The B-ADENOMA Study: Bowelscope – Accuracy of Detection using Endocuff Optimisation of Mucosal Abnormalities: Study Protocol for randomised controlled trial
submitted 16 November 2017
accepted after revision 26 February 2018
04 July 2018 (online)
Background and study aims UK Bowel Cancer Screening flexible sigmoidoscopy (BowelScope) currently offers patients aged 55 a one-off flexible sigmoidoscopy for adenoma clearance to decrease colorectal cancer incidence by interrupting the adenoma-carcinoma sequence. Recent evidence has shown maximum benefit in increasing adenoma detection rate (ADR) using the Endocuff Vision device in the left side of the colon and in screening patients. Currently, ADR is low and shows unacceptable variation in BowelScope. ADR is a quality indicator in screening sigmoidoscopy and higher rates have been shown to reduce colorectal cancer incidence.
Patients and methods This will be a prospective, multicenter, UK-based randomized controlled trial (RCT) comparing ADR in Endocuff-assisted versus standard bowel cancer screening flexible sigmoidoscopy (BowelScope). All patients aged 55 to 61 years invited to BowelScope screening and able to give informed consent will be eligible for recruitment. Exclusion criteria include absolute contraindications to flexible sigmoidoscopy, known or suspected large bowel obstruction or pseudo-obstruction, colonic strictures or polyposis syndromes, known severe diverticular segment, active colitis, inability to give informed consent, anticoagulation precluding polypectomy and pregnancy. Patients will be randomized on the day of procedure to Endocuff-assisted flexible sigmoidoscopy or standard flexible sigmoidoscopy, stratified by age group and sex. Baseline, endoscopy and polyp data were collected as well as nurse and patient assessment of comfort. Polyp histology was collected when available. Patients will be asked to return a comfort questionnaire the following day and were followed up for 14 days for complications.
The study will take place across 12 to 20 hospital trusts across the UK and recruited 3222 patients.
Results The ADENOMA trial will be designed to demonstrate a significant improvement in ADR with maximal effect in the left colon and in fecal occult blood test-positive screening patients. This trial will be the first RCT to look at Endocuff Vision in bowel cancer screening flexible sigmoidoscopy. We will aim to establish whether Endocuff vision improves ADR in this population.
Clinicaltrials.gov Identifier: NCT03072472
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