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

Cholecystectomy Clinical Trial

— SPARC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04551820
• Other study ID #: ISI-AHC-2020
• Status: Completed
• Start date: August 5, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: November 2021
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 520
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cholecystectomy

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	St. David's Medical Center	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Conversion to open	The rate of conversion of the cholecystectomy to open, defined as robotic-assisted surgery converted to an open approach.	Intra-operative
Primary	Number of adverse events	Intra-operative or post-operative adverse events related to the cholecystectomy	Intra-operative through the 30 day follow-up period
Primary	Re-admissions	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
Primary	Re-operations	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	Operative time	Operative time, defined as first incision to closure of the incision	Intra-operative
Secondary	Use of intra-operative imaging	The rate of use of intra-operative imaging, including indocyanine green fluorescent imaging and cholangiography	Intra-operative
Secondary	Length of Hospital Stay (LOS)	How long the patient was admitted to the hospital	From admission to discharge, up to approximately one week