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Trial protocol for COLO-DETECT: A randomized controlled trial of lesion detection comparing colonoscopy assisted by the GI Genius™ artificial intelligence endoscopy module with standard colonoscopy

Lookup NU author(s): Alexander Seager, Professor Linda Sharp, Dr James Hampton, Dr Laura Neilson, Dr Tom Lee, Professor Luke ValeORCiD, Professor Colin Rees

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Abstract

© 2022 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on behalf of Association of Coloproctology of Great Britain and Ireland.Aim: Colorectal cancer is the second commonest cause of cancer death worldwide. Colonoscopy plays a key role in the control of colorectal cancer and, in that regard, maximizing detection (and removal) of pre-cancerous adenomas at colonoscopy is imperative. GI Genius™ (Medtronic Ltd) is a computer-aided detection system that integrates with existing endoscopy systems and improves adenoma detection during colonoscopy. COLO-DETECT aims to assess the clinical and cost effectiveness of GI Genius™ in UK routine colonoscopy practice. Methods and analysis: Participants will be recruited from patients attending for colonoscopy at National Health Service sites in England, for clinical symptoms, surveillance or within the national Bowel Cancer Screening Programme. Randomization will involve a 1:1 allocation ratio (GI Genius™-assisted colonoscopy:standard colonoscopy) and will be stratified by age category (<60 years, 60–<74 years, ≥74 years), sex, hospital site and indication for colonoscopy. Demographic data, procedural data, histology and post-procedure patient experience and quality of life will be recorded. COLO-DETECT is designed and powered to detect clinically meaningful differences in mean adenomas per procedure and adenoma detection rate between GI Genius™-assisted colonoscopy and standard colonoscopy groups. The study will close when 1828 participants have had a complete colonoscopy. An economic evaluation will be conducted from the perspective of the National Health Service. A patient and public representative is contributing to all stages of the trial. Registered at ClinicalTrials.gov (NCT04723758) and ISRCTN (10451355). What will this trial add to the literature?: COLO-DETECT will be the first multi-centre randomized controlled trial evaluating GI Genius™ in real world colonoscopy practice and will, uniquely, evaluate both clinical and cost effectiveness.


Publication metadata

Author(s): Seager A, Sharp L, Hampton JS, Neilson LJ, Lee TJW, Brand A, Evans R, Vale L, Whelpton J, Rees CJ

Publication type: Article

Publication status: Published

Journal: Colorectal Disease

Year: 2022

Pages: epub ahead of print

Print publication date: 28/06/2022

Online publication date: 09/06/2022

Acceptance date: 29/05/2022

ISSN (print): 1462-8910

ISSN (electronic): 1463-1318

Publisher: John Wiley and Sons Inc

URL: https://doi.org/10.1111/codi.16219

DOI: 10.1111/codi.16219

PubMed id: 35680613


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