Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate

Not Applicable

Completed

• Conditions: Colonic Polyp; Colonic Adenoma; Colonoscopy
• Interventions: Device: Endocuff Vision (ECV) second generation

• Registration Number: NCT03344055
• Lead Sponsor: Société Française d'Endoscopie Digestive

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-11-12
• Study First Submitted QC: 2017-11-14
• Study Start: 2017-11-15
• Study First Posted: 2017-11-17
• Primary Completion: 2018-11-15
• Study Completion: 2018-11-15
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-26
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2059

Inclusion Criteria

1. Patient scheduled for total colonoscopic exploration, during the period study
2. Patient over or equal to 18 years
3. ASA 1, ASA 2, ASA 3
4. No participation in another clinical study
5. Certificate of non opposition signed

Exclusion Criteria

1. Patient under 18 years old
2. ASA 4, ASA 5
3. Pregnant woman
4. Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
5. Inflammatory bowel disease
6. Known colonic stenosis
7. Diverticulitis less than 6 weeks old
8. Patient unable to give consent or protected by law
9. Opposition expressed for inclusion in the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colonoscopy with Endocuff Vision (ECV)	Endocuff Vision (ECV) second generation	ECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation)

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate (ADR)	during procedure	rate (%) of colonoscopies with one or more adenoma detected

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinique PARIS-BERCY; 🇫🇷 Charenton-le-Pont, France