Flexible Ureteroscopy , Extracorporeal Shock Wave Lithotripsy and Mini Percutaneous Nephrolithotomy for Management of Lower Pole Renal Hard Stones ≤2 cm: Prospective Comparative Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 414
- 试验地点
- 1
- 主要终点
- stone free rate
研究概览
简要总结
The study has been conducted in Urology department at Kafrelsheikh University Hospital between March 2022 to March 2023. informed consent was taken from eligible patients and were randomized into three groups, Group A :Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue) while, Group B : extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany) .Group C : Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.
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
- 是
入选标准
- •Adult patient older than 18 years.
- •single renal stone.
- •medium sized Stone up to 2.0 cm .
- •Stone in lower calyceal stone
- •Hard stone
排除标准
- •• multiple renal stones
- •stone size > 2 cm
- •age group < 18
- •solitary kidney
- •Patients with BMI > 40 kg/m2
- •bleeding disorders
- •anatomical renal abnormalities
- •Obstruction distal to the stone.
- •Musculoskeletal deformities
结局指标
主要结局
stone free rate
时间窗: after two weeks from primary procedure
no stone residual fragments or asymptomatic insignificant residual fragments less than or equal to 4 mm during patients follow up two weeks.
次要结局
- Post operative complication(Up to 48 hours)
- Radiation time(during the procedure)
- assess operative time.(during the procedure)
- visual analog scale(immediately after the surgery)
研究者
Elsayed Abdelhalim Elsayed
Principal Investigator
Kafrelsheikh University