Double Extracorporeal Shockwave Lithotripsy for Renal Stones.
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Region Skane
- 入组人数
- 600
- 试验地点
- 2
- 主要终点
- Time to stone free status
研究概览
简要总结
Extracorporeal shockwave lithotripsy (ESWL) is one way to treat renal stones. In this clinical trial our goal is to evaluate if two ESWL the same week is equal good and safe to two ESWL 3 weeks regarding renal stones 8-15 mm.
详细描述
All patients with a renal stone 8-15 mm are asked to participate. If they give consent they are randomized to ESWL with an interval of 2 days or 3 weeks. Data regarding age, gender, stone size, Hounsfield unit, skin to stone distance, urine culture, results from the follow up CT and need for auxillary interventions are extraced from the medical records.
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
- •All patients with a renal stone 8-15 mm who are planned for intervention -
排除标准
- •Those who decline to participate, those who are put under guardianship or is less than 18 years old.
研究组 & 干预措施
ESWL, two days
干预措施: Extracorporeal shockwave lithotripsy (ESWL) (Procedure)
ESWL, three weeks
干预措施: Extracorporeal shockwave lithotripsy (ESWL) (Procedure)
结局指标
主要结局
Time to stone free status
时间窗: From enrollment until closure
Number of days from the day the treatment starts until the end of follow up.
Complications
时间窗: From enrollment until closure
Are there any differences in complications
Number of participants considered stone free at follow up
时间窗: From enrollment until closure.
Number of participants who are stone free at the follow up after two ESWL. Stone status will be assessed with computer tomography.
次要结局
- Participant´s experiences(From enrollment until closure)