Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2025-12-27 @ 8:23 PM
Study NCT ID:
NCT01217866
Status:
COMPLETED
Last Update Posted:
2012-12-20
First Post:
2010-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-19', 'studyFirstSubmitDate': '2010-10-06', 'studyFirstSubmitQcDate': '2010-10-07', 'lastUpdatePostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surgical time', 'timeFrame': 'Operating room time in minutes', 'description': 'The total time the subject spent in surgery was compared between the two groups'}, {'measure': 'Estimated blood loss', 'timeFrame': 'Blood loss during surgery in cc per minute', 'description': 'The total blood loss in cc per minutes operating was compared between the two groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['laparoscopic', 'vaginal', 'hysterectomy'], 'conditions': ['Benign Uterine Disease']}, 'descriptionModule': {'briefSummary': 'Retrospective charts review from one surgeon to compare Group A- cases where the laparoscopic portion of the case used an EN\\~SEAL device to Group B - the laparoscopic BSO was done using a 3mm EN-SEAL device through 2 lateral 5mm ports.', 'detailedDescription': '79 women with benign uterine disease underwent laparoscopic assisted vaginal hysterectomy with or without bilateral salpingo-oophorectomy. Subjects charts were divided into two groups based on surgical technique and the following parameters were reviewed retrospectively: surgical time, blood loss, uterine weight, patient weight, patient age, post operative fever \\>100.4 F, readmission to hospital within one week, return to operating room within 24 hours, length of hospital stay, and blood transfusion. Group A, N=35 used traditional suture technique vaginally. Group B, N=44 used Enseal coagulation cutting device vaginally.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '35 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients who underwent Laparoscopically Assisted Vaginal Hysterectomy (LAVH)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* none, observational study\n\nExclusion Criteria:\n\n* none, observational study'}, 'identificationModule': {'nctId': 'NCT01217866', 'briefTitle': 'A Retrospective Review of Enseal Laparoscopic Vaginal Assisted Hysterectomy (LAVH) Versus Traditional LAVH', 'organization': {'class': 'OTHER', 'fullName': 'Womens Care'}, 'officialTitle': 'A Retrospective Analysis of a Complete Enseal Laparoscopic Vaginal Assisted Hysterectomy Versus a Traditional Suture Laparoscopic Vaginal Hysterectomy', 'orgStudyIdInfo': {'id': '1-44206615'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'LAVH, techniques', 'description': 'Women aged 35-75 who underwent laparoscopic assisted vaginal hysterectomy via either suture technique vaginally or Enseal coagulation cutting device vaginally', 'interventionNames': ['Procedure: Laparoscopic assisted vaginal hysterectomy']}], 'interventions': [{'name': 'Laparoscopic assisted vaginal hysterectomy', 'type': 'PROCEDURE', 'description': 'Surgical removal of uterus vaginally', 'armGroupLabels': ['LAVH, techniques']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': "Katie O'Keeffe, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Glens Falls Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Womens Care', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ethicon Endo-Surgery', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Kathryn OKeeffe MD', 'investigatorAffiliation': 'Womens Care'}}}}