Endocuff Adenoma Detection Rate Pilot Study

Not Applicable

• Conditions: Colorectal Adenoma; Colorectal Cancer
• Interventions: Device: Endocuff attachment

• Registration Number: NCT01761097
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

Colorectal cancer is the second leading cause of cancer deaths in the UK(1) . Detection of cancer at an early stage, as well as detection and removal of polyps through gold standard colonoscopy examination decreases mortality from the disease. However colonoscopy has a well documented miss rate, with some areas of the bowel difficult to visualise and neoplastic lesions potentially hidden behind folds in the colon.

The Endocuff© is a disposable polymer sleeve with hinged lateral arms. The arms flatten mucosal folds and fix the colonoscope centrally in the bowel lumen allowing controlled withdrawal and improving mucosal visualization. The cap easily attaches to the tip of current colonoscopes without modification. In this single centre, randomised controlled trial, the investigators aim to assess the performance of the current gold standard colonoscopic examination against the current gold standard colonoscopic examination with the Endocuff© attached to the colonoscope.

The investigators aim to recruit 300 patients (150 in each group) who have previously been identified to have colonic polyps or cancers undergoing surveillance colonoscopy following NICE guidelines(2). Colonoscopy will be performed by Joint Advisory Group on gastro-intestinal endoscopy (JAG) certified colonoscopists following quality indicator guidance. All patients undertaking follow up surveillance colonoscopy for previous polyps or cancer will be invited to participate and those agreeing will be randomly allocated to one or other technique.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-01
• Study Start: 2013-01
• Study First Submitted: 2013-01-03
• Study First Submitted QC: 2013-01-03
• Study First Posted: 2013-01-04
• Last Update Submitted: 2013-01-04
• Last Update Posted: 2013-01-08
• Primary Completion: 2013-10
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• Patients undergoing surveillance colonoscopy test as part of the colonic adenoma and cancer surveillance programme.
• Ability to understand the nature and requirements of the study and to provide written informed consent.

Exclusion Criteria

• Contraindication to undergo standard colonoscopy.
• Severe active colitis.
• Known colonic stricture

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endocuff assisted colonoscopy	Endocuff attachment	Endocuff attachment

Primary Outcome Measures

Name	Time	Method
Proportion of patients with adenomas and cancers detected	immediate

Secondary Outcome Measures

Name	Time	Method
Caecal intubation time	Immediate

Trial Locations

Locations (1)

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom