Ignite Creation Date:
2025-12-24 @ 10:50 PM
Ignite Modification Date:
2026-02-25 @ 4:49 PM
Study NCT ID:
NCT02293369
Status:
COMPLETED
Last Update Posted:
2016-01-08
First Post:
2014-11-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 58}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-07', 'studyFirstSubmitDate': '2014-11-13', 'studyFirstSubmitQcDate': '2014-11-17', 'lastUpdatePostDateStruct': {'date': '2016-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Female Sexual Function', 'timeFrame': 'Three months', 'description': 'Patients will be asked to fill out female sexual function index (FSFI) prior to surgery and at the 3-month follow-up.'}, {'measure': 'Vaginal length', 'timeFrame': 'One months', 'description': 'Vaginal measure will be taken prior to surgery and at 1-month follow-up.'}], 'secondaryOutcomes': [{'measure': 'Vaginal cuff granulation/infection', 'timeFrame': 'One month', 'description': 'Vaginal cuff granulation and any evidence of vaginal cuff infection will be carefully examined and documented during the 4-week follow-up visit'}, {'measure': 'Vaginal cuff closure time', 'timeFrame': 'One day', 'description': 'Cuff closure time will be recorded for each patient during the surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Total Laparoscopic Hysterectomy', 'Benign Conditions']}, 'descriptionModule': {'briefSummary': 'American Congress of Obstetricians and Gynecologists (ACOG) advises minimally invasive methods in gynecological surgery to ensure increased benefits to the patient and reduce potential hospitalization costs.\n\nLaparoscopic hysterectomy has become the standard approach in gynecological benign disorders. During laparoscopic hysterectomy, vaginal cuff can be closed with different sutures, techniques and approaches, which is one of the challenges of this surgery. Data is limited on potential impact of different sutures, techniques and approaches for vaginal cuff closure on female sexual function in relation to vaginal length.\n\nVarious studies in the literature evaluated different approaches (abdominal, vaginal, laparoscopic, robotic-assisted laparoscopic). In addition, for cuff closure, different techniques (interrupted, continuous) and sutures (barbed, Vicryl) were compared. Measures like operation time, cuff healing, complications, cost effectiveness, etc. were usually measured. However, there is no prospective randomized clinical study in the literature that compares laparoscopic approach with vaginal route for cuff closure in terms of female sexual function in relation to vaginal length.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to have total laparoscopic hysterectomy because of benign conditions only\n\nExclusion Criteria:\n\n* Suspicion of malignancy\n* Presence of large adnexal masses (maximum diameter \\>10 cm at preoperative ultrasonography)'}, 'identificationModule': {'nctId': 'NCT02293369', 'briefTitle': 'Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Istanbul University'}, 'officialTitle': 'Comparison of Two Methods of Vaginal Cuff Closure at Laparoscopic Hysterectomy and Their Effect on Female Sexual Function and Vaginal Length', 'orgStudyIdInfo': {'id': '1424'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Cuff closure via vaginal route', 'description': 'For vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. The repair will start at one end of the vaginal cuff, taking care to incorporate the uterosacral ligament into the initial bite and will continue toward the surgeon until the other uterosacral ligament will be incorporated into the repair, using a continuous 0-Vicryl suture in the vaginal route.', 'interventionNames': ['Procedure: Cuff closure via vaginal route']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Cuff closure via laparoscopic route', 'description': 'For vaginal cuff closure both in laparoscopic approach and vaginal route, we will use the same horizontal method, which can be described as closing the vagina anterior to posterior by leaving a horizontal scar. In the laparoscopic approach, needles will be introduced through the umbilical trocar and removed through the peripheral trocars and intracorporeal knots will be utilized.', 'interventionNames': ['Procedure: Cuff closure via laparoscopic route']}], 'interventions': [{'name': 'Cuff closure via vaginal route', 'type': 'PROCEDURE', 'description': 'Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.', 'armGroupLabels': ['Cuff closure via vaginal route']}, {'name': 'Cuff closure via laparoscopic route', 'type': 'PROCEDURE', 'description': 'Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.', 'armGroupLabels': ['Cuff closure via laparoscopic route']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34093', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Department of Obstetrics and Gynecology, Istanbul University School of Medicine', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'overallOfficials': [{'name': 'Faruk Buyru, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Istanbul University School of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istanbul University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Surrey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Obstetrics and Gynecology', 'investigatorFullName': 'Ercan Bastu', 'investigatorAffiliation': 'Istanbul University'}}}}