CompletedNot Applicable

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

United States520 participantsStarted 2020-08-05

Plain-language summary

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

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Conversion to open

Timeframe: Intra-operative

Number of adverse events

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

Re-admissions

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

Re-operations

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

Trial details

NCT IDNCT04551820

SponsorIntuitive Surgical

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-09-30

View on ClinicalTrials.gov More Cholecystectomy trials