The B-ADENOMA Study
Research type
Research Study
Full title
The B-ADENOMA Study: Bowel Scope - Accuracy of Detection using ENdocuff Optimisation of Mucosal Abnormalities
IRAS ID
213012
Contact name
Colin Rees
Contact email
Sponsor organisation
South Tyneside NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 30 days
Research summary
Bowel cancer is common in the UK, 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.
The NHS Bowel Scope screening programme is a relatively new screening test to help prevent bowel cancer. It is being gradually rolled out to all men and women in England aged 55 who are invited for a flexible sigmoidoscopy (camera test that looks into the lower part of the large bowel) to find and remove any polyps that could eventually turn into cancer. In the NHS Bowel Scope screening programme, a flexible sigmoidoscopy is performed instead of a colonoscopy as that is where most polyps are found.
A new device, called the Endocuff Vision (a small plastic device attached to the end of the camera 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 and make polyp removal easier during colonoscopy. A colonoscopy is another type of camera test that examines all of the large bowel. 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%). Endoscopists who have used the Endocuff Vision before also feel that polyp removal is easier when the Endocuff Vision is on the colonoscope.
This study will randomise patients to have their procedure performed as usual (i.e. without the Endocuff Vision attached) or as an Endocuff-assisted flexible sigmoidoscopy. We will record polyp and adenoma detection rates, duration of procedure, participant comfort levels, and complications.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
16/WM/0514
Date of REC Opinion
28 Dec 2016
REC opinion
Favourable Opinion