Antibiotics Postcholecystectomy Do Not Prevent Infection

Ricki Lewis, PhD

July 09, 2014

Antibiotic treatment after cholecystectomy for acute calculous cholecystitis did not appear to lower risk for infection, according to a study published in the July 9 issue of JAMA.

Approximately 20% of the 750,000 or so cholecystectomies performed each year in the United States are to treat acute calculous cholecystitis. Postoperative antibiotics are administered to lower the incidence of infection, based on observations that in 40% to 60% of cases, bile from patients yields bacterial cultures.

Although guidelines from the Infectious Diseases Society of America, the World Society of Emergency Surgery, and the Tokyo consensus meeting say to treat patients postoperatively with amoxicillin plus clavulanic acid, controlled studies of actual infection rates have only evaluated antibiotic use before and during surgery. However, the trend has been to shorten length of treatment. The researchers hypothesized that the treatment would not alter infection incidence.

To evaluate the efficacy of antibiotic use in preventing postoperative infection, Jean Marc Regimbeau, MD, PhD, from the Amiens University Medical Center in France, and colleagues randomly assigned 414 patients with mild or moderate acute calculous cholecystitis either to continue preoperative amoxicillin plus clavulanic acid 3 times daily for 5 days or to not receive antibiotics after laparoscopic cholecystectomy.

The primary outcome was surgical site or other infection at or before the 4-week follow-up examination. The open-label, noninferiority trial took place at 17 medical centers in France between May 2010 and August 2012.

Postoperative infection rates were 17% (35/207) in the nontreatment group and 15% (31/207) in the antibiotic group (absolute difference, 1.93%; 95% confidence interval [CI], −8.98% to 5.12%). Both groups had similar outcomes on the Clavien severity scale of surgical complications, length of hospital stay, and readmission rates. Corresponding infection rates in a per protocol analysis of 338 patients were 13% for both groups.

The study did not reveal a benefit to postoperative antibiotic therapy. Eliminating unnecessary antibiotic therapy could cut costs and counter selection of antibiotic-resistant bacteria, the researchers conclude.

Joseph S. Solomkin, MD, from the University of Cincinnati College of Medicine in Ohio, addressed a limitation of the study in an accompanying editorial: lack of blind assessment (although a blinded re-review of a subset of the participants was part of the analysis and patients were randomized in a blinded manner preoperatively).

However, "the study findings support not administering postoperative antibiotic therapy to cholecystectomy patients with mild to moderate clinical severity of illness and [are] an important addition to the evidence base for future guidelines regarding postoperative antibiotic use in the absence of established infections," Dr. Solomkin writes.

This study was funded by the French Ministry of Health's Programme Hospitalier de Recherche Clinique 2009 program. This study was supported with cooperative agreements from the National Clinical Research Protocol. The researchers and the commentator have disclosed no relevant financial relationships.

JAMA. 2014;312:135-136, 145-154. Article abstract, Editorial extract

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