Assessing antibiotic effectiveness for reducing postoperative infectious complications in acute cholecystitis: a multicenter randomized controlled trial.

Abstract

Background: Patients with acute cholecystitis (AC) often receive antibiotics to reduce the risk of infectious complications after cholecystectomy. This study investigated the clinical significance of antibiotic use in patients with mild-to-moderate AC who required emergency laparoscopic cholecystectomy.

Methods: This multicenter, double-blind, randomized controlled trial was conducted at four centers between February 2023 and January 2024. Patients with AC eligible for emergency laparoscopic cholecystectomy were randomly assigned to the antibiotic or placebo group. The antibiotic group received 1 g of intravenous cefazolin daily for three days during hospitalization and oral antibiotics for 4 days after discharge, whereas the placebo group received 10 mL of intravenous normal saline during their hospital stay. The primary endpoint was the rate of infectious complications.

Results: An imputed per-protocol analysis of 370 patients (185 in each group) found comparable postoperative infection rates between the antibiotic group (7.6%, 14 patients) and placebo group (7%, 13 patients), showing no statistically significant difference ( P = 0.842). Overall, the non-infectious complication rates did not differ significantly between the two groups: 21 (11.5%) cases in the antibiotic group vs. 30 (16.2%) cases in the placebo group ( P = 0.591). Considering a non-inferiority margin of 10%, the absence of antibiotic treatment did not result in worse clinical outcomes than the antibiotic treatment.

Conclusions: Administering antibiotics, even in sufficient doses, did not significantly reduce the risk of infectious complications in patients with AC compared to the group that did not receive antibiotics.