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Clinical Trials/NCT05624567
NCT05624567
Not yet recruiting
Not Applicable

Symptoms and Quality of Life of Patients With Suspected Endometriosis - a Prospective Multi-center Observational Study

Medical University of Vienna0 sites800 target enrollmentDecember 20, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometriosis
Sponsor
Medical University of Vienna
Enrollment
800
Primary Endpoint
Symptom correlation with #ENZIAN
Status
Not yet recruiting
Last Updated
3 years ago

Overview

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.
Registry
clinicaltrials.gov
Start Date
December 20, 2022
End Date
January 31, 2024
Last Updated
3 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

René Wenzl

Ao. Univ. Prof. Dr.

Medical University of Vienna

Eligibility Criteria

Inclusion Criteria

  • Planned surgery for suspected endometriosis
  • Age between 18 and 50
  • signed informed consent

Exclusion Criteria

  • menopause
  • current malignant disease

Outcomes

Primary Outcomes

Symptom correlation with #ENZIAN

Time Frame: 12/2022-12/2024

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

Endometriosis surgery and #ENZIAN - Correlation with quality of life?

Time Frame: 12/2022-12/2024

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

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