Video Analysis of Errors and Technical Performance Within Minimally Invasive Surgery
Conditions: Prostate Cancer, Rectal Cancer
Sponsor: The Griffin Institute

IRAS number 309024 
Version number 17, 10 January 24 
 
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Final Version 1.1 March 2016- Qualitative Protocol Tool  
 
 
IRAS Ethics -qualitative-protocol (017) VAMIS 
 
The research protocol forms an essential part of a research project. It is a full description of the 
research study and will act as a ‘manual’ for members of the research team to ensure adherence to 
the methods outlined. As the study gets underway, it can then be used to monitor the study’s progress 
and evaluate its outcomes.  
The protocol should go into as much detail about the research project as possible, to enable the 
review bodies to fully understand your study. 
 
The use of this collated consensus guidance and template is not mandatory. The guidance and 
template are published as standards to encourage and enable responsible research.  
The document will:  
• 
Support researchers developing protocols where the sponsor does not already use a template  
• 
Support sponsors wishing to develop template protocols in line with national guidance  
• 
Support sponsors to review their existing protocol template to ensure that it is in line with 
national guidance.  
 
A protocol which contains all the elements that review bodies consider is less likely to be delayed 
during the review process because there will be less likelihood that the review body will require 
clarification from the applicant. 
 
We would appreciate self-declaration of how you’ve used this template so we are able to measure its 
uptake.  
Please indicate the compatibility of this template with any existing templates you already use by 
stating one of the following on the front of each submitted protocol: 
• This protocol has regard for the HRA guidance and order of content; OR 
• This protocol has regard for the HRA guidance; OR 
• This protocol does not have regard to the HRA guidance and order of content 
 
 
 
 
 
 
 
 
 
 
 
 

IRAS number 309024 
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FULL/LONG TITLE OF THE STUDY 
Video analysis of errors and technical performance within minimally invasive surgery 
SHORT STUDY TITLE / ACRONYM  
Video Analysis in Minimally Invasive Surgery (VAMIS) 
PROTOCOL VERSION NUMBER AND DATE 
Version 17 
Date: 10/1/2024  
 
RESEARCH REFERENCE NUMBERS 
 
IRAS Number: 
309024 
 
SPONSORS Number: 
TGI 001 
FUNDERS Number: 
TGI-DS-001&2 
 
 
 

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Final Version 1.1 March 2016- Template & Guidance 
 
SIGNATURE PAGE 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to 
the principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory 
requirement. 
I agree to ensure that the confidential information contained in this document will not be used for any 
other purpose other than the evaluation or conduct of the investigation without the prior written 
consent of the Sponsor 
I also confirm that I will make the findings of the study publically available through publication or other 
dissemination tools without any unnecessary delay and that an honest accurate and transparent 
account of the study will be given; and that any discrepancies from the study as planned in this 
protocol will be explained. 
 
 
For and on behalf of the Study Sponsor: 
Signature:  
 
...................................................................................................... 
 
Date: 
..10../.1../.24. 
Name (please print): Mrs Vasiliki Kiparoglou 
 
 
Position: Chief Executive Officer, The Griffin Institute 
 
 
 
Chief Investigator: 
Signature: 
...................................................................................................... 
 
Date: 
..10../.1./..24. 
Name: (please print): Professor Nader Francis  
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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LIST of CONTENTS 
GENERAL INFORMATION 
Page No. 
HRA PROTOCOL COMPLIANCE DECLARATION  
i 
TITLE PAGE  
ii 
RESEARCH REFERENCE NUMBERS 
 
ii 
SIGNATURE PAGE 
iii 
LIST OF CONTENTS  
iv 
KEY STUDY CONTACTS 
v 
STUDY SUMMARY 
v 
FUNDING 
 
vi 
ROLE OF SPONSOR AND FUNDER 
vi 
ROLES & RESPONSIBILITIES OF STUDY STEERING GROUPS AND INDIVIDUALS   
vi 
STUDY FLOW CHART 
 
vii 
SECTION  
1. BACKGROUND 
 
1 
2. RATIONALE 
 
 
3. THEORETICAL FRAMEWORK 
 
4. RESEARCH QUESTION/AIM(S)  
 
5. STUDY DESIGN/METHODS 
 
6. STUDY SETTING 
 
7. SAMPLE AND RECRUITMENT 
 
8. ETHICAL AND REGULATORY COMPLIANCE 
 
9. DISSEMINATION POLICY 
 
10. REFERENCES 
 
11. APPENDICES 
 
 
 

IRAS number 309024 
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Final Version 1.1 March 2016- Template & Guidance 
 
KEY STUDY CONTACTS 
Insert full details of the key study contacts including the following 
Chief Investigator 
Professor Nader Francis, n.francis@griffininstitute.org.uk, 
The Griffin Institute, Northwick Park and St Mark’s Hospital, 
Y Block, Watford, Harrow, HA13UJ 
Principal Investigator 
Mr Matt Boal, m.boal@griffininstitute.org.uk, The Griffin 
Institute, Northwick Park and St Mark’s Hospital, Y Block, 
Watford, Harrow, HA13UJ 
Study Co-ordinator 
Mr Matt Boal, m.boal@griffininstitute.org.uk, The Griffin 
Institute, Northwick Park and St Mark’s Hospital, Y Block, 
Watford, Harrow, HA13UJ 
 
Dr Walaa Ghamrawi, w.ghamrawi@griffininstitute.org.uk 
The Griffin Institute, Northwick Park and St Mark’s Hospital, 
Y Block, Watford, Harrow, HA13UJ  
Dr Freweini Tesfai f.tesfai@griffinsintitute.org.uk 
 The Griffin Institute, Northwick Park and St Mark’s Hospital, 
Y Block, Watford, Harrow, HA13UJ 
Ms Claudia Reali Claudia.reali@ydh.nhs.uk 
Yeovil District Hospital NHS Foundation Trust, Higher 
Kingston, Yeovil BA214AT and The Griffin Institute, 
Northwick Park and St Mark’s Hospital, Y Block, Watford, 
Harrow, HA13UJ.  
Sponsor 
Mrs Vasiliki Kiparoglou, Chief Executive Officer, The Griffin 
Institute, Northwick Park and St Mark’s Hospital, Y Block, 
Watford, Harrow, HA13UJ (“Research Center”) 
v.kiparoglou@griffininstitute.org.uk 
Joint-sponsor(s)/co-sponsor(s)  
N/A 
 
 
Funder(s) 
Names and contact details of ALL organisations providing 
funding and/or support in kind for this study 
Medtronic plc: Dr Karen Kerr, karen.kerr@medtronic.com,  
Digital Surgery Limited, 230 City Road, London EC1V 2QY 
 
The Griffin Institute, Northwick Park and St Mark’s Hospital, 
Y Block, Watford, Harrow, HA13UJ. Professor Nader 
Francis, n.francis@griffininstitute.org.uk,  
 
Professor Danail Stoyanov, Professor of Robot Vision, 
Wellcome/EPSRC for Interventional and Surgical Sciences 
(WEISS), University College London Charles Bell House 

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43–45 Foley Street, London, W1W 7TY  
danail.stoyanov@ucl.ac.uk +44 (0)20 3108 7013 
 
Key Protocol Contributors 
Full contact details including phone, email and fax numbers 
(If applicable)  
Professor Nader Francis, Director of Training, The Griffin 
Institute, Northwick Park and St Mark’s Hospital, Y Block, 
Watford, Harrow, HA13UJ, n.francis@griffininstitute.org.uk,  
Professor John Kelly, Professor of Urology, University 
College London Hospitals 235 Euston Rd, London NW1 
2BU, j.d.kelly@ucl.ac.uk  
Associate Professor Justin Collins, Urology Consultant, 
University College London Hospitals 235 Euston Rd, London 
NW1 2BU, justin.collins@ucl.ac.uk,  
Mr Ashwin Sridhar, Urology Consultant, University College 
London Hospitals, 235 Euston Rd, London NW1 2BU, 
Ashwin.sridhar@nhs.net  
Professor Danail Stoyanov, Professor of Robot Vision, 
Wellcome/EPSRC for Interventional and Surgical Sciences 
(WEISS), University College London Charles Bell House 
43–45 Foley Street, London, W1W 7TY  
danail.stoyanov@ucl.ac.uk  
Dr Eddie Edwards, Wellcome/EPSRC for Interventional and 
Surgical Sciences (WEISS), University College London 
Charles Bell House 
43–45 Foley Street, London, W1W 7TY 
eddie.edwards@ucl.ac.uk,  
Dr Evangelos Mazomenos, Wellcome/EPSRC for 
Interventional and Surgical Sciences (WEISS), University 
College London Charles Bell House 
43–45 Foley Street, London, W1W 7TY 
e.mazomenos@ucl.ac.uk  
 
