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Symptoms and Quality of Life of Patients With Suspected Endometriosis

Sponsor
Medical University of Vienna (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05624567
Collaborator
(none)
800
Enrollment
13.4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

All patients undergoing surgery due to suspected endometriosis in a previously selected 3-month period within the study period (between 12/2022 and 12/24) (each participating center will define the particular 3 months in question) will be asked to participate in this study. Upon inclusion, patients will be asked to fill out questionnaires regarding endometriosis-associated symptoms as well as a detailed patient history. Furthermore, patients will be asked to fill out 2 standardized questionnaires, one regarding quality of life (Endometriosis-Health Profile-30) and one regarding sexual function (Female Sexual Function Index). Six and 12 months after surgery, patients will again be asked to fill out these two standardized questionnaires as well as a questionnaire regarding postsurgical therapy and endometriosis-associated symptoms. The surgeon will be asked to fill out a form regarding the surgical procedure and possible surgical complications.

The primary endpoints of this multicenter observational study are to prospectively examine:

  1. if the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification

  2. if the surgical intervention has an effect on the quality of life in relation to the individual #ENZIAN compartments.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    800 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Symptoms and Quality of Life of Patients With Suspected Endometriosis - a Prospective Multi-center Observational Study
    Anticipated Study Start Date :
    Dec 20, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Jan 31, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Symptom correlation with #ENZIAN [12/2022-12/2024]

      Do the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification

    2. Endometriosis surgery and #ENZIAN - Correlation with quality of life? [12/2022-12/2024]

      Does the surgical intervention have an effect on the quality of life in relation to the individual #ENZIAN compartments.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Inclusion Criteria:

    • Planned surgery for suspected endometriosis

    • Age between 18 and 50

    • signed informed consent

    Exclusion Criteria:

    • menopause

    • current malignant disease

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    René Wenzl, Ao. Univ. Prof. Dr., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT05624567
    Other Study ID Numbers:
    • 1629/2022
    First Posted:
    Nov 22, 2022
    Last Update Posted:
    Nov 22, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Endometriosis
    Dyspareunia
    Dysmenorrhea

    Study Results

    No Results Posted as of Nov 22, 2022