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7.5F 型微型柔性输尿管镜逆行肾内手术:一项多中心随机临床试验的初步结果。

7.5F Mini Flexible Ureteroscope in Retrograde Intrarenal Surgery: Initial Results from a Multicenter Randomized Clinical Trial.

机构信息

Department of Urology and Key Laboratory of Guangdong Province, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, China.

Department of Urology, West China Hospital, Sichuan University, Chengdu, China.

出版信息

J Endourol. 2024 May;38(5):421-425. doi: 10.1089/end.2023.0540. Epub 2024 Apr 4.

Abstract

To report the initial results of an randomized clinical trail comparing the safety and efficacy between 7.5F and 9.2F flexible ureteroscope (FUS) in the management of renal calculi <2 cm. Eighty patients were enrolled and received retrograde intrarenal surgery (RIRS) with a different size FUS. The operation results and complications were compared. Two cases in the 7.5F group and four cases in the 9.2F group failed to insert the 12/14F ureteral access sheath (UAS), respectively, and no significant difference ( = 0.396) was noted. However, 10/12F UAS was inserted in the 7.5F group, but not available in the 9.2F group, and thus, the 10/12F UAS inserting rate in the 7.5F group was higher than in the 9.2F group (100% 0%,  = 0.014), and the UAS insertion failure rate in 9.2F group was higher than in the 7.5F group (10% 0%,  = 0.040). The operation time in 7.5F group was shorter than the 9.2F group (35.60 ± 7.86 41.05 ± 8.14,  = 0.003). Less irrigation was required in 7.5F group (813.93 ± 279.47 mL 1504.18 ± 385.31 mL,  = 0.000). The postoperative fever rate in 9.2F group was higher than 7.5F group (20% 5%,  = 0.043). There was no significant difference in sepsis (0% 2.5%,  = 0.314) between the two groups. No significant difference was noted in hospital stay (0.93 ± 0.49 days 1.14 ± 0.64 days,  = 0.099) between the two groups. The final stone-free rate (SFR) in 7.5F group was higher than 9.2F group (95% 80%,  = 0.043). The latest 7.5F mini FUS was a reliable instrument in RIRS to keep a good visualization with low requirement of irrigation, low postoperative infection complication, and also a high SFR when compared with the conventional 9.2F FUS. NCT05231577.

摘要

报告比较 7.5F 和 9.2F 柔性输尿管镜(FUS)在处理 <2cm 肾结石安全性和疗效的随机临床试验的初步结果。80 名患者接受了不同大小 FUS 的逆行肾内手术(RIRS)。比较手术结果和并发症。7.5F 组有 2 例和 9.2F 组有 4 例未能插入 12/14F 输尿管接入鞘(UAS),差异无统计学意义( = 0.396)。然而,7.5F 组插入了 10/12F UAS,但 9.2F 组没有,因此,7.5F 组的 10/12F UAS 插入率高于 9.2F 组(100% 0%, = 0.014),9.2F 组的 UAS 插入失败率高于 7.5F 组(10% 0%, = 0.040)。7.5F 组的手术时间短于 9.2F 组(35.60 ± 7.86 41.05 ± 8.14, = 0.003)。7.5F 组需要的冲洗液更少(813.93 ± 279.47 mL 1504.18 ± 385.31 mL, = 0.000)。9.2F 组术后发热率高于 7.5F 组(20% 5%, = 0.043)。两组间败血症(0% 2.5%, = 0.314)无显著差异。两组住院时间无显著差异(0.93 ± 0.49 天 1.14 ± 0.64 天, = 0.099)。7.5F 组的最终结石清除率(SFR)高于 9.2F 组(95% 80%, = 0.043)。最新的 7.5F 迷你 FUS 在 RIRS 中是一种可靠的仪器,具有良好的可视化效果,对冲洗的要求较低,术后感染并发症较低,与传统的 9.2F FUS 相比,结石清除率也较高。NCT05231577。

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