Symptoms and Quality of Life of Patients With Suspected Endometriosis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Endometriosis; Surgery; Dysmenorrhea; Dyspareunia

• Study Type: Observational
• Enrollment (Anticipated): 800

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women between 18 and 50 years of age undergoing surgery for suspected endometriosis.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• menopause
• current malignant disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom correlation with #ENZIAN	Do the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification	12/2022-12/2024
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

Collaborators and Investigators

• Sponsor: Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Anticipated): December 20, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: November 14, 2022
• First Submitted That Met QC Criteria: November 14, 2022
• First Posted (Actual): November 22, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Sexual Dysfunctions, Psychological; Sexual Dysfunction, Physiological; Menstruation Disturbances; Pelvic Pain; Endometriosis; Dysmenorrhea; Dyspareunia
• Other Study ID Numbers: 1629/2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No