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URINA: Urinary Procedures Performed by Gynecologists, Results and Learning Curves.

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT05150262
Collaborator
(none)
96
Enrollment
1
Location
8.9
Anticipated Duration (Months)
10.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Urinary procedures such as placing a JJ catheter, performing a psoic bladder, a Bricker technique or even a partial cystectomy are relatively frequent procedures in the context of the surgical management of gynecological cancer or endometriosis in order to obtain maximum reduction in oncology, or to overcome all endometriotic lesions when they affect the urinary tract. However, gynecological surgeons are not always trained in these specific procedures, the learning of which is crucial in the optimal management of these patients.

The aim of the research is to describe the surgical experience in terms of urinary actions (JJ catheter placement, psoic bladder, Bricker technique, cystectomy) over the past 10 years and determine a learning curve for a surgical team made up of only gynecological surgeons

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    96 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Urinary Procedures Performed by Gynecologists, Results and Learning Curves.
    Actual Study Start Date :
    Nov 1, 2021
    Anticipated Primary Completion Date :
    Jul 1, 2022
    Anticipated Study Completion Date :
    Jul 30, 2022

    Outcome Measures

    Primary Outcome Measures

    1. Describe the surgical experience in terms of urinary procedures (JJ catheter placement, psoic bladder, Bricker's technique, cystectomy) over the past 10 years [Files analysed retrospectively from January 01, 2010 to April 30, 2021 will be examined]]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Adult woman (≥18 years old)

    • Woman with gynecological cancer or endometriosis, having undergone surgery between 01/01/2010 and 04/30/2021 at Strasbourg University Hospital

    • With the performance of urological procedures during the operation performed by a surgical team composed of a gynecological surgeon

    • Woman who did not express her opposition to the reuse of her data for the purposes of this research.

    Exclusion criteria:

    • Woman who expressed her opposition to participating in the study

    • Surgery performed by a team of surgeons not composed exclusively of gynecologists

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    • Principal Investigator: Lise LECOINTRE, MD, Service de gynécologie Obstétrique - Hôpitaux Universitaires de Strasbourg

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT05150262
    Other Study ID Numbers:
    • 8417
    First Posted:
    Dec 9, 2021
    Last Update Posted:
    Dec 9, 2021
    Last Verified:
    Nov 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
    Gynecologic Cancer
    Endometriosis
    Additional relevant MeSH terms:
    Endometriosis

    Study Results

    No Results Posted as of Dec 9, 2021