Detection of Adenomas in Screening Colonoscopy

November 25, 2020 updated by: Claudia Jaensch, Herning Hospital

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 2 weeks
number of adenomas found during colonoscopy
2 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Herning Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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