Comparison of ceftibuten vs. amoxicillin/clavulanic acid as antibiotic prophylaxis in cholecystectomy and/or biliary tract surgery.

A randomized, comparative, prospective clinical trial was carried out at a tertiary care center to compare the efficacy of two antibiotic regimens in the prophylaxis of postoperative infection in patients undergoing biliary tract surgery. One hundred patients undergoing cholecystectomy or biliary tract exploration were randomly allocated to one of the following antibiotic regimens: the standard regimen of three doses of amoxicillin/clavulanic acid (1000/200 mg) given by intravenous infusion, or a single dose of ceftibuten (400 mg) given orally. Patients were monitored during their stay in the hospital and over a 2 week period as outpatients. Fifty adult patients were included in each group. Mean age was 49 years, and sex distribution was 82 women and 18 men. The groups were comparable in terms of demographic characteristics and comorbidity. There were no cases of postoperative infection in the ceftibuten group, but five cases of infection occurred in the amoxicillin/clavulanic acid group (P < 0.05). No adverse effects were observed with either antibiotic. The treatment cost per patient was significantly lower for ceftibuten. The results indicate that ceftibuten is well tolerated and more effective than amoxicillin/clavulanic acid for prophylaxis following gallbladder and biliary tract surgery. In addition, ceftibuten has the advantage of being more cost-effective and easier to administer than amoxicillin/clavulanic acid so it could be considered as an alternative for antibiotic prophylaxis in these types of surgical procedures.

RCT Entities:   Population Interventions Outcomes