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Lookup NU author(s): Alexander Seager, Professor Linda Sharp, Dr James Hampton, Dr Laura Neilson, Dr Tom Lee, Professor Luke ValeORCiD, Professor Colin Rees
This work is licensed under a Creative Commons Attribution 4.0 International License (CC BY 4.0).
© 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.
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
Volume: 24
Issue: 10
Pages: 1227-1237
Print publication date: 01/10/2022
Online publication date: 09/06/2022
Acceptance date: 29/05/2022
Date deposited: 29/06/2023
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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