To present a prospective randomize trail in comparison of multiple-, single-, zero-dose antibiotic prophylaxis in RIRS, and investigate the ideal protocol for antibiotic prophylaxis in RIRS.
A prospective randomized trial was conducted between August 2014 and November 2016. 300 consecutive patients with preoperative sterile urine undergoing RIRS were randomized into three groups and received ciprofloxacin-based different ABP regimes (group 1, zero-dose; group 2, single dose, 30 min before the surgery; group 3, two doses, first dose at 30 min before the surgery and additional dose within 12 hours after surgery. The primary endpoint was the systemic inflammatory response syndrome (SIRS).
A total of 265 patients (group 1: 88, group 2: 88, group 3:89) were eligible for final analysis. Baseline characteristics were similar between three groups. SIRS was recorded in 8 (9.1%), 3 (3.4%) and 1(1.2%) patients in group 1, 2, 3, respectively. In subgroup analysis, SIRS occurred respectively in 5.0%, 5.1% and 0% of patients with stones ≤ 200 mm2; for stones > 200 mm2, low rates of SIRS were still observed in group 2 (0%) and group 3 (2.7%), however, 17.9% were developed in group 1. No urosepsis was developed in any groups.
RIRS without antibiotic prophylaxis is safe for patients with with preoperative sterile urine and stones ≤200 mm2, and prophylactic antibiotics are not recommended for those patients. However, single dose prophylaxis seems necessary and sufficient for patients with stones >200 mm2.