Mr Matt Boal, Surgical Research Fellow, The Griffin Institute, 
Northwick Park and St Mark’s Hospital, Y Block, Watford, 
Harrow, HA13UJ; m.boal@griffininstitute.org.uk,  
Dr Aimee Bambury, aimee.l.bambury@medtronic.com, 
Digital Surgery Limited, Medtronic, 230 City Road, London 
EC1V 2QY 
Dr Karen Kerr, karen.kerr@medtronic.com,Digital Surgery 
Limited, Medtronic, 230 City Road, London EC1V 2QY 
Dr Lucy Culshaw, lucy.culshaw@medtronic.com, Digital 
Surgery Limited, Medtronic, 230 City Road, London EC1V 
2QY 

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Miss Anna-Rita Boydell, Clinical Research Specialist anna-
rita.boydell@medtronic.com, Digital Surgery Limited, 
Medtronic, 230 City Road, London EC1V 2QY 
 
Committees 
Full contact details including phone, email and fax numbers  
Management committee:  
Professor Nader Francis, n.francis@griffininstitute.org.uk,  
Professor Danail Stoyanov, Professor of Robot Vision, 
Wellcome/EPSRC for Interventional and Surgical Sciences 
(WEISS), University College London Charles Bell House 
43–45 Foley Street, London, W1W 7TY  
danail.stoyanov@ucl.ac.uk  
Professor Jim Khan, jim.khan@porthosp.nhs.uk, Portsmouth 
Hospitals NHS Trust, Queen Alexandra Hospital, Southwick 
Hill Road, PO63LY, United Kingdom 
Mr Chelliah Selvasekar, The Christie NHS Foundation Trust, 
Wilmslow Road, Manchester, M204BX  
crselvasekar@gmail.com  
Mr Danilo Miskovic, Northwick Park & St Marks Hospitals 
and Central Middlesex Hospitals, London North West 
University Healthcare NHS Trust, Watford, Harrow, HA13UJ. 
danilo.miskovic@nhs.net  
Dr Karen Kerr; Digital Surgery Limited- Medtronic plc; 
karen.kerr@medtronic.com;  
Dr Lucy Culshaw; Digital Surgery Limited- Medtronic plc; 
lucy.h.culshaw@medtronic.com 
Dr Aimee Bambury, aimee.l.bambury@medtronic.com, 
Digital Surgery Limited, Medtronic, 230 City Road, London 
EC1V 2QY 
Mr Matt Boal, Surgical Research Fellow, The Griffin Institute, 
Northwick Park and St Mark’s Hospital, Y Block, Watford, 
Harrow, HA13UJ m.boal@griffininstitute.org.uk,  
Dr Walaa Ghamrawi, Surgical Research Fellow, The Griffin 
Institute, Northwick Park and St Mark’s Hospital, Y Block, 
Watford, Harrow, HA13UJ 
w.ghamrawi@griffininstitute.org.uk; 
Mrs Fiona Carter; Education Manager, The Griffin Institute, 
Northwick Park and St Mark’s Hospital, Y Block, Watford, 
Harrow, HA13UJ. f.carter@griffininstitute.org.uk  
Mr Jake Foad, Head Theatre Assistant, The Griffin Institute, 
Northwick Park and St Mark’s Hospital, Y Block, Watford, 
Harrow, HA13UJ, j.foad@griffininstitute.org.uk,  
 
STUDY SUMMARY 

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Study Title 
Video analysis of errors and technical performance within 
minimally invasive surgery  
Internal ref. no. (or short title) 
VAMIS 
Study Design 
Observational 
Study Participants 
Patients undergoing minimally invasive surgical procedures 
Planned Size of Sample (if applicable) This project requires uploading a large number of video 
recorded cases in order to conduct the research and achieve 
all the primary and secondary end points. 
The type of cases will vary from generic laparoscopic 
procedures that will aid development initial phases of the 
project such as segmentation, to more advanced procedure 
segmentation e.g. laparoscopic cholecystectomy, robotic 
prostatectomy and robotic rectal cancer surgery and robotic 
hysterectomy. 
Since the methodology for technical performance analysis 
(Objective Clinical Human Reliability Analysis- OCHRA) was 
applied extensively in laparoscopic rectal cancer surgery, a 
comparison will also be made with robotic, hence, video 
recording of laparoscopic colorectal cases will be required. In 
order to achieve this number we will partner with a number of 
hospitals including Yeovil District Hospital NHS Foundation 
Trusts, University College London Hospitals, Queen 
Alexandra Hospital (Portsmouth), The Christie NHS 
Foundation Trust and Northwick Park & St Marks Hospitals 
and Central Middlesex Hospitals London North West 
University Healthcare NHS Trust, North East and North 
Cumbria Integrated Care System. 
There is no formal power calculation in this study but we aim 
to record as many procedures as possible within the time 
frame of the project and with a maximum 250 from each 
centre. 
We aim to conduct full OCHRA analysis including error 
annotation up to 50 videos per specialty. 
 
Additional study arm: real-time visualisation: A further aim is 
to gain additional consent from a subsample of patients (up to 
20 cases) undergoing laparoscopic cholecystectomy 
procedures to assess the feasibility and usability of real-time 
visualisation on a secondary screen in the operating room, for 
training and education purposes. 

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Additional study arm: real-time insights: A further aim is to 
gain additional consent from a subsample of patients (up to 
20 cases) undergoing laparoscopic cholecystectomy 
procedures to assess the feasibility and usability of real-time 
insights through procedural time stamps, recorded on the 
system in the operating room, for training and education 
purposes that will be viewed post-operatively by the user. 
 
 
 
Follow up duration (if applicable) 
No direct patient follow-up or visits required in this study 
outside of standard care.  
Planned Study Period 
January 2022 – September 2025  
Research Question/Aim(s) 
 
 
 
 
 
 
 
 
 
This research project aims to assess/compare laparoscopic 
and robotic techniques for surgical phases and error 
detection that would permit the objective assessment of 
surgical performance, allowing for enrichened feedback and 
learning as well as certification of minimally invasive 
surgeons. The project will evaluate metrics for surgical 
performance and assess surgical procedural progression by 
analysing retrospective and prospective data, including 
pseudonymised patient data, including outcomes, and 
anonymized surgical video that is captured using the Touch 
Surgery EnterpriseTM. Additional robot kinematic 
(movement) data will be collected by dVLogger and analysed 
by computer scientists to further understand differences in 
skill and errors (novice vs expert). 
In the subsample of cases where real-time visualisation will 
be shown in the operating room on a secondary screen (that 
is separate to the main surgeon’s operating screen), the 
project aims to understand the technical feasibility and 
surgeon opinions on the usability and utility of the technology. 
The overlays will highlight anatomical landmarks in lap chole 
procedures. The secondary screen and associated real-time 
visualisations will not be shown to the operating surgeon 
during the procedure. The long-term hypothesis is that the 
use of augmented visualization may help surgeons achieve 
Critical View of Safety through the identification of anatomical 
structures such as the Cystic Duct and Cystic Artery – further 
studies will follow this initial feasibility study.  
Similarly, the real-time insights arm will detect anatomical 
landmarks in real-time throughout the lap chole procedure, 
through a record of procedure time stamps, which will be 
available for the user to review post-operatively for education 
and review purposes. The study arm aims to test the 
feasibility and utility of a new real-time algorithm to detect 

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critical structures in laparoscopic cholecystectomy 
procedures.  
 
