跳至主要内容
临床试验/NCT03599297
NCT03599297招募中不适用

Evaluation of Efficacy and Safety Profile of Bilateral Synchronous Simultaneous Stone Surgery for Kidney Stones

Marmara University2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9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
100
试验地点
2
主要终点
Stone free rate

研究概览

简要总结

Advancements in technology and endourological armamentarium provides multiple surgical options for complicated stone patients. To avoid multiple operations and shorten the total operation durations, bilateral synchronous simultaneous stone surgery (BSSSS) has been popularized in recent years.

Our aim is to evaluate the preliminary outcomes of BSSSS in patients undergoing supine percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled for kidney stone surgery according to European Association Urology, Urolithiasis guidelines
  • patients with bilateral kidney stones

排除标准

  • 未提供

结局指标

主要结局

Stone free rate

时间窗: at the 24th hour of the surgery

stone free status is decided according to both the immediate evaluation of the endoscopic view at the end of the operation and the post operative imaging with kidney, ureter, bladder X-ray at the 24th hour of the surgery

次要结局

  • Post operative urinary diversion(at the 24th hour of surgery)
  • Radiation exposure(At 1st hour of surgery)
  • Complications(at the 1st week of surgery)
  • Hospital stay(will be assessed through completion of study, an average of 1 year.)
  • Hemoglobin level change(from baseline to 24th hour of surgery)
  • Residual stone(at the 24th hour of surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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