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

Not Applicable

Completed

• Conditions: Colonic Neoplasms; Colonic Polyps
• Interventions: Device: Endo-cuff; Other: Standard colonoscopy

• Registration Number: NCT02529007
• Lead Sponsor: Portsmouth Hospitals NHS Trust

Brief 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

Study Timeline

• Study Start: 2014-09
• Status Verified: 2015-07
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-08-18
• Study First Posted: 2015-08-19
• Primary Completion: 2015-09
• Study Completion: 2015-09
• Last Update Submitted: 2016-05-27
• Last Update Posted: 2016-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 534

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endocuff	Endo-cuff	These patients have colonoscopy performed with the endo-cuff attached to the end of the colonoscope
Standard	Standard colonoscopy	These patients have standard colonoscopy performed

Primary Outcome Measures

Name	Time	Method
Number of polyps detected per patient	1 month (when pathology report available)

Secondary Outcome Measures

Name	Time	Method
Caecal intubation rate	1 day	will be recorded at the time of the procedure
Total procedure time - from scope insertion to removal	1 day	will be recorded at the time of the procedure
Time taken to reach caecum	1 day	will be recorded at the time of the procedure
Time taken to withdraw scope (from caecum to removal of scope)	1 day	will be recorded at the time of the procedure
Polyp detection rate	1 month (when pathology report available)
Adenoma detection rate	1 month (when pathology report available)
Cancer detection rate	1 month (when pathology report available)
Patient comfort score	1 day	will be recorded at the time of the procedure
Adenomas per patient	1 month (when pathology report available)

Trial Locations

Locations (1)

Portsmouth Hospitals NHS Trust; 🇬🇧 Portsmouth, Hampshire, United Kingdom