EndometriosisNCT05624567
Symptoms and Quality of Life of Patients With Suspected Endometriosis
An observational study of Endometriosis and Surgery, run by Medical University of Vienna.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Endometriosis, Surgery, Pain
- How many people
- 800 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2022to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Adult
Study population: Women between 18 and 50 years of age undergoing surgery for suspected endometriosis.
Who may be able to join
- Planned surgery for suspected endometriosis
- Age between 18 and 50
- signed informed consent
Who cannot join
- menopause
- current malignant disease
About this study
Official title: 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:
- if the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification
- if the surgical intervention has an effect on the quality of life in relation to the individual #ENZIAN compartments.
- Conditions
- Endometriosis, Surgery, Pain, Dysmenorrhea, Dyspareunia
- Medical subject headings
- Endometriosis, Pain, Dysmenorrhea, Dyspareunia
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptom correlation with #ENZIAN
Do the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification
Measured: 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.
Measured: 12/2022-12/2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2022
- Study start20 Dec 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, René Wenzl, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05624567
- Sponsor's protocol ID
- 1629/2022
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 22 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Perricos-Hess A, Gstoettner M, Heinzl F, Reiser E, 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, Seeber B, Wenzl R. Quality of life improves after endometriosis surgery independent of #ENZIAN classification: a multicenter cohort study. BMC Med. 2026 Aug 7;24(1):616. doi: 10.1186/s12916-026-05136-9.
PubMed 42983411Reiser 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.
PubMed 40682308
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Symptoms and Quality of Life of Patients With Suspected Endometriosis - a Prospective Multi-center Observational Study
- ClinicalTrials.gov ID
- NCT05624567
- Acronym / sponsor ID
- 1629/2022
- Conditions
- Endometriosis, Surgery, Pain, Dysmenorrhea, Dyspareunia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 20 Dec 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 22 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- if the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification
- if the surgical intervention has an effect on the quality of life in relation to the individual #ENZIAN compartments.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Women between 18 and 50 years of age undergoing surgery for suspected endometriosis.
Key inclusion criteria (3 listed)
- Planned surgery for suspected endometriosis
- Age between 18 and 50
- signed informed consent
Key exclusion criteria (2 listed)
- menopause
- current malignant disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- Derived from this study: PubMed 42983411Perricos-Hess A, Gstoettner M, Heinzl F, Reiser E, 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, Seeber B, Wenzl R. Quality of life improves after endometriosis surgery independent of #ENZIAN classification: a multicenter cohort study. BMC Med. 2026 Aug 7;24(1):616. doi: 10.1186/s12916-026-05136-9.
- Derived from this study: PubMed 40682308Reiser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Surgery, run by Medical University of Vienna.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom correlation with #ENZIAN (time frame: 12/2022-12/2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05624567, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2022.