BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities (B-ADENOMA)

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.

Study Overview

• Status: Completed
• Conditions: Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Colonic Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Adenoma; Polyps; Colonic Polyp; Intestinal Polyps; Digestive Disease; Neoplasia GI
• Intervention / Treatment: Device: Endocuff Vision

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).

• Study Type: Interventional
• Enrollment (Actual): 3221
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Bolton, United Kingdom
    • Bolton NHS Foundation Trust
  • Cheltenham, United Kingdom, GL53 7AN
    • Gloucestershire Hospitals NHS Foundation Trust
  • Dorchester, United Kingdom
    • Dorset Healthcare University NHS Trust
  • Durham, United Kingdom, DH1 5TW
    • County Durham and Darlington NHS Foundation Trust
  • Kendal, United Kingdom, LA9 7RG
    • University Hospitals of Morecambe Bay NHS Foundation Trust
  • Kettering, United Kingdom, NN16 8UZ
    • Kettering General Hospital NHS Trust
  • London, United Kingdom, HA1 3UJ
    • North West London Hospitals NHS Trust
  • North Shields, United Kingdom, NE29 8NH
    • Northumbria Healthcare NHS Foundation Trust
  • Oxford, United Kingdom, OX3 9DU
    • Oxford Health NHS Trust
  • Portsmouth, United Kingdom, PO6 3LY
    • Portsmouth Hospitals NHS Trust
  • Rochdale, United Kingdom, OL12 0NB
    • Pennine Acute Hospitals NHS Trust
  • Sheffield, United Kingdom, S5 7AU
    • Sheffield Teaching Hospitals NHS Foundation Trust
  • Stockton on Tees, United Kingdom, TS19 8PE
    • North Tees and Hartlepool NHS Trust
  • Watford, United Kingdom
    • West Hertfordshire Hospitals NHS Trust
  • Wolverhampton, United Kingdom, WV10 0QP
    • The Royal Wolverhamptom NHS Trust
  • Tyne And Wear
    • South Shields, Tyne And Wear, United Kingdom, NE34 0PL
      • South Tyneside NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 61 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 18 years and over
2. Referral for screening flexible sigmoidoscopy
3. Ability to give informed consent

Exclusion Criteria:

1. Absolute contraindications to flexible sigmoidoscopy
2. Established or suspicion of large bowel obstruction or pseudo-obstruction
3. Known colon cancer or polyposis syndromes
4. Known colonic strictures
5. Known severe diverticular segment (that is likely to impede sigmoidoscope passage)
6. Patients with known active colitis (ulcerative colitis, Crohn's colitis, diverticulitis, infective colitis)
7. Patients lacking capacity to give informed consent
8. Patients who are on clopidogrel, warfarin, or other new generation anticoagulants which have not been stopped for the procedure as these will preclude polyp removal
9. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Endocuff-assisted Flexible Sigmoidoscopy; Patients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope	Device: Endocuff Vision; 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.
No Intervention: Standard Flexible Sigmoidoscopy; Patients in this arm will receive their screening sigmoidoscopy without the Endocuff on the scope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adenoma Detection Rate	Proportion of examinations expressed as a percentage where at least one adenoma is found	Day of procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean adenomas detected per procedure	Number of adenomas found in each procedure	Day of procedure
Rate of cuff exchange	How often the cuff is removed	Day of procedure
Non-inferiority of complete withdrawal time in procedures where no polyps are detected	Length of procedure in minutes and seconds	Day of procedure
Compare overall procedure time between groups	Length of procedure in minutes and seconds	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	Day of procedure
Compare the rate of discovered cancers between groups	Number of cancers found	On histology check 48-72 hours post procedure
Examination extent between groups based on presumed anatomical location with a straight endoscope	Anatomical location	Day of procedure
Examination extent between groups based on distance of insertion in centimetres with a straight endoscope	Depth of insertion in centimetres	Day of procedure
Patient satisfaction between groups using the Gloucester scale of assessment of patient comfort	Numerical 4 point patient comfort score	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	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	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	18 months

Collaborators and Investigators

• Sponsor: South Tyneside and Sunderland NHS Foundation Trust
• Collaborators: Norgine; ARC Medical Design Ltd
• Investigators: Principal Investigator: Colin J Rees, MBBS MRCP FRCP, South Tyneside and Sunderland NHS Foundation Trust

Publications and helpful links

General Publications

• Rees CJ, Brand A, Ngu WS, Stokes C, Hoare Z, Totton N, Bhandari P, Sharp L, Bastable A, Rutter MD, Verma AM, Lee TJ, Walls M; B-ADENOMA trial group comprises. BowelScope: Accuracy of Detection Using Endocuff Optimisation of Mucosal Abnormalities (the B-ADENOMA Study): a multicentre, randomised controlled flexible sigmoidoscopy trial. Gut. 2020 Nov;69(11):1959-1965. doi: 10.1136/gutjnl-2019-319621. Epub 2020 Apr 3.

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2017
• Primary Completion (Actual): February 13, 2018
• Study Completion (Actual): February 13, 2018

Study Registration Dates

• First Submitted: January 16, 2017
• First Submitted That Met QC Criteria: March 1, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): September 6, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Screening; Endoscopy; Colorectal Cancer; Adenoma Detection Rate; Endocuff; Endocuff Vision; Colonic Adenoma
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Gastrointestinal Diseases; Neoplasms; Colorectal Neoplasms; Adenoma; Gastrointestinal Neoplasms; Digestive System Neoplasms; Polyps; Colonic Polyps; Intestinal Diseases; Intestinal Neoplasms; Neoplasms, Glandular and Epithelial; Colonic Diseases; Rectal Diseases; Intestinal Polyps; Pathological Conditions, Anatomical
• Other Study ID Numbers: B-ADENOMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No