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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colonoscopy with Endocuff Vision (ECV) | Active Comparator | ECV-assisted colonoscopy ( with the use of Endocuff Vision (ECV) Second generation) |
|
| Standard colonoscopy | No Intervention | Standard colonoscopy (without the use of Endocuff Vision (ECV) Second generation) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endocuff Vision (ECV) second generation | Device | Colonoscopy performed with the use of "Endocuff Vision (ECV) second generation" at the tip of the scope |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma detection rate (ADR) | rate (%) of colonoscopies with one or more adenoma detected | during procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique PARIS-BERCY | Charenton-le-Pont | 94220 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32209605 | Derived | Karsenti D, Tharsis G, Perrot B, Cattan P, Tordjman G, Venezia F, Zrihen E, Gillot D, Gillet A, Hagege C, Samama J, Etienney I, Lab JP, Guigui B, Zago J, Benkessou B, Burtin P, Cavicchi M. Adenoma detection by Endocuff-assisted versus standard colonoscopy in routine practice: a cluster-randomised crossover trial. Gut. 2020 Dec;69(12):2159-2164. doi: 10.1136/gutjnl-2019-319565. Epub 2020 Mar 24. |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |