Efficacy and Safety of Endoscopic Combined Intrarenal Surgery vs. Percutaneous Nephrolithotomy for Treatment of Staghorn Calculi, A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- stone-free rate
研究概览
简要总结
This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety
详细描述
This is a prospective randomized study to compare endoscopic combined intrarenal surgery and PCNL as modalities of treatment for staghorn stones. In terms of efficacy and safety The efficacy will be studied at stone-free rate While efficacy will be studied using DMSA scan pre- and post-procedures in addition to the safety of each procedure with regard to intra- and post-operative complications,.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are more than 18 and less than 65 years old.
- •Patients with renal staghorn stones based on imaging modalities (stones occupying the renal pelvis and extending into at least 2 major calyces).
排除标准
- •Patients with renal insufficiency (serum creatinine > 1.6 mg/dl)
- •patients with active urinary tract infection.
- •Patients with congenital renal anomalies.
- •Morbid obesity (BMI > 35 kg/m2).
- •Pregnancy.
- •Bleeding Coagulopathy.
- •Skeletal deformity
结局指标
主要结局
stone-free rate
时间窗: 3 months postoperative
Stone-free is defined as no residual stones on CT-UT or clinically insignificant residual fragments (CIRF) less than 4 mm in diameter. It will be measured twice, first immediately postoperatively, and then again after 3 months of the procedure.
次要结局
- Safety of the procedure(intraoperative, early (in the first day postoperative) and late complications (3 months after the surgery).)
研究者
Maher Mohamed Abdelrehem Mohamed
Assistant Lecturer of Urology Faculty of Medicine, Al-Azhar University (Damietta)
Al-Azhar University