Detection of Adenomas in Screening Colonoscopy

Herning Hospital

Status: Completed

Conditions: Adenoma Colon

Treatments: Device: endocuff; Procedure: no endocuff

Study type: Interventional

Funder types: Other

Identifiers

NCT04651062

1-16-02-828-17

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,178 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,178 participants in 2 patient groups

endocuff

Experimental group

Description:

all patients having performed a screeningscolonoscopy and being randomized to colonoscopy with the use of endocuff

Treatment:

Device: endocuff

no cuff

Active Comparator group

Description:

all patients participating in a screeningscolonoscopy being randomized to colonoscopy without the use of endocuff

Treatment:

Procedure: no endocuff