跳至主要内容
临床试验/NCT05894668
NCT05894668招募中不适用

A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Endoscopic Combined Intrarenal Surgery (ECIRS) in Asia

Chinese University of Hong Kong3 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
3
主要终点
Target Stone status

研究概览

简要总结

This is an observational, international, multicenter, cohort study, prospectively collecting clinical data registry on consecutive patients with urinary stone undergoing ECIRS.

详细描述

Patients diagnosed with urinary stones and planned for ECIRS in different centres will be recruited for the study. This registry collects clinical data on patients with ECIRS performed, includes baseline information on demography, symptoms, risk factors, and laboratory variables. Treatment information, perioperative outcomes, and follow-up details (up to 3 months after surgery) will also be collected. In summary, it captures patterns of presentation and treatment parameters, as well as perioperative and short-term outcomes of patients managed by ECIRS.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Patients with urinary calculi
  • Undergoing Endoscopic Combined Intrarenal Surgery (ECIRS)
  • Agreed to consent for the study

排除标准

  • Patients who have ECIRS for other conditions, such as urothelial cancer etc.
  • Patients who intraoperative record was incomplete.
  • Patients only have either PCNL or ureteroscopy done (not both)

结局指标

主要结局

Target Stone status

时间窗: up to 1 year

The fragmentation rate of target stone

Treatment related complication

时间窗: Thirty days after the operation

he 30-day complications will be graded according to the Clavien-Dindo classification

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chi Fai NG

Professor

Chinese University of Hong Kong

研究点 (3)

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