Colorectal Neoplasms Clinical Trial
Official title:
Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
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.
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.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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