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临床试验/NCT00873054
NCT00873054已完成不适用

Percutaneous Nephrolithotomy Versus Extracorporeal Shock Wave Lithotripsy

CAMC Health System1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32
试验地点
1
主要终点
The primary objective of this study is to compare the stone-free status after Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous Nephrolithotomy (PCNL) for kidney stones 10-20 mm in size.

研究概览

简要总结

The investigators main hypothesis is that the stone free rate will be much higher (95%) in patients treated with PCNL than patients treated with ESWL where stone free rate is (60%) to determine which treatment is safe and prevent less stone recurrence.

详细描述

Extracorporeal shock wave lithotripsy is preferred for small stones less than 10 mm in size. Percutaneous nephrolithotomy is the standard therapy used for large kidney stones greater than 20 millimeters or stones in the lower kidney. For moderate sized kidney stone (10-20 mm),currently the options for treatment include both methods. However, no studies have proven that one procedure is better than the other. So, we will compare both the procedures for breaking the kidney stone. Our main outcome measures will be the stone-free status after the procedure. Other outcome measures are assessment of morbidity associated with use of the procedures i.e. any minor or major complications within 3 months of initial treatment. Patient will be assessed for infection at post-operative office visits to include a basic urinalysis only if they have systemic indicators of infection (fever, dysuria, frequency, etc.). Pain will be monitored with the scale of 0-10 points. Also we will review of stone density on Computerized Tomography (CT) scans and the effect this has on success of both procedures. We hope with PCNL stone-free rates will be minimum with minimal morbidity and ultimately improve patient care.

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 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of both sex with age greater than 18 years to 90 years
  • Stone burden between 10 and 20 mm diagnosed by CT scan
  • Patient must be agreeable to randomization between shock wave lithotripsy and percutaneous stone removal

排除标准

  • Patients with bleeding diathesis or taking anti-platelet or anti-coagulant medication
  • Patients who are pregnant based on routine pre-operative pregnancy testing
  • Patients with skin to stone size greater than 12 cm (measured routinely on CT scan)
  • Patients with either Horseshoe kidney, transplant kidney or a solitary kidney
  • Patients with ureteral calculi
  • Patients with stone size of < 10 mm and > 20 mm
  • Ureteropelvic junction obstruction

结局指标

主要结局

The primary objective of this study is to compare the stone-free status after Extracorporeal Shock Wave Lithotripsy (ESWL) and Percutaneous Nephrolithotomy (PCNL) for kidney stones 10-20 mm in size.

时间窗: Within 3 months of enrollment

次要结局

  • A secondary objective is to assess the morbidity associated with use of the procedures i.e. any minor or major complications within 3 months of initial treatment.(Within 3 months of enrollment)

研究者

发起方
CAMC Health System
申办方类型
Other
责任方
Principal Investigator
主要研究者

Samuel Deem, DO

Principal Investigator

CAMC Health System

研究点 (1)

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