Ignite Creation Date:
2025-12-24 @ 3:48 PM
Ignite Modification Date:
2026-01-05 @ 1:05 PM
Study NCT ID:
NCT05960292
Status:
UNKNOWN
Last Update Posted:
2023-09-07
First Post:
2023-07-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Laparoscopic Versus Vaginal Approach Closure Complications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056887', 'term': 'Pelvic Organ Prolapse'}], 'ancestors': [{'id': 'D011391', 'term': 'Prolapse'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010535', 'term': 'Laparoscopy'}, {'id': 'D007045', 'term': 'Hysterectomy, Vaginal'}], 'ancestors': [{'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D007044', 'term': 'Hysterectomy'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-06', 'studyFirstSubmitDate': '2023-07-12', 'studyFirstSubmitQcDate': '2023-07-21', 'lastUpdatePostDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post operative bleeding (defined as blood loss ≥500 cc)', 'timeFrame': 'First 24 hours after The Operations', 'description': 'Amount of lost blood will be measured in terms of assessment of Hemoglobin and Hematocrit levels before and after operation.'}, {'measure': 'Postoperative pain', 'timeFrame': 'First 24 hours after The Operations', 'description': 'Assessment of the pain post-operatively in patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopic hysterectomy', 'Vaginal hysterectomy'], 'conditions': ['Vaginal Vault Prolapse']}, 'descriptionModule': {'briefSummary': 'Hysterectomy is considered as a common operation in Gynecology. Hysterectomy could be made by vaginally, laparoscopically or abdominally. The American Congress of Obstetricians and Gynecologist advises the use of a minimally invasive technique for the sake of women and to decrease hospital stay and costs.', 'detailedDescription': 'Laparoscopic hysterectomy (LH) is a minimally invasive operation that could be made when vaginal hysterectomy is not accessible due to anatomical problems.\n\nVaginal cuff dehiscence (VCD) is a severe adverse event and occurs more frequently after total laparoscopic hysterectomy (TLH) compared with abdominal and vaginal hysterectomy.\n\nThe study shows effects of the laparoscopic approach versus the vaginal route for the management of vaginal cuff closure during total laparoscopic hysterectomy on female sexual function.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who undergo laparoscopic hysterectomy\n2. Age ranged from 40 to 80 years.\n3. Patients suffering from chronic pelvic inflammatory disease (PID)\n4. Dysfunctional uterine bleeding\n5. Adenomyosis\n6. Endometriosis\n7. Fibroid\n8. Endometrial hyperplasia\n9. Benign ovarian cyst\n\nExclusion Criteria:\n\n* Patients with known malignancy'}, 'identificationModule': {'nctId': 'NCT05960292', 'briefTitle': 'Laparoscopic Versus Vaginal Approach Closure Complications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Egymedicalpedia'}, 'officialTitle': 'Laparoscopic Versus Vaginal Approach Closure Complications of Vaginal Vault in Laparoscopic Hysterectomy', 'orgStudyIdInfo': {'id': 'Mohamed Adel Hussien'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vaginal Hysterectomy (Group)', 'description': 'About 28 female patients will have vaginal vault closure by vaginal approach', 'interventionNames': ['Procedure: Laparoscopic and Vaginal Hysterectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Abdominal Laparoscopic Hysterectomy (Group)', 'description': 'About 28 female patients will have vaginal vault closure by Abdominal Laparoscopic approach', 'interventionNames': ['Procedure: Laparoscopic and Vaginal Hysterectomy']}], 'interventions': [{'name': 'Laparoscopic and Vaginal Hysterectomy', 'type': 'PROCEDURE', 'description': 'To make a comparison between the Vaginal Vault complications after Hysterectomy', 'armGroupLabels': ['Abdominal Laparoscopic Hysterectomy (Group)', 'Vaginal Hysterectomy (Group)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13111', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ElSayed ElDesouky, Assist.Prof', 'role': 'CONTACT', 'email': 'elsayedeldesouky@yahoo.com', 'phone': '01092934978'}, {'name': 'Ahmed Altaf, Professor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Al-Azhar University hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed Adel, MSC', 'role': 'CONTACT', 'email': 'elhoseeeeeeny@gmail.com', 'phone': '+201065702255'}], 'overallOfficials': [{'name': 'ElSayed ElDesouky, Assist.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University, Faculty of medicine for boys'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Egymedicalpedia', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}