Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-30 @ 9:02 PM
Study NCT ID:
NCT07365969
Status:
COMPLETED
Last Update Posted:
2026-01-30
First Post:
2026-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Risk of Hysterectomy at Time of Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 293}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-01-28', 'studyFirstSubmitDate': '2026-01-17', 'studyFirstSubmitQcDate': '2026-01-17', 'lastUpdatePostDateStruct': {'date': '2026-01-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of hysterectomy at time of myomectomy.', 'timeFrame': 'Jan 2020- Dec 2024'}], 'secondaryOutcomes': [{'measure': 'Characteristics of the Myomas who required hysterectomy', 'timeFrame': 'Jan 2020- Dec 2024', 'description': 'number, site, size, Figo staging'}, {'measure': 'Intraoperative complications', 'timeFrame': 'Jan 2020- Dec 2024', 'description': 'Anesthesia complication, organ injury, blood transfusion.'}, {'measure': 'Postoperative complications', 'timeFrame': 'Jan 2020- Dec 2024', 'description': 'Anemia, hemorrhage, fever, wound infection, wound hematoma'}, {'measure': 'Duration of hospital stay', 'timeFrame': 'Jan 2020- Dec 2024', 'description': 'in days'}, {'measure': 'Reoperation', 'timeFrame': 'Jan 2020- Dec 2024', 'description': 'within 5 days of surgery'}, {'measure': 'Readmission after discharge from the hospital', 'timeFrame': 'Jan 2020- Dec 2024', 'description': 'within 14 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['hysterectomy', 'myomectomy', 'fibroid uterus'], 'conditions': ['Myomectomy', 'Fibroid Uterus', 'Hysterectomy']}, 'descriptionModule': {'briefSummary': 'Uterine fibroids are the commonest tumor affecting the female reproductive tract and many instances they are asymptomatic but in some women there does appear to be an association with heavy menstrual blood loss and possibly subfertility. Classically, treatment has been surgical with hysterectomy the most common approach for women who have completed their fertility and myomectomy for those who wish to conceive. The surgery can be carried out laparoscopically, vaginally and abdominally. The aim of this study is to evaluate the risk of hysterectomy at the time of myomectomy, and the associated 30-day postoperative morbidity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women who were planned to undergo abdominal myomectomy in the past 4 years', 'genderDescription': 'Women who were planned for abdominal myomectomy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women planned for abdominal myomectomy in the previous 4 years.\n* Availability of complete medical records for pre-, intra- and post-operative data.\n\nExclusion Criteria:\n\n* Missing or lacking information in the patients records like preoperative assessment of the fibroid uterus.\n* Absence of operative notes and relevant data in the medical files.'}, 'identificationModule': {'nctId': 'NCT07365969', 'briefTitle': 'Risk of Hysterectomy at Time of Myomectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'The Risk of Hysterectomy at Time of Myomectomy at Ain Shams University Hospital: A Retrospective Cohort Study.', 'orgStudyIdInfo': {'id': 'FMASU MS 778/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient who were planned for abdomoinal myomectomy', 'description': 'A retrospective study on women who were candidates for abdominal myomectomy in the previous 4 years'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Faculty of Medicine, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Maya Abdelrazek', 'investigatorAffiliation': 'Ain Shams University'}}}}