Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

Not Applicable

• Conditions: Adenoma; Colorectal Neoplasms; Colonic Polyps
• Interventions: Device: Endocuff Vision

• Registration Number: NCT02552017
• Lead Sponsor: South Tyneside and Sunderland NHS Foundation Trust

Brief Summary

The purpose of this study is to determine if a new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) will significantly improve the detection of adenomas when used in all patients referred for colonoscopy.

Detailed Description

Bowel cancer is common in the United Kingdom, with around 1 in 16 men and 1 in 20 women developing it at some point in their lives. Most bowel cancers happen when a type of polyp (a growth in the bowel) called an adenoma becomes cancerous. Doctors use a camera test, known as a colonoscopy, to look inside the bowel and find these polyps and remove them. Removing precancerous polyps is known to reduce the chances of a person developing bowel cancer in the future. How good colonoscopists are at finding these polyps varies, and there is a lot of research into how to improve "adenoma detection rates".

A new device, called the Endocuff Vision (a small plastic device attached to the end of the colonoscope which helps by holding the folds of the bowel back to give a clear view of the inside of the bowel) has been shown to improve the rate of polyp detection at colonoscopy, and to make polyp removal easier. Previous small studies have shown that there is a significant improvement in detection of adenomas when an Endocuff Vision is used (with the rate of detection of adenomas rising from 49% to 66%). Colonoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when it is on the colonoscope. This study will randomise patients coming for colonoscopy to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff Vision-assisted colonoscopy. The investigators will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications. All patients referred for colonoscopy (via the symptomatic service, surveillance procedures, and the Bowel Cancer Screening Programme) will be invited in 7 centres (a mixture of specialist centres and district general hospitals), recruiting a total of 1772 participants.

Study Timeline

• Study Start: 2014-11
• Status Verified: 2015-09
• Study First Submitted: 2015-09-10
• Study First Submitted QC: 2015-09-15
• Last Update Submitted: 2015-09-15
• Study First Posted: 2015-09-16
• Last Update Posted: 2015-09-16
• Primary Completion: 2016-06
• Study Completion: 2016-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1772

Inclusion Criteria

1. All patients referred for screening, surveillance, or diagnostic colonoscopy
2. All patients must be able to give informed consent

Exclusion Criteria

1. Patients with any absolute contraindications to colonoscopy
2. Patients with established or suspicion of large bowel obstruction or pseudo-obstruction
3. Patients with known colon cancer or polyposis syndromes
4. Patients with known colonic strictures
5. Patients with known severe diverticular segments (that is likely to impede colonoscope passage)
6. Patients with active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
7. Patients lacking capacity to give informed consent
8. Pregnancy
9. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants who have not stopped this for the procedure.
10. Patients who are attending for a therapeutic procedure or assessment of a known lesion

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endocuff Vision-assisted Colonoscopy	Endocuff Vision	Participants in this arm undergo Endocuff Vision-assisted colonoscopy

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	10 months	A difference in adenoma detection rate between Endocuff Vision-assisted colonoscopy and standard colonoscopy.

Secondary Outcome Measures

Name	Time	Method
Mean adenomas detected per procedure	10 months	A difference in mean adenomas detected per procedure between both groups
Rate of cuff exchange	10 months	The rate of cuff exchange (that is, how often the cuff has to be removed) between both groups
Effect on duration of caecal intubation rates	10 months	Duration of complete withdrawal time in procedures where no polyps are detected between both groups
Patient satisfaction using validated patient comfort Bowel Cancer Screening Programme (BCSP) questionnaires	10 months	Patient satisfaction measured from no pain (0) to severe pain (3), episodes of discomfort from no discomfort (0) to frequent (more than 4 times)(3), length of discomfort from no discomfort (0) to more than 1 minute(3).
Increase in surveillance colonoscopies caused by increased adenoma detection rate	10 months	Increase in surveillance colonoscopies due to increased adenoma detection rate in terms of number of potential follow up procedures based on British Society of Gastroenterology adenoma surveillance guidelines in both groups
Number of proximal sessile serrated polyps by histology	10 months	Number of of proximal sessile serrated polyps in both groups
Polyp location	10 months	Distribution of polyps in the colon in both groups by location
Adenoma detection rate of BCSP and non-BCSP endoscopists	10 months	Adenoma detection rate of BCSP and non-BCSP colonoscopists
Change in adenoma detection rate of each endoscopist during the course of the trial	10 months	Adenoma detection rate (ADR) of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR.
Adenoma detection rate of individual endoscopist before and after trial commencement	10 months	Baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where Endocuff Vision was not used.

Trial Locations

Locations (7)

St Mark's Hospital and Academic Institute; 🇬🇧 Harrow, Middlesex, United Kingdom

South Tyneside NHS Foundation Trust; 🇬🇧 South Shields, Tyne and Wear, United Kingdom

City Hospitals Sunderland NHS Foundation Trust; 🇬🇧 Sunderland, Tyne and Wear, United Kingdom

North Tees and Hartlepool NHS Foundation Trust; 🇬🇧 Stockton-on-Tees, County Durham, United Kingdom

South Tees Hospitals NHS Foundation Trust; 🇬🇧 Middlesbrough, North Yorkshire, United Kingdom

County Durham and Darlington NHS Foundation Trust; 🇬🇧 Durham, County Durham, United Kingdom

Northumbria Healthcare NHS Foundation Trust; 🇬🇧 North Shields, Tyne and Wear, United Kingdom