Symptoms and Quality of Life of Patients With Suspected Endometriosis

NCT ID: NCT05624567

Last Updated: 2022-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-20

Study Completion Date

2024-01-31

Brief Summary

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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

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Conditions

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Endometriosis Surgery Pain Dysmenorrhea Dyspareunia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* menopause
* current malignant disease
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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René Wenzl

Ao. Univ. Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Reiser E, Gobel G, Perricos-Hess A, Buchweitz O, Jaekel M, Westphal E, Rimbach S, Woelfler M, Kraemer B, Kolben T, Pempelfort SD, Pashkunova D, Metzler J, Derihaci RP, Klein P, Janschek E, Guttenberg P, Wuester M, Wolfrum A, Seifert-Klauss V, Enzelsberger SH, Keckstein J, Wenzl R, Seeber B. Evaluation of the association between self-reported pre-operative symptoms with surgically diagnosed endometriosis using the #ENZIAN classification in a multi-centre cohort. Hum Reprod. 2025 Sep 1;40(9):1643-1650. doi: 10.1093/humrep/deaf120.

Reference Type DERIVED
PMID: 40682308 (View on PubMed)

Other Identifiers

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1629/2022

Identifier Type: -

Identifier Source: org_study_id

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