NCT04153461Unknown不适用
Mini- Percutaneous Nephrolithotomy Versus Standard Percutaneous Nephrolithotomy in the Treatment of Renal Stones. A Randomized Controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Assessment of stone free rate (SFR)
研究概览
简要总结
The EUA Urolithiasis Guidelines Panel meta-analysis suggest that mPNL is at least as efficacious and safe as sPNL for the removal of renal calculi. However, the quality of the evidence was poor, drawn mainly from small studies, the majority of which were single-arm case series, and only one of which was RCT. The risks of bias and confounding were high, highlighting the need for more reliable data from RCTs. So, the Panel recommended for more clinical research .
The aim of this study is to compare between PNL and mPNL through a randomized controlled trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18 years or older.
- •ASA I or II
- •Renal stones ≥ 2 cm
- •Lower calyceal stone ≥ 1 cm
- •Failure of other modalities of treatment as ESWL and RIRS.
排除标准
- •S.creatinine > 2mg/dl.
- •Patients with active UTI.
- •Patients on anticoagulant.
- •Age <18 years.
- •Ureteral obstruction preventing the insertion of a ureteral stent.
结局指标
主要结局
Assessment of stone free rate (SFR)
时间窗: 2 years
defined as less than 4mm by non contrast computed tomography
次要结局
- assessment of renal function(2 years)
- assessment of pain(2 years)
- assessment of patient satisfaction(2 years)
- assessment of haemoglobin loss(2 years)
研究者
Mostafa Elgamal
Principal Investigator
Mansoura University
研究点 (2)
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