Clinical trial NCT03344055: Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate
Official title: Endocuff-assisted Colonoscopy vs Standard Colonoscopy on Adenoma Detection Rate: A Comparative Prospective Study in Common Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Adenoma
Colonic Polyp
Colonoscopy
Keywords: Adenoma Detection Rate
Endocuff
Colonoscopy
Lead sponsor: Société Française d'Endoscopie Digestive
Sponsor class: OTHER
First posted: 2017-11-17
Enrollment: 2059
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Adenoma detection rate (ADR)
timeFrame: during procedure
Secondary outcomes:
measure: Polyp detection rate (PDR)
timeFrame: during procedure
measure: Advanced neoplasia detection rate (ANDR)
timeFrame: during procedure
measure: Serrated polyp detection rate (SPDR)
timeFrame: during procedure
measure: Morbidity: perforation rate (%)
timeFrame: 21 days after procedure
measure: Morbidity: bleeding rate (%)
timeFrame: 21 days after procedure
measure: caecal intubation rate (%)
timeFrame: during procedure
measure: Time to reach caecum (sec)
timeFrame: during procedure
measure: withdrawal time (sec)
timeFrame: during procedure
Other outcomes:
Locations:
city: Charenton-le-Pont
country: France
facility: Clinique PARIS-BERCY
Study officials:
References:
citation: 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.