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Brief Title: BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Official Title: BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Study ID: NCT03072472
Brief Summary: This study aims to assess the effect, if any, on the adenoma detection rate of BowelScope bowel cancer screening flexible sigmoidoscopies by using the Endocuff Vision device.
Detailed Description: Colorectal cancer (CRC) is the fourth most common cancer in the UK with 40,000 new cases diagnosed annually. Most CRCs arise from the adenoma-carcinoma sequence which is a process that can take up to 10 years. Population screening programmes allow for earlier detection and removal of adenomas that may become malignant over time thus reducing CRC mortality. The English Bowel Scope Screening (BSS) programme began in 2013 and invites adults aged 55 and above for a one-off flexible sigmoidoscopy. The aim of the BSS programme is to reduce CRC development via the adenoma-carcinoma sequence through the detection and removal of adenomas from the left side of the colon. A large UK study has shown that offering one-off flexible sigmoidoscopy screening with adenoma clearance to adults aged 55-64 years reduced CRC incidence by 23% and mortality by 31%. Adenoma detection rate (ADR) is the most important marker of mucosal visualisation and is a surrogate marker of high quality colonoscopy. Data from colonoscopy studies have illustrated that a 1% increase in ADR is associated with a 3% decrease in interval colorectal cancer. In the BSS programme, ADR is comparatively lower the that shown in the initial sigmoidoscopy screening trials with a wide variation between endoscopists. Another marker that is often used is adenoma miss rates which also demonstrate a wide variation in clinical practice. Reasons for lesions not being detected at flexible sigmoidoscopy can be extrapolated from colonoscopy data and include; suboptimal technique; shorter withdrawal time; inadequate bowel preparation; presence of flat, depressed or subtle lesions; and the inability to visualise the proximal side of haustral folds, flexures (blind spots) and rectal valves. With the aid of the colonoscopic cuff Endocuff Vision®, the investigators aim to improve visualisation of the colonic mucosa by flattening colonic folds and manipulating them away from the field of forward view the investigators hypothesise that the Endocuff Vision® will improve adenoma detection rates by providing better fold retraction, a wider field of view and better scope tip stabilisation. This clinical randomised study will be conducted in subjects referred and scheduled for screening flexible sigmoidoscopy via the NHS English Bowel Scope Screening (BSS) Programme and will compare Endocuff Vision®-Assisted Flexible Sigmoidoscopy (EAFS) with Standard Flexible Sigmoidoscopy (SFS).
Minimum Age: 55 Years
Eligible Ages: ADULT
Sex: ALL
Healthy Volunteers: Yes
South Tyneside NHS Foundation Trust, South Shields, Tyne And Wear, United Kingdom
Bolton NHS Foundation Trust, Bolton, , United Kingdom
Gloucestershire Hospitals NHS Foundation Trust, Cheltenham, , United Kingdom
Dorset Healthcare University NHS Trust, Dorchester, , United Kingdom
County Durham and Darlington NHS Foundation Trust, Durham, , United Kingdom
University Hospitals of Morecambe Bay NHS Foundation Trust, Kendal, , United Kingdom
Kettering General Hospital NHS Trust, Kettering, , United Kingdom
North West London Hospitals NHS Trust, London, , United Kingdom
Northumbria Healthcare NHS Foundation Trust, North Shields, , United Kingdom
Oxford Health NHS Trust, Oxford, , United Kingdom
Portsmouth Hospitals NHS Trust, Portsmouth, , United Kingdom
Pennine Acute Hospitals NHS Trust, Rochdale, , United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, , United Kingdom
North Tees and Hartlepool NHS Trust, Stockton on Tees, , United Kingdom
West Hertfordshire Hospitals NHS Trust, Watford, , United Kingdom
The Royal Wolverhamptom NHS Trust, Wolverhampton, , United Kingdom
Name: Colin J Rees, MBBS MRCP FRCP
Affiliation: South Tyneside and Sunderland NHS Foundation Trust
Role: PRINCIPAL_INVESTIGATOR