CompletedPhase 3

Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis

France414 participantsStarted 2010-05

Plain-language summary

Assess whether postoperative antibiotics after cholecystectomy for acute lithiasic cholecystitis little or moderately severe, is effective and therefore justified. The main objective is to compare the occurrence of postoperative infectious complications including surgical site infections (SSI) and remote infections after early cholecystectomy (performed within 5 days after onset of symptoms) for acute lithiasic cholecystitis (ALC) little or moderately serious (without organ dysfunction) with and without postoperative antibiotics. The secondary objectives are: * Rates of infectious complications according to duration of preoperative antibiotic * Influence of surgical drainage after surgery for occurrence of postoperative infectious complications * Analysis of the nature of infectious complications (surgical site infections, remote surgical site infections) * Comparison of germs found in the bile during the postoperative infectious complications * Duration of hospitalization * Readmission rate for surgical site infections * Rate of reoperation for surgical site infection * Overall mortality rate at 30 days * Mortality rates specific to 30 days

Who can participate

Age range

18 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: * Acute lithiasic cholecystitis low or moderately severe (confined to the gall bladder) * Requiring early cholecystectomy (progression of symptoms \<5 days * In an adult patient (\>18 years) * For each patient included the consent form must have been read, understood and signed. Exclusion Criteria: * Severe acute cholecystitis (with organ dysfunction) * Acalculous cholecystitis * Biliary peritonitis * Abscess perivesicular * Cholangitis * Acute Pancreatitis * Septic shock * Stone of bile duct * Physical or mental state does not allow participation in the study * Contraindication to surgery * Classification ASA (American Society of Anesthesiologists) IV-V or life expectancy \<48 hours * Suspected pre-or intraoperative cancer of the gallbladder * Pregnancy or breastfeeding * Treatment course with methotrexate, imidazole * Known history of allergy to Augmentin ®

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

All complications occurring during hospitalization or within 30 days postoperative. There are 2 main types of postoperative infectious complications: - Surgical site infections (SSI) - Systemic infections - Remote surgical site infections.

Timeframe: 30 days postoperative

Trial details

NCT IDNCT01015417

SponsorCentre Hospitalier Universitaire, Amiens

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-11

View on ClinicalTrials.gov More Acute Lithiasic Cholecystitis Grade I or II trials