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

被引：10

作者：

Seager, Alexander ^{[1
,2
]}

Sharp, Linda ^{[2
]}

Hampton, James S. ^{[1
,2
]}

Neilson, Laura J. ^{[1
]}

Lee, Tom J. W. ^{[2
,3
]}

Brand, Andrew ^{[4
]}

Evans, Rachel ^{[4
]}

Vale, Luke ^{[5
]}

Whelpton, John ^{[6
]}

Rees, Colin J. ^{[1
,2
]}

机构：

[1] South Tyneside & Sunderland NHS Fdn Trust, South Tyneside Dist Hosp, South Shields, Tyne & Wear, England

[2] Newcastle Univ, Populat Hlth Sci Inst, Ctr Canc, Newcastle Upon Tyne, Tyne & Wear, England

[3] Northumbria Healthcare NHS Fdn Trust, North Tyneside Gen Hosp, North Shields, England

[4] North Wales Org Randomised Trials Hlth NWORTH, Bangor, Gwynedd, Wales

[5] Newcastle Univ, Populat Hlth Sci Inst, Hlth Econ Grp, Ctr Canc, Newcastle Upon Tyne, Tyne & Wear, England

[6] Newcastle Univ, Patient & Participant Involvement Representat, Populat Hlth Sci Inst, Ctr Canc, Newcastle Upon Tyne, Tyne & Wear, England

来源：

COLORECTAL DISEASE | 2022年 / 24卷 / 10期

关键词：

adenoma; artificial intelligence; colonoscopy; colorectal cancer; computer-aided detection; economic evaluation; POSTCOLONOSCOPY COLORECTAL CANCERS; INCREASES POLYP DETECTION; COMPUTER-AIDED DETECTION; ADENOMA DETECTION RATE; MISS RATE; QUALITY; RISK; TIME; METAANALYSIS; EXPERIENCE;

D O I：

10.1111/codi.16219

中图分类号：

R57 [消化系及腹部疾病];

学科分类号：

摘要：

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 (TM) (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 (TM) 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 (TM)-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 (TM)-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 (TM) in real world colonoscopy practice and will, uniquely, evaluate both clinical and cost effectiveness.

引用

页码：1227 / 1237

页数：11

共 51 条

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