An interventional study of Endocuff Vision in Colorectal Neoplasms, Colonic Polyp and Adenoma, sponsored by South Tyneside and Sunderland NHS Foundation Trust. Completed at 16 sites in United Kingdom. Open to participants aged 55 Years to 61 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-06.
Sponsored by South Tyneside and Sunderland NHS Foundation Trust · Not applicable, Interventional, and Prevention
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.
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).
9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.
This study's enrollment of 3,221 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.
Browse Neoplasms studies →South Tyneside and Sunderland NHS Foundation Trust is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope
Device: Endocuff Vision
Patients in this arm will receive their screening sigmoidoscopy without the Endocuff on the scope
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.
Adenoma Detection Rate
Proportion of examinations expressed as a percentage where at least one adenoma is found
Time frame: Day of procedure
Mean adenomas detected per procedure
Number of adenomas found in each procedure
Time frame: Day of procedure
Rate of cuff exchange
How often the cuff is removed
Time frame: Day of procedure
Non-inferiority of complete withdrawal time in procedures where no polyps are detected
Length of procedure in minutes and seconds
Time frame: Day of procedure
Compare overall procedure time between groups
Length of procedure in minutes and seconds
Time frame: Day of procedure
Measure differences in ADR accounting for patient procedure based variables (e.g. accounting for extent of examination and bowel preparation).
Proportion of examinations expressed as a percentage where at least one adenoma is found
Time frame: Day of procedure
Compare the rate of discovered cancers between groups
Number of cancers found
Time frame: On histology check 48-72 hours post procedure
Examination extent between groups based on presumed anatomical location with a straight endoscope
Anatomical location
Time frame: Day of procedure
Examination extent between groups based on distance of insertion in centimetres with a straight endoscope
Depth of insertion in centimetres
Time frame: Day of procedure
Patient satisfaction between groups using the Gloucester scale of assessment of patient comfort
Numerical 4 point patient comfort score
Time frame: Day of procedure
Identify any difference in future colonoscopic workload produced by increased ADR in terms of number of patients referred for full colonoscopy between the EAFS and SFS groups.
Number of additional colonoscopies required
Time frame: Day of procedure
Compare the ADR of the first 20% of patients scoped by each colonoscopist with the last 20% of patients in each arm to identify any changes in ADR to assess any learning curve effect.
Proportion of examinations expressed as a percentage where at least one adenoma is found
Time frame: 18 months
Compare the baseline ADR of each colonoscopist prior to trial recruitment with their individual ADR in patients where EndocuffTM Vision was not used.
Proportion of examinations expressed as a percentage where at least one adenoma is found
Time frame: 18 months
Plan to share: No
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South Tyneside and Sunderland NHS Foundation Trust