 
 
 
FUNDING AND SUPPORT IN KIND 
FUNDER(S) 
(Names and contact details of ALL organisations 
providing funding and/or support in kind for this 
study) 
FINANCIAL AND NON FINANCIAL SUPPORT 
GIVEN 
Digital Surgery, Medtronic 
Karen.kerr@medtronic.com 
Full funding for PhD theses (Salaries for Mr Matt 
Boal and Dr Walaa Ghamrawi) (including 
annotation) in addition to standard analytics 
reporting.  
The Griffin Institute 
Nader Francis n.francis@griffininstitute.org.uk 
Matt Boal m.boal@griffininstitute.org.uk  
Walaa Ghamrawi, 
w.ghamrawi@griffininstitute.org.uk 
Freweini Tesfai f.tesfai@griffinsintitute.org.uk 
Claudia Reali Claudia.reali@ydh.nhs.uk 
 
Robotics training suite and national courses in 
minimally invasive surgery 
Employ PhD research fellows 
WEISS 
Danail Stoyanov danail.stoyanov@ucl.ac.uk, 
Eddie Edwards Eddie.edwards@ucl.ac.uk 
Evangelos Mazomenos 
E.mazomenos@ucl.ac.uk 
 
University College London/University College 
Hospitals London 
John Kelly j.d.kelly@ucl.ac.uk 
Ashwin Sridhar Ashwin.sridhar@nhs.net 
Justin Collins justin.collins@ucl.ac.uk 
Dhivya Chandrasekaran 
d.chandrasekaran@nhs.net 
Georgia Zachou georgia.zachou@nhs.net 
 
Access to expert computer scientists in robotics 
analysis including automated performance 
metrics 
 
 
 
 
Urology department 
Minimally invasive operative videos for analysis. 
Consultant gynaecologist, Gynaecology 
Oncology department 
O&G trainee and research fellow, supporting the 
gynaecology arm of the VAMIS trial.  

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ROLE OF STUDY SPONSOR AND FUNDER 
MEDTRONIC 
Touch SurgeryTM Enterprise, (https://www.touchsurgery.com/) by Digital Surgery Limited, a Medtronic 
company, will record, process and provide analytics on video recordings of minimal-access surgical 
procedures. These are recorded through the standard operating stack and require no additional steps 
or changes to standard care. Currently, procedures are routinely recorded in the operating room, at the 
clinical sites, for training purposes to allow review and debrief after a procedure or to evaluate where 
improvements could be made. We do not anticipate that there will be any new material ethical issues 
associated with the recording system and surgical video feed. Medtronic will fund Dr Walaa Ghamrawi 
and Mr Matthew Boal’s PhD thesis’ looking into video analytics of minimally-invasive surgery initially 
radical prostatectomy and general colorectal cancer procedures which will be further extended to other 
operations. 
The Griffin Institute (TGI) 
TGI is a not-for-profit charitable research institute in Harrow, London, which employs Mr Matthew Boal 
and Dr Walaa Ghamrawi. Here there are many opportunities for research into training and evaluation of 
robotics and laparoscopic surgery pre-clinical simulation courses including dry, cadaver and live animal 
models. 
Professor Nader Francis is the Director of Training at TGI and a Consultant Colorectal Surgeon with 
extensive experience within surgical training and education, including a key role in a UK wide 
laparoscopic training programme for consultant colorectal surgeons (LAPCO). As part of this 
programme, bespoke formative, Global Assessment Scale (GAS), and summative, Competency 
Assessment Tool (CAT), forms were developed and validated. These assessments inversely correlated 
to errors using Objective Clinical Human Reliability Analysis (OCHRA) and had predictive validity to 
patient outcomes. 
Part of more recent work by Professor Francis has been applying OCHRA methodology to video analysis 
of laparoscopic colorectal procedures (TME in anterior resection), publishing the findings in JAMA. 
Using Professor Francis’ and the research teams experience a protocol has been developed from 
previous work to analyse video data from minimally invasive surgery. OCHRA methodology will be 
further applied to robotic assisted radical prostatectomy (RARP) and anterior resection (rectal cancer 
excision). From this, any operation could have this methodology applied through the same process, 
defining phases and errors through a Delphi process with experts in that field.  
TGI has established a partnership with Medtronic and Intuitive to support MIS training. Both companies 
have a laparoscopic and robotic training suite respectively at the TGI, with a goal to repatriate MIS work 
back to the UK. Traditionally advanced MIS training for British surgeons happened outside the UK in 
mainland Europe. Within this project, the organisations will work together in a partnership to support 
educational research that can generate and evaluate novel assessment tools, in the hopes of improving 
training in surgery and potentially patient safety and outcomes. 
It is the aim to reproduce this transferable methodology to robotics assisted surgery, applying the same 
principles to further understand how surgical skill and error can potentially affect patient outcome, 
therefore, informing surgical training and credentialing. 
Wellcome/EPSRC for Interventional and Surgical Sciences (WEISS) 

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WEISS provide specialists in computer science as a well as analysis of robotic performance metrics 
including kinematics and deep learning models/artificial intelligence (AI). This is hoped to ultimately 
allow automated feedback to surgeons including segmentation e.g., recognition of, and highlighting, 
an anatomical structure or instruments.  
 
ROLES AND RESPONSIBILITIES OF STUDY MANAGEMENT COMMITEES/GROUPS & 
INDIVIDUALS 
Study management group: 
Clinical team at The Griffin Institute: Professor Nader Francis, Mr Matt Boal, Dr Walaa Ghamrawi, Mrs 
Fiona Carter and Mr Jake Foad.  
 
Funders: Dr Karen Kerr, Dr Lucy Culshaw and Ms Aimee Bambury from Digital Surgery- Medtronic, 
are appointed to the management committee as representatives of Digital Surgery Ltd. who will 
process the surgical video, provide access to data annotation platform, and provide advanced data 
analytics through Touch Surgery TM Enterprise. 
 
 
PROTOCOL CONTRIBUTORS 
 
The Griffin Institute: Mr Matthew Boal and Professor Francis have helped write the protocol and guide 
the research aims, providing the background and justification for it. 
University College Hospitals London: Professor John Kelly, Professor Justin Collins, Mr Ashwin 
Sridhar additionally provided background knowledge and scientific justification for this research. They 
will provide video data for analysis from their senior trainees and consultant colleagues. 
Medtronic: Dr Karen Kerr, Dr Aimee Bambury and Dr Lucy Culshaw will provide equipment (Touch 
Surgery Enterprise TM) to securely record, and store anonymised surgical video, and provide data 
analytics from this data set to the Sponsor.  Medtronic has reviewed and contributed to the study 
protocol to ensure compliance with the research collaboration agreement pertaining to this submission 
and the technical capacities and terms of Medtronic products and services.  
WEISS: Professor Danail Stoyanov, Dr Eddie Edwards and Dr Evangelos Mazomenos will aid in data 
analysis and interpretation of results of retrospective video data as well as additional kinematic data 
collected from dVLogger in da Vinci robot systems. WEISS will be responsible for sharing dVLogger 
data with Intuitive in anonymised form.  
 
KEY WORDS: 
Minimally Invasive or Minimal Access Surgery 
Assessment and Evaluation 
Clinical Competence/Credentialing 
Artificial Neural Network 
Video analysis 
Objective Clinical Human Reliability Analysis (OCHRA) 
 
STUDY FLOW CHART 
 
 
 

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STUDY PROTOCOL 
Video analysis of errors and technical performance within minimally invasive surgery  
Installation of recording devices 
in hospitals 
Participant identification and selection : Informed consent 
from patients undergoing minimally invasive surgery 
Video (anonymised) upload from external recording devices i.e. DS1 and encrypted hard drives 
and patient (pseudonymised) data, including outcomes, collected and stored securely. Use of 
second screen for augmented, real-time visualisation of anatomical structures e.g. Cystic 
artery/duct 
Video analysis,  
including kinematics, 
applying OCHRA 
methodology to identify 
errors and assess skill 
within operations 
Development and evaluation of 
validity and reliability of formative 
and summative assessment tools to 
inform training and competency 
assessment of a MIS skill or 
procedure 
Pilot application of valid tools to surgical procedures 
linking to patient outcomes in the hope of enrichening 
training and improving patient care 
Allow use on an available, easy to use platform for 
surgeons and trainees to use 
Qualitative questionnaires to surgeons involved 
Development of AI to aid 
deep/machine learning of 
surgical phase and error 
recognition including 
prelabelled analysed 
retrospective videos 

