Ignite Creation Date:
2025-12-25 @ 4:26 AM
Ignite Modification Date:
2025-12-26 @ 3:29 AM
Study NCT ID:
NCT04551820
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2020-08-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D039602', 'term': 'After-Hours Care'}], 'ancestors': [{'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 520}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-24', 'studyFirstSubmitDate': '2020-08-05', 'studyFirstSubmitQcDate': '2020-09-15', 'lastUpdatePostDateStruct': {'date': '2021-11-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conversion to open', 'timeFrame': 'Intra-operative', 'description': 'The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach.'}, {'measure': 'Number of adverse events', 'timeFrame': 'Intra-operative through the 30 day follow-up period', 'description': 'Intra-operative or post-operative adverse events related to the cholecystectomy'}, {'measure': 'Re-admissions', 'timeFrame': 'After discharge from the hospital post-procedure through the 30 day follow-up period', 'description': 'Re-admissions to the hospital related to the cholecystectomy through the 30 day follow-up period'}, {'measure': 'Re-operations', 'timeFrame': 'After the procedure but prior to discharge, through the 30 day follow-up period', 'description': 'Re-operations related to the cholecystectomy through the 30 day follow-up period'}], 'secondaryOutcomes': [{'measure': 'Operative time', 'timeFrame': 'Intra-operative', 'description': 'Operative time, defined as first incision to closure of the incision'}, {'measure': 'Use of intra-operative imaging', 'timeFrame': 'Intra-operative', 'description': 'The rate of use of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography'}, {'measure': 'Length of Hospital Stay (LOS)', 'timeFrame': 'From admission to discharge, up to approximately one week', 'description': 'How long the patient was admitted to the hospital'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cholecystectomy']}, 'referencesModule': {'references': [{'pmid': '38244145', 'type': 'DERIVED', 'citation': 'Choudhry V, Patel YK, McIntosh BB, Badrudduja M, Jandali M, Vijan S, Brown K. Retrospective multi-center study of robotic-assisted cholecystectomy: after-hours surgery and business-hours surgery outcomes. J Robot Surg. 2024 Jan 20;18(1):48. doi: 10.1007/s11701-023-01765-x.'}]}, 'descriptionModule': {'briefSummary': 'A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.', 'detailedDescription': 'The study is a retrospective multi-center chart review study of short-term patient outcomes through 30 days after robotic-assisted cholecystectomies performed during regular hours and after-hours. The primary outcomes include the rate of conversion to open, rate of intra-operative adverse events, the rate of post-operative adverse events relating to the cholecystectomy within 30 days, and re-admissions and re-operations relating to the cholecystectomy within 30 days. In addition, operative time, the rate of use of intra-operative imaging, and the hospital length of stay will be collected as secondary outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent a robotic-assisted cholecystectomy procedure and meet all eligibility criteria will be considered for enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject between 18 and 80 years of age at the time of surgery.\n* Subject underwent a robotic-assisted cholecystectomy during the study time period.\n\nExclusion Criteria:\n\n* Cholecystectomy was performed as a secondary procedure.'}, 'identificationModule': {'nctId': 'NCT04551820', 'acronym': 'SPARC', 'briefTitle': 'Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intuitive Surgical'}, 'officialTitle': 'SPARC: Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy', 'orgStudyIdInfo': {'id': 'ISI-AHC-2020'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Regular Hours', 'description': 'These subjects have undergone a cholecystectomy during regular hours at the Institution.', 'interventionNames': ['Procedure: Regular Hours', 'Device: Robotic-assisted Cholecystectomy']}, {'label': 'After Hours', 'description': 'These subjects have undergone a cholecystectomy during after hours at the Institution.', 'interventionNames': ['Procedure: After Hours', 'Device: Robotic-assisted Cholecystectomy']}], 'interventions': [{'name': 'Regular Hours', 'type': 'PROCEDURE', 'description': 'The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.', 'armGroupLabels': ['Regular Hours']}, {'name': 'After Hours', 'type': 'PROCEDURE', 'description': 'The after hours cohort includes cholecystectomies performed outside of the day shift at the Institution during Monday through Friday, on the weekend, or during a national holiday.', 'armGroupLabels': ['After Hours']}, {'name': 'Robotic-assisted Cholecystectomy', 'type': 'DEVICE', 'description': "With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the cholecystectomy according to the surgeon's standard of care.", 'armGroupLabels': ['After Hours', 'Regular Hours']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78758', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': "St. David's Medical Center", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Intuitive Surgical', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}