Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-09 @ 1:20 AM
Study NCT ID:
NCT03009812
Status:
COMPLETED
Last Update Posted:
2019-04-08
First Post:
2017-01-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transverse vs Longitudinal Incision in Myomectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047708', 'term': 'Myofibroma'}], 'ancestors': [{'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-01-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-05', 'studyFirstSubmitDate': '2017-01-01', 'studyFirstSubmitQcDate': '2017-01-03', 'lastUpdatePostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraoperative blood loss', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Myoma;Uterus']}, 'referencesModule': {'references': [{'pmid': '33357218', 'type': 'DERIVED', 'citation': 'Elguindy A, Hemeda H, Shawky ME, Elsenity M, Elsayed MA, Fahim A, Afifi K, Nawara M. Blood loss from transverse versus longitudinal uterine incision in abdominal myomectomy: a randomized controlled trial. BMC Womens Health. 2020 Dec 28;20(1):259. doi: 10.1186/s12905-020-01113-3.'}]}, 'descriptionModule': {'briefSummary': 'The Aim of the study is to compare between transverse and longitudinal uterine incision in abdominal myomectomy regarding intraoperative blood loss.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Inclusion criteria for myomectomy as; abnormal uterine, pressure related symptoms, infertility and recurrent pregnancy loss in patients between 18 and 45 years old\n2. Single myoma.\n3. Women with BMI between 18.5-29.9 kg/m2.\n\nExclusion Criteria:\n\n1. Pregnancy.\n2. Patients with bleeding tendency\n3. Previous laparotomies.\n4. Patients with concomitant pelvic pathologies, such as ovarian cysts.'}, 'identificationModule': {'nctId': 'NCT03009812', 'briefTitle': 'Transverse vs Longitudinal Incision in Myomectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Transverse Versus Longitudinal Uterine Incision in Abdominal Myomectomy', 'orgStudyIdInfo': {'id': 'MY-789'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': '26 subjects who are planned for transverse uterine incision', 'interventionNames': ['Procedure: Transverse uterine incision']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': '26 subjects who are planned for longitudinal uterine incision', 'interventionNames': ['Procedure: Longitudinal uterine incision']}], 'interventions': [{'name': 'Longitudinal uterine incision', 'type': 'PROCEDURE', 'armGroupLabels': ['Group 2']}, {'name': 'Transverse uterine incision', 'type': 'PROCEDURE', 'armGroupLabels': ['Group 1']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'maii medhat nawara', 'investigatorAffiliation': 'Ain Shams University'}}}}