Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy
Completed
Conditions studied: Laparoscopic Cholecystectomy, Robotic-assisted Cholecystectomy
In brief
The study aims to evaluate the short-term clinical outcomes after complex robotic-assisted and laparoscopic cholecystectomies.
Key facts
- Study ID
- NCT04888117
- Run by
- Intuitive Surgical
- People needed
- 186
- Starts
- 2021-06-05
- Expected to finish
- 2025-01-27
- Last updated by the study team
- 2025-05-31
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Baptist Health-South Florida — Miami, Florida, United States
- Progressive Surgical Associates, Silver Cross Hospital — New Lenox, Illinois, United States
- Lovelace Medical Group — Albuquerque, New Mexico, United States
- St. David's Healthcare — Austin, Texas, United States
Full record on ClinicalTrials.gov
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