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1 
BACKGROUND & RATIONALE  
  
There are 2.5 million people who have cancer in the UK, projected to increase to 4M by 2030 1. Over 
the past three decades, there has been a rapid uptake of minimally invasive (keyhole) surgery i.e. 
laparoscopic and robotic techniques, to treat cancer across different specialties. Robotic surgery is a 
well-established modality; the most commonly used robot for surgery (da Vinci) has been used in more 
than 8.5 million procedures, 1.25 million of which were in 20202.  
With an increasing use of robotic systems across different specialties, there is a need for standardization 
of training, assessment, testing and sign-off as a competent robotic surgeon in order to improve patient 
safety. Despite the high volumes, advanced minimally invasive surgery is not standardised and 
variations often occur in technique, performance, delivery, team communication, and surgical approach.  
Such variations can result in errors and complications that can potentially be avoided.  
A study from the 1990s estimated that more than 250,000 people die in the USA every year from medical 
error3. Another study from the USA reported between 2000-2013 10,624 adverse events relating to 
robotic procedures 4. Experts raised concerns over surgical curricula being random and insufficient to 
ensure patient safety5. In addition, an independent review by the Emergency Care Research Institute 
(ECRI) on health technology hazards identified a lack of robotic surgical training as one of the top 10 
risks to patients6,7. Comparisons are frequently made between the aviation industry and surgery in terms 
of adverse event analysis and non-technical skills. The aviation industry, however, has mandatory, 
recurrent, reassessment and requalification throughout the career pathway and an internationally 
agreed standard for training, which robotic surgery does not6. 
This project aims to analyse surgical phases (stage of the operation), skill and errors to anonymised, 
surgical video data through Medtronic's Touch Surgery™ Enterprise DS1 Computer which can capture 
video data anonymously in any minimally invasive procedure in the operating room, allowing immediate, 
upload of data to a platform for immediate feedback and assessment to surgeons. Anonymised surgical 
video will be collected for any minimally invasive surgery, including but not exclusively robotic assisted 
radical prostatectomy (RARP), robotic rectal cancer operations, robotic gynaecology and laparoscopic 
general surgery. Additional minimally-invasive operations or specialties may be included, the list above 
is not exhaustive. 
This project will apply the validated Objective Clinical Human Reliability Analysis (OCHRA) methodology 
for skill and error analysis to captured surgical video data. OCHRA was developed by this research 
group from the industrial model of Human Reliability Analysis to capture and analyse surgical 
performance, reporting errors enacted during rectal cancer surgery. This aided the development of a 
classification system to report on errors and operative events during surgical performance8. Additionally, 
it was able to link surgeons’ technical skill, including errors made, to patient outcome i.e. those who 
scored better had better outcomes9,10. Additional objectives include use of automated assessment 
(artificial intelligence) to aid machine learning to assess its feasibility in operative phase and error 
recognition. Assessment tools can then be developed with the hope to improve feedback, learning and 
ultimately surgeons’ performances. We also aim to validate these methods by correlating video "scores" 
of skill/errors to patient outcomes9 e.g. complications, cancer outcome. 

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Kinematic robot movement data will be assessed from the dVLogger, which inserts to the robot system 
to record this, in combination with artificial intelligence and machine learning, in the hope to further 
develop our understanding of these data and the possible implications within surgery i.e., errors and 
outcomes. This will be accessible to WEISS for analysis and shared with Intuitive Surgical Inc. in an 
anonymised format.  
Given the link between surgical skill and error counts to patient outcome, this research team aims to 
analyse surgical video within robotic (keyhole) surgery in different procedures to further understand the 
surgical process and errors made. We hypothesise that understanding and optimising surgical 
processes, and errors will reduce unwarranted variations and improve the performance of the entire 
surgical team that is ultimately hoped to enhance patient safety and outcomes. 
 
3 
THEORETICAL FRAMEWORK 
Valid tools for formative and summative assessment exist both within laparoscopic and robotic surgery. 
Robot-assisted surgery is a growing area of minimal access surgery with great promise to improve 
surgical skill and reduce error through improved dexterity and vision.  
Most robotic assessment tools currently exist as summative rather than formative. Moreover, these tools 
are not used in everyday clinical life due to time constraints and availability of an easy-to-use tool. With 
the advent of digital platforms in recent years, it opens a huge opportunity to provide these tools on the 
smartphones of surgeons, allowing real time assessment and learning.  
There is a lack of models in robotic surgery particularly to assess and analyse surgical technique and 
error. The most widely used validated tool for generic skills assessment within robotics is GEARS 11 
which misses certain domains of assessment, such as robotic console control12. However, GEARS could 
be modified to address this, then piloted and evaluated for validity. If successful, it is reasonable to 
suggest that a modified GEARS form could be used as a more comprehensive formative and summative 
tool for generic robotic skills.  
Development of robotic procedure-specific formative and summative forms is transferable from already 
validated laparoscopic tools. LAPCO developed, validated, and implemented the competency 
assessment tool (CAT). Construct validity was confirmed between those who passed and failed. 
Concurrent validity was tested by comparing CAT scores with error analysis using objective clinical 
human reliability analysis (OCHRA). The study developing the tool found that CAT scores were inversely 
proportional to OCHRA counts10 i.e. a better surgical skill score equated to fewer errors. The CAT can 
reliably assess technical performance in laparoscopic colorectal surgery, which could be adapted by 
other specialties.  In-training GAS and CAT forms had predictive validity in surgical performance after 
LAPCO when assessing patient outcomes 
Further development of error and skills analysis through OCHRA methodology within robotics is 
transferable from video analysis research done in laparoscopy. This would allow development of further 
competency assessment tools within other specific procedures; the ultimate goal would be to have 
machine learning through artificial intelligence (AI) and have immediate feedback during and after any 
minimally-invasive case. AI is already widely used in industry and other healthcare systems, but there 
is a gap for its application in surgical training. OCHRA methodology currently is incredible time 
consuming and labour intensive, AI we hope will be able to address this in the future, although we 
appreciate that these are still in the initial steps within the time frame of this study. 
 

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4 
RESEARCH QUESTION/AIM(S) 
Aim 
This research project aims to assess robotic techniques for surgical phases and error  detection that 
would permit the objective assessment of surgical performance, allowing the assessment of surgeon 
and procedure specific proficiency gain curves (learning curves) and identifying training needs. 
4.1 
Objectives 
 
1. Develop a standardised and agreed segmentation of the operations (Delphi system) 
2. Video error analysis: Application of OCHRA into minimally surgical operations (benign and 
malignant) 
3. Validation of assessment tool scoring, video analysis to patient outcomes i.e., morbidity, 
histopathological data 
4. Development of formative assessment tools for generic and specific procedures  
5. Video error analysis: Development, evaluation and application of automation and video error 
analysis (artificial intelligence and machine learning) in minimally-invasive surgery.  
6. Qualitative data review of surgeons’ perception of TSE after using the platform.  
7. Qualitative data review of surgeons’ perception of effect on learning curve. 
8. Analyse kinematic data to further understand its role in errors and skill in minimally-invasive 
surgery 
9. Development of summative assessment tools to aid certification and accreditation. 
10. Application of artificial intelligence to previously analysed, anonymous retrospective video, to 
train recognition of skills and errors within minimally invasive surgery 
11. Assess the technical feasibility and surgeon opinions on the usability and utility of real-time 
visualisation on a secondary screen in the operating room, on a subsample of patients 
undergoing laparoscopic cholecystectomy procedures 
12. Assess the technical feasibility and surgeon opinions on the usability and utility of real-time 
visualisation on a secondary screen in the operating room, on a subsample of patients 
undergoing laparoscopic cholecystectomy procedures 
 
4.2 
Outcome 
Primary outcome measure: 
- Number of errors in an operation using OCHRA 
Secondary outcome measures:  
-Review operative factors: Age (years), ASA grade I-V (internationally accepted anaesthetic risk 
score), BMI (kg/m^2), neoadjuvant treatment (Type-chemotherapy/radiotherapy- Yes or No), Total 
operating time (minutes) Operative blood loss (millilitres), Conversion to open surgery (binary- Yes or 
No), length of post-operative stay (days) 30-day readmission rate (Yes or No), 30 day readmission 
reason (aetiology), histopathological outcomes (pTNM cancer staging), Postoperative complications 
using Clavien-Dindo classification (1-5 scale of severity and necessary corrective action), 30-day 
mortality (Yes or No), all cause mortality (Yes or No). 
- To enhance training through formative assessment tools which will have been validated for generic 
and procedure-specific skills. Similarly, to standardise competency assessment through validated 
summative tools.  
- Apply assessment tools and OCHRA to analyse defined surgical phases of a procedure in order to 
enhance understanding of surgical skill and error. The hope is to enhance training so that surgeons 
learn more effectively from operations and therefore, perform better intraoperatively, therefore, 
improving patient outcome.  
- Apply initial results to understand the feasibility of machine learning to identify surgical phases and 
errors based on kinematic and video data, or video data alone. 

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Study arm: real-time visualisation and real time insights: 
- Distribute surveys to clinical teams to understand surgeon opinion opinions on the usability and utility 
of real-time visualisation of anatomical structures on a secondary screen in the operating room. 
- Assess technical feasibility and performance of the real-time visualisation during laparoscopic 
cholecystectomy procedures. 
 
