NCT03344055

Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 2,059 (actual)
• Sponsor: Société Française d'Endoscopie Digestive · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colonic Adenoma
• Colonic Polyp
• Colonoscopy

Interventions

Type	Name	Description
DEVICE	Endocuff Vision (ECV) second generation	Colonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope

Timeline

• Start date: 2017-11-15
• Primary completion: 2018-11-15
• Completion: 2018-11-15
• First posted: 2017-11-17
• Last updated: 2019-01-29

Locations

1 site across 1 country: France