Supine Versus Prone Percutaneous Nephrolithotomy in the Pediatric Age Group? A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- stone free rate
研究概览
简要总结
there is an increased incidence of renal stones, especially in the pediatric age group. the percutaneous approach in the pediatric age took a long time till it again accepted among surgeons worldwide. the prone position is the preferred approach to perform percutaneous nephrolithotomy in the pediatric age group. this study aims to compare supine versus prone position percutaneous nephrolithotomy in the pediatric age group.
详细描述
The incidence of renal stones in the pediatric age group increased from 18.4 to 57.0% per100,000 children in the period from 1999 to 2008. The acceptance of PCNL in pediatrics was slow at first due to concerns of the small kidney size compared to relatively large instruments percutaneous nephrolithotomy in pediatric patients was conventionally performed in the prone position for historical reasons, being more familiar to surgeons and it was considered safer to avoid colonic injury.
Supine PCNL has several valuable advantages to pediatric patients in particular better irrigation shorter operative time with a comparable outcome with the prone position.
our study aims to assess the efficacy and the safety of percutaneous nephrolithotomy in the supine position in comparison to the prone position in the pediatric age group.
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
- Double (Participant, Outcomes Assessor)
盲法说明
patients and the statistician were blinded to the type of the intervention
入排标准
- 年龄范围
- 2 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients aged from two to sixteen years old with single or multiple renal stones indicated for percutaneous nephrolithotomy
排除标准
- •patients with renal anomalies, bleeding tendency, elevated kidney function tests for age, previous renal surgical intervention on the same site of intervention.
- •patients with skeletal abnormalities and spine deformities were also excluded
- •patients with a single kidney were also excluded
结局指标
主要结局
stone free rate
时间窗: first day postoperative
evaluation of our patients after surgery with Xray or CT to detect residual stones
次要结局
- hospital stay(first 2 days post surgery)
- operative time of the procedure in minutes(intraoperative finding in minutes,)
- incidence of intraoperative colonic injury(intraoperative finding)
- rate of Hemoglobin drop(day 1 post operative)
- postoperative fever(first 2 days post surgery)
- Fluoroscopy time during the procedure in minutes(intraoperative finding in minutes,)
- irrigation fluid usage(intraoperative finding)
- need for DJ application(intraoperative finding)
- incidence of urinary tract infection(first 7 days post surgery)
- urine leakage(first 3 days postoperative)
研究者
Ahmed Maher Gamil Ahmed Higazy
assistant lecturer
Ain Shams University