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Coelios: The Safety of Direct Laparoscopic Introduction: Retrospective Observational Study at the University Hospital of Strasbourg

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05858554
Collaborator
(none)
100
Enrollment
1
Location
8
Anticipated Duration (Months)
12.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Veress techniques and open laparoscopy are the techniques most used by gynecological surgeons to date. Advantages of the direct introduction unknown because technique still little used.

The research hypothesis is that very few major complications are expected showing the safety of direct introduction.

A look back at our practice of direct introduction into laparoscopy from 2012 to 2022 at the CMCO (Medical-Surgical and Obstetrical Center of Strasbourg)

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    The Safety of Direct Laparoscopic Introduction: Retrospective Observational Study at the University Hospital of Strasbourg
    Actual Study Start Date :
    Apr 19, 2023
    Anticipated Primary Completion Date :
    Dec 19, 2023
    Anticipated Study Completion Date :
    Dec 19, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Study of intraoperative complications of direct introduction in open laparoscopy [Files analysed retrospectively from from January 01, 2010 to December 31, 2022 will be examined]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Inclusion criteria:

    • Adult woman who had a scheduled or emergency laparoscopy at the CMCO between 01/01/2010 and 12/31/2022.

    • Subject, having not expressed their opposition to the reuse of data of their data for the purposes of scientific research.

    Exclusion criteria:
    • Subject having expressed its opposition to the reuse of its data for scientific res

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Gynécologie Obstétrique - CHU de Strasbourg - France 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:
    NCT05858554
    Other Study ID Numbers:
    • 8952
    First Posted:
    May 15, 2023
    Last Update Posted:
    May 15, 2023
    Last Verified:
    May 1, 2023
    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
    Laparoscopy
    coelioscopie
    Veress Needle Technique

    Study Results

    No Results Posted as of May 15, 2023