Video Analysis of Errors and Technical Performance Within Minimally Invasive Surgery Short Title: Video Analysis in Minimally Invasive Surgery (VAMIS)

NCT05279287 | Recruiting

• 1 other identifier: TGI 001
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 5

Brief Summary

Despite the high volumes, advanced minimally invasive surgery is non-standardised and variations often occur in surgical technique, performance, delivery, team communication, and surgical approach. Such variations can result in errors and complications that can potentially be avoided. 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 (key hole) procedure in the operating room, allowing immediate, upload of data to a platform for immediate feedback and assessment to surgeons. The investigators hypothesise that understanding technical performance and surgical processes, may reduce unwarranted variations, errors and near misses, and improve the performance of the entire surgical team that is ultimately hoped to enhance patient safety and outcomes. Investigators plan to develop assessment tools with the hope to improve feedback, learning and ultimately surgeons' performances. The latest methodology of manual (OCHRA) and automated assessment (artificial intelligence) will be applied. Investigators aim to validate these methods by correlating video "scores" of skill/errors to patient outcomes e.g. complications, cancer outcome.

Conditions

Prostate Cancer; Rectal Cancer

Keywords

Robotics; Surgery; Laparoscopy; Error; Analysis; Evaluation; Objective; Assessment; Performance

Outcome Measures

Primary Outcomes (1)

• Number of errors in an operation using validated methodology- Objective Clinical Human Reliability Analysis (OCHRA)

  Objective Clinical Human Reliability Analysis (OCHRA) methodology will be applied to video visual data to assess number, type and severity of errors within the operation.

  2 years of video data will be recorded prospectively

Secondary Outcomes (15)

• Secondary outcome measure- Age

  Up to 5 years, the normal time period of follow-up for cancer related outcomes

• Secondary outcome measure- ASA grade

  Up to 2 years and 6 months, duration of the study

• Secondary outcome measure -BMI

  Up to 2 years and 6 months, duration of the study

• Secondary outcome measure

  Up to 2 years and 6 months, duration of the study

• Secondary outcome measure

  Up to 2 years and 6 months, duration of the study

Study Arms (1)

Minimally invasive surgical procedure

Patients undergoing any minimally invasive procedure can be included in the study. Initial focus will be on robotic prostatectomy and robotic TME (rectal cancer removal).

Other: Video and kinematic data recording of minimally invasive surgical procedure

Interventions

Video and kinematic data recording of minimally invasive surgical procedure OTHER

Analysis of video and kinematic data through validated methodology in order to analyse technical performance and errors enacted intraoperatively.

Minimally invasive surgical procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Any patient undergoing a minimally invasive (laparosopic or robotic) surgical procedure who meets the inclusion criteria

You may qualify if:

• Patient undergoing elective minimally-invasive urological/gastrointestinal surgery
• years old or over
• Have capacity to provide informed consent

You may not qualify if:

• Surgery performed with palliative intent or under unplanned/emergency settings
• Under 18 years old
• Cannot consent

Sponsors & Collaborators

• The Griffin Institute: lead
• Medtronic: collaborator
• Wellcome/EPSRC for Interventional and Surgical Sciences (WEISS): collaborator

Study Sites (5)

Yeovil Hospital, Somerset NHS Foundation Trust

Yeovil, Somerset, HA13UJ, United Kingdom

RECRUITING

University College London Hospitals NHS Trust

London, NW1 2PG, United Kingdom

RECRUITING

London North West University Healthcare NHS Trust

London, United Kingdom

RECRUITING

Portsmouth Hospitals NHS Foundation Trust

Portsmouth, United Kingdom

RECRUITING

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, United Kingdom

RECRUITING

Related Publications (10)

• Brennan TA, Leape LL, Laird NM, Hebert L, Localio AR, Lawthers AG, Newhouse JP, Weiler PC, Hiatt HH. Incidence of adverse events and negligence in hospitalized patients. Results of the Harvard Medical Practice Study I. N Engl J Med. 1991 Feb 7;324(6):370-6. doi: 10.1056/NEJM199102073240604.

  PMID: 1987460 BACKGROUND

• Collins JW, Levy J, Stefanidis D, Gallagher A, Coleman M, Cecil T, Ericsson A, Mottrie A, Wiklund P, Ahmed K, Pratschke J, Casali G, Ghazi A, Gomez M, Hung A, Arnold A, Dunning J, Martino M, Vaz C, Friedman E, Baste JM, Bergamaschi R, Feins R, Earle D, Pusic M, Montgomery O, Pugh C, Satava RM. Utilising the Delphi Process to Develop a Proficiency-based Progression Train-the-trainer Course for Robotic Surgery Training. Eur Urol. 2019 May;75(5):775-785. doi: 10.1016/j.eururo.2018.12.044. Epub 2019 Jan 19.

