Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy (SPARC)

• ClinicalTrials.gov Identifier: NCT04551820
• Recruitment Status: Completed
• First Posted: September 16, 2020
• Last Update Posted: November 26, 2021
• Sponsor: Intuitive Surgical
• Information provided by (Responsible Party): Intuitive Surgical

Study Description

Brief Summary:

A multi-center retrospective chart review of short-term outcomes associated with robotic-assisted cholecystectomies performed during regular hours and after-hours.

Condition or disease	Intervention/treatment
Cholecystectomy	Procedure: Regular Hours; Procedure: After Hours; Device: Robotic-assisted Cholecystectomy

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 Design

• Study Type: Observational
• Actual Enrollment: 520 participants
• Observational Model: Case-Only
• Time Perspective: Retrospective
• Official Title: SPARC: Study of Peri-operative and Acute Outcomes After Robotic-assisted Cholecystectomy
• Actual Study Start Date: August 5, 2020
• Actual Primary Completion Date: September 30, 2021
• Actual Study Completion Date: September 30, 2021

Groups and Cohorts

Group/Cohort	Intervention/treatment
Regular Hours; These subjects have undergone a cholecystectomy during regular hours at the Institution.	Procedure: Regular Hours; The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.; Device: Robotic-assisted Cholecystectomy; 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.	Procedure: After Hours; 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.; Device: Robotic-assisted Cholecystectomy; 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.

Outcome Measures

Primary Outcome Measures :

1. 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.
2. 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
3. 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
4. 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

Secondary Outcome Measures :

1. Operative time [ Time Frame: Intra-operative ]
   Operative time, defined as first incision to closure of the incision
2. Use of intra-operative imaging [ Time Frame: Intra-operative ]
   The rate of use of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography
3. 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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Patients who underwent a robotic-assisted cholecystectomy procedure and meet all eligibility criteria will be considered for enrollment.

Criteria

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.

Contacts and Locations

Locations

United States, Texas

St. David's Medical Center

Austin, Texas, United States, 78758

Sponsors and Collaborators

Intuitive Surgical

More Information

• Responsible Party: Intuitive Surgical
• ClinicalTrials.gov Identifier: NCT04551820
• Other Study ID Numbers: ISI-AHC-2020
• First Posted: September 16, 2020
• Last Update Posted: November 26, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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