Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities (ADENOMA)

South Tyneside and Sunderland NHS Foundation Trust

Status

Unknown

Conditions

Colonic Polyps

Colorectal Neoplasms

Adenoma

Treatments

Device: Endocuff Vision

Study type

Interventional

Funder types

Other

Identifiers

NCT02552017

1182104 (Registry Identifier)

039/2014

17718

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,772 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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