Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-24 @ 2:58 PM
Study NCT ID:
NCT02276261
Status:
COMPLETED
Last Update Posted:
2016-07-20
First Post:
2014-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Vertical Versus Horizontal Vaginal Cuff Closure on Vaginal Length After 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': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-18', 'studyFirstSubmitDate': '2014-10-20', 'studyFirstSubmitQcDate': '2014-10-27', 'lastUpdatePostDateStruct': {'date': '2016-07-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-10-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Complications', 'timeFrame': 'Up to 4 months post-op', 'description': 'Including urinary retention, bladder injury, ureteral injury, cuff dehiscence, cuff bleeding requiring further procedures or cauterization'}], 'primaryOutcomes': [{'measure': 'Vaginal length', 'timeFrame': '1-3 weeks postop', 'description': 'Vaginal length will be measured in cm by standard POP-Q measurements'}], 'secondaryOutcomes': [{'measure': 'Vaginal length', 'timeFrame': '3-4 months postop', 'description': 'Vaginal length will be measured in cm by standard POP-Q measurements'}, {'measure': 'Cuff closure time', 'timeFrame': 'intra-op', 'description': 'Time will be recorded by the circulating nurse in seconds'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hysterectomy']}, 'descriptionModule': {'briefSummary': 'This study has been designed as a prospective randomized trial to be performed at Bridgeport Hospital. Patients planning to undergo a laparoscopic or robotically assisted total laparoscopic hysterectomy with or without removal of adnexal structures will be recruited by the Bridgeport Hospital Minimally Invasive Gynecologic Surgery fellows during their preoperative office visit at the Bridgeport Hospital Gynecologic Oncology office. If enrolled, they will be assigned a sequential study identification number. During their preoperative exam, a baseline POP-Q will be performed. Demographic information will be recorded from the electronic medical record.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing laparoscopic or robotic-assisted laparoscopic hysterectomy\n* Under the care of Dr. Dan-Arin Silasi or Dr. Masoud Azodi at Bridgeport Hospital\n* Planning to follow up at the Gynecologic Oncology office at Bridgeport Hospital\n* Age 18 or older\n* Able to give informed consent to participate in the research study\n\nExclusion Criteria:\n\n* Age less than 18\n* Unable to give informed consent\n* Patients undergoing radical hysterectomy\n* Patients receiving vaginal cuff radiation within the study period\n* Patients undergoing concomitant pelvic floor or vaginal suspension procedure'}, 'identificationModule': {'nctId': 'NCT02276261', 'briefTitle': 'The Effect of Vertical Versus Horizontal Vaginal Cuff Closure on Vaginal Length After Laparoscopic Hysterectomy', 'organization': {'class': 'OTHER', 'fullName': 'Bridgeport Hospital'}, 'orgStudyIdInfo': {'id': '111401'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vertical', 'description': 'Vaginal cuff closure performed in a vertical manner.', 'interventionNames': ['Procedure: Vaginal cuff closure - vertical']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Horizontal', 'description': 'Vaginal cuff closure performed in a horizontal manner.', 'interventionNames': ['Procedure: Vaginal cuff closure - horizontal']}], 'interventions': [{'name': 'Vaginal cuff closure - vertical', 'type': 'PROCEDURE', 'description': 'Vaginal cuff is closed vertically.', 'armGroupLabels': ['Vertical']}, {'name': 'Vaginal cuff closure - horizontal', 'type': 'PROCEDURE', 'description': 'Vaginal cuff is closed horizontally.', 'armGroupLabels': ['Horizontal']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06610', 'city': 'Bridgeport', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Bridgeport Hospital', 'geoPoint': {'lat': 41.17923, 'lon': -73.18945}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bridgeport Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow', 'investigatorFullName': 'Amanda Tower', 'investigatorAffiliation': 'Bridgeport Hospital'}}}}