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OpenTrials
Completed

NCT Number: NCT03758872

CUFF-assisted Colonoscopy vs 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 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

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Key information

Conditions

Colonic Polyp Colonic Polyps Colonoscopy Intestinal Polyps Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Du Trocadero

Paris, 75016, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Diagnostic Test

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)

Primary outcomes

  1. detection of polyp or adenoma with cuff

    Time frame: during procedure

Secondary outcomes

  1. POLYP DETECTION RATE

    Time frame: during procedure

  2. morbidity : perforation rate

    Time frame: 21 DAYS AFTER PROCEDURE

  3. CAECAL INTUBATION RATE

    Time frame: DURING PROCEDURE

  4. TIME TO REACH CAECUM

    Time frame: DURING PROCEDURE

    SEC

  5. WITHDRAWAL TIME

    Time frame: DURING PROCEDURE

    SEC

Sponsors and collaborators

Lead sponsor

Clinique du Trocadéro

Other

Registry information

Official study title

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

Acronym: CUFF-TROCADERO

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 29, 2018
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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