Ignite Creation Date:
2025-12-25 @ 12:46 AM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT05624567
Status:
UNKNOWN
Last Update Posted:
2022-11-22
First Post:
2022-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Symptoms and Quality of Life of Patients With Suspected Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D004412', 'term': 'Dysmenorrhea'}, {'id': 'D004414', 'term': 'Dyspareunia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D012735', 'term': 'Sexual Dysfunction, Physiological'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D020018', 'term': 'Sexual Dysfunctions, Psychological'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2024-01-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-14', 'studyFirstSubmitDate': '2022-11-14', 'studyFirstSubmitQcDate': '2022-11-14', 'lastUpdatePostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom correlation with #ENZIAN', 'timeFrame': '12/2022-12/2024', 'description': 'Do the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification'}, {'measure': 'Endometriosis surgery and #ENZIAN - Correlation with quality of life?', 'timeFrame': '12/2022-12/2024', 'description': 'Does the surgical intervention have an effect on the quality of life in relation to the individual #ENZIAN compartments.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Endometriosis', 'Surgery', 'Pain', 'Dysmenorrhea', 'Dyspareunia']}, 'referencesModule': {'references': [{'pmid': '40682308', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThe primary endpoints of this multicenter observational study are to prospectively examine:\n\n1. if the individual symptoms correlate with the individual compartments of the surgical #ENZIAN Endometriosis classification\n2. if the surgical intervention has an effect on the quality of life in relation to the individual #ENZIAN compartments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women between 18 and 50 years of age undergoing surgery for suspected endometriosis.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Planned surgery for suspected endometriosis\n* Age between 18 and 50\n* signed informed consent\n\nExclusion Criteria:\n\n* menopause\n* current malignant disease'}, 'identificationModule': {'nctId': 'NCT05624567', 'briefTitle': 'Symptoms and Quality of Life of Patients With Suspected Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Symptoms and Quality of Life of Patients With Suspected Endometriosis - a Prospective Multi-center Observational Study', 'orgStudyIdInfo': {'id': '1629/2022'}}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Ao. Univ. Prof. Dr.', 'investigatorFullName': 'René Wenzl', 'investigatorAffiliation': 'Medical University of Vienna'}}}}