Ignite Creation Date:
2025-12-24 @ 9:56 PM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT03692832
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2018-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-31', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-09-30', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'duration of surgical procedure', 'description': 'Total operative time (minutes) for LH versus VH; from introduction of the first laparoscopy port or vaginal incision, till suturing the vaginal vault.'}], 'secondaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': 'intra-operative', 'description': 'Blood loss (mL): by measuring suctioned blood (subtracting irrigation volumes), Weighing sponges (weight difference of soaked and dry surgical gauzes, 1 g ≃ 1 mL), or according to Gross (1983) formula (mL)'}, {'measure': 'Blood transfusion', 'timeFrame': '24 hours post-operative', 'description': 'Need for blood transfusion'}, {'measure': 'Proportion of successful vaginal opportunistic salpingectomy', 'timeFrame': 'intra-operative', 'description': 'Proportion of patients with successful vaginal opportunistic salpingectomy or salpingo-oophorectomy compared to laparoscopic approach, and factors for non completion'}, {'measure': 'Surgical complications', 'timeFrame': 'intra-operative', 'description': 'Surgical complications: visceral or vascular injuries, vaginal cuff haematoma or dehiscence'}, {'measure': 'Post-operative pain assessed using visual analogue scale for pain intensity', 'timeFrame': 'first 24 hours post-operative', 'description': 'Post-operative pain: assessed using visual analogue scale for pain intensity at 2, 6 and 24 hours post-operative'}, {'measure': 'Febrile morbidity', 'timeFrame': 'first 24 hours post-operative', 'description': 'Post-operative fever (temperature assessed in degrees Celsius)'}, {'measure': 'Change in serum markers for inflammation', 'timeFrame': 'first 24 hours post-operative', 'description': 'Inflammatory response serum markers compared pre- and 24-h postoperatively (e.g. C-reactive protein or interleukin-6 according to availability)'}, {'measure': 'Hospital-stay', 'timeFrame': '1 week', 'description': 'Post-operative hospital-stay (hours)'}, {'measure': 'Healthcare costs', 'timeFrame': '1 week', 'description': 'Healthcare costs (EGP), including consumables, medications, and admission fees.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benign Gynecological Disease']}, 'descriptionModule': {'briefSummary': 'This study is designed to compare laparoscopic and vaginal hysterectomy in women with benign gynaecological disease in Ain Shams University Maternity Hospital.', 'detailedDescription': "The current trial evaluates the performance and short-term postoperative outcomes of these two approaches for hysterectomy in Ain Shams University Maternity Hospital, a major tertiary hospital in Greater Cairo, and one of Egypt's leading centers in terms of provision of public medical service.\n\nEighty patients with benign indications, with no contraindications to neither laparoscopic nor vaginal approaches, were randomized into two equal groups, to undergo either of the two procedures: LH or VH."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing hysterectomy for benign gynaecological disease (e.g., dysfunctional uterine bleeding, adenomyosis, fibroids).\n\nExclusion Criteria: Women with:\n\n* known tubo-ovarian pathology requiring primary laparotomy, e.g. large adnexal masses\n* known neoplasia requiring pelvic lymphadenectomy\n* pelvic organ prolapse requiring additional procedures, e.g., uterine procidentia (complete prolapse), enterocoele\n* conditions interfering with laparoscopic surgery, e.g. cardio-pulmonary disease, obesity (BMI 30 kg/m2 or more)\n* large uteri interfering with vaginal hysterectomy (size \\>16 gestational weeks)'}, 'identificationModule': {'nctId': 'NCT03692832', 'briefTitle': 'Laparoscopic vs Vaginal Hysterectomy for Benign Gynaecological Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Laparoscopic Versus Vaginal Hysterectomy for Benign Gynaecological Disease in Ain Shams University Maternity Hospital: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'LH-VH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group L', 'description': '40 patients undergoing laparoscopic hysterectomy', 'interventionNames': ['Procedure: LH']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group V', 'description': '40 patients undergoing vaginal hysterectomy', 'interventionNames': ['Procedure: VH']}], 'interventions': [{'name': 'LH', 'type': 'PROCEDURE', 'description': 'Laparoscopic hysterectomy following AAGL class IV E, vault closed vaginally', 'armGroupLabels': ['Group L']}, {'name': 'VH', 'type': 'PROCEDURE', 'description': 'Vaginal hysterectomy following Heaney technique', 'armGroupLabels': ['Group V']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Faculty of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Lecturer', 'investigatorFullName': 'Hamdy Bakry Alqenawy', 'investigatorAffiliation': 'Ain Shams University'}}}}