Prospective Multi-Center Study of Short-Term Outcomes After Complex Cholecystectomy (NCT04888117) | Clinical Trial Compass
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.
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 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 criteria
. 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
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
1
Conversion to open
Timeframe: Intra-operative
2
Number of adverse events
Timeframe: Intra-operative through the 30 days follow-up period
3
Re-admissions
Timeframe: After discharge from the hospital post-procedure through the 30 days follow-up period
4
Re-operations
Timeframe: After the procedure but prior to discharge, through the 30 day follow-up period