BowelScope: Accuracy of Detection Using ENdocuff Optimisation of Mucosal Abnormalities

NCT ID: NCT03072472

Last Updated: 2018-09-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3221 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-14
• Study Completion Date: 2018-02-13

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).

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Endocuff-assisted Flexible Sigmoidoscopy

Patients in this arm will receive their screening sigmoidoscopy with the Endocuff Vision in situ on the scope

Group Type: EXPERIMENTAL

Endocuff Vision

Intervention Type: DEVICE

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.

Standard Flexible Sigmoidoscopy

Patients in this arm will receive their screening sigmoidoscopy without the Endocuff on the scope

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 61 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

ARC Medical Design Ltd

UNKNOWN

Sponsor Role: collaborator

Norgine

INDUSTRY

Sponsor Role: collaborator

South Tyneside and Sunderland NHS Foundation Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Colin J Rees, MBBS MRCP FRCP

Role: PRINCIPAL_INVESTIGATOR

South Tyneside and Sunderland NHS Foundation Trust

Locations

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

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 32245908 (View on PubMed)

Other Identifiers

B-ADENOMA

Identifier Type: -

Identifier Source: org_study_id