A Comparative Study Between Ultra Mini Percutaneous Nephrolithotomy Versus Stented Extracorporeal Shock Wave Lithotripsy for Treatment of Renal Stones in Egypt
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Stone-free status
研究概览
简要总结
Nephrolithiasis is the third most common disease of the urinary tract. As minimally invasive technologies develop, shock wave lithotripsy (SWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL) are different surgeries to treat renal stones.
Aim of the Study is to compare results, safety and outcome of Ultra mini PCNL versus stented extracorporeal shock wave lithotripsy (SWL) for the management of renal calculi from 10 - 20 mm. Patients were randomized to either Ultra-Mini-Percutaneous nephrolithotomy group or stented SWL group via the closed envelope method. Patient data was collected preoperatively, immediately postoperatively and 2 and 4 weeks postoperatively to assess operative time, hospital stay, complications regarding fever, hematuria and need for blood transfusion, residual stones and need for retreatment.
详细描述
Nephrolithiasis is the third most common disease of the urinary tract, following urinary tract infections and Prostatic diseases. It also has a 1-year recurrence rate of 7% and 10-year recurrence rate of 50%.
Management of renal stones had seen a great shift over the last ten years. The need to find a balance between morbidity and stone clearance is always the milestone of treatment choice. Low risk procedure with high retreatment percentage vs another relatively higher risk procedure with lower retreatment chances.
As minimally invasive technologies develop, shock wave lithotripsy (SWL), retrograde intrarenal surgery (RIRS), and percutaneous nephrolithotomy (PCNL) are different surgeries to treat renal stones. Open, laparoscopic, and robotic surgeries have their place only in highly selected patients.
In the European Association of Urology (EAU) Guidelines on Urolithiasis, PCNL is a treatment of choice (TOC) for renal stones > 20 mm, SWL or RIRS is the first-line therapy for renal stones < 10 mm, and SWL or endourologic treatment (all PCNL and ureteroscopic interventions) can be performed for stones 10-20 mm.
SWL is a minimally invasive intervention with good patient tolerance; it is regarded as the first line treatment for nephrolithiasis < 20 mm in size. Poor clearance of lower calyceal stone fragments due to gravity or unfavorable infundibulopelvic angle limits the efficacy of SWL for treating lower calyceal stones.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients between 18 and 60 years
- •complaining of radioopaque renal stones ranging from 10-20 mm.
- •BMI not exceeding 40
排除标准
- •radiolucent stones,
- •smaller than 10 mm or larger than 20 mm stones
- •congenital renal anomalies or spinal deformity
- •BMI exceeding
- •Patients with uncorrected bleeding diathesis
- •pregnant females
- •untreated UTI.
结局指标
主要结局
Stone-free status
时间窗: at 2 or 4 weeks after ultra-mini-PCNL or stented SWL
The complete stone clearance or presence of clinically insignificant residual fragments (\<4 mm) 2 or 4 weeks after the final procedure was regarded as stone-free
次要结局
未报告次要终点
研究者
Younan Ramsis Samir
Lecturer of Urology, Faculty of medicine
Ain Shams University