背景:Sotn输尿管镜检查是在输尿管镜检查的基础上开发的一种新的碎石术,包括刚性输尿管入路鞘,标准镜子,碎石镜,和Sotn灌注抽吸器。因此,我们进行了一项前瞻性多中心随机对照试验,比较了Sotn输尿管镜治疗肾结石和输尿管上段结石的安全性和有效性.
方法:在本研究中,选取2018年3月至2022年3月224例肾结石和输尿管上段结石患者,随机均分为研究组和对照组。所有患者均获得中国广州中医药大学第二附属医院医院伦理委员会批准(证明编号:ZF-2018-164-01和ZF-2018-165-01)。主要结果是治疗后第1天和第1个月通过计算机断层扫描评估的结石发生率(SFR)以及手术时间。次要结果是术后并发症发生率。
结果:总计,输尿管上段结石,Sotn输尿管镜组术后1天的SFR明显高于刚性输尿管镜组(83.6%vs.60%,P=0.006)。此外,手术时间(33.7±1.80vs.52.9±2.73min,Sotn输尿管镜组的P<0.005)明显低于刚性输尿管镜组。此外,研究组(Sotn输尿管镜联合输尿管软镜)和对照组(单纯输尿管软镜)术后1天SFR分别为63.2%和36.8%(P=0.005),65.6±4.06和80.3±4.91(P=0.023),分别。然而,术后1个月SFR无显著性差异,输尿管入路鞘放置成功率,两组术后并发症发生率比较(P>0.05)。在结石直径≥1.5cm且结石CT值≥1000Hounsfield单位的亚组中,Sotn输尿管镜在术后1天的SFR方面显示出更多优势。重要的是,并发症,如输尿管损伤,脓毒症,发烧,两组血尿和重度血尿比较差异无统计学意义(P>0.05)。
结论:对于肾和输尿管上段结石,Sotn输尿管镜具有术后1天SFR较高、手术时间较短的优点,这表明Sotn输尿管镜检查可能在临床上有进一步的潜在应用。
BACKGROUND: Sotn
ureteroscopy is a new lithotripsy procedure developed on the basis of
ureteroscopy and includes a rigid ureteral access sheath, standard mirror, lithotripsy mirror, and Sotn perfusion aspirator. Thus, we performed a prospective multicenter randomized controlled
trial comparing the safety and efficacy of Sotn ureteroscopy in the treatment of renal and upper ureteral calculi.
METHODS: In this
study, 224 patients with renal and upper ureteral calculi were randomly divided equally into
study and control groups from March 2018 to March 2022. All the patients were approved by the hospital ethics committee (proof number: ZF-2018-164-01 and ZF-2018-165-01) of the Second Affiliate Hospital of Guangzhou University of Chinese Medicine in China. The primary outcome was stone-free rate (SFR) assessed by computed tomography on the 1st day and month after treatment and operation duration. The secondary outcome was postoperative complication rate.
RESULTS: In total, for upper ureteral calculi, the SFR of 1 day after operation of the Sotn ureteroscopy group was significantly higher than the rigid ureteroscopy group (83.6% vs. 60%, P=0.006). Moreover, operative time (33.7±1.80 vs. 52.9±2.73 min, P<0.005) of the Sotn ureteroscopy group was significantly lower than the rigid ureteroscopy group. Additionally, the SFR of 1 day after operation and operative time for the
study group (Sotn
ureteroscopy combined with flexible ureteroscopy) and the control group (flexible ureteroscopy alone) were 63.2% and 36.8% (P=0.005), 65.6±4.06 and 80.3±4.91 (P=0.023), respectively. However, there were no significant differences in the SFR of 1 month after operation, success rate of ureteral access sheath placement, and postoperative complications between the two groups (P>0.05). In subgroups with stone diameters ≥1.5 cm and stone CT values ≥1000 Hounsfield units, Sotn ureteroscopy showed more advantages in terms of the SFR of 1 day after operation. Importantly, complications such as ureteral injury, sepsis, fever, and severe hematuria were not statistically different between the two groups (P>0.05).
CONCLUSIONS: For renal and upper ureteral calculi, Sotn ureteroscopy has the advantage of a higher SFR of 1 day after the operation and a shorter operative time, suggesting that the Sotn ureteroscopy may have further potential applications in clinics.