Colonic Adenoma, Colonic Polyp, Colonoscopy
Conditions
Keywords
Adenoma Detection Rate, Endocuff, Colonoscopy
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.
Interventions
DEVICEEndocuff Vision (ECV) second generation
Colonoscopy performed with the use of Endocuff Vision (ECV) second generation at the tip of the scope
Sponsors
Société Française d'Endoscopie Digestive
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adenoma detection rate (ADR) | during procedure | rate (%) of colonoscopies with one or more adenoma detected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Advanced neoplasia detection rate (ANDR) | during procedure | rate (%) of colonoscopies with one or more advanced neoplasia detected |
| Serrated polyp detection rate (SPDR) | during procedure | rate (%) of colonoscopies with one or more serrated polyp detected |
| Morbidity: perforation rate (%) | 21 days after procedure | Perforation rates (%) |
| Polyp detection rate (PDR) | during procedure | rate (%) of colonoscopies with one or more polyp detected |
| caecal intubation rate (%) | during procedure | caecal intubation rate (complete colonoscopy) |
| Time to reach caecum (sec) | during procedure | Time to reach caecum from the beginning of the procedure (in seconds) |
| withdrawal time (sec) | during procedure | withdrawal time of the scope from the caecum to the end of the procedure (in seconds) |
| Morbidity: bleeding rate (%) | 21 days after procedure | Bleeding rates (%) |
Countries
France
Outcome results
None listed