ColonoScopy: Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05172713
Collaborator
(none)
100
1
14.9
6.7

Study Details

Study Description

Brief Summary

In France, colorectal cancer (CRC) is the second leading cause of cancer death. Its organized screening (Organized ColoRectal Cancer Screening: DOCCR), now carried out by immunological test for occult blood in the stool, has proven its effectiveness. When the immunological test is positive, the Haute Autorité de Santé recommends a total colonoscopy. In 5 to 10% of cases, this colonoscopy is incomplete. The renewal of the endoscopic procedure or the performance of additional second-line examinations are then recommended. At present, however, the respective place of second-line examinations to be performed in this situation is not the subject of specific and validated recommendations.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Outcomes of Patients Who Had an Incomplete Colonoscopy After a Positive Fecal Immunological Test: Study of Practices in the Grand-Est
    Actual Study Start Date :
    Jan 16, 2021
    Anticipated Primary Completion Date :
    Apr 1, 2022
    Anticipated Study Completion Date :
    Apr 16, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Retrospective study of the patient outcomes who had an incomplete colonoscopy after a positive immunological fecal test [Files analysed retrospectively from January 01, 2018 to December 31, 2018 will be examined]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Age between 50 and 75 years old at the time of the colonoscopy

    • With incomplete colonoscopy performed in 2018 after a positive fecal immunological test as part of the DOCCR

    • Patient whose follow-up has ended

    • Patient living in the Grand-Est region and in the department of the site concerned

    • Examination carried out by a gastroenterologist from the Grand-Est region

    • Subject not having expressed, after information, his opposition to the reuse of his data for the purposes of this research

    Exclusion criteria:
    • Age ≥ 76 years at the time of colonoscopy

    • Colonoscopy performed after a positive Hemoccult® test (screening technique older than the immunological test and different sensitivity / specificity)

    • Colonoscopy performed before the fecal immunological test

    • Gastroenterologist performing the examination practicing outside the Grand-Est region

    • Subject not able to understand the objectives of this research

    • Subject under judicial control

    • Subject under tutorship or curatorship

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service Hépato-Gastroentérologie et Assistance Nutritive - Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05172713
    Other Study ID Numbers:
    • 8090
    First Posted:
    Dec 29, 2021
    Last Update Posted:
    Dec 29, 2021
    Last Verified:
    Oct 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 29, 2021