Primary Versus Deferred Ureteroscopy for Management of Calculus Anuria in Children: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- renal function
研究概览
简要总结
To evaluate the role of both primary and deferred URS in the management of calculus anuria concerning the feasibility, clinical outcome, and cost-effectiveness in children in a comparative study
详细描述
Thirty group B (30) patients will be admitted to do urinary drainage through the insertion of a JJ stent or percutaneous nephrostomy (PCN) at first , then a deferred URS will be done children will undergo primary URS( group A ) and in. Ureteral dilatation will be done when the stone size exceeds 10 mm to facilitate the extraction of the fragments. Ureteroscopic lithotripsy will be done using a 6.5:7.5 Fr semi-rigid ureteroscope and holmium laser. The ureteric stent will last for one week after lithotripsy. Postoperatively, the patients in both groups will monitored for post obstructive diuresis, fever, hematuria, and extent of renal function improvement.
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
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ˂12 years with calculus anuria.
- •Clinically stable (serum creatinine < 3.5 mg/dl, blood urea < 100 mg/dl,serum potassium level < 7 milliequivalent /L and /or ph of blood > 7.1)
- •All the patients free of sepsis.
排除标准
- •Unstable children (serum creatinine ≥ 3.5 mg/dl, blood urea ≥ 100 mg/dl, serum potassium ≥ 7 milliequivalent/l, and/or blood pH ≤ 7.1, signs of acidosis, sepsis, or fluid retention).
- •Children with underlying urological structural abnormalities
结局指标
主要结局
renal function
时间窗: one month .
improvement in creatinine level mg/dl urea level mg/dl
次要结局
- the stone-free rates(one month)
研究者
Mostafa Mohamed Mostafa
Principal Investigator
South Valley University