Background: Colonoscopy is the gold standard investigation for the diagnosis of bowel pathology
and colorectal cancer screening. Adenoma detection rate is a marker of high quality
colonoscopy and a high adenoma detection rate is associated with a lower incidence
of interval cancers. Several technological advancements have been explored to improve
adenoma detection rate. A new device called Endocuff Vision™ has been shown to improve
adenoma detection rate in pilot studies.
Methods/Design: This is a prospective, multicenter, randomized controlled trial comparing the adenoma
detection rate in patients undergoing Endocuff Vision™-assisted colonoscopy with standard
colonoscopy. All patients above 18 years of age referred for screening, surveillance,
or diagnostic colonoscopy who are able to consent are invited to the study. Patients
with absolute contraindications to colonoscopy, large bowel obstruction or pseudo-obstruction,
colon cancer or polyposis syndromes, colonic strictures, severe diverticular segments,
active colitis, anticoagulant therapy, or pregnancy are excluded. Patients are randomized
according to site, age, sex, and bowel cancer screening status to receive Endocuff
Vision™-assisted colonoscopy or standard colonoscopy on the day of procedure. Baseline
data, colonoscopy, and polyp data including histology are collected. Nurse assessment
of patient comfort and patient comfort questionnaires are completed post procedure.
Patients are followed up at 21 days and complete a patient experience questionnaire.
This study will take place across seven NHS Hospital Trusts: one in London and six
within the Northern Region Endoscopy Group. A maximum of 10 colonoscopists per site
will recruit a total of 1772 patients, with a maximum of four bowel screening colonoscopists
permitted per site.
Discussion: This is the first trial to evaluate the adenoma detection rate of Endocuff Vision™
in all screening, surveillance, and diagnostic patient groups. This timely study will
guide clinicians as to the role of Endocuff Vision™ in routine colonoscopy.
Study registration: ISRCTN11821044.
