There’s a new randomized trial published in the Journal of the American Medical Association that evaluates the efficacy of post-cholecystectomy antibiotics in patients presenting with mild/moderate acute calculous cholecystitis. Upon diagnosis, all patient received amoxicillin+clavulanic acid 3 times a day pre-operatively and once during surgery. This open-label trial compared patients randomized to 5 days of post-operative antibiotics with the same antibiotic regimen vs. no post-operative antibiotics. Patients were followed up to four weeks post-operatively for SSI and other infections.
In the 414 patients, in the intention-to-treat analysis, the infection rate was 15% (31/207) in the post-operative antibiotic group and 17% (35/207) in the no-antibiotic group. The absolute risk difference was small (+/- 2.0%) and the 95% CI for the difference included zero for all key outcomes in the intention-to-treat analysis including superficial, deep and organ space infections.
The study appears to have high internal validity and randomization looks adequate. However, the lack of placebo and a relatively large non-inferiority outcome threshold (11%) are potential limitations. Of course, the study was also limited to amox-clav and perhaps some would favor testing other antibiotic regimens.
However, the lack of true difference will hopefully lead to further validation studies or adoption of a no post-operative antibiotic recommendation for this surgical procedure. This study and hopefully more like it are exactly what we need in order to reduce antibiotic exposure in hospitals and subsequent selection of antimicrobial resistant pathogens, including Clostridium difficile. It’s great to see important antimicrobial stewardship questions asked and answered.
Eli N. Perencevich, MD, ACP Member, is an infectious disease physician and epidemiologist in Iowa City, Iowa, who studies methods to halt the spread of resistant bacteria in our hospitals (including novel ways to get everyone to wash their hands). This post originally appeared at the blog Controversies in Hospital Infection Prevention.