Status:
COMPLETED
Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy
Lead Sponsor:
Intuitive Surgical
Conditions:
Laparoscopic Cholecystectomy
Robotic-assisted Cholecystectomy
Eligibility:
All Genders
18-80 years
Brief Summary
The study aims to evaluate the short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies.
Detailed 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 o...
Eligibility Criteria
Inclusion
- Subject is between 18 and 80 years of age at the time of surgery
- Subject is a candidate for a cholecystectomy
- Subject has a diagnosis of acute cholecystitis and is being admitted through the Emergency Room (ER)
Exclusion
- A single port (single site or single incision procedure) cholecystectomy will be performed
- Subject will undergo a concomitant procedure
- Subject is contraindicated for surgery or a minimally invasive approach
- Subject has a known bleeding or clotting disorder that is not able to be controlled during surgery
- Pregnant or suspect pregnant
- 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
- Subject belonging to other vulnerable population, e.g. prisoner or ward of the state
- Subject is unable to comply with the follow-up visit schedule
- Subject is currently participating in another research study
Key Trial Info
Start Date :
June 5 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 27 2025
Estimated Enrollment :
186 Patients enrolled
Trial Details
Trial ID
NCT04888117
Start Date
June 5 2021
End Date
January 27 2025
Last Update
May 31 2025
Active Locations (4)
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1
Baptist Health-South Florida
Miami, Florida, United States, 33176
2
Progressive Surgical Associates, Silver Cross Hospital
New Lenox, Illinois, United States, 60451
3
Lovelace Medical Group
Albuquerque, New Mexico, United States, 87102
4
St. David's Healthcare
Austin, Texas, United States, 78701