Department of Urology, Humanitas Mater Domini, Via Gerenzano 2, 21053, Castellanza, Varese, Italy.
ESUT European Section for UroTechnology, Arnhem, Netherlands.
World J Urol. 2017 Dec;35(12):1967-1975. doi: 10.1007/s00345-017-2084-7. Epub 2017 Sep 5.
To prospectively evaluate the efficacy and safety of RIRS, SWL and PCNL for lower calyceal stones sized 1-2 cm.
Patients with a single lower calyceal stone with an evidence of a CT diameter between 1 and 2 cm were enrolled in this multicenter, randomized, unblinded, clinical trial study. Patients were randomized into three groups: group A: SWL (194 pts); group B: RIRS (207 pts); group C: PCNL (181 pts). Patients were evaluated with KUB radiography (US for uric acid stones) at day 10 and a CT scan after 3 months. The CONSORT 2010 statement was adhered to where possible. The collected data were analyzed.
The mean stone size was 13.78 mm in group A, 14.82 mm in group B and 15.23 mm in group C (p = 0.34). Group C compared to group B showed longer operative time [72.3 vs. 55.8 min (p = 0.082)], fluoroscopic time [175.6 vs. 31.8 min (p = 0.004)] and hospital stay [3.7 vs. 1.3 days (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 2 cm. RIRS compared to PCNL offers the best outcome in terms of procedure length, radiation exposure and hospital stay. ISRCTN 55546280.
前瞻性评估 RIRS、SWL 和 PCNL 治疗 CT 直径 1-2cm 下盏结石的疗效和安全性。
本多中心、随机、非盲、临床试验研究纳入了单枚下盏结石且 CT 直径为 1-2cm 的患者。患者被随机分为三组：A 组：SWL（194 例）；B 组：RIRS（207 例）；C 组：PCNL（181 例）。患者在第 10 天接受 KUB 射线检查（尿酸结石行 US 检查），3 个月后进行 CT 扫描。尽可能遵循 CONSORT 2010 声明。分析收集的数据。
A 组的平均结石大小为 13.78mm，B 组为 14.82mm，C 组为 15.23mm（p=0.34）。与 B 组相比，C 组的手术时间更长[72.3 比 55.8 分钟（p=0.082）]，透视时间更长[175.6 比 31.8 分钟（p=0.004）]，住院时间更长[3.7 比 1.3 天（p=0.039）]。A 组的总体结石清除率（SFR）为 61.8%，B 组为 82.1%，C 组为 87.3%。A 组的再次治疗率明显高于其他两组，为 61.3%（p<0.05）。A 组和 B 组的辅助手术率相当，而 C 组较低（p<0.05）。A、B 和 C 组的并发症发生率分别为 6.7%、14.5%和 19.3%。
在 CT 直径 1-2cm 的单枚下盏结石中，RIRS 和 PCNL 比 SWL 更有效，能获得更好的 SFR 和更低的辅助和再次治疗率。与 PCNL 相比，RIRS 在手术时间、辐射暴露和住院时间方面提供了最佳结果。ISRCTN55546280。
