Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate

Study Overview
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Brief Summary
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This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy. This is a prospective comparative study, on 2000 patients, 1000 in each group (with and without ECV)

Detailed Description
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This is a prospective study comparing endocuff-assisted colonoscopy to standard colonoscopy. The goal of this study is to evaluate the interest of second-generation Endocuff Vision (ECV) to improve Adenoma detection rate and / or Polyp detection rate as the Mean Number of Polyps (average number of polyps) in routine colonoscopy. Number of patients: 2000 patients, 1000 in each group (with and without ECV). To limit the risk of bias, the investigators will random two teams of 12 endoscopists matched in number, volume of activity and Adenoma Detection Rate (evaluated over a period of the year preceding the study). Both periods of study will be approximately 3-4 months in length. In order to achieve a perfect balance between the two groups of patients, an inclusion tracking chart will be initiate and will be carefully controlled. Rebalancing will be done for both periods of study to obtain 500 patients per group and per period (= 2000 patients included). Inclusion of 500 consecutive colonoscopies in each team of investigators, a colonoscopy with ECV team, a colonoscopy without ECV team then switch and inclusion of 500 new consecutive colonoscopies in each team, ie 2000 colonoscopies in total. The selection of the team that will begin with ECV (Team A) and the team that will finish with ECV (Team B) will be chosen at random before the start of the study. A comparison of the two colonoscopy groups with ECV vs without ECV will be made for each team (the investigator will be his own control) and then on the overall population after the end of the trial.

Official Title
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Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice

Conditions
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Colonic Adenoma, Colonic Polyp, Colonoscopy

Intervention / Treatment
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* Device: Endocuff Vision (ECV) second generation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient scheduled for total colonoscopic exploration, during the period study Patient over or equal to 18 years ASA 1, ASA 2, ASA 3 No participation in another clinical study Certificate of non opposition signed Exclusion Criteria: Patient under 18 years old ASA 4, ASA 5 Pregnant woman Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress. Inflammatory bowel disease Known colonic stenosis Diverticulitis less than 6 weeks old Patient unable to give consent or protected by law Opposition expressed for inclusion in the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colonoscopy with Endocuff Vision (ECV)<br>ECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation) | Device: Endocuff Vision (ECV) second generation<br>* Colonoscopy performed with the use of Endocuff Vision (ECV) second generation at the tip of the scope<br>|
| No Intervention: Standard colonoscopy<br>Standard colonoscopy (without the use of Endocuff Vision (ECV) Second generation) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adenoma detection rate (ADR) | rate (%) of colonoscopies with one or more adenoma detected | during procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate (PDR) | rate (%) of colonoscopies with one or more polyp detected | during procedure | 
| Advanced neoplasia detection rate (ANDR) | rate (%) of colonoscopies with one or more advanced neoplasia detected | during procedure | 
| Serrated polyp detection rate (SPDR) | rate (%) of colonoscopies with one or more serrated polyp detected | during procedure | 
| Morbidity: perforation rate (%) | Perforation rates (%) | 21 days after procedure | 
| Morbidity: bleeding rate (%) | Bleeding rates (%) | 21 days after procedure | 
| caecal intubation rate (%) | caecal intubation rate (complete colonoscopy) | during procedure | 
| Time to reach caecum (sec) | Time to reach caecum from the beginning of the procedure (in seconds) | during procedure | 
| withdrawal time (sec) | withdrawal time of the scope from the caecum to the end of the procedure (in seconds) | during procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adenoma Detection Rate, Endocuff, Colonoscopy