Colonic Neoplasms Clinical Trial
Official title:
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Screening
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