DEtection in Tandem Endocuff Cap Trial (DETECT)
Research type
Research Study
Full title
Is Endocuff Vision assisted colonoscopy superior to Cap assisted colonoscopy to detect adenomas:\nDEtection in Tandem Endocuff Cap Trial (DETECT)\n
IRAS ID
181292
Contact name
Brian Saunders
Contact email
Sponsor organisation
London North West Healthcare NHS Trust
ISRCTN Number
ISRCTN58994883
Duration of Study in the UK
1 years, 3 months, 9 days
Research summary
Colonoscopy screening with the removal of adenomas has been considered as the preferred and most effective strategy to reduce colorectal cancer (CRC) incidence. However colonoscopy remains as an imperfect tool for the prevention of CRC. One of the important reason is that adenomas can be missed during colonoscopic inspection. \nReasons for lesions not being detected at colonoscopy include; suboptimal technique; shorter withdrawal time; inadequate bowel preparation; presence of flat and subtle lesions; and the inability to visualise the proximal side of haustral folds . Lesions located on the proximal sides of colonic folds may be missed during standard conventional colonoscopy. Although views may be improved with dynamic patient position changing, these manoeuvres may not be effective, particularly in the narrower colonic segments.\n\nTotal procedure time would be prolonged by about 10-15 minutes. \n\nA transparent cap attached to the tip of the scope has been shown to improve mucosal visualisation by stretching or splaying the mucosal folds. However, they make the tip of the scope more rigid and longer .\nWith the aid of the new colonoscopic cuff EndocuffTM Vision, we aim to improve access in the large bowel by flattening colonic folds. We hypothesise that the EndocuffTM Vision will improve adenoma detection rates by providing better fold retraction, a wider field of view and better scope tip stabilisation when compared to cap. \nThis clinical randomised prospective tandem study will be conducted in subjects referred and scheduled for diagnostic or surveillance colonoscopy through the symptomatic NHS service, and will compare Endocuff-Assisted Colonoscopy (EAC) with Cap Assisted Colonoscopy (CAC). \n All procedures will be done by experienced endoscopists (colonoscopic experience of 1500). The study data will be collected and analysed by the principal investigators. \n\nEach patient will undergo two consecutive colonoscopies by the same endoscopist.
REC name
East of England - Cambridge East Research Ethics Committee
REC reference
15/EE/0415
Date of REC Opinion
4 Jan 2016
REC opinion
Further Information Favourable Opinion