Abstract
To prospectively evaluate the efficacy and safety of RIRS, SWL and PCNL for lower calyceal stones sized 1-2cm. Patients with a single lower calyceal stone with an evidence of a CT diameter between 1 and 2cm were enrolled in this multicenter, randomized, unblinded, clinical trial study. Patients were randomized into three groups: group A: SWL (194pts); group B: RIRS (207pts); group C: PCNL (181pts). Patients were evaluated with KUB radiography (US for uric acid stones) at day 10 and a CT scan after 3months. The CONSORT 2010 statement was adhered to where possible. The collected data were analyzed. The mean stone size was 13.78mm in group A, 14.82mm in group B and 15.23mm in group C (p=0.34). Group C compared to group B showed longer operative time [72.3 vs. 55.8min (p=0.082)], fluoroscopic time [175.6 vs. 31.8min (p=0.004)] and hospital stay [3.7 vs. 1.3days (p=0.039)]. The overall stone-free rate (SFR) was 61.8% for group A, 82.1% for group B and 87.3% for group C. The re-treatment rate was significantly higher in group A compared to the other two groups, 61.3% (p<0.05). The auxiliary procedure rate was comparable for groups A and B and lower for group C (p<0.05). The complication rate was 6.7, 14.5 and 19.3% for groups A, B and C, respectively. RIRS and PCNL were more effective than SWL to obtain a better SFR and less auxiliary and re-treatment rate in single lower calyceal stone with a CT diameter between 1 and 2cm. RIRS compared to PCNL offers the best outcome in terms of procedure length, radiation exposure and hospital stay. ISRCTN 55546280.
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