Detection of Adenomas in Screening Colonoscopy

Detection of Adenomas in Screening Colonoscopy - Endocuff Study

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.

Study Overview

• Status: Completed
• Conditions: Adenoma Colon
• Intervention / Treatment: Device: endocuff; Procedure: no endocuff

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 Type: Interventional
• Enrollment (Actual): 1178
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Midtjylland
    • Herning, Midtjylland, Denmark, 7400
      • Kirurgisk Afdeling

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: endocuff; all patients having performed a screeningscolonoscopy and being randomized to colonoscopy with the use of endocuff	Device: endocuff; Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.
Active Comparator: no cuff; all patients participating in a screeningscolonoscopy being randomized to colonoscopy without the use of endocuff	Procedure: no endocuff; colonoscopy is performed without endocuff.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
adenoma	number of adenomas found during colonoscopy	2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Herning Hospital

Publications and helpful links

General Publications

• Jaensch C, Jepsen MH, Christiansen DH, Madsen AH, Madsen MR. Adenoma and serrated lesion detection with distal attachment in screening colonoscopy: a randomized controlled trial. Surg Endosc. 2022 Sep;36(9):1-9. doi: 10.1007/s00464-022-09049-5. Epub 2022 Feb 9.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2017
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): April 1, 2020

Study Registration Dates

• First Submitted: March 1, 2018
• First Submitted That Met QC Criteria: November 25, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): December 3, 2020
• Last Update Submitted That Met QC Criteria: November 25, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: adenoma detection rate; screening colonoscopy
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Adenoma
• Other Study ID Numbers: 1-16-02-828-17

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No