Endo-cuff Assisted Vs. Standard Colonoscopy for Polyp Detection in Bowel Cancer Screening (E-CAP)

Portsmouth Hospitals NHS Trust

Status: Completed

Conditions: Colonic Polyps; Colonic Neoplasms

Treatments: Other: Standard colonoscopy; Device: Endo-cuff

Study type: Interventional

Funder types: Other

Identifiers

NCT02529007

PHT/2013/71

Details and patient eligibility

About

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.

Full 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

Enrollment: 534 patients

Sex: All

Ages: 60 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients referred for colonoscopy under the national bowel cancer screening programme
• Able to provide written informed consent

Exclusion criteria

• History of Inflammatory bowel disease
• History of Hereditary non polyposis colorectal cancer

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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534 participants in 2 patient groups

Standard

Active Comparator group

Description:

These patients have standard colonoscopy performed

Treatment:

Other: Standard colonoscopy

Endocuff

Experimental group

Description:

These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope

Treatment:

Device: Endo-cuff