- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04551820
Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy (SPARC)
November 24, 2021 updated by: Intuitive Surgical
SPARC: Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
520
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Austin, Texas, United States, 78758
- St. David's Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients who underwent a robotic-assisted cholecystectomy procedure and meet all eligibility criteria will be considered for enrollment.
Description
Inclusion Criteria:
- Subject between 18 and 80 years of age at the time of surgery.
- Subject underwent a robotic-assisted cholecystectomy during the study time period.
Exclusion Criteria:
- Cholecystectomy was performed as a secondary procedure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Regular Hours
These subjects have undergone a cholecystectomy during regular hours at the Institution.
|
The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.
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.
|
After Hours
These subjects have undergone a cholecystectomy during after hours at the Institution.
|
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Conversion to open
Time Frame: Intra-operative
|
The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach.
|
Intra-operative
|
Number of adverse events
Time Frame: Intra-operative through the 30 day follow-up period
|
Intra-operative or post-operative adverse events related to the cholecystectomy
|
Intra-operative through the 30 day follow-up period
|
Re-admissions
Time Frame: After discharge from the hospital post-procedure through the 30 day follow-up period
|
Re-admissions to the hospital related to the cholecystectomy through the 30 day follow-up period
|
After discharge from the hospital post-procedure through the 30 day follow-up period
|
Re-operations
Time Frame: After the procedure but prior to discharge, through the 30 day follow-up period
|
Re-operations related to the cholecystectomy through the 30 day follow-up period
|
After the procedure but prior to discharge, through the 30 day follow-up period
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative time
Time Frame: Intra-operative
|
Operative time, defined as first incision to closure of the incision
|
Intra-operative
|
Use of intra-operative imaging
Time Frame: Intra-operative
|
The rate of use of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography
|
Intra-operative
|
Length of Hospital Stay (LOS)
Time Frame: From admission to discharge, up to approximately one week
|
How long the patient was admitted to the hospital
|
From admission to discharge, up to approximately one week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 5, 2020
Primary Completion (Actual)
September 30, 2021
Study Completion (Actual)
September 30, 2021
Study Registration Dates
First Submitted
August 5, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 16, 2020
Study Record Updates
Last Update Posted (Actual)
November 26, 2021
Last Update Submitted That Met QC Criteria
November 24, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- ISI-AHC-2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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