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

Intuitive Surgical

Status: Completed

Conditions: Cholecystectomy

Treatments: Procedure: After Hours; Procedure: Regular Hours; Device: Robotic-assisted Cholecystectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT04551820

ISI-AHC-2020

Details and patient eligibility

About

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

Full 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.

Enrollment: 520 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

520 participants in 2 patient groups

Regular Hours

Description:

These subjects have undergone a cholecystectomy during regular hours at the Institution.

Treatment:

Procedure: Regular Hours

Device: Robotic-assisted Cholecystectomy

After Hours

Description:

These subjects have undergone a cholecystectomy during after hours at the Institution.

Treatment:

Procedure: After Hours

Device: Robotic-assisted Cholecystectomy