Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 3:16 AM
Study NCT ID:
NCT04399668
Status:
COMPLETED
Last Update Posted:
2021-09-14
First Post:
2020-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Ultrasound-determined and Intraoperative #Enzian-classification in Patients With Deep Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 745}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-11', 'studyFirstSubmitDate': '2020-05-18', 'studyFirstSubmitQcDate': '2020-05-18', 'lastUpdatePostDateStruct': {'date': '2021-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentages of concordances between preoperative TVS defined #Enzian with the intraoperatively determined #Enzian classification in each #Enzian compartment', 'timeFrame': '1 to 7 days', 'description': 'The percentages of concordantly described endometriotic lesions including the respective lesion sizes by the preoperative TVS defined #Enzian in each #Enzian compartment will be assessed, with the intraoperatively determined #Enzian classification taken as the reference, i.e. gold standard.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and specificity for the detection of endometriotic lesions by preoperative TVS examination using #Enzian', 'timeFrame': '1 to 7 days', 'description': 'Sensitivity and specificity for the detection of endometriotic lesions in different #Enzian compartments by the preoperative TVS examination (#Enzian) will be calculated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Endometriosis', 'Deep endometriosis (DE)', 'Transvaginal sonography (TVS)', 'Enzian classification', '#Enzian classification'], 'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'The Enzian classification, which was developed in order to describe deep endometriotic (DE) lesions, is determined intraoperatively by the surgeon. Transvaginal ultrasound (TVS) examination is considered as the first-line imaging technique for endometriosis. The aim of this study is to compare the assessment of presence and severity grade of endometriotic lesions in different #Enzian compartments by a preoperative ultrasound examination to the definitive intraoperative Enzian classification using the latest revision of the Enzian classification (#Enzian).', 'detailedDescription': 'Endometriosis is a common disease with endometriotic lesions being found in the ovaries, peritoneum, or as deep endometriosis (DE) involving different pelvic organs and structures. In order to describe DE lesions, the Enzian classification was developed. In the last revision of this Enzian classification, the so-called #Enzian, presence and severity grades of ovarian and peritoneal endometriosis as well as adhesions involving tubes and ovaries are also described in addition to DE lesions.\n\nThe Enzian classification is determined intraoperatively by the surgeon. Transvaginal ultrasound (TVS) examination is considered to be the first-line imaging technique for this disease. Therefore, the aim of this study is to compare the assessment of presence and severity grade of endometriotic lesions in different #Enzian compartments by a preoperative ultrasound examination (in the form of an US-#Enzian classification) to the definitive intraoperative Enzian classification (OP-#Enzian) using the latest revision of the Enzian classification (#Enzian).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "All women who are scheduled for a radical surgical treatment of deep endometriosis (DE), undergo preoperative evaluation by transvaginal sonography (TVS) and don't fall under the exclusion criteria will be included in this study.", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All women who are scheduled for a radical surgical treatment of deep endometriosis (DE) and who undergo preoperative evaluation by transvaginal sonography (TVS)\n\nExclusion Criteria:\n\n* Diagnosed or suspected malignancy\n* Previous colorectal surgery or previous surgery for DE including full thickness bowel resection, vaginal resection or excision of a DE lesion involving the urinary bladder\n* Virgo intacta women'}, 'identificationModule': {'nctId': 'NCT04399668', 'briefTitle': 'Comparison of Ultrasound-determined and Intraoperative #Enzian-classification in Patients With Deep Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Woman and Health Private Clinic Vienna'}, 'officialTitle': 'Comparison of a Preoperative Ultrasound-determined and the Intraoperative #Enzian-classification in Patients With Deep Endometriosis (DE)', 'orgStudyIdInfo': {'id': '1'}}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Vienna', 'country': 'Austria', 'facility': 'St. John of God Hospital Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'overallOfficials': [{'name': 'Gernot Hudelist, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Woman & Health Private Clinic Vienna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, MSc Clinical Lecturer', 'investigatorFullName': 'Univ.-Doz. Dr.med.univ. Gernot Hudelist, MSc.', 'investigatorAffiliation': 'Woman and Health Private Clinic Vienna'}}}}