  PMID: 30665812 BACKGROUND

• Ahmed K, Khan R, Mottrie A, Lovegrove C, Abaza R, Ahlawat R, Ahlering T, Ahlgren G, Artibani W, Barret E, Cathelineau X, Challacombe B, Coloby P, Khan MS, Hubert J, Michel MS, Montorsi F, Murphy D, Palou J, Patel V, Piechaud PT, Van Poppel H, Rischmann P, Sanchez-Salas R, Siemer S, Stoeckle M, Stolzenburg JU, Terrier JE, Thuroff JW, Vaessen C, Van Der Poel HG, Van Cleynenbreugel B, Volpe A, Wagner C, Wiklund P, Wilson T, Wirth M, Witt J, Dasgupta P. Development of a standardised training curriculum for robotic surgery: a consensus statement from an international multidisciplinary group of experts. BJU Int. 2015 Jul;116(1):93-101. doi: 10.1111/bju.12974. Epub 2015 Mar 23.

  PMID: 25359658 BACKGROUND

• Collins JW, Wisz P. Training in robotic surgery, replicating the airline industry. How far have we come? World J Urol. 2020 Jul;38(7):1645-1651. doi: 10.1007/s00345-019-02976-4. Epub 2019 Oct 17.

  PMID: 31624867 BACKGROUND

• Foster JD, Miskovic D, Allison AS, Conti JA, Ockrim J, Cooper EJ, Hanna GB, Francis NK. Application of objective clinical human reliability analysis (OCHRA) in assessment of technical performance in laparoscopic rectal cancer surgery. Tech Coloproctol. 2016 Jun;20(6):361-367. doi: 10.1007/s10151-016-1444-4. Epub 2016 May 6.

  PMID: 27154295 BACKGROUND

• Curtis NJ, Foster JD, Miskovic D, Brown CSB, Hewett PJ, Abbott S, Hanna GB, Stevenson ARL, Francis NK. Association of Surgical Skill Assessment With Clinical Outcomes in Cancer Surgery. JAMA Surg. 2020 Jul 1;155(7):590-598. doi: 10.1001/jamasurg.2020.1004.

  PMID: 32374371 BACKGROUND

• Hanna GB, Mackenzie H, Miskovic D, Ni M, Wyles S, Aylin P, Parvaiz A, Cecil T, Gudgeon A, Griffith J, Robinson JM, Selvasekar C, Rockall T, Acheson A, Maxwell-Armstrong C, Jenkins JT, Horgan A, Cunningham C, Lindsey I, Arulampalam T, Motson RW, Francis NK, Kennedy RH, Coleman MG; on behalfofLapco program. Laparoscopic Colorectal Surgery Outcomes Improved After National Training Program (LAPCO) for Specialists in England. Ann Surg. 2022 Jun 1;275(6):1149-1155. doi: 10.1097/SLA.0000000000004584. Epub 2020 Oct 19.

  PMID: 33086313 BACKGROUND

• Goh AC, Goldfarb DW, Sander JC, Miles BJ, Dunkin BJ. Global evaluative assessment of robotic skills: validation of a clinical assessment tool to measure robotic surgical skills. J Urol. 2012 Jan;187(1):247-52. doi: 10.1016/j.juro.2011.09.032. Epub 2011 Nov 17.

  PMID: 22099993 BACKGROUND

• Chen J, Cheng N, Cacciamani G, Oh P, Lin-Brande M, Remulla D, Gill IS, Hung AJ. Objective Assessment of Robotic Surgical Technical Skill: A Systematic Review. J Urol. 2019 Mar;201(3):461-469. doi: 10.1016/j.juro.2018.06.078.

  PMID: 30053510 BACKGROUND

• Boal M, Reali C, Duhoky R, Gill T, Khan J, Miskovic D, Francis N. Association of skill and errors with outcomes in robotic rectal cancer surgery. Surg Endosc. 2025 Dec 10. doi: 10.1007/s00464-025-12393-x. Online ahead of print.

  PMID: 41369760 DERIVED

Related Links

• Related Info
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MeSH Terms

Conditions

Prostatic Neoplasms; Rectal Neoplasms

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Tape Recording; Audiovisual Aids; Educational Technology; Technology; Technology, Industry, and Agriculture; Television

Study Officials

• Nader Francis, PhD, FRCS

  The Griffin Institute

  STUDY DIRECTOR

Central Study Contacts

Nader Francis, PhD, FRCS

CONTACT

00447718901029; n.francis@griffininstitute.org.uk

Matthew Boal, MBChB, MRCS

CONTACT

00447919594823; m.boal@griffininstitute.org.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Surgical PhD Research Fellow

Study Record Dates

• First Submitted: January 4, 2022
• First Posted: March 15, 2022
• Study Start: February 1, 2023
• Primary Completion: August 1, 2024
• Study Completion: August 31, 2024
• Last Updated: February 22, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)