CUFF-assisted Colonoscopy vs Standard Colonoscopy (CUFF-TROCADERO)

Clinique du Trocadéro

Status: Completed

Conditions: Colonic Polyp; Colonoscopy

Treatments: Diagnostic Test: cuff assisted colonoscopy(with cuff use of endocuff vision second generation)

Study type: Observational

Funder types: Other

Identifiers

NCT03758872

2018-A01397-48

Details and patient eligibility

About

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

Enrollment: 1,034 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

1,034 participants in 1 patient group

historical comparaison whithout cuff

Description:

517 patients included in 2017 without CUFF and 517 patients will be included in 2018 with CUFF for polyp detection

Treatment:

Diagnostic Test: cuff assisted colonoscopy(with cuff use of endocuff vision second generation)