Prospective Randomized Trial of Antibiotic Prophylaxis Duration for Percutaneous Nephrolithotomy in Low-Risk Patients

Introduction and Objective: Postoperative infection and sepsis account for the most common complications following percutaneous nephrolithotomy (PCNL), as high as 14% in low-risk patients. Although the American Urological Association (AUA) recommends perioperative antibiotics for 24 hours or less for PCNL, practice patterns vary regarding duration of antibiotic therapy. We aimed to compare the efficacy of 24-hour antibiotic coverage vs short-course protocol of antibiotic prophylaxis for PCNL. Materials and Methods: Low-risk patients with a sterile preoperative urine culture undergoing PCNL were prospectively randomized to antibiotics for up to 24 hours after procedure (24Hr) or continued until external urinary catheters were removed (CR) study groups. Patients were given a first generation cephalosporin, or ciprofloxacin in patients with penicillin allergy. Exclusion criteria included age <18 years, receiving antibiotics immediately before the procedure, history of urosepsis, presence of indwelling catheter >1 week, multistage procedure, immunosuppression, pregnancy, multiple antibiotic allergies, and patients who are breastfeeding. Results: Ninety-eight patients were randomized to either 24Hr (n = 49) or CR (n = 49). Mean duration of antibiotic administration was 20.6 and 34.0 hours in the 24Hr and CR groups (p = 0.04), respectively. Age, comorbidities, stone size, operative time, number of punctures, dilations, and proportion of "tubeless" procedures were similar between groups. There were no differences in febrile episodes, rates of systemic inflammatory response syndrome, bacteremia, or culture-proven postoperative urinary tract infection between the 24Hr and CR groups. Overall complication rates were similar between groups. In a subgroup analysis which excluded "tubeless" patients (24 and 29 patients in 24Hr and CR groups, respectively), no differences were seen in postoperative outcomes. Conclusions: In a randomized, prospective study, we found that a 24-hour protocol for antibiotic prophylaxis is not associated with increased risk of infection-related events compared to giving antibiotics until external catheters are removed in patients with low infectious risk undergoing PCNL. Clinicaltrials.gov: NCT02579161.