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
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‐aid...
Saved in:
| Published in: | Colorectal disease Vol. 24; no. 10; pp. 1227 - 1237 |
|---|---|
| Main Authors: | , , , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
Wiley Subscription Services, Inc
01-10-2022
|
| Subjects: | |
| Online Access: | Get full text |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| Summary: | 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. |
|---|---|
| Bibliography: | Funding information COLO‐DETECT is an industry‐funded, investigator‐led study; funding is through an unrestricted grant awarded from Medtronic Ltd (ERP 2020‐12257) covering study delivery, GI Genius™ devices, CTU costs and results analysis costs. The funder will have no role in study design or delivery. COLO‐DETECT is sponsored by South Tyneside and Sunderland NHS Foundation Trust, who are the grant holder for the study. Colonoscopies will be conducted on existing NHS lists, incurring no additional costs to the NHS. Sponsor contact details: Claire Livingstone (Head of Research and Innovation), South Tyneside and Sunderland NHS Foundation Trust, South Tyneside District Hospital, Harton Lane, South Shields, NE34 0PL, UK. claire.livingstone5@nhs.net . ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 |
| ISSN: | 1462-8910 1463-1318 |
| DOI: | 10.1111/codi.16219 |