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临床试验/NCT06737497
NCT06737497尚未招募不适用

Analysis of the Effectiveness and Safety of Retrograde Intrarenal Surgery (RIRS) Under Local Anesthesia and Its Influencing Factors

The First Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2026年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
pain score

研究概览

简要总结

Retrograde intrarenal surgery (RIRS) is a well-established technique and is the first-line treatment option for upper urinary tract stones <2cm. Currently, most ureteroscopic procedures are performed under general or epidural anesthesia, both of which are safe and feasible. In recent years, more and more studies have shown that retrograde intrarenal surgery (RIRS) under local anesthesia is safe and feasible. However, we can see that the current studies on RIRS under local anesthesia are mostly case reports, and there is a lack of systematic studies on the safety and effectiveness of RIRS under local anesthesia and its influencing factors. Therefore, the researchers hope to conduct a single-center prospective observational study to explore the safety, effectiveness and influencing factors of RIRS under local anesthesia, so as to optimize the surgical process of RIRS under local anesthesia, improve the surgical success rate and ensure surgical safety。

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Kidney stones or upper ureteral stones 1-4cm;
  • Age 18-70 years old;
  • American Society of Anesthesiologists(ASA) score Ⅰ, Ⅱ and Ⅲ;

排除标准

  • Surgical operations other than RIRS are required for patients with middle and lower ureteral calculi;
  • There are anatomical abnormalities, such as ureteral stenosis, urine flow diversion, ectopic kidney, horseshoe kidney, duplicate kidney, etc.
  • Severe heart, brain and lung diseases;

结局指标

主要结局

pain score

时间窗: 1 day after sugery

Visual Analogue Scale(VAS),The basic method is to use a moving ruler about 10cm long, with 10 scales on one side and "0" and "10" points on both ends, where 0 represents no pain and 10 represents the most unbearable pain.

Operative time

时间窗: During surgery

Surgery duration, minutes. From the insertion of the guide wire to the end of the indwelling ureteral stent.

次要结局

  • stone-free rate(From enrollment to the end of treatment at 24 hours)
  • Complication rate(1 month after sugery)

研究者

发起方
The First Affiliated Hospital of Guangzhou Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guohua Zeng

Ph.D and M.D

The First Affiliated Hospital of Guangzhou Medical University

研究点 (1)

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