NCT02529007

Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening

Endo-cuff Assisted Colonoscopy Versus Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening Patients: A Randomised Controlled Trial. The E-CAP Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 534 (actual)
• Sponsor: Portsmouth Hospitals NHS Trust · Other Government
• Sex: All
• Age: 60 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Colonic Polyps
• Colonic Neoplasms

Interventions

Type	Name	Description
DEVICE	Endo-cuff	Colonoscopy performed with endo-cuff attached to the colonoscope
OTHER	Standard colonoscopy	Standard colonoscopy without end-cuff

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2015-08-19
• Last updated: 2016-05-30

Locations

1 site across 1 country: United Kingdom