Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2026-02-18 @ 8:12 PM
Study NCT ID:
NCT02117492
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2014-04-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-19', 'studyFirstSubmitDate': '2014-04-16', 'studyFirstSubmitQcDate': '2014-04-17', 'lastUpdatePostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complication Rates', 'timeFrame': 'up to 12 months post-operativey', 'description': 'Overall complication rates will be monitored.'}], 'primaryOutcomes': [{'measure': 'Vaginal Length', 'timeFrame': 'up to 4-6 weeks post-operative', 'description': 'The primary endpoint measured in the study will be total vaginal length. This will be measured preoperatively, at 4-6 weeks postoperatively.'}], 'secondaryOutcomes': [{'measure': 'Sexual Function', 'timeFrame': 'Pre-operative, 6 and 12 months post-operativey', 'description': 'Secondary outcomes will include sexual function measured with FSFI preoperatively and at 6 months and 12 months post operatively.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['hysterectomy', 'vaginal cuff'], 'conditions': ['Hysterectomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the possible impacts of two techniques of vaginal cuff closure during robotic hysterectomy. We aim to compare vertical vs horizontal vaginal cuff closure and the impact that these techniques have on vaginal length, sexual function, and overall complication rates.', 'detailedDescription': 'A Validated questionnaire the Female Sexual Function Index (FSFI) and total vaginal lengths will be used to evaluate patients pre-operatively, at 4-6 weeks post-operatively, and 6 months post operatively. The FSFI will also be sent to the patient 12 months post operatively. These data will be used to assess sexual function and total vaginal length in patients undergoing minimally invasive hysterectomy. The study endpoint will occur after the 12 month follow-up questionnaire. Additionally, all complications following surgery will be tracked over the study period for comparison.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Female premenopausal patients undergoing robot assisted total laparoscopic hysterectomy\n\nExclusion Criteria:\n\n1. Adults unable to consent\n2. Children under the age of 18\n3. Pregnant women\n4. Prisoners\n5. Post-menopausal women\n6. Women with the known preoperative need for bowel or genitourinary surgery at the time of hysterectomy\n7. Patients unable to consent to the procedure in the English language'}, 'identificationModule': {'nctId': 'NCT02117492', 'briefTitle': 'A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'A Randomized Trial Comparing Horizontal and Vertical Vaginal Cuff Closure', 'orgStudyIdInfo': {'id': '00000143'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vertical Cuff', 'description': 'Vaginal cuff closure will be done vertically.', 'interventionNames': ['Procedure: Cuff Closure']}, {'type': 'EXPERIMENTAL', 'label': 'Horizontal Cuff', 'description': 'Vaginal cuff closure will be done horizontally.', 'interventionNames': ['Procedure: Cuff Closure']}], 'interventions': [{'name': 'Cuff Closure', 'type': 'PROCEDURE', 'description': 'Closure of the vaginal cuff following hysterectomy.', 'armGroupLabels': ['Horizontal Cuff', 'Vertical Cuff']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'overallOfficials': [{'name': 'Timothy A Deimling, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Minimally Invastive GYN Surgery', 'investigatorFullName': 'Timothy A Deimling', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}