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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03758872
Recruitment Status : Completed
First Posted : November 29, 2018
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Clinique du Trocadéro

Study Description
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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


Condition or disease Intervention/treatment
Colonic Polyp Colonoscopy Diagnostic Test: cuff assisted colonoscopy(with cuff use of endocuff vision second generation)

Study Design
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Study Type : Observational
Actual Enrollment : 1034 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: USE OF ENDOCUFF SECOND GENERATION IN THE COLIC POLYPS DETECTION: HISTORIC COHORTE PROSPECTIVE COMPARATIVE
Actual Study Start Date : October 25, 2018
Actual Primary Completion Date : September 26, 2019
Actual Study Completion Date : September 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Groups and Cohorts
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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)


Outcome Measures
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Primary Outcome Measures :
  1. detection of polyp or adenoma with cuff [ Time Frame: during procedure ]

Secondary Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patient of all participating physicians for total colonoscopic exploration over the study periods
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03758872


Locations
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France
Clinique Du Trocadero
Paris, France, 75016
Sponsors and Collaborators
Clinique du Trocadéro
More Information
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Responsible Party: Clinique du Trocadéro
ClinicalTrials.gov Identifier: NCT03758872    
Other Study ID Numbers: 2018-A01397-48
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polyps
Colonic Polyps
Pathological Conditions, Anatomical
Intestinal Polyps