5 
STUDY DESIGN and METHODS of DATA COLLECTION AND DATA ANALYSIS 
.  
Study design: Observational study collecting anonymised video data and uploaded to Touch Surgery 
platform. 
Recruiting sites and Principal investigators: University College London Hospitals (Mr Ashwin Sridhar, 
Dhivya Chandrasekaran), Yeovil District Hospital NHS Foundation Trust (Professor Nader Francis), 
Queen Alexandra Hospital, Portsmouth (Professor Jim Khan), The Christie NHS Foundation Trust (Mr 
Chelliah Selvasekar) and Northwick Park & St Marks Hospitals and Central Middlesex Hospitals, 
London North West University Healthcare NHS Trust (Mr Danilo Miskovic),  North Tees & Hartlepool 
NHS Trust (Mr Talvinder Gill), The Royal Cornwall NHS Hospital (Mr James Clark),  HCA Wellington 
Hospital (Miss Adeola Olaitan),The Royal Surrey NHS Trust (Miss Hersha Patel), Gemelli Hospital, 
Rome, Italy (Dr Valentina Lacobelli), Leiden University Medical Center (LUMC), Leiden, The 
Netherlands (Dr Jogchum Beltman). Interested international sites will be eligible to join the VAMIS 
study 
Prospective data upload: 
Patient identification: The local team will identify patients in clinic/ team meetings based on adherence 
to inclusion criteria. The patient will be approached by a GCP trained member of the research team, 
we will aim to give 24 hours to consider the information before providing informed consent. However, 
from a pragmatic and feasible standpoint we may recruit participants on the day of surgery as it is a 
low risk study with low risk of coercion and without change to the patient care pathway. 
Any surgeon willing to contribute their video data for analysis will be given access to the Touch 
Surgery Platform to review their own videos and annotate, these videos will also be added to a shared 
group with the clinical research team for analysis. The surgeon will be consented to allow their data to 
be analysed and results disseminated, which will be anonymised. If they wish, they can ask for 
analysis feedback.  
Surgeons will be recruited by their local Principal Investigator at each site, who will be working closely 
with the research team at The Griffin Institute.  
Retrospective data upload: 
Analysed, anonymised video from a previous study (IRAS no: 195969) can be further used with 
artificial intelligence and its application to start recognition of skills and error within minimally invasive 
surgery. With our colleagues at WEISS, we can initiate research into an area poorly studied but at the 
forefront of research questions. It is hypothesised as our understanding and training of AI develops to 
automatically recognise and warn surgeons of “poor” technique or errors, we will likely improve patient 
safety, with the ultimate goal of an early warning system to prevent errors. This suggested research 
we believe is a step towards that. 
Data capture and analysis 

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Surgical videos will be recorded via an encrypted hard drive or The Touch Surgery™ Enterprise DS1 
Computer.  
The Touch Surgery™ Enterprise DS1 Computer is connected to the operating room’s video imaging 
system with a HDMI cable (or other compatible wired connectivity). A member of the operating room 
staff uses the Touch Surgery™ Enterprise DS1 Wireless Controller to select the procedure and surgeon 
name. A custom file name and notes can also be added, and users are prompted with a reminder not 
to input any patient personal information. Throughout the case, and whilst the recording is in process, 
the video passes through our AI-powered safeguard, RedactOR™, before it is saved to the Touch 
Surgery™ Enterprise DS1 Computer. RedactOR™ works on the video in real-time to determine when 
the scope has exited the patient. The algorithm then pixelates the video frames, and will continue to do 
so, until the scope re-enters the patient. All videos will be uploaded to TSE and therefore be processed 
through RedactOR™. This redaction is irreversible, thereby giving additional confidence that visual 
information that could identify a patient is transmitted, processed or stored. Upon direction by the 
authorised user, the video is uploaded from the Touch Surgery™ Enterprise DS1 Computer to our 
secure cloud provided by Amazon Web Services (AWS). AWS complies with ISO 9001, ISO 27001, ISO 
27017, and ISO 27018, and audited against HDS (France). 
 
Touch SurgeryTM Enterprise DS1 Computer will record, process and provide analytics on video 
recordings of minimal-access surgical procedures. These are recorded through the standard operating 
stack and require no additional steps or changes to standard care. Currently, procedures are routinely 
recorded in the operating room for training purposes to allow review and debrief after a procedure or to 
evaluate where improvements could be made.  
The dVLogger box additionally records endoscope video in stereo and robotic movement data. No audio 
will be recorded. This data is collected by an encrypted hard drive and used by WEISS who will 
anonymise the data sent to Intuitive Surgical Inc. WEISS will have access to the study ID to link analysis 
to patient data, Intuitive will not. 
We do not anticipate that there will be any new material ethical issues associated with the recording 
system and surgical video feed.  
Operative steps will be closely analysed using this software, applying machine learning and OCHRA 
methodology techniques to identify phases and errors of minimally-invasive surgical operations. 
Researchers trained in these methodologies will be observing and analysing the data. Data upload to 
TSE will be anonymised with no patient identifiable data, but the clinical research team will 
pseudonymise patient data and outcomes including demography, identifiers to follow up outcome, 
surgeons’ grade/level of expertise.  Video editing software will be used to annotate and highlight surgical 
video data to categorise phases and errors.  
Study arm: real-time visualisation: 
For a subsample of laparoscopic cholecystectomy procedures, a secondary screen with a computing 
unit will be deployed in the operating room to augment visualization of anatomical structures such as 
the Cystic Artery and Cystic Duct. The video feed of a laparoscopic cholecystectomy procedure will be 
processed in real-time and the system will detect anatomical structures such as the Cystic Duct and 
Cystic Artery.  The secondary screen will display a visual overlay by highlighting the identified structures 
when they are in the field-of-view. This additional feature aims to support surgical training and the 

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sharing of best practices. The secondary screen and associated real-time visualisations will not be 
shown to the operating surgeon during the procedure. However, hospital staff who are not directly 
involved with the procedure will be given the opportunity to view the secondary screen. The purpose of 
introducing this feature is to initially assess the technical feasibility and surgeon opinions on usability 
and utility. This is in line with the study aims to  support training and best practicse  through the use of 
innovative technology. Participation in this study arm is optional for participants, as detailed in the 
Participation Information Sheets. Participants do not have to agree to this in order to participate in the 
study. It is hoped that this feature could be expanded to other minimally invasive surgical procedures in 
the future, for the purpose of supporting surgical training and sharing best practice. 
 
In the ‘real time insights’ optional study arm, the real-time algorithm will detect lap chole critical structures 
(Cystic Duct, Cystic Artery) that will run in the background of computer system in the form of timestamps. 
There is no additional equipment such as secondary screen, or intraoperative outputs such as visual 
overlays. A record of timestamp outputs will then be visible to the user on upload of the video to Touch 
SurgeryTM Enterprise for review post-operatively. This requires the software product feature ‘Preview 
mode’ to be enabled that offers faster surgical video upload to the cloud to support training and 
education. The end-user (healthcare professional) will be provided with training, and remote support 
(initially in-person) by Medtronic. The end-user will be able to select to upload the video on the day of 
the procedure or later, at a date of their choosing.  
The real time insights study arm aims to test the feasibility and utility of a new real-time algorithm, in 
development, to detect critical structures in laparoscopic cholecystectomy procedures. In order to test 
this, the RedactORTM algorithm (which is run over surgical video feed in real time to blur the environment 
outside of the patient's abdomen to reduce the likelihood of inadvertent personal data collection in the 
operating room) needs to be disabled temporarily, to enable the critical structures algorithm to run in 
real time. The likelihood of capturing personal data in the operating room is considered to be low 
because the system captures the laparoscopic video feed in the patient’s abdomen. However, as a 
failsafe, to support patient confidentiality, Medtronic will  run the RedactORTM algorithm over the surgical 
videos in the cloud following upload. Both cohorts, patients and end-users (healthcare professionals) 
will be informed of this feature, and the details of the study arm, through the participant information 
sheets. 
The 2 sub studies will not be available to participating sites at the same time.  
 
6 
STUDY SETTING 
Data will be collected at multiple centres that have the capability to capture minimally-invasive surgery 
videos in the following procedures initially: patients undergoing a robotic-assisted cancer procedures 
including prostatectomy, cystectomy and anterior resection (rectal cancer operation), but can 
incorporate any minimally invasive surgical procedure. Patients will be approached during the consent 
process at participating research sites: University College London Hospitals, Queen Alexandra 
Hospital (Portsmouth), The Christie NHS Foundation Trust, Northwick Park & St Marks Hospitals and 
Central Middlesex Hospitals, London North West University Healthcare NHS Trust, Newcastle upon 
Tyne Hospitals NHS Foundation Trust, North Tees & Hartlepool NHS Trust and Yeovil District Hospital 
NHS Foundation Trust. However, it will expand to any NHS site performing minimally-invasive surgery 
and willing to participate. 

