Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2026-01-01 @ 9:04 AM
Study NCT ID:
NCT04237558
Status:
COMPLETED
Last Update Posted:
2022-09-21
First Post:
2019-07-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014592', 'term': 'Uterine Hemorrhage'}], 'ancestors': [{'id': 'D014591', 'term': 'Uterine Diseases'}, {'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': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007045', 'term': 'Hysterectomy, Vaginal'}], 'ancestors': [{'id': 'D007044', 'term': 'Hysterectomy'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'comparison between laparoscopic hysterectomy versus non-descent vaginal hysterectomy using bipolar vessel sealers in patients with abnormal uterine bleeding'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2019-07-26', 'studyFirstSubmitQcDate': '2020-01-21', 'lastUpdatePostDateStruct': {'date': '2022-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of operation', 'timeFrame': 'From start of surgery up to 24 hours', 'description': 'Duration of operation'}], 'secondaryOutcomes': [{'measure': 'Time of requiring analgesics', 'timeFrame': 'Until 24 hours postoperatively', 'description': 'The time of the first request for analgesics'}, {'measure': 'Number of requiring analgesics', 'timeFrame': 'Until 24 hours postoperatively', 'description': 'The number of requests for analgesics'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vaginal hysterectomy', 'Laparoscopic hysterectomy'], 'conditions': ['Uterine Bleeding']}, 'descriptionModule': {'briefSummary': 'This study will be a randomized clinical trial to evaluate the surgical performance and outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy ,using bipolar vessel sealer,in cases of abnormal uterine bleeding in Mansoura University Hospital in order to reach the optimum technique for our locality', 'detailedDescription': 'Hysterectomy is the surgical removal of the uterus. It is the commonest major gynecological surgery, next to caesarean section, with millions of procedures performed annually throughout the world.Approximately 90% of hysterectomies are performed for benign conditions.\n\nAlthough there are many approaches to hysterectomy, which depend on clinical criteria, certain patients may be eligible to be operated in any of the several available approaches. The optimal route of hysterectomy for a patient will depend on the pathological nature, size and shape of the vagina and uterus, uterine descent, endometriosis and the likelihood of pelvic adhesions, adnexal masses, previous pelvic surgery, available hospital technology, devices and the surgeon\'s preference.\n\nApproaches to hysterectomy may be broadly categorized into four options: abdominal hysterectomy (AH); vaginal hysterectomy (VH); laparoscopic hysterectomy (LH) where at least some of the operation is conducted laparoscopically and robotic-assisted hysterectomy (RH).Vaginal and laparoscopic procedures are considered "minimally invasive" surgical approaches because they do not require a large abdominal incision and, thus, typically are associated with shortened hospitalization and postoperative recovery times compared with open abdominal hysterectomy.\n\nThis study will be a randomized clinical trial to evaluate the surgical performance and outcome of total laparoscopic hysterectomy compared to non-descent vaginal hysterectomy, using bipolar vessel sealer, in cases of abnormal uterine bleeding in order to reach the optimum technique with lower cost to be easily applied to low resource settings.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women assigned for performing hysterectomy for abnormal uterine bleeding due to benign pathology.\n* Uterine size by bimanual examination ≤14 weeks gestational size.\n* Cases with uterine volumes ≤ 400cm3 will be included in this study.\n\nExclusion Criteria:\n\n* Patients with BMI \\> 30kg/m2\n* Uteri \\> 14 weeks gestational size by bimanual examination or volume \\> 400cm3\n* Women with positive pap smear for CIN or endometrial biopsy with atypia or carcinoma.\n* Patient with other known body malignancy.\n* Patient with other pelvic pathology, endometriosis or pelvic abscesses.\n* Patients with abdominal scars.'}, 'identificationModule': {'nctId': 'NCT04237558', 'briefTitle': 'Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer', 'organization': {'class': 'OTHER', 'fullName': 'Mansoura University'}, 'officialTitle': 'Laparoscopic Versus Vaginal Hysterectomy in Women With Abnormal Uterine Bleeding Using Bipolar Vessel Sealer in Mansoura University Hospitals: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'AM1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vaginal hysterectomy', 'description': 'Removal of uterus through vagina in absence of prolapse', 'interventionNames': ['Procedure: Vaginal hysterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Laparoscopic hysterectomy', 'description': 'Key hole surgery through small incisions of the abdomen', 'interventionNames': ['Procedure: Laparoscopic hysterectomy']}], 'interventions': [{'name': 'Vaginal hysterectomy', 'type': 'PROCEDURE', 'description': 'Vaginal hysterectomy by removal of uterus through vagina in absence of prolapse', 'armGroupLabels': ['Vaginal hysterectomy']}, {'name': 'Laparoscopic hysterectomy', 'type': 'PROCEDURE', 'description': 'Laparoscopic hysterectomy through key hole surgery through small incisions of the abdomen', 'armGroupLabels': ['Laparoscopic hysterectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35111', 'city': 'Al Mansurah', 'state': 'Dakahlia Governorate', 'country': 'Egypt', 'facility': 'Mansoura University Hospital', 'geoPoint': {'lat': 31.03637, 'lon': 31.38069}}], 'overallOfficials': [{'name': 'Amany A Makroum, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mansoura University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mansoura University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}