Clinical significance of preoperative antibiotic use in mild to moderate acute inflammatory gallbladder disease: A randomized controlled trial
Sung Eun Park, Hojung Choi, Young Kyoung You, Tae Ho Hong
Abstract
BACKGROUND: Many patients receive empirical antibiotics for the prevention of postoperative infectious complications following cholecystectomy due to acute cholecystitis (AC). The purpose of this study was to investigate the clinical significance of preoperative antibiotics in mild to moderate AC patients undergoing emergency laparoscopic cholecystectomy. METHODS: This was a double-blind, placebo-controlled, randomized study. Patients with AC eligible for emergency laparoscopic cholecystectomy were randomly assigned to an antibiotic or a placebo group. Clinical outcomes including infectious complications were reviewed. RESULTS: An imputed per-protocol analysis of 234 patients showed that the postoperative infection rate was 8.6% (10 of 116 patients) in the antibiotic group and 7.6% (9 of 118 patients) in the placebo group (absolute difference, 1%; 95% CI: -8.1% to 6.1%; P = .815). Based on a noninferiority margin of 10%, the lack of preoperative antibiotic treatment was not associated with worse clinical outcomes than antibiotic treatment. Surgical site infection was the most common complication among the infectious complications, and there was no significant difference between the two groups (7.8% in the antibiotic group vs 7.6%, in the placebo group, P = .53). CONCLUSIONS: The absence of prophylactic antibiotics has no significant impact on the incidence of infectious complications in mild to moderated AC.