BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities
Condition: Colorectal Neoplasms; Colonic Polyp; Adenoma; Neoplasia GI; Digestive System Neoplasms; Intestinal Neoplasms; Neoplasms, Glandular and Epithelial; Digestive Disease; Intestinal Diseases; Colonic Diseases; Rectal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical
MeSH terms: Neoplasms; Adenoma; Colorectal Neoplasms; Digestive System Neoplasms; Gastrointestinal Neoplasms; Intestinal Neoplasms; Neoplasms, Glandular and Epithelial; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Polyps; Colonic Polyps; Intestinal Polyps; Pathological Conditions, Anatomical
Study type: Interventional

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).
    

Intervention name(s): Endocuff Vision
Intervention type(s): Device
Intervention description(s): The EndocuffTM (ARC Medical Design Ltd and Diagmed, UK) is a device (CE marked in UK) made of a soft plastic material with a unique dynamic shape. Endocuff Vision™ is placed snugly around the colonoscope tip prior to insertion. It does not project beyond the tip of the scope, providing an unrestricted view. It helps anchor the scope tip against the bowel wall to provide a stable platform of access. The soft, elastic projections are pushed back (recoiled) towards the scope shaft during insertion but evert during withdrawal to hold colon folds away from the field of view.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Colorectal Cancer; Endoscopy; Screening; Colonic Adenoma; Adenoma Detection Rate; Endocuff; Endocuff Vision