内镜联合肾内手术中的俯卧分腿位与 Galdakao 改良仰卧瓦尔迪维亚位:非劣效性设计随机对照试验

Teruaki Sugino, S. Hamamoto, K. Taguchi, Takaaki Inoue, S. Okada, T. Yanase, Yasuhito Sue, K. Kawase, R. Unno, R. Ando, A. Okada, T. Yasui
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引用次数: 1

摘要

内镜联合肾内手术(ECIRS)结合了经皮肾镜碎石术和输尿管镜检查。随着俯卧分腿式(PRO)和Galdakao-modified仰卧瓦尔迪维亚式(GMSV)体位的发展,这种手术已变得很常见。在本研究中,我们评估了 ECIRS 期间这些体位的手术效果。 根据《试验报告综合标准》,我们进行了一项非劣效随机对照试验。研究对象的资格标准是:年龄在20至80岁之间,肾结石和/或输尿管结石大于15毫米。他们被分配到PRO组或GMSV组,分别以PRO或GMSV体位接受ECIRS检查。主要结果是术后3个月的无结石率(SFR)。次要结果是手术结果--手术时间、经皮入路时间和并发症发生率。非劣效边际为 30%。 对 86 名患者(PRO 组 46 人,GMSV 组 43 人)进行了分析。PRO组和GMSV组的SFR分别为91.3%和90.7%。在总体并发症发生率方面,没有观察到组间差异。对于上萼穿刺,PRO 组的经皮穿刺时间长于 GMSV 组,而对于中萼穿刺,PRO 组的手术和经皮穿刺时间较短。 手术位置对成功率没有影响。除肾周血肿形成外,两组的并发症没有差异。
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Prone Split-Leg vs Galdakao-Modified Supine Valdivia Position During Endoscopic Combined Intrarenal Surgery: A Noninferiority Design Randomized Controlled Trial
Endoscopic combined intrarenal surgery (ECIRS) combines percutaneous nephrolithotomy and ureteroscopy. This procedure has become common with the development of the prone split-leg (PRO) and Galdakao-modified supine Valdivia (GMSV) positions. In this study, we evaluated the surgical outcomes of these positions during ECIRS. A noninferior randomized controlled trial was performed in accordance with the Consolidated Standards of Reporting Trials. The eligibility criteria were age 20 to 80 years and presence of > 15-mm renal and/or ureteral stones. They were assigned to the PRO or GMSV groups and underwent ECIRS in the PRO or GMSV position, respectively. The primary outcome was stone-free rate (SFR) 3 months after surgery. The secondary outcomes were surgical outcomes—surgery time, percutaneous access time, and complication rate. A noninferiority margin of 30% was used. Eighty-six patients (46 in the PRO group and 43 in the GMSV group) were analyzed. The SFR was 91.3% and 90.7% in the PRO and GMSV groups, respectively. No between-group differences were observed regarding the overall complication rates. Percutaneous access time was longer in the PRO group than in the GMSV group for upper calyx punctures, whereas surgery and percutaneous access times were shorter in the PRO group for those with a middle calyx puncture. Surgical position did not affect the success rates. There was no difference in complications between the groups, except for perinephric hematoma formation.
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