Detection of Adenomas in Screening Colonoscopy

Adenoma Colon Clinical Trial

Official title:

Detection of Adenomas in Screening Colonoscopy - Endocuff Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651062
• Other study ID #: 1-16-02-828-17
• Status: Completed
• Phase: N/A
• Start date: October 1, 2017
• Est. completion date: April 1, 2020

Study information

• Verified date: November 2020
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1178
• Est. completion date: April 1, 2020
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Adenoma Colon

Intervention

Device:
• endocuff
Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.

Procedure:
• no endocuff
colonoscopy is performed without endocuff.

Locations

Country	Name	City	State
Denmark	Kirurgisk Afdeling	Herning	Midtjylland

Sponsors (1)

Lead Sponsor	Collaborator
Herning Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

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