Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2026-02-22 @ 12:39 AM
Study NCT ID:
NCT06875518
Status:
RECRUITING
Last Update Posted:
2025-06-24
First Post:
2025-03-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Blood Loss in Total Laparoscopic Hysterectomy by Ligation the Uterine Arteries in Different Techniques.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}], 'ancestors': [{'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-21', 'studyFirstSubmitDate': '2025-03-09', 'studyFirstSubmitQcDate': '2025-03-09', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intra operative blood loss', 'timeFrame': '24 hours', 'description': 'Vaginal vault is identified and cut laparoscopically using monopolar hook over the manipulator cup and bipolar grasper for hemostasis until the specimen is detached completely. The uterus with cervix is delivered vaginally. The vaginal vault is sutured laparoscopically with number 1 delayed absorbable suture (Polyglactin; vicryl).\n\nThe total blood loss is calculated from the suction apparatus.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Disease']}, 'descriptionModule': {'briefSummary': 'Following Caesarean section, hysterectomy is the second most common major gynecological surgery, with approximately 600,000 procedures performed annually in the USA. Since Reich et al. first reported a total laparoscopic hysterectomy (TLH) in 1989, numerous studies have confirmed its feasibility and reproducibility. Evidence increasingly supports TLH over vaginal hysterectomy (VH) and total abdominal hysterectomy (TAH) for benign gynecological conditions. The development and rapid advancement of laparoscopic instruments and techniques have enabled the safe and successful completion of complex procedures using minimally invasive approaches. Women with a higher BMI or requiring complex surgeries benefit from reduced postoperative complications with laparoscopic operations.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged between 35-60 years Patients presented with menometrorrhagia unresponsive to medical treatment, and uterine pathology such as adenomyosis or multiple fibroids.\n\nExclusion Criteria:\n\n* Patients were excluded if they had: medical conditions preventing pneumo-peritoneum\n* Patients with medical conditions hindering proper ventilation during general anesthesia.\n* Patients diagnosed with endometrial carcinoma and patients with uterine size larger than 24 weeks were excluded.\n* Patients with excessive adhesions precluding access to the uterine arteries were not enrolled in the study.'}, 'identificationModule': {'nctId': 'NCT06875518', 'briefTitle': 'Comparative Study of Blood Loss in Total Laparoscopic Hysterectomy by Ligation the Uterine Arteries in Different Techniques.', 'organization': {'class': 'OTHER', 'fullName': 'Tanta University'}, 'officialTitle': 'Comparative Study of Blood Loss in Total Laparoscopic Hysterectomy by Ligation the Uterine Arteries in Different Techniques.', 'orgStudyIdInfo': {'id': '8749'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Group 1 (BTLH with bilateral uterine artery ligation from its origin): The round ligament close to the pelvic side wall is first coagulated and separated before the procedure is applied.', 'interventionNames': ['Procedure: BTLH with bilateral uterine artery ligation from its origin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional TLH', 'description': "The conventional TLH technique involved division of the corneal pedicles and securing the uterine pedicles. Preoperative Preparation of bowel wasn't routinely done to improve enhanced recovery of patients.", 'interventionNames': ['Procedure: Conventional TLH']}], 'interventions': [{'name': 'BTLH with bilateral uterine artery ligation from its origin', 'type': 'PROCEDURE', 'description': "The round ligament close to the pelvic side wall is first coagulated and separated before the procedure is applied. Further incision is then made in the peritoneum. The bladder fold is pulled downward by opening the anterior leaf of the wide ligament. It shows the ureters lateralized and the posterior leaf of the wide ligament. After that, the ureters' path is shown, the retroperitoneal area is revealed, and the location where the uterine artery leaves the iliac artery is seen.", 'armGroupLabels': ['Control group']}, {'name': 'Conventional TLH', 'type': 'PROCEDURE', 'description': "The conventional TLH technique involved division of the corneal pedicles and securing the uterine pedicles. Preoperative Preparation of bowel wasn't routinely done to improve enhanced recovery of patients. Antibiotic prophylaxis with 3rd generation cephalosporin and metronidazole was given one hour preoperatively. Obese patients received subcutaneous low molecular weight heparin and compression devices after surgery. Under general anesthesia, patients were placed in a Lloyd Davis position.", 'armGroupLabels': ['Conventional TLH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34518', 'city': 'Damietta', 'state': 'New Damietta', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mostafa Bahaa, PhD', 'role': 'CONTACT', 'email': 'mbahaa@horus.edu.eg', 'phone': '0201025538337'}], 'facility': 'Mostafa Bahaa', 'geoPoint': {'lat': 31.41648, 'lon': 31.81332}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mostafa Bahaa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Mostafa Bahaa', 'investigatorAffiliation': 'Tanta University'}}}}