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It is appropriate to have multiple sites, as this will provide the most data and ensure a richer data set 
to address the research objectives  
Site requirements; to perform minimally-invasive surgery and have video capturing devices installed.  
Data will be collected at each site and analysed by the clinical research team. 
 
7 
SAMPLE AND RECRUITMENT 
7.1  
Eligibility Criteria 
7.1.1 Inclusion criteria  
Patients must be: 
- 
Patient undergoing elective minimally-invasive surgery  
- 
18 years old or over 
- 
Have capacity to provide informed consent 
7.1.2 Exclusion criteria  
- 
Surgery performed with palliative intent or under unplanned/emergency settings 
- 
Under 18 years old 
- 
Cannot consent 
7.2  
Sampling including size of sample 
 
Sampling will be from a clinical setting during the consent process. 
Participant number: 
This project requires uploading a large number of video recorded cases in order to conduct the research 
and achieve all the primary and secondary end points. 
The type of cases will vary from generic laparoscopic procedures that will aid development initial phases 
of the project such as segmentation, to more advanced procedure segmentation e.g. Robotic 
prostatectomy and robotic rectal cancer surgery. 
Since OCHRA was applied extensively in laparoscopic rectal cancer surgery, a comparison will also be 
made with robotic, hence, video recording of laparoscopic colorectal cases will be required. In order to 
achieve this number, we will partner with a number of hospitals including Yeovil District Hospital NHS 
Foundation Trusts, University College London Hospitals, The Christie NHS Foundation Trust, Queen 
Alexandra Hospital (Portsmouth) and Northwick Park & St Marks Hospitals and Central Middlesex 
Hospitals, London North West University Healthcare NHS Trust. 
There is no formal power calculation in this study, but we aim to record as many procedures as possible 
within the time frame of the project and with a maximum 250 from each centre. 
We aim to conduct full OCHRA analysis including error annotation up to 50 videos per specialty. 
For the study arm: real time visualisation, up to 20 cases will be recruited from each participating site.  
For the study arm: real time insights, up to 20 cases will be recruited from each participating site. 
 
7.3 
 Recruitment 
Patients at sites contributing to video analysis will be identified before surgery and consented using a 
standardised form and information leaflet.  
Patients will be identified and clinic or multidisciplinary team meetings and approached by the local 
research team by a GCP trained healthcare professional. They will explain the study and provide a 
patient information sheet which they can read at home. Over 24 hours after the first approach they will 
then be asked if they would consent to the study, this can be easily done on the day of the operation, 
using a separate consent form to the procedure consent form. 

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There is minimal risk of coercion as it is a low risk, observational study, with no intervention or change 
to standard care. 
 
7.3.1 Sample identification 
Healthcare professionals such as doctors, clinical nurse specialists or research nurses can identify 
patients who may be eligible for the study. Similarly, if trained appropriately, any of the above could 
take consent as it is low risk. If any healthcare professional not involved in the study is asked 
questions about it, they could let the research team know to contact the patient. 
Patients will be identified before surgery and will be provided with a patient information sheet and 
consented using a standardised form stating that the data will be anonymised and used for video 
analysis only. Clinical data and patient participants will be pseudonymized with a unique study 
identification number. Study ID numbers will be assigned with a local trust code e.g. UCL-001 and in 
order of upload to Touch Surgery, there is no need to randomise the numbers. 
There will be no advertisements or external recruitment, patients will only be approached if they are 
undergoing a minimally-invasive surgical procedure and have capacity and time to consent. A 
Participant Information Sheet will be provided to the identified patient to describe the study and what 
their involvement means explaining they can withdraw at any time, that it is anonymous and that we 
believe ultimately through their involvement they will improve patient care through improving 
knowledge of surgical skill. 
 
7.3.2 Consent 
Participants will be informed of the study and will be provided with 24 hours to consider participation 
before we invite them to consent, if they wish. It’s anticipated participants will be approached and 
informed in clinic, then consented on the day of the operation. Participants will be allowed to ask 
questions, withdraw without reason at any time and it will not affect their care. 
Research entry and consent would take place at the same time as procedure consent. The use of 
translators (friends/relatives or professional services) would be at the discretion of the PI or co-
investigator taking consent. Research entry is not possible without informed written consent. 
Where possible, translation for the PIS and consent form will be provided through the Trust 
translational services. If it is not available or there is not enough time pre-operatively, non-English 
speakers will be excluded from the study if they do not have the fluency to read & comprehend PIS 
and ICF. 
During the sub study involving real-time visualisation on a secondary screen, and real time insights 
sub study, participation will remain optional, and participants can withdraw at any time. Participants do 
not have to agree to this in order to participate in the study. 
 
8 
ETHICAL AND REGULATORY CONSIDERATIONS 
Patient confidentiality 
Patient confidentiality will be maintained. Surgical videos will be stored securely on Touch SurgeryTM 
Enterprise (TSE; https://www.touchsurgery.com/). No patient identifying information will be attached to 
the videos that are uploaded to the Touch SurgeryTM Enterprise platform, which will be monitored at the 
point of capture, using a real-time safeguarding algorithm, to ensure confidentiality. No audio is collected 
to maintain confidentiality. Clinical data will be collected and accessed by only the clinical research 
team, who all have employment or honorary contracts at the clinical sites. All clinical data will be kept 

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on NHS password-protected computers, on a password-protected Microsoft Excel spreadsheet on Trust 
premises, accessible only by the clinical research team. Digital Surgery Ltd team cannot access clinical 
data and patient participants will be assigned with a unique study identification number, so the identity 
of the patient is not known to them, to preserve patient confidentiality.  
The data from dVLogger data sent to Intuitive is anonymised and sent on an encrypted hard drive.  
Data protection 
To capture the surgical videos, a video cable non-intrusively connects the standard video outputs of the 
surgical video monitor, surgical robotic device, or stack into the Touch SurgeryTM Enterprise encrypted 
computing equipment, the DS1. The DS1 is not a medical device. The DS1 runs Digital Surgery Limited’s 
proprietary, in-situ AI safeguarding algorithm (RedactOR™), which redacts, via automatic pixelation, 
out-of-body surgical video footage, to remove identifiable personal data, in real-time. The encrypted 
computing equipment then transfers the anonymised videos to Touch SurgeryTM Enterprise platform;  
built upon a secure cloud server provided by Amazon Web Services in Europe, operated by Digital 
Surgery Limited. All anonymised data handling will be performed by designated, trained members of the 
clinical research team at TGI and technical research team at Digital Surgery Limited. All clinical data 
handling will be performed only by designated, trained members of the clinical team at The Griffin 
Institute. Digital Surgery Limited products and services (Touch Surgery ™ Enterprise) are compliant 
with the General Data Protection Regulation of 2018 (GDPR) and UK Data Protection Act of 2018 (UK 
GDPR).  
The data custodian will be the Chief Investigator Professor Nader Francis. Personal data will be stored 
in line with respective trust data retention standard procedures. This will remain for up to 5 years. 
 
In the ‘real time insights’ optional study arm, the real-time algorithm will detect lap chole critical 
structures (Cystic Duct, Cystic Artery) that will run in the background of thecomputer system in the 
form of timestamps.  This requires the software product feature ‘Preview mode’ to be enabled that 
offers faster surgical video upload to the cloud to support training and education. The end-user 
(healthcare professional) will be provided with training, and remote support (initially in-person) by 
Medtronic. The end-user will be able to select to upload the video on the day of the procedure or later, 
at a date of their choosing.  The RedactORTM algorithm (which is run over surgical video feed in real 
time to blur the environment outside of the patient's abdomen to reduce the likelihood of inadvertent 
personal data collection in the operating room) needs to be disabled temporarily, to enable the critical 
structures algorithm to run in real time. The likelihood of capturing personal data in the operating room 
is considered to be low because the system captures the laparoscopic video feed in the patient’s 
abdomen. However, to support patient confidentiality, Medtronic will  run the RedactORTM algorithm 
over the surgical videos in the cloud following upload.  
 
