Ignite Creation Date:
2025-12-24 @ 5:38 PM
Ignite Modification Date:
2025-12-30 @ 4:21 AM
Study NCT ID:
NCT00910468
Status:
COMPLETED
Last Update Posted:
2009-05-29
First Post:
2009-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007889', 'term': 'Leiomyoma'}], 'ancestors': [{'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-05', 'completionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-05-28', 'studyFirstSubmitDate': '2009-05-28', 'studyFirstSubmitQcDate': '2009-05-28', 'lastUpdatePostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative variables, including estimated blood loss, length of stay, days to a regular diet and febrile morbidity', 'timeFrame': '1 day'}]}, 'conditionsModule': {'conditions': ['Fibroid Uterus']}, 'descriptionModule': {'briefSummary': 'This is a retrospective, case-control study of 75 patients having undergone a robotic-assisted laparoscopic myomectomy were compared to patients having undergone myomectomy via laparotomy. Both groups had 3 or fewer fibroids confirmed by pre-operative MRI or on final pathology report. Charts were reviewed for surgical and post-operative variables'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women with fibroid uterus desiring surgical management', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* uterus less than or equal to 20 weeks in size by office exam and no greater than three intramural fibroids on pre-operative MRI.\n\nExclusion Criteria:\n\n* significant medical problems limiting their ability to undergo a prolonged laparoscopic procedure and could not have had previous uterine surgery.'}, 'identificationModule': {'nctId': 'NCT00910468', 'briefTitle': 'Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids', 'organization': {'class': 'INDIV', 'fullName': 'Ascher-Walsh, Charles, M.D.'}, 'officialTitle': 'Robot-Assisted Laparoscopic Myomectomy Is an Improvement Over Laparotomy in Patients With a Limited Number of Fibroids', 'orgStudyIdInfo': {'id': 'HSD08-00631'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Robot Assisted Laparoscopic Myomectomy', 'interventionNames': ['Procedure: Robot-assisted Laparoscopic myomectomy']}, {'label': 'Myomectomy via Laparotomy'}], 'interventions': [{'name': 'Robot-assisted Laparoscopic myomectomy', 'type': 'PROCEDURE', 'description': 'Robot-assisted Laparoscopic myomectomy', 'armGroupLabels': ['Robot Assisted Laparoscopic Myomectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount SInai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Charles Ascher-Walsh, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mt Sinai School of Medicine, Dept Obstetrics and Gynecology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ascher-Walsh, Charles, M.D.', 'class': 'INDIV'}, 'responsibleParty': {'oldNameTitle': 'Char;es Ascher-Walsh', 'oldOrganization': 'Mount Sinai School of Medicine'}}}}