drugset / Trial / NCT01015417

Place of Antibiotics in the Postoperative Acute Lithiasic Cholecystitis

NCT01015417

Phase 3 Completed 414 enrolled Centre Hospitalier Universitaire, Amiens
RandomizedParallel-groupOpen-labelTreatment

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

Timeline

Start
2010-05
Primary completion
2012-11
Completion
2012-11

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Amoxicillin Other / unclassified 2 g Intravenous

Indications