Detection of Adenomas in Screening Colonoscopy

Not Applicable

Completed

• Conditions: Adenoma Colon
• Interventions: Device: endocuff; Procedure: no endocuff

• Registration Number: NCT04651062
• Lead Sponsor: Herning Hospital

Brief Summary

The Endocuff study aims to show an increase of the number of detected adenomas in screening colonoscopies when a endocuff vision (Arc Medical Design Ldt Leeds England) is used.

Detailed Description

Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope. Several minor studies have shown that the use of Endocuff probably increases the number of detected polyps in colonoscopy. Endocuff is made of soft plastic and has been designed to give an optimal view of the entire colon. It gently averts and flattens folds in order to see small polyps "hiding" in the space behind colonic folds.

The purpose of this study is to investigate into the effect of the Endocuff in screening colonoscopy compared with screening colonoscopy performed without Endocuff. The device has been used during several years yet an effect on the number of polyps detected during screenings colonoscopy has not been shown. This studies main hypothesis is that the use of Endocuff in screenings colonoscopy will increase the adenoma detection rate in these patients, with a potential to reduce interval cancer.

This study is a randomized controlled trial with 900 patients.

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2018-03-01
• Primary Completion: 2018-12-01
• Study Completion: 2020-04-01
• Status Verified: 2020-11
• Study First Submitted QC: 2020-11-25
• Last Update Submitted: 2020-11-25
• Study First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1178

Inclusion Criteria

• all Citizens participating in the national bowel screening program

Exclusion Criteria

• persons who are disabled and who do not understand the Danish language
• persons treated with Marcoumar, Marevan, Eliquis, Pradaxa e.g. and who are not eligible to polyp resection
• persons who due to diseases of the eyes or Heart are not allowed to receive Buscopan.
• persons with active colitis/diverticulitis, colon stenosis e.g. due to cancer, where a complete colonoscopy is not possible to achieve

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
endocuff	endocuff	all patients having performed a screeningscolonoscopy and being randomized to colonoscopy with the use of endocuff
no cuff	no endocuff	all patients participating in a screeningscolonoscopy being randomized to colonoscopy without the use of endocuff

Primary Outcome Measures

Name	Time	Method
adenoma	2 weeks	number of adenomas found during colonoscopy

Secondary Outcome Measures

Name	Time	Method
cecal intubation time	up to 2 hours	number of minutes from start procedure to cecum reached
cecal intubation rate	up to 2 hours	is the cecum reached during the colonoscopy
adenoma size	up to 4 weeks	size of adenomas detected
withdrawal time	up to 60 minutes	number of minutes from cecum reached to end of the procedure, only if no polyps are found
adenoma site	up to 4 weeks	where in the bowel the adenoma was detected

Trial Locations

Locations (1)

Kirurgisk Afdeling; 🇩🇰 Herning, Midtjylland, Denmark