Antibiotics No Help Following Gallbladder Surgery

A new study reveals that prescribing postoperative amoxicillin plus clavulanic acid (ACA) after cholecystectomy does not reduce the risk of infection.

Researchers at CHU Nord (Amiens, France), the University of Picardie (Amiens, France), and other institutions conducted a randomized clinical trial involving 414 patients treated for calculous cholecystitis at 17 medical centers between May 2010 and August 2012, and who received no treatment or 2 grams of ACA (3 times a day for 5 days) following surgery. The main outcome measure was the proportion of postoperative surgical site infections (SSIs) or distant infections recorded before or at the 4-week follow-up visit.

The results showed that all told, there were 66 postoperative infections, including 35 in the nontreatment group and 31 in the antibiotic group. Intent to treat analysis showed that the rates were 17% in the nontreatment group and 15% in the ACA antibiotic group. A per-protocol analysis involving 338 patients saw infection rates of 13% in both arms. In all, the researchers concluded that the infection rate after cholecystectomy was virtually identical with and without postoperative ACA. The study was published in the July 9, 2014, issue of the Journal of the American Medical Association (JAMA).

“Among patients with mild or moderate calculous cholecystitis who received preoperative and intraoperative antibiotics, lack of postoperative treatment with amoxicillin plus clavulanic acid did not result in a greater incidence of postoperative infections,” concluded lead author Jean-Marc Regimbeau, MD, PhD, and colleagues, cautioning that “the absence of placebo in the nontreatment arm and the lack of blinding might have decreased the reliability of our evaluation of the primary outcome and the groups’ comparability.”

The combination of Amoxicillin trihydrate (a β-lactam antibiotic) and clavulanic acid (potassium clavulanate, a β-lactamase inhibitor) results in an antibiotic with an increased spectrum of action and restored efficacy against amoxicillin-resistant bacteria that produce β-lactamase. Trade names include Augmentin (by GlaxoSmithKline), Clavamox (by Pfizer), Tyclav (by Beximco Pharma), and many others. Rarely, cholestatic jaundice, a form of liver toxicity, has been associated with ACA. The reaction may occur up to several weeks after treatment has stopped, and usually takes weeks to resolve.

Related Links:

CHU Nord
University of Picardie