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一次性软性输尿管镜(LITHOVUE)在肾结石患者中的性能参数评估:一项前瞻性、观察性、单臂、多中心研究。

Evaluation of Performance Parameters of the Disposable Flexible Ureterorenoscope (LITHOVUE) in Patients with Renal Stones: A Prospective, Observational, Single-arm, Multicenter Study.

机构信息

Department of Urology, SMG-SNU Boramae Medical Center, Seoul, Korea.

Department of Urology, Severance Hospital, Urological Science Institute, Yonsei University College of Medicine, Seoul, Korea.

出版信息

Sci Rep. 2018 Jun 28;8(1):9795. doi: 10.1038/s41598-018-28247-7.

Abstract

We investigated performance parameters of disposable flexible ureterorenoscopy (LITHOVUE) in patients with renal stones in a prospective, multicenter, observational study. Sixty two patients who underwent ureterorenoscopic surgery by LITHOVUE were included. Surgeons using a numerical scale, evaluated the maneuverability of the scopes and general perceptions of visibility related to the monitor and irrigation systems. General pain and fatigue scores were evaluated and compared to existing scopes. Mean patient age was 57.3 years and stone size was 15.4 mm. Clinical success of overall stone removal was 82.3%. Complications occurred in 4 cases of the Clavien classification grade I in a single case and II in 3 cases. Comparative parameters of maneuverability, perception of the monitor system and perception of the irrigation channel were 2.5, 2.5, and 3.0, respectively. The most favorable evaluation of physical strain was about 'shoulder fatigue' and 'hand fatigue'. Unfavorable evaluations were recorded for 'wrist stiffness' and 'thumb fatigue'. Maximal deflection angles of 270° were preserved in 53 cases (85.5%). No pre-stenting procedure and the longer operative time were significant predictors of poorly-preserved deflection angles <270°. LITHOVUE showed good maneuverability and perception scores for the monitor and irrigation systems. LITHOVUE received favorable evaluations on pain and fatigue scores.

摘要

我们在一项前瞻性、多中心、观察性研究中调查了一次性软性输尿管镜(LITHOVUE)在肾结石患者中的性能参数。共有 62 名接受 LITHOVUE 输尿管镜手术的患者纳入研究。外科医生使用数字评分,评估了内镜的可操作性以及与监视器和冲洗系统相关的可视性的总体感知。评估并比较了一般疼痛和疲劳评分与现有内镜。患者平均年龄为 57.3 岁,结石大小为 15.4mm。整体结石清除的临床成功率为 82.3%。并发症发生在 4 例 Clavien 分级 I 级中,1 例为 II 级,3 例为 III 级。可操作性、监视器系统感知和冲洗通道感知的比较参数分别为 2.5、2.5 和 3.0。对体力消耗评价最有利的是“肩部疲劳”和“手部疲劳”。记录到不利的评价是“腕部僵硬”和“拇指疲劳”。在 53 例(85.5%)中保留了 270°的最大偏转角。无预置支架和较长的手术时间是保留<270°的偏转角不佳的显著预测因素。LITHOVUE 显示出良好的可操作性和监视器及冲洗系统的感知评分。LITHOVUE 在疼痛和疲劳评分方面获得了良好的评价。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/04d6/6023915/a70d2b3e61fd/41598_2018_28247_Fig1_HTML.jpg

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