Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-29 @ 1:32 AM
Study NCT ID:
NCT04669756
Status:
COMPLETED
Last Update Posted:
2021-04-28
First Post:
2020-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D000267', 'term': 'Tissue Adhesions'}], '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': 'D002921', 'term': 'Cicatrix'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 409}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-26', 'studyFirstSubmitDate': '2020-12-04', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'prevalence of postoperative ovarian adhesions', 'timeFrame': '3 months after operation', 'description': 'prevalence of postoperative ovarian adhesions'}], 'secondaryOutcomes': [{'measure': 'postoperative pain', 'timeFrame': 'daily during postoperative hospitalisation and at follow up visit after 3 months', 'description': 'postoperative pain (NRS)'}, {'measure': 'AMH', 'timeFrame': 'at follow up visit after 3 months', 'description': 'AMH level'}, {'measure': 'postoperative infectious complications', 'timeFrame': 'up to 3 months after operation', 'description': 'postoperative infectious complications'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endometriosis', 'ovariopexy', 'adhesion prevention', 'laparoscopy', 'complications', 'AMH'], 'conditions': ['Endometriosis', 'Adhesion', 'Surgery']}, 'descriptionModule': {'briefSummary': 'prospective randomized Trial comparing ovariopexy over 2, 4 or 6 days vs Placebo after surgery because of endometriosis of the pelvic side wall or the ovary or both'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* premenopausal\n* wants to participate\n* removal of endometriosis of the pelvic side wall or ovary\n\nExclusion Criteria:\n\n* postmenopausal\n* cannot give informed consent\n* no endometriosis during Operation\n* no Opening of pelvic side wall or ovary during the Operation\n* pregnant\n* breast feeding'}, 'identificationModule': {'nctId': 'NCT04669756', 'briefTitle': 'Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Muenster'}, 'officialTitle': 'Ovariopexy for Adhesion Prevention After Laparoscopic Removal of Endometriosis of the Pelvic Side Wall or the Ovary', 'orgStudyIdInfo': {'id': 'Schäfer_Endo_Ovariopexie'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'A', 'description': 'ovariopexy for 2 days', 'interventionNames': ['Procedure: ovariopexy']}, {'type': 'EXPERIMENTAL', 'label': 'B', 'description': 'ovariopexy for 4 days', 'interventionNames': ['Procedure: ovariopexy']}, {'type': 'EXPERIMENTAL', 'label': 'C', 'description': 'ovariopexy for 6 days', 'interventionNames': ['Procedure: ovariopexy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'D', 'description': 'Placebo Operation for 2 days', 'interventionNames': ['Procedure: placebo operation']}], 'interventions': [{'name': 'ovariopexy', 'type': 'PROCEDURE', 'description': 'if endometriosis was removed from the pelvic side wall or the ovary or both leading to an open wound adjacent to the ovary, ovariopexy was performed on both sides using a transabdominal-transovarian suture being tied extracorporeally on the patients Skin leading to uplifting of the ovary to the abdominal wall', 'armGroupLabels': ['A', 'B', 'C']}, {'name': 'placebo operation', 'type': 'PROCEDURE', 'description': 'in arm D sutures are transabdominal only', 'armGroupLabels': ['D']}]}, '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': 'data can 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'}}}}