Endosc Int Open 2016; 04(02): E205-E212
DOI: 10.1055/s-0041-107900
Original article
© Georg Thieme Verlag KG Stuttgart · New York

The ADENOMA Study. Accuracy of Detection using Endocuff Vision™ Optimization of Mucosal Abnormalities: study protocol for randomized controlled trial

Roisin Bevan1, Wee Sing Ngu1, Brian P. Saunders2, Zacharias Tsiamoulos2, Paul Bassett3, Zoe Hoare4, Colin J. Rees1
  • 1South Tyneside NHS Foundation Trust, Harton Lane, South Shields, Tyne and Wear, UK
  • 2Wolfson Unit for Endoscopy, St Mark’s Hospital, Harrow, Middlesex, UK
  • 340 Longwood Lane, Amersham, Bucks, UK
  • 4North Wales Organisation for Randomised Trials in Health, Bangor University, Holyhead Road, Bangor, Gwynedd, UK
Further Information

Publication History

submitted 03 June 2015

accepted after revision 01 October 2015

Publication Date:
27 November 2015 (eFirst)

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.