Symptoms and Quality of Life of Patients With Suspected Endometriosis

Not yet recruiting

• Conditions: Endometriosis; Surgery; Dyspareunia; Pain; Dysmenorrhea

• Registration Number: NCT05624567
• Lead Sponsor: Medical University of Vienna

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study First Submitted: 2022-11-14
• Study First Submitted QC: 2022-11-14
• Last Update Submitted: 2022-11-14
• Study First Posted: 2022-11-22
• Last Update Posted: 2022-11-22
• Study Start: 2022-12-20
• Primary Completion: 2023-12-31
• Study Completion: 2024-01-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 800

Inclusion Criteria

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

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Exclusion Criteria

• menopause
• current malignant disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptom correlation with #ENZIAN	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?	12/2022-12/2024	Does the surgical intervention have an effect on the quality of life in relation to the individual #ENZIAN compartments.