Comparative Outcomes of FURS, ESWL and Mini-PCNL for Non-Lower Pole Hard Renal Stones: A Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 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 Feburary 2021 to December 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
- 否
入选标准
- •Adult patient older than 18 years.
- •single renal stone.
- •medium sized Stone up to 2.0 cm .
- •Stone in plevicalyceal except lower calyceal stone
- •Hard stone
排除标准
- •multiple renal stones
- •Stone in lower calyceal stone
- •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
研究组 & 干预措施
Group C : Mini perc group
Mini perc group underwent holmium laser lithotripsy using Karl® Storz MIP set.
干预措施: holmium laser lithotripsy using Karl® Storz MIP (Procedure)
Group A :Flexible ureteroscope group
Flexible ureteroscope (F-URS) group underwent holmium laser lithotripsy using flexible ureteroscopy (Boston® scientific (lithovue)
干预措施: Lithotripsy using Flexible ureteroscope (Procedure)
Group B : extracorporeal shock wave lithotripsy (ESWL) group
extracorporeal shock wave lithotripsy (ESWL) group underwent electromagnetic extracorporeal shock wave lithotripsy (STORZ® MEDICAL Modulith SLX-F2 FD21, Germany)
干预措施: Extracorporeal shock wave lithotripsy (ESWL) (Procedure)
结局指标
主要结局
stone free rate
时间窗: 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
- Radiation time(during the procedure)
- Post operative complication(Up to 48 hours)
- ssess operative time(during the procedure)
研究者
Elsayed Abdelhalim Elsayed
assistant lecturer of urology
Kafrelsheikh University