Clinique PARIS-BERCY
Charenton-le-Pont, 94220, France
NCT Number: NCT03344055
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)
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Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Charenton-le-Pont, 94220, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Colonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope
Time frame: during procedure
rate (%) of colonoscopies with one or more adenoma detected
Time frame: during procedure
rate (%) of colonoscopies with one or more polyp detected
Time frame: during procedure
rate (%) of colonoscopies with one or more advanced neoplasia detected
Time frame: during procedure
rate (%) of colonoscopies with one or more serrated polyp detected
Time frame: 21 days after procedure
Perforation rates (%)
Time frame: 21 days after procedure
Bleeding rates (%)
Time frame: during procedure
caecal intubation rate (complete colonoscopy)
Time frame: during procedure
Time to reach caecum from the beginning of the procedure (in seconds)
Time frame: during procedure
withdrawal time of the scope from the caecum to the end of the procedure (in seconds)
Société Française d'Endoscopie Digestive
Other
Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice
Acronym: Cuff-Bercy
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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