Exit Strategy After Percutaneous Nephrolithotomy: Large or Small Bore Tube? Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Rate of hemoglobin reduction difference between groups
研究概览
简要总结
Regarding to the distribution of nephrostomy tube (NT) size usage by country. There was a clear distinction between countries that used solely the small bore (SB) NT (Chile and Australia) and those that used solely the large bore (LB) NT (Czech Republic and Japan). There is also a trend toward SB NT in North America (~75% in USA and Canada) and toward LB NT in South America (~80% in Argentina and Mexico). In Europe the trend is equal (~50% in Germany, France, Greece and UK). Based on previous data and in view of conflicting data about postoperative complication including extravasation, bleeding and hemoglobin change and pain between previous studies, we will conduct this randomised trial comparing SB and LB NT following PNL.
Our aim to evaluate the safety of small versus large bore NT reporting complications using the Clavien-Dindo system with categorisation of PNL-specific complications
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
- •Staghorn calculi
- •Renal pelvis stones =>2 cm
- •Lower pole stones= >1.5 cm
- •upper ureteral calculi =>1.5 cm
- •SWL-resistant stones
排除标准
- •Age <18 years or Pregnancy
- •Tubeless PNL
- •Need for 3 percutaneous tracts intraoperative
- •Morbid obesity (BMI >40)
- •Refuse to complete study requirements
- •Tumour in the presumptive access tract area or Potential malignant kidney tumour
结局指标
主要结局
Rate of hemoglobin reduction difference between groups
时间窗: 8 months
measured in gram/liter
次要结局
- postoperative pain score(8 months)
- postoperative patient satisfaction(8 months)
- overall postoperative complication(8 months)
研究者
Ahmed Shoma
Principal Investigator
Mansoura University