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临床试验/NCT05297331
NCT05297331招募中不适用

A Prospective Assessment of the Perioperative Parameter and Treatment Outcomes of Urinary Calculi - International Registry

Chinese University of Hong Kong3 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2022年3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
3,000
试验地点
3
主要终点
Target Stone status

研究概览

简要总结

This is an international prospective data registry to assess the treatment outcomes and complications of different treatment approaches for different surgical treatment of urolithiasis.

详细描述

Renal stone is a common condition, and many patients suffered from recurrent diseases and required multiple interventions in their lifetime. Currently, there are many treatment options available for stone treatment, including shockwave lithotripsy, ureteroscopy, percutaneous nephrolithotomy etc.

Different treatment approaches will result in different treatment successful rate and also potential adverse effects to patients. The main challenge for stone management is the decision on the best treatment approach for individual stone of each patient. This is because for the same type of stone (such as lower caliceal stone or upper ureteric stone), different surgical treatment could be applied. The decision will depend on various patients (such as age, premorbid etc.) and stone factors (such as size, density etc) and also patients' preference.

New advances in technology have improved treatment outcomes for urolithiasis, such as single use flexible ureteroscopes, flexible and navigable ureteral access sheaths (FANS), direct in scope suction (DISS), intrarenal pressure (IRP) and intrarenal temperature (IRT) monitoring devices, new lasers and pulse modulation, etc.

Therefore, in order to have more information to guide treatment decision during discussion with patients, a prospective data registry is created to assess the treatment outcomes and complications of different treatment approaches in our hospital clusters. This information will be important for audit, treatment comparison and also patient education.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient at the age of 18 or above

排除标准

  • Patient is unable to give consent

结局指标

主要结局

Target Stone status

时间窗: postoperative, at 1 and/or 3 months

stone free rate

次要结局

  • Intraoperative parameters(intraoperative)
  • Treatment related complication(Thirty days after the operation)
  • Recurrence of stone(At 12 months)
  • QOL and pain scores(preoperative, postoperative on day 0 and at follow up)

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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