CompletedNot Applicable

Early Versus Delayed Laparoscopic Cholecystectomy for Acute Cholecystitis

Yemen81 participantsStarted 2022-01-01

Plain-language summary

The goal of this clinical trial is to learn if performing gallbladder surgery early is as safe and effective as delaying it for people with acute cholecystitis (a sudden gallbladder infection). The main questions it aims to answer are: * Do participants who have early surgery have a similar rate of complications compared to those who have delayed surgery? * How does the timing of surgery affect the length of the hospital stay? Researchers will compare two groups: 1. An early surgery group 2. A delayed surgery group Participants in the early surgery group had their gallbladder removed within 72 hours of when their symptoms started. Participants in the delayed surgery group were first treated with medications and had their surgery 6-8 weeks later.

Who can participate

Age range

18 Years – 70 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: * Yemeni nationals aged 18-70 years * A clinical diagnosis of acute cholecystitis confirmed by clinical presentation, laboratory findings, and imaging studies * Symptom duration of less than 72 hours at presentation * Fitness for general anesthesia (American Society of Anesthesiologists \[ASA\] physical status classification I-III) * Provision of written informed consent Exclusion Criteria: * Evidence of choledocholithiasis or acute cholangitis * Severe comorbidities precluding surgery (ASA class IV-V) * Coagulopathy (INR \>1.5 or platelet count \<100,000/μL) * Pregnancy * Previous major upper abdominal surgery * Patient refusal to participate

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

Overall Postoperative Complications

Timeframe: Within 30 days post-surgery

Conversion to Open Surgery

Timeframe: Intraoperative

Operative Time

Timeframe: Intraoperative

Trial details

NCT IDNCT07101315

SponsorSana'a University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-30

View on ClinicalTrials.gov More Acute Cholecystitis trials