 Synopsis of findings……………………………………………………….40 1.4.4 Conclusions………………………………………………………………..52 1.5 Evidence-based review of VR simulation in Otolaryngology……………………53 1.5.1 Method……………………………………………………………………..54 1.5.2 Results……………………………………………………………………...56 1.5.3 Synopsis of findings……………………………………………………….60 . 1.5.4 Conclusions………………………………………………………………..63 1.6 Hypothesis………………………………………………………………………….63 1.7 Aim…………………………………………………………………………………63 1.7.1 Robotic surgery……………………………………………………………63 8 1.7.2 VR Simulation……………………………………………………………..64 1.8 Chapter summaries and how they relate…………………………………………64 1.9 Contribution to the field…………………………………………………………...68 1.9.1 Robotic Head & Neck surgery……………………………………………..68 1.9.2 Robotic Surgery: list of publications………………………………………69 1.9.3 Research awards…………………………………………………………...69 1.9.4 Temporal bone simulation…………………………………………………70 1.9.5 VR simulation: list of publications………………………………………...71 1.9.6 Robotic surgery and VR simulation training………………………………71 Chapter 2 Scar-less in the neck endocrine surgery: Patient perception & robotic thyroidectomy……………………………...73 2.1 Objective……………………………………………………………………………74 2.2 Method.......................................................................................................................74 2.3 Evaluation of the patient perspective regarding scar cosmesis…………………74 2.3.1 Method..........................................................................................................74 2.3.2 Results...........................................................................................................76 2.3.3 Synopsis of findings……………………………………………………….84 2.4 Evaluation of robotic thyroidectomy.......................................................................87 2.4.1 Method..........................................................................................................87 2.4.1.1 Robotic training, funding and ethics approval…………………...87 2.4.1.2 Preclinical evaluation…………………………………………….88 2.4.1.3 Clinical evaluation………………………………………………..91 2.4.1.4 Study design……………………………………………………...91 2.4.1.5 Surgical technique………………………………………………..92 2.4.1.6 Outcome measures.………………………………………………97 2.4.1.7 Statistical analysis…………………………………......................99 2.4.2 Results...........................................................................................................99 2.4.2.1 Demographics…………………………………………………….99 2.4.2.2 Operative data……………………………………………………99 2.4.2.3 Complications…………………………………………………...102 9 2.4.2.4 Patient-reported outcome measures (PROMs)………………….103 2.4.3 Synopsis of findings...................................................................................106 2.5 Discussion.................................................................................................................109 2.6 Conclusion................................................................................................................115 Chapter 3 Development of a novel retractor to improve exposure for robotic thyroid surgery...................................................................116 3.1 Background..............................................................................................................117 3.1.1 Objective.....................................................................................................118 3.2 Method.....................................................................................................................118 3.3 Cadaver study 1 and initial prototype design.......................................................119 3.3.1 Method........................................................................................................119 3.3.2 Results.........................................................................................................119 3.3.3 Synopsis of findings...................................................................................120 3.3.4 Initial prototype design…………………………………………………...120 3.3.5 Design development of 1st prototype……………………………………..125 3.3.6 Simulation stress analysis of 1st prototype………………………………..126 3.3.7 Manufacture of 1st prototype……………………………………………..127 3.3.8 Design development of 2nd prototype…………………………………….128 3.3.9 Manufacture of 2nd prototype……………………………………………..130 3.4 Cadaver study 2 and further prototype development.........................................131 3.4.1 Method........................................................................................................131 3.4.2 Results.........................................................................................................132 3.4.3 Synopsis of findings...................................................................................135 3.4.4 Design and manufacture of 3rd prototype………………………………...135 3.5 Cadaver study 3 and further prototype development.........................................137 3.5.1 Method........................................................................................................137 3.5.2 Results…………………………………………………………………….138 3.5.3 Synopsis of findings……………………………………………………...138 3.5.4 Modelling, manufacture and mechanical testing of 4th prototype………………………………………………………………….139 3.5.4.1 Method.........................................................................................139 10