CompletedNot Applicable

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

United States186 participantsStarted 2021-06-05

Plain-language summary

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

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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)

✕. 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

Conversion to open

Timeframe: Intra-operative

Number of adverse events

Timeframe: Intra-operative through the 30 days follow-up period

Re-admissions

Timeframe: After discharge from the hospital post-procedure through the 30 days follow-up period

Re-operations

Timeframe: After the procedure but prior to discharge, through the 30 day follow-up period

NCT IDNCT04888117

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-01-27

Who can participate