CUFF-assisted Colonoscopy vs Standard Colonoscopy

Completed

• Conditions: Colonic Polyp; Colonoscopy
• Interventions: Diagnostic Test: cuff assisted colonoscopy(with cuff use of endocuff vision second generation)

• Registration Number: NCT03758872
• Lead Sponsor: Clinique du Trocadéro

Brief Summary

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 in routine colonoscopy.

This is a prospective comparative cohort, on 1034 patients, 517 patients with ECV in prospective group and 517 without ECV in retrospective group

Detailed Description

Not available

Study Timeline

• Status Verified: 2018-10
• Study Start: 2018-10-25
• Study First Submitted: 2018-10-26
• Study First Submitted QC: 2018-11-28
• Study First Posted: 2018-11-29
• Primary Completion: 2019-09-26
• Study Completion: 2019-09-26
• Last Update Submitted: 2021-01-26
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1034

Inclusion Criteria

• Patient scheduled for total colonoscopic exploration, during the period study
• Patient over or equal to 18 years
• ASA 1, ASA 2, ASA 3
• No participation in another clinical study
• Certificate of non opposition signed

Exclusion Criteria

• Patient under 18 years old
• ASA 4, ASA 5
• Pregnant woman
• Patient with coagulation abnormalities preventing polypectomy: prothrombin level <50%, -Platelets <50000 / mm3, effective anti-coagulation in progress, clopidogrel in progress.
• Inflammatory bowel disease
• Known colonic stenosis
• Diverticulitis less than 6 weeks old
• Patient unable to give consent or protected by law
• Opposition expressed for inclusion in the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
historical comparaison whithout cuff	cuff assisted colonoscopy(with cuff use of endocuff vision second generation)	517 patients included in 2017 without CUFF and 517 patients will be included in 2018 with CUFF for polyp detection

Primary Outcome Measures

Name	Time	Method
detection of polyp or adenoma with cuff	during procedure

Secondary Outcome Measures

Name	Time	Method
POLYP DETECTION RATE	during procedure
morbidity : perforation rate	21 DAYS AFTER PROCEDURE
CAECAL INTUBATION RATE	DURING PROCEDURE
TIME TO REACH CAECUM	DURING PROCEDURE	SEC
WITHDRAWAL TIME	DURING PROCEDURE	SEC

Trial Locations

Locations (1)

Clinique Du Trocadero; 🇫🇷 Paris, France