STEPWISE SHOCK WAVE LITHOTRIPSY IN PEDIATRIC UROLITHIASIS: A COMPARATIVE STUDY.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Stone burden on plain X-ray.
研究概览
简要总结
To evaluate and compare the results of conventional and stepwise shock wave lithotripsy treatment modalities in pediatric urinary lithiasis.
详细描述
Between March 2008 and February 2012, 81 patients were randomized and included in this study. Shock wave lithotripsy was performed by using a Dornier Compact Delta instrument. Localizations of radiopaque and non-opaque stones were estimated by using flouroscopy and ultrasonography, respectively. Treatment energy was set on 13 kV in the conventional group. In the stepwise group, treatment energy was initially set on 10 kV and gradually increased up to 13 kV per 250 shocks. The maximum numbers of shocks in both groups were limited to 3000. Patients were followed up with 15 days interval. In each visit, patients were respectively questioned for pain, hematuria and history of stone passage. In case of treatment failure, shock wave lithotripsy was repeated.
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
- 12 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with pediatric urinary lithiasis.
排除标准
- •Resistant urinary tract infections Coagulopathies Anatomically obstructed urinary system
研究组 & 干预措施
conventional Shock wave lithotripsy group
All procedures were performed under continu¬ous intravenous sedo-analgesia (using a combi-nation of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiply¬ing the largest length and width of the individual stones measured from the abdominal plain X-ray.
干预措施: Shock wave lithotripsy (Procedure)
stepwise Shock wave lithotripsy group
All procedures were performed under continu¬ous intravenous sedo-analgesia (using a combi-nation of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave number was limited to a maximum of 3000 waves/session. In the stepwise group, the voltage was started at 10 kV and increased stepwise (every 250 shock waves) to 13 kV. The stone burden was defined as the stone area that was calculated by multiply¬ing the largest length and width of the individual stones measured from the abdominal plain X-ray.
干预措施: Shock wave lithotripsy (Procedure)
结局指标
主要结局
Stone burden on plain X-ray.
时间窗: Three months.
The stone burden was defined as the stone area that was calculated by multiplying the largest length(cm)and width (cm)of the individual stones measured from the abdominal plain X-ray. To detect fragmentation of the stone and necessity of re-treatment a plain film were used during control. Stone clearance was assessed at three months. Stone-free state was defined as the absence of stone fragments on a good quality plain X-ray. Clinical success was considered if the residual fragments were 2-3 mm or less in asymptomatic patients.
次要结局
未报告次要终点
研究者
Abdullah Demirtas
Assistant Professor
TC Erciyes University