Perrella Rodrigo, Vicentini Fabio C, Paro Eliane D, Torricelli Fabio C M, Marchini Giovani S, Danilovic Alexandre, Batagello Carlos A, Mota Priscila K V, Ferreira Daniel B, Cohen David J, Murta Claudio B, Claro Joaquim F A, Giusti Guido, Monga Manoj, Nahas William C, Srougi Miguel, Mazzucchi Eduardo
Department of Urology, Hospital das Clinicas, University of São Paulo Medical School, São Paulo, Brazil.
Department of Urology, Hospital Brigadeiro, São Paulo, Brazil.
J Urol. 2022 Mar;207(3):647-656. doi: 10.1097/JU.0000000000002291. Epub 2021 Oct 25.
High-quality evidence comparing supine to prone percutaneous nephrolithotomy (PCNL) for the treatment of complex stones is lacking. This study aimed to compare the outcomes of supine position (SUP) and prone position (PRO) PCNL.
A noninferior randomized controlled trial was performed according to the CONSORT (Consolidated Standards for Reporting Trials) criteria. The inclusion criteria were patients over 18 years of age with complex stones. SUP was performed in the Barts flank-free modified position. Except for positioning, all the surgical parameters were identical. The primary outcome was the difference in the success rate on the first postoperative day (POD1) between groups. The secondary outcome was the difference in the stone-free rate (SFR) on the 90th postoperative day (final SFR). A noninferiority margin of 15% was used. Demographic, operative, and safety variables were compared between the groups. Statistical significance was set at p <0.05.
Overall, 112 patients were randomized and their demographic characteristics were comparable. The success rates on POD1 were similar (SUP: 62.5% vs PRO: 57.1%, p=0.563). The difference observed (-5.4%) was lower than the predefined limit. The final SFRs were also similar (SUP: 55.4% vs PRO: 50.0%, p=0.571). SUP had a shorter operative time (mean±SD 117.9±39.1 minutes vs 147.6±38.8 minutes, p <0.001) and PRO had a higher rate of Clavien ≥3 complications (14.3% vs 3.6%, p=0.045).
Positioning during PCNL for complex kidney stones did not impact the success rates; consequently, both positions may be suitable. However, SUP might be associated with a lower high-grade complication rate.
缺乏高质量证据来比较仰卧位与俯卧位经皮肾镜取石术（PCNL）治疗复杂结石的效果。本研究旨在比较仰卧位（SUP）和俯卧位（PRO）PCNL的治疗结果。
根据CONSORT（试验报告统一标准）标准进行了一项非劣效性随机对照试验。纳入标准为年龄超过18岁的复杂结石患者。SUP采用巴茨无侧腹改良体位进行。除体位外，所有手术参数均相同。主要结局是两组术后第1天（POD1）成功率的差异。次要结局是术后第90天结石清除率（最终SFR）的差异。采用15%的非劣效性界值。比较两组间的人口统计学、手术和安全变量。设定统计学显著性为p<0.05。
总体而言，112例患者被随机分组，其人口统计学特征具有可比性。POD1的成功率相似（SUP：62.5% vs PRO：57.1%，p=0.563）。观察到的差异（-5.4%）低于预定义限值。最终SFR也相似（SUP：55.4% vs PRO：50.0%，p=0.571）。SUP的手术时间较短（平均±标准差117.9±39.1分钟 vs 147.6±38.8分钟，p<0.001），PRO的Clavien≥3级并发症发生率较高（14.3% vs 3.6%，p=0.045）。
复杂肾结石PCNL术中的体位不影响成功率；因此，两种体位可能都适用。然而，SUP可能与较低的高级别并发症发生率相关。
