Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?

Study Overview
=================
Brief Summary
-----------------
Screening colonoscopy for colorectal cancer is essential to diagnose and remove adenomas, precancerous stages of colorectal cancer. Unfortunately approximately 25 % of all adenomas are missed during the examination. Recently a new colonoscopy accessory, the Endorings-2 (EndoAid Ltd., Casearea, Israel), has been designed to improved the detection of adenomas during colonoscopy (adenoma detection rate). Endorings-2 is a silicone-rubber device that is fitted on the colonoscope and is equipped with circular flexible silicon rings mechanically stretching the colonic folds during withdrawal. This study aims to evaluate the efficacy of Endorings-2 to improve the adenoma detection rate in a prospective, blinded clinical trial. 292 patients with an indication for a screening colonoscopy shall be included (1:1 randomization in standard colonoscopy versus Endorings-2-assisted colonoscopy).

Official Title
-----------------
Evaluation of Endorings-2-assisted Colonoscopy: a New Accessory for Improvement of Adenoma Detection Rate?

Conditions
-----------------
Colonic Adenoma, Colonic Polyp, Colonic Neoplasms, Colonoscopy

Intervention / Treatment
-----------------
* Device: Endorings-2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with an indication for a screening colonoscopy. Exclusion Criteria: Patients under 18 years, pregnancy Patients with prior colectomy or partial colectomy Patients with a history of colorectal cancer Patients with hereditary polyposis syndromes (FAP, HNPCC) Patients with a stricture of the colon Patients receiving anticoagulation prohibiting a colonoscopy inability to have a patient education bad conditions prohibiting a colonoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endorings-assisted screening colonoscopy<br>146 patients with an indication for screening endoscopy will receive an Endorings-2-assisted colonoscopy. | Device: Endorings-2<br>* 292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy).<br>* Other names: Endorings-2 (EndoAid Ltd, Caesarea, Israel);|
| No Intervention: Standard screening colonoscopy<br>146 patients with an indication for screening endoscopy will receive a standard colonoscopy. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the adenoma detection rate during screening colonoscopy | The primary outcome of this study is the adenoma detection rate of the standard colonoscopy in comparison to the Endorings-assisted colonoscopy. | Intraoperative. Adenomas detected directly during the examination. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colonoscopy; adenoma detection rate; endorings-2; endorings; device-assisted colonoscopy