Antibiotics following gallbladder surgery unnecessary: Study

Postoperative antibiotics after cholecystectomy (gallbladder surgery) do not reduce the risk of infection, according to a study published in the Journal of the American Medical Association.

Lead author Jean-Marc Regimbeau, MD, PhD, of CHU Nord Amiens and the University of Picardie in Amiens, France, and colleagues conducted an open-label, multicenter, noninferiority, randomized clinical trial involving 414 patients with mild or moderate calculous cholecystitis. In the trial, patients received a regimen of antibiotics before and during surgery.

“We then compared patients who received no postoperative antibiotics with patients who continued receiving the same regimen of antibiotics for 5 days after surgery,” Dr Regimbeau said.

Based on a noninferiority (not worse than) margin of 11% established for this trial, the lack of postoperative antibiotic treatment was not associated with worse outcomes than antibiotic treatment.

“We found that the absence of postoperative administration of amoxicillin plus clavulanic acid did not improve the occurrence of postoperative infections in patients with mild or moderate acute calculous cholecystitis,” he said.

The bile cultures were pathogen-free in 60% of case. Moreover, the researchers showed that less than 2% of the overall population presented a major complication defined according to the Clavien Dindo Classification (Clavien score ≥3a). After cholecystectomy the readmission rate was 6%.

“Currently, the health ministry’s recommendation is to reduce the antibiotics’ administration only for necessity in France,” Dr Regimbeau said. “It is well known that continuation of antibiotic treatment increases costs and promotes the selection of multi-resistant bacteria.”

In 2010, 37,499 cholecystectomies for acute calculous cholecystitis were performed in France, and 90% of these were for grades I and II [mild or moderate] acute calculous cholecystitis.

“Supposing that these patients did not really need postoperative antibiotics-which are generally prescribed for 5 days)-we estimate that many days of antibiotic treatment could be avoided each year,” he said. “Reduction of the use of unnecessary antibiotics is important given that there is an increasing antibiotic resistance and a higher incidence of antibiotic complications such as Clostridium difficile infection. Our study demonstrates that postoperative antibiotics following acute calculous cholecystitis are not necessary.”

“The main data taken away from this study are that postoperative administration of amoxicillin plus clavulanic acid after mild or moderate acute calculous cholecystitis lasting for less than 5 days is not necessary-the treatment of this condition should include preoperative antibiotic and cholecystectomy; and whatever the treatment course the readmission rate is around 6%,” Regimbeau said.