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Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study
The study evaluates whether the use of a novel endoscopic cap (the endo-cuff) at the tip of a colonoscope improves the numbers of polyps detected during bowel cancer screening colonoscopy. Half the patients will have standard colonoscopy and half will have colonoscopy with the cap attached.
Problem statement: In England, everyone in the age group of 60-69 years is invited to participate in bowel cancer screening. Those who test positive in the initial screening stool test are invited to have a colonoscopy. The purpose of colonoscopy is to detect any obvious cancers, and in the absence of obvious cancers the purpose is to detect and remove all the polyps present in the colon, as polyps have the potential to develop into cancers. However, colonoscopy still misses up to 25% of polyps. Cap assisted colonoscopy improves polyp detection but still misses a significant number of polyps. There is a need for an improved cap design which will help improve polyp detection. Research question/hypothesis: Does using an endocuff on a colonoscope improve polyp detection as compared to standard colonoscopy in bowel cancer screening patients? Study design: Parallel group, single blinded randomised controlled trial Study participants: Patients attending for colonoscopy under the bowel cancer screening programme Planned sample size: 534 Planned study period: 12 months Primary objective: To assess the impact of endocuff assisted colonoscopy on the number of polyps detected per patient
Age
60 - 75 years
Sex
ALL
Healthy Volunteers
No
Portsmouth Hospitals NHS Trust
Portsmouth, Hampshire, United Kingdom
Start Date
September 1, 2014
Primary Completion Date
September 1, 2015
Completion Date
September 1, 2015
Last Updated
May 30, 2016
534
ACTUAL participants
Endo-cuff
DEVICE
Standard colonoscopy
OTHER
Lead Sponsor
Portsmouth Hospitals NHS Trust
NCT06885697
NCT07089615
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT05789433