Safety and efficacy of mini percutaneous nephrolithotomy using suction sheath versus conventional sheath: A randomised controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- Not Applicable
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Stone free rates
研究概览
简要总结
Mini percutaneous nephrolithotomy (mPCNL) is standard treatment for nephrolithiasis with greater advantages of comparable stone free rates and decreased complications as compared to standard PCNL. Application of suctioning systems in mPCNL has been found to further enhance the stone free rates and decrease the postoperative complications. In addition to this, as far as the literature search in Nepal is concerned, no randomized control trial has been published yet. This study aims to identify if mPCNL using suction sheath is safe and efficacious in the treatment of nephrolithiasis.
This is a hospital based randomised study. All the patients undergoing mPCNL at department of urology and kidney transplant surgery will be eligible for study. Patients will be divided into mPCNL using suction sheath and conventional sheath by simple random sampling and comparison of various intraoperative and post-operative parameters will be done to assess the safety and efficacy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •All patients undergoing mPCNL in the Department of Urology and Kidney Transplant Surgery, TUTH.
排除标准
- •Age less than 18 years male and female patients Patients with congenital anomalies of kidney like horse shoe kidney, duplex system or with diverticular disease History of open intervention in ipsilateral kidney Patients undergoing bilateral mPCNL or simultaneous retrograde intrarenal surgery (RIRS) or ureteroscopic lithotripsy.
结局指标
主要结局
Stone free rates
时间窗: 6 weeks after surgery
次要结局
- 1 Operative time(2 Complications)
研究者
Rabindra Tamang
Maharajgunj Medical Campus, Institute of Medicine