Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2025 May 1;111(5):3314-3322.
doi: 10.1097/JS9.0000000000002346.

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

Sung Eun Park  1 , Tae Yoon Lee  2 , Chang Ho Seo  3 , Eui Soo Han  4 , Tae Ho Hong  1
Affiliations
Randomized Controlled Trial

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

Sung Eun Park et al. Int J Surg. .

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.

Keywords: acute cholecystitis; anti-bacterial agents; cephalosporin; cholecystectomy; surgical wound infection.

PubMed Disclaimer

Conflict of interest statement

The authors declare no potential conflicts of interest relevant to this article.

Figures

Figure 1.
Figure 1.
Schematic diagram of patient enrollment.
See this image and copyright information in PMC

References

    1. Kim EY, Yoon YC, Choi HJ, et al. Is there a real role of postoperative antibiotic administration for mildmoderate acute cholecystitis? A prospective randomized controlled trial. J Hepatobiliary Pancreat Sci 2017;24:550–58. - PubMed
    1. Colling KP, Besshoff KE, Forrester JD, et al. Surgical infection society guidelines for antibiotic use in patients undergoing cholecystectomy for gallbladder disease. Surg Infect (Larchmt) 2022;23:339–50. - PubMed
    1. Markotic F, Grgic S, Poropat G, et al. Antibiotics for adults with acute cholecystitis or acute cholangitis or both. Cochrane Database Syst Rev 2020;2020:CD013646.
    1. Roulin D, Saadi A, Di Mare L, et al. Early versus delayed cholecystectomy for acute cholecystitis, are the 72 hours still the rule?: a randomized trial. Ann Surg 2016;264:717–22. - PubMed
    1. de Santibañes M, Glinka J, Pelegrini P, et al. Extended antibiotic therapy versus placebo after laparoscopic cholecystectomy for mild and moderate acute calculous cholecystitis: a randomized double-blind clinical trial. Surgery 2018;164:24–30. - PubMed

Publication types