 
Potential risks 
We expect no difference between those patients in the trial or not. All patients require the operation as 
part of their routine care and this study does not alter the way the surgeon performs the case in any 
way, routinely surgeons will record operations, there is no change to standard care nor are additional 
patient visits required. Any potential risk to patient confidentiality has been addressed and sufficiently 

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mitigated by the study protocol. There are no additional risks to the staff as part of this study. It will not 
impact surgical rotas; theatre lists or scheduled operations. 
The only possible potential risk with this study is identification of significant errors on the video analysis 
that are not detected by the operating team and therefore no corrective action taken. However, the 
nature of this project involves reviewing the videos a significant period of time after the operation. Any 
sequelae from this event would have been apparent in the post operative period well before video 
analysis is conducted. If there are any learning points, however, these will be communicated with the PI 
at each site. 
For the sub study, real-time visualisation, there is no anticipated change to standard care or the duration 
of the surgery. The secondary screen and surgical video overlay will be tested in the operating room 
ahead of any use where a patient is present. Deployment and training from Medtronic will include 
teaching the OR staff how to stop visual overlays at their discretion, at any time during the procedure. 
Any potential risk associated with this study arm has been sufficiently mitigated, due to the overlays 
being presented on a secondary screen only and not being viewable by the operating surgeon. 
Participation from the surgeon and patient is optional on the informed consent form and detailed in the 
participant information sheet. 
Surgeons will use the main surgical screen to operate as per normal. The information provided on the 
secondary screen is entirely separate and the surgeons who are operating will not be able to view the 
real-time visualisations. However, hospital staff who are not directly involved with the procedure will be 
given the opportunity to view the secondary screen if they choose to.  
 
For the sub study, real-time insights, there is no anticipated change to standard care or the duration of 
the surgery. There is no additional hardware or equipment in the operating room, instead the computer 
records timestamps throughout the procedure that are available for user to review post operatively. 
The end-user (healthcare professional) will be provided with training, and remote support (initially in-
person) by Medtronic. Participation from the surgeon and patient is optional on the informed consent 
form and detailed in the participant information sheet. To support patient confidentiality, Medtronic will  
run the RedactORTM algorithm over the surgical videos in the cloud, post operatively.  
 
Potential benefits 
We hypothesise that understanding and optimising surgical processes, and errors will reduce 
unwarranted variations and improve the performance of the entire surgical team that will ultimately 
enhance the patient’s surgery and outcomes. We do note that there is no direct benefit to the individual 
patient taking part other than potentially helping to improve the safety of standard routine surgical 
procedures in future operations.  
We hope that this technology (including the real-time visualisation study arm and real time insights) will 
be used to improve surgical training and preparation of the entire operating theatre team and optimise 
performance and standardisation. It is hypothesised that the implementation of this technology may 
benefit patients by reducing surgical variations and errors and may also enable monitoring and 
assessment of surgical competence based on reliable, actionable data.  
The real time insights sub study, in addition, will provide review of timestamps of specific anatomical 
structures following upload of surgical video upload to the cloud to support training and education, 

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enabled through the product feature ‘Preview mode’ that allows faster upload of video and algorithm 
outputs 
 
If patient loses capacity to consent during study 
If the patient loses capacity before consent then they will not be invited to participate (in accordance 
with inclusion criteria). In the event that the research team are informed that the participant has lost 
mental capacity then their consent and participation will be withdrawn from the project. 
 
Physical security arrangements for storage of personal data 
Videos will be in electronic format and retained in encrypted storage. Procedural data will be directly 
uploaded from the device to a secure cloud server provided by AWS (Ireland, Europe), which is GDPR 
compliant. AWS will be used to store all media and data, which conforms to the ISO 27001 security 
management standard and is a member of the Cloud Security Alliance. Any transfer between the study 
sites would be in encrypted storage formats or through a secured internet connection.  
Data from the video recordings of surgery will be extracted, transferred and analysed using 
computerised software based at Digital Surgery Ltd. in London, UK. No patient data will be shared with 
Digital Surgery Limited in the duration of this study. Only Yeovil District Hospital NHS Foundation 
Trust/TGI (restricted to the clinical research team) will access and retain identifiable information such 
as study files. Yeovil District Hospital NHS Foundation Trust will only collect the minimum required 
information for the purposes of the study.  
Recruitment Arrangements and informed Consent   
 
Following informed consent to participate, the study patient participants will be assigned with a unique 
study identification number. This identifier is pseudonymised to the clinical research team. Patient 
consent forms will be securely stored in locked cupboards and password protected NHS equipment, 
NHS sites, with access restricted to the only authorised members of the clinical research team.  
How will you ensure the confidentiality of personal data? / Who will have access to participants’ 
personal data during the study?  
The surgical video and associated metadata on Touch SurgeryTM Enterprise cannot identify the 
participant. Participant personal data (any data that may identify a participant) is not necessary for the 
service Touch SurgeryTM Enterprise provides to the study site.  
Only the clinical research team has access to identifiable information about the participant. Access 
restrictions are in place to mitigate any risk to confidentiality of participant personal data.   
Data will be used, stored and transferred in an encrypted format, and handled in accordance with the 
UK Data Protection Act of 2018 (UK GDPR).   
Where will the data generated by the study be analysed and by whom?  
Data generated will be analysed by the clinical research team. Only anonymised data will be transferred 
to Touch SurgeryTM Enterprise (UK) and analysed by authorised members of the Digital Surgery Limited 
team for the purpose of the study, to identify key markers such as surgical phases and associated 
variations. 
Intuitive Surgical Inc. will receive anonymised data from the dVLogger via an encrypted hard drive. 

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Pseudonymised data will be analysed by the research team at TGI and WEISS. This will be stored on 
secure servers with access limited to the team. 
Based on previous similar uses of OCHRA errors in colonic surgery (Miskovic D, Surg Endosc 2011), 
we expect error count results to be normally distributed (however, this will be confirmed using detrended 
QQ statistical plots prior to analysis). Task and type specific error counts can be compared with Mann-
Whitney U test.  
OCHRA as previously described is a validated methodology to manually, accurately and reliably assess 
errors in a minimally invasive procedure. Data from this can then be statistically analysed and linked to 
patient data including demography and outcome 
Digital Surgery data science team will be involved in video analysis through analytic reporting. 
Qualitative questionnaires will be used at the end of the study to evaluate surgeons' opinion and gain 
insights on the use of surgical video and novel analytics. This will be done using thematic analysis.  
SPSS will be used for all data analysis. 
8.2  
 Research Ethics Committee (REC) and other Regulatory review & reports 
Regulatory Review & Compliance  
Local sites submitting participant video data will all gain local approval from local research team, 
theatre manager and IT for any installation of video recording equipment. 
Amendments  
Any amendments to the protocol will be submitted to the REC for consideration. 
8.3  
Peer review 
Peer review of the study protocol will be performed by specialists in video analysis and OCHRA 
methodology.  
8.4  
Patient & Public Involvement 
There is no impact on the patient pathway, all data is anonymised or pseudonymised to link video 
analysis to outcomes. This is an observational, prospective study without active patient follow 
up/involvement.  
Patient groups have been consulted on their opinions on recording and analysing their surgical video 
as part of another study in laparoscopic rectal cancer surgery with almost identical methodology.  
Study results will be forwarded to patients upon request only. Should a large proportion of the patient 
wish to hear results, we would invite them to attend the results presentation given at each study site. 
8.5 
Protocol compliance  
Protocol deviations will be managed by an internal review management and steering group, with root 
cause analysis, cause, and effect. Steps aiming to prevent any further deviations will be discussed and 
implemented. 
 
8.8 
Access to the final study dataset 
Only the clinical research team has access to identifiable information about the participant. Access 
restrictions are in place to mitigate any risk to confidentiality of participant personal data.   
The anonymity and confidentiality of the information provided for this study will be ensured by de- 
identification wherein a study ID will be allocated to the patient; only the Chief Investigator and 
Principal Investigator will be able to link the study ID to the patient identity and health information, 

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once the data set has been populated the code to the patient ID will be destroyed. This will leave a 
fully anonymised dataset. Only this dataset will be used in analysis. All electronic information relating 
to the study will be stored on a secure password protected database and all hardcopy information will 
be stored under lock and key.  
 
9 
DISSEMINATION POLICY 
9.1  
Dissemination policy 
The study will generate a final report and additional smaller projects which will be published in peer 
reviewed journals, presented at meetings and conferences. 
 
