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

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.

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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