At a glance
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Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe
In Brief
A Phase 3 clinical trial evaluating Amoxicillin clavulanic acid and No medication for Acute Lithiasic Cholecystitis Grade I or II and 3 related conditions. Completed, enrolled 414 participants across 21 sites.
Detailed 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
Study Details
Timeline
Interventions
Postoperative administration of 2g, 3 times daily, since 5 days, of amoxicillin clavulanic acid (Augmentin or generic) oral form or parenteral form according to clinical patient and by the choice of medical teams
no postoperative antibiotics