Detection of Adenomas in Screening Colonoscopy

Study Overview
=================
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.

Official Title
-----------------
Detection of Adenomas in Screening Colonoscopy - Endocuff Study

Conditions
-----------------
Adenoma Colon

Intervention / Treatment
-----------------
* Device: endocuff
* Procedure: no endocuff


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: this is a randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

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

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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adenoma detection rate, screening colonoscopy