Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-03-11 @ 8:47 PM
Study NCT ID:
NCT04669769
Status:
COMPLETED
Last Update Posted:
2020-12-17
First Post:
2020-12-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retrospective Analysis of Results of Surgery for Deep Bowel 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007407', 'term': 'Interviews as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'complications', 'timeFrame': 'up to 10 years', 'description': 'complications according to Clavien Dindo Classification'}], 'secondaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': 'up to 10 years', 'description': 'pregancy after surgery'}, {'measure': 'live birth', 'timeFrame': 'up to 10 years', 'description': 'live birth after surgery'}, {'measure': 'pain recurrence', 'timeFrame': 'up to 10 years', 'description': 'pain recurrence after operation'}, {'measure': 'disease recurrence', 'timeFrame': 'up to 10 years', 'description': 'disease recurrence after operation'}, {'measure': 'recurrent surgery', 'timeFrame': 'up to 10 years', 'description': 'recurrent surgery after surgery for bowel endometriosis'}, {'measure': 'pregnancy rate with ongoing bowel endometriosis', 'timeFrame': 'up to 10 years', 'description': 'pregnancy rate with ongoing bowel endometriosis'}, {'measure': 'live birth with ongoing bowel endometriosis', 'timeFrame': 'up to 10 years', 'description': 'live birth with ongoing bowel endometriosis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometriosis', 'deep endometriosis', 'bowel endometriosis', 'conception', 'ART', 'spontaneous conception', 'pregnancy rate'], 'conditions': ['Endometriosis', 'Deep Endometriosis', 'Bowel Endometriosis', 'Reproductive Issues', 'Complication']}, 'descriptionModule': {'briefSummary': 'identification of patients operated becaus of bowel endometriosis at the endometriosis center, University Hospital Muenster, Germany, starting 2009, Analysis of Patient history, surgical procedurie, intraoperative complications, postoperative complications, phone call assessing further complications, complaints after surgery, pregnancy, live birth, additional surgery, spontaneous conception, conception by IUI, ART'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'patients treated because of deep Infiltrating bowel endometriosis at the endometriosis Center, University Hospital Muenster, Germany starting 2009', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* deep Infiltrating endometriosis, surgery with complete or partial resection of bowel endometriosis or conservative Management, Treatment at endometriosis Center University Hospital Muenster, Germany, wants to participate\n\nExclusion Criteria:\n\n* declines participation'}, 'identificationModule': {'nctId': 'NCT04669769', 'briefTitle': 'Retrospective Analysis of Results of Surgery for Deep Bowel Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Retrospective Analysis of Outcomes After Surgery for Deep Infiltrating Endometriosis of the Bowel', 'orgStudyIdInfo': {'id': 'Schäfer_Endo_DIE_Bowel_Com'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'shaving', 'description': 'patients with DIE and shaving', 'interventionNames': ['Other: interview']}, {'label': 'disc resection', 'description': 'patients with DIE and Disc resection', 'interventionNames': ['Other: interview']}, {'label': 'segmental resection', 'description': 'patients with DIE and segmental resection', 'interventionNames': ['Other: interview']}, {'label': 'multifocal', 'description': 'patients with multifocal DIE having more than one bowel procedure', 'interventionNames': ['Other: interview']}], 'interventions': [{'name': 'interview', 'type': 'OTHER', 'description': 'telephone interview', 'armGroupLabels': ['disc resection', 'multifocal', 'segmental resection', 'shaving']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48149', 'city': 'Münster', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'University Hospital Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}], 'overallOfficials': [{'name': 'Sebastian D Schaefer, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Muenster, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'will be shared upon reasonable request and according to regulations'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Muenster', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Gynecology', 'investigatorFullName': 'Dr. med. Sebastian Daniel Schäfer', 'investigatorAffiliation': 'University Hospital Muenster'}}}}