Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

Study Overview
=================
Brief Summary
-----------------
Colonoscopy is the gold standard for colorectal cancer prevention by allowing the resection of superficial colorectal adenomas or adenocarcinomas. This protection, more effective in the left colon than in the right colon, is imperfect and there are some adenomas and cancers omitted during colonoscopy. The G-EYE colonoscope equipped with an integrated distal balloon would better unfold the haustrations and stabilize the endoscope. Thus, the detection rate of adenomas would be improved by this better vision. The main objective of this study is to confirm that the use of the G-EYE colonoscope allows better detection of adenomatous polyps, decrease the rate of omitted adenomes and then is more effective.

Official Title
-----------------
Panoramic Screening by Complete Colonoscopy in the Management of Colorectal Adenomas

Conditions
-----------------
Colorectal Adenoma

Intervention / Treatment
-----------------
* Device: G-EYE first and standard colonoscope
* Device: standard colonoscope first and G-EYE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication of complete colonoscopy for classic indications (bleeding, abdominal pain, transit disorders) or for family and personal antecedents of adenomas or colorectal cancers with the need for endoscopic control, FIT + test (current blood test for stool used for mass screening in France), PET-CT fixation, Consent of participation signed, Affiliation to a social security scheme, or beneficiary of such a scheme. Exclusion Criteria: Non-optimal preparation (boston score <7 or segment <2), Adenomatous polyposis, familial or assimilated (juvenile, etc.), Pregnant or likely to be pregnant (without effective contraception) or breastfeeding, Patient in emergency or deprived of liberty or placed under the authority of a tutor, Patient considered geographically socially or psychologically unable to comply with the study procedure and the medical follow-up.

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

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, single-phase, two-stage, randomized phase II study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A: Standard colonoscopy then colonoscopy with G-EYE<br>Arm A: Standard colonoscopy then colonoscopy with G-EYE | Device: standard colonoscope first and G-EYE<br>* Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)<br>|
| Experimental: Arm B: G-EYE colonoscopy then standard colonoscopy<br>Arm B: G-EYE colonoscopy then standard colonoscopy | Device: G-EYE first and standard colonoscope<br>* Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) | Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections | Colonoscopy time | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of missed advanced adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) | Rate between the number of advanced adenomas detected by the second examination and the number of advanced adenomas detected by the two inspections | Colonoscopy time | 
| Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in male and female | Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in male and female | Colonoscopy time | 
| Rate of complications | Global and for each arm | Colonoscopy time and 1 month after | 
| Rate of missed adenomas during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in positive fetal immunochemical test (FIT+) subgroup | Rate between the number of adenomas detected by the second examination and the number of adenomas detected by the two inspections in FIT+ subgroup | Colonoscopy time | 
| Adenoma detected rate during standard colonoscopy and balloon-assisted colonoscopy (G-EYE device) in FIT+ subgroup | Rate between the number of detected adenomas with each endoscope and the number of colonoscopies performed in FIT+ subgroup | Colonoscopy time | 
| G-EYE assistance for endoscope stabilization | Yes or no | Colonoscopy time | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, g-eye, adenomas