A Prospective, Randomized Controlled Pilot Study Of Standard Percutaneous Nephrolithotomy (PNL) Versus Tubeless PNL Versus Tubeless Stentless PNL
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Length of hospital stay
研究概览
简要总结
The purpose of the study is to assess and compare the efficacy and morbidity standard percutaneous nephrolithotomy with tubeless PNL. A total of approximately 60 patients will be enrolled. Patients will be randomized to one of four groups: standard percutaneous nephrostomy, double-J ureteral stent, open-ended ureteral catheter and no nephrostomy or ureteral stent/catheter. Primary Outcome Measures will include length of procedure and estimated blood loss. Post-operative analgesic use (both parenteral and oral), pain scores, time to ambulation, time to oral intake, and pain scores will also be recorded. Time to nephrostomy tube removal, external ureteral and Foley catheter removal and patient discharge from the hospital will also be recorded. Incidence and type of post-operative complications will also be recorded.
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
- •Age >18 years old
- •Planned single tract percutaneous nephrolithotomy
- •General anesthesia for percutaneous nephrolithotomy
排除标准
- •Age<18 years old
- •Known residual calculi at the end of the procedure
- •Significant hemorrhage during procedure
- •Bleeding disorder (This does not include patients taking anti-coagulants as these are stopped prior to surgery.)
- •Prisoners
- •Inability to give informed consent
- •Pregnant females
- •Solitary kidney
- •Transplant kidney
- •Pleural effusion during procedure requiring drainage
- •Perforation of renal collecting system during procedure
- •Incomplete stone clearance
- •Chronic pain syndrome
结局指标
主要结局
Length of hospital stay
时间窗: until hospital discharge, about 2-3 days
measuring days of hospital stay after procedure, and the effect that the location of the puncture has on the length of hospital stay
Change in CBC and Chemistry Panel
时间窗: at time of hospital discharge, about 2-3 days
Loss of blood
次要结局
未报告次要终点