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

January 26, 2021 updated by: Clinique du Trocadéro

USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1034

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75016
        • Clinique du Trocadero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient of all participating physicians for total colonoscopic exploration over the study periods

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
historical comparaison whithout cuff
517 patients included in 2017 without CUFF and 517 patients will be included in 2018 with CUFF for polyp detection
Diagnostic test: cuff assisted colonoscopy(with cuff use of endocuff vision second generation)
this is a cohort prospective comparative, a group without cuff in 2017, 517 patient included in the retrospective phase, and in 2018, 517 patient will be included in the prospective phase with CUFF for detecting polyps
Other Names:
  • colonoscopy with polypectomy or mucosectomy
  • standard colonoscopy ( without use of endocuff vision)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
detection of polyp or adenoma with cuff
Time Frame: during procedure
during procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
POLYP DETECTION RATE
Time Frame: during procedure
during procedure
morbidity : perforation rate
Time Frame: 21 DAYS AFTER PROCEDURE
21 DAYS AFTER PROCEDURE
CAECAL INTUBATION RATE
Time Frame: DURING PROCEDURE
DURING PROCEDURE
TIME TO REACH CAECUM
Time Frame: DURING PROCEDURE
SEC
DURING PROCEDURE
WITHDRAWAL TIME
Time Frame: DURING PROCEDURE
SEC
DURING PROCEDURE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique du Trocadéro

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 25, 2018

Primary Completion (Actual)

September 26, 2019

Study Completion (Actual)

September 26, 2019

Study Registration Dates

First Submitted

October 26, 2018

First Submitted That Met QC Criteria

November 28, 2018

First Posted (Actual)

November 29, 2018

Study Record Updates

Last Update Posted (Actual)

January 29, 2021

Last Update Submitted That Met QC Criteria

January 26, 2021

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-A01397-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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