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NCT05624567 Clinical Trial

Symptoms and Quality of Life of Patients With Suspected Endometriosis

Pain Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05624567
Other study ID # 1629/2022
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 20, 2022
Est. completion date January 31, 2024

Study information
Verified date November 2022
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 800
Est. completion date January 31, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers
Gender Female
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: - Planned surgery for suspected endometriosis - Age between 18 and 50 - signed informed consent Exclusion Criteria: - menopause - current malignant disease

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Medical University of Vienna

Outcome
Type Measure Description Time frame Safety issue
Primary Symptom correlation with #ENZIAN Do the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification 12/2022-12/2024
Primary Endometriosis surgery and #ENZIAN - Correlation with quality of life? Does the surgical intervention have an effect on the quality of life in relation to the individual #ENZIAN compartments. 12/2022-12/2024
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