Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy

Intuitive Surgical

Status: Completed

Conditions: Robotic-assisted Cholecystectomy; Laparoscopic Cholecystectomy

Treatments: Procedure: Robotic-assisted cholecystectomy; Procedure: Laparoscopic cholecystectomy

Study type: Observational

Funder types: Industry

Identifiers

NCT04888117

COMPaCT

Details and patient eligibility

About

The study aims to evaluate the short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies.

Full description

This is a multi-center cohort study, evaluating short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies. 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, the hospital length of stay, and pain and QOL scores will be collected as secondary outcomes.

Enrollment: 186 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Subject is between 18 and 80 years of age at the time of surgery
2. Subject is a candidate for a cholecystectomy
3. Subject has a diagnosis of acute cholecystitis and is being admitted through the Emergency Room (ER)

Exclusion criteria

1. A single port (single site or single incision procedure) cholecystectomy will be performed
2. Subject will undergo a concomitant procedure
3. Subject is contraindicated for surgery or a minimally invasive approach
4. Subject has a known bleeding or clotting disorder that is not able to be controlled during surgery
5. Pregnant or suspect pregnant
6. Subject is mentally handicapped or has a psychological disorder or severe systematic illness that would preclude compliance with the study requirements or ability to provide informed consent
7. Subject belonging to other vulnerable population, e.g. prisoner or ward of the state
8. Subject is unable to comply with the follow-up visit schedule
9. Subject is currently participating in another research study

Trial design

186 participants in 2 patient groups

Laparoscopic cholecystectomy

Description:

Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a laparoscopic cholecystectomy.

Treatment:

Procedure: Laparoscopic cholecystectomy

Robotic-assisted cholecystectomy

Description:

Subject has a diagnosis of acute cholecystitis and is admitted through the ER for a robotic-assisted cholecystectomy.

Treatment:

Procedure: Robotic-assisted cholecystectomy