9.2  
Authorship eligibility guidelines and any intended use of professional writers 
The researchers will work to find suitable journals for publication and meetings for presentation. As 
this is not a clinical trial the trial will not be registered on a database however, a summary will be 
publicly available on the HRA website. 
Any significant finding from the study will be made available to the medical community. In the 
interested of public interest, presentation and international publication in peer reviewed journals will be 
sought as quickly as possible. 
All researchers who have been involved in the project will have authorship of the paper and 
responsibility for the review and dissemination of the results 
 
 
 
 

IRAS number 309024 
Version number 17, 10 January 24 
 
15 
Final Version 1.1 March 2016- Template & Guidance 
 
11.  
APPENDICIES 
 
11.1 
Appendix 1- Required documentation  
Patient information sheet, patient consent form, surgeon information sheet, surgeon consent form, 
organisation information document, schedule of events, signature and delegation log, 
inclusion/exclusion criteria and excel data collection sheet linked to secure cloud will be provided by 
this research team 
11.2  Appendix 2 – Schedule of Procedures (Example) 
 
11.3 
Appendix 3 – Amendment History 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made 
1.0 
Version 11 
20.6.22 
M Boal 
Allowing approach to participant for 
consent within 24 hours if needed. 
2.0 
Version 12 
25.7.22 
M Boal 
Retrospective analysis (OCHRA and 
application of artificial intelligence) of 
videos with previous ethical approval 
from other studies of this research 
group 
3.0 
Version 13 
30.9.22  
M.Boal and 
Aimee 
Bambury 
Change 1: add new sites: North East 
and North Cumbria Integrated Care 
System, Newcastle upon Tyne 
Hospitals NHS Foundation Trust (Mr 
Richard Brady), and North Tees & 
Hartlepool NHS Trust (Mr Talvinder 
Gill). 
Change 2: revise patient inclusion 
criteria from elective minimally invasive 
urological/gastrointestinal surgery to 
elective any minimally invasive 
procedures including gynaecology.  
Change 3: added optional study arm: 
real time visualisation (overlay) 
4.0 
Version 14 
19.1.23 
Aimee 
Bambury 
F. Tesfai 
M. Boal 
Change 1: add new sites and PI 
HCA Wellington Hospital, Royal 
Cornwall Hospital, Removed Newcastle 
Upon Tyne Hospital. 
Change 2: Added co investigators: Dr 
Tesfai on behalf of The Griffin Institue 
and added her as study co-ordinator. 
We have added Miss Chandrasekaran 
as co-investigator on behalf of 
University College of London Hospital 
NHS trust.  

IRAS number 309024 
Version number 17, 10 January 24 
 
 
Change 3: Established new optional 
study arm for real time insights (instead 
of visualisation (overlay)- changes to 
participant and surgeon consent form + 
information sheets 
Change 4: Minor amendment surgeon 
consent form highlighted in yellow (age, 
handedness, email) 
5.0 
Version 15 
9.3.23 
M. Boal 
A. Boydell 
F.Tesfai 
Change 1:New Names on documents: 
New CEO at The Griffin Institute, Mrs 
Vasiliki Kiparoglou, reviewed the 
protocol and signed. Contact details 
inserted page 5 protocol and both 
surgeon/participant information sheets. 
New study co-ordinator added Ms 
Claudia Reali, as another   PhD fellow 
on minimally invasive colorectal video 
analysis. Details inserted on protocol, 
both information sheets and consent 
forms, please note she is part of The 
Griffin Institute as a PhD fellow of 
Professor Francis' but without an email 
there yet, hence using her consultant 
NHS email. New study protocol 
contributor from medtronic for this 
amendment Anna Boydell. Change 2: 
Page 8 Protocol, inclusion criteria is 
any minimally-invasive surgery, 
therefore deleted 
urological/gastrointestinal surgery. It is 
stipulated elsewhere in the protocol 
(Page 2) we will include other 
specialties. No change to ethics.  On 
both PIS forms: Change 3: Participant 
Information Sheet inserted area for 
PALS/Local research team details to be 
inserted, or section deleted, depending 
on local site preference, as requested 
by a local research team. Change 4: 
Surgeon Consent form, original text at 
point 4 was August 2024, and in 
amendment 4 had been changed 
erroneously to August 2022, I have 
corrrected this to August 2024. Change 
5: Phone number standardised for all 
The Griffin co-investigators, changing it 
from Dr Tesfai's personal number on 
information sheets and consent form. 
Change 6: Both consent forms for 
version number and date of the 
Information sheets to be written on the 
consent form, as requested by a local 
research team, highlighting this is 

IRAS number 309024 
Version number 17, 10 January 24 
 
17 
Final Version 1.1 March 2016- Template & Guidance 
 
standard of practice Change 7: 
Surgeon consent form grammar error in 
order of words changed to "will store 
my". This refers to the normal 
information name and email to have an 
account with Touch Surgery. Change 8: 
Participant/surgeon information sheet 
and IRAS protocol- clarity provided in 
protocol in regards who is able to view 
secondary screen in the optional study 
arm “real time visualisation”. Change 9: 
Addition of new research site: The 
Royal Surrey NHS Trust 
6.0 
16 
18.09.2023 
F. Tesfai 
Change 1:Addition of two new sites: 
Gemelli Hospital, Rome, Italy with PI: 
Dr Valentina Lacobelli and Leiden 
Univeristy Medical Center (LUMC), 
Leiden, The Netherland with PI: Dr 
Jogchum Beltman. Furthermore, we are 
stating in the protocol that international 
sites are eligble to join the study. 
Change 2: Dr Georgia Zachou 
(Gynaecology Research fellow) has 
been added to the protocol for the 
gynaecology arm. 
7.0 
17 
10/01/2024 
F. Tesfai 
M. Boal 
Change 1: Study date extended due to 
additional research fellows' time period 
of study and due to delayed initial 
recruitment to obtain enough videos for 
analysis (page ix).Change 2: Objective 
point 2 & 3 have merged as multiple 
surgical specialities are now recruiting 
for vamis and this generic explanantion 
covers all operations. As a note this has 
been changed on the advice of other 
sites not performing previously defined 
operations within these objectives (i.e. 
prosatectomy and rectal cancer 
surgery) (page 4). Change 3 as per 
change 2 we are ensuring inclusivity of 
any minimally invasive surgical 
procedure (page 7).  
 
12.  
References 
1. 
Macmillan Statistics fact sheet. https://www.macmillan.org.uk/_images/cancer-statistics-
factsheet_tcm9-260514.pdf (2019). 
2. 
The Fountain Group blog on Intuitive Surgical. 
https://www.fountaingroup.ca/blog/2021/05/10/intuitive-surgical-a-leader-in-surgical-
robots?sc_lang=en. 

IRAS number 309024 
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3. 
Brennan, T. A. et al. Incidence of Adverse Events and Negligence in Hospitalized Patients. New 
England Journal of Medicine 324, (1991). 
4. 
Collins, J. W. et al. Utilising the Delphi Process to Develop a Proficiency-based Progression 
Train-the-trainer Course for Robotic Surgery Training. European Urology vol. 75 775–785 
(2019). 
5. 
Ahmed, K. et al. Development of a standardised training curriculum for robotic surgery: a 
consensus statement from an international multidisciplinary group of experts. BJU International 
116, (2015). 
6. 
Collins, J. W. & Wisz, P. Training in robotic surgery, replicating the airline industry. How far 
have we come? World Journal of Urology 38, 1645–1651 (2020). 
7. 
Institute, E. Top 10 Health Technology Hazards for 2015. www.ecri.org/2015hazards, (2014). 
8. 
Foster, J. D. et al. Application of objective clinical human reliability analysis (OCHRA) in 
assessment of technical performance in laparoscopic rectal cancer surgery. Techniques in 
Coloproctology 20, 361–367 (2016). 
9. 
Curtis, N. J. et al. Association of Surgical Skill Assessment with Clinical Outcomes in Cancer 
Surgery. JAMA Surgery 155, 590–598 (2020). 
10. 
Hanna, G. B. et al. Laparoscopic Colorectal Surgery Outcomes Improved After National 
Training Program (LAPCO) for Specialists in England. Annals of surgery (2020) 
doi:10.1097/SLA.0000000000004584. 
11. 
Goh, A. C., Goldfarb, D. W., Sander, J. C., Miles, B. J. & Dunkin, B. J. Global evaluative 
assessment of robotic skills: Validation of a clinical assessment tool to measure robotic surgical 
skills. Journal of Urology 187, 247–252 (2012). 
12. 
Chen, J. et al. Objective Assessment of Robotic Surgical Technical Skill: A Systematic Review. 
Journal of Urology vol. 201 461–469 (2019).