A Randomized Controlled Trial Comparing Ultrasound Versus Fluoroscopy Guided Percutaneous Nephrolithotomy.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the calyceal puncture time, tract dilatation time and stone-free status between ultrasound-guided and fluoroscopic-guided PCNL
研究概览
简要总结
This is a single center, prospective, randomized controlled trial comparing ultrasound guided versus fluoroscopy guided Percutaneous Nephrolithotomy in patients falling under inclusion criteia.The study aims to evaluate intraoperative parameters like Calyceal puncture time, tract dilatation time and stone free status, as well as secondary outcomes such as radiation exposure time, complications like bleeding, infection.Patients will be randomly assigned to either Group A or Group B with all the other surgical tips standardized.
Hypothesis of the study is that ultrasound guided Percutaneous Nephrolithotomy is non inferior to fluoroscopic guided Percutaneous Nephrolithotomy in terms of stone free status and radiation exposure time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with renal calculi size more than or equal to 2 cm.
- •Patients with staghorn calculus.
排除标准
- •Paediatric age group.
- •Urinary tract Anomalies like Horseshoe kidney, Crossed ectopic kidney and Fused ectopic kidney.
- •Uncorrected bleeding disorders or Coagulopathies.
- •Active urinary tract infection at time of surgery.
- •Post renal transplant.
结局指标
主要结局
To compare the calyceal puncture time, tract dilatation time and stone-free status between ultrasound-guided and fluoroscopic-guided PCNL
时间窗: inta-op, intra-op, intra-op and 4 weeks
次要结局
- Radiation exposure time,(Evaluation of safety profile- Bleeding and Infection)
研究者
Nirmalya Ghosh
AIIMS Kalyani