Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children. Is it Useful for Diagnosis and Follow up?
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
研究概览
简要总结
Diagnosis and follow up of hydronephrosis is actually based on repeat ultrasonography and scintigraphy wich is a binding exam for children. We wanted to evaluate the use of ultrasonography sensibilized by an oral hydration and to determine its efficiency to detect which hydronephrosis need a surgery or not.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •child of 30 days old or less
- •unilateral or bilateral hydronephrosis (pelvis > 5mm )
排除标准
- •complex uropathy
- •diuretic administration 6 hours prior to ultrasonography or scintigraphy
- •oral feeding trouble
结局指标
主要结局
Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care
时间窗: V2 (Age of 6 months)
The primary outcome measure is a composite outcome measure consisting of multiple measures. Indeed, the treating surgeon will make a decision (ie to operate or not) upon the clinical exam, ultrasonography with oral hydratation and scintigraphy results. The independent surgeon will only be given data from the clinical exam and the ultrasonography. For ultrasonography, the following parameters will be measured: cortical thickness, anteroposterior renal pelvis diameter, calyx diameter, kidney echogenicity, kidney size. The measures will be done before, 30 min and 90 min following oral hydration. For scintigraphy, the relative kidney function, T1/2, Tmax and NORA will be analyzed. The result will be reported as a single value, ie: * the treating surgeon's decision and the independent surgeon's decision are similar (=1) or * the treating surgeon's decision and the independent surgeon's decision are not similar (=0)
次要结局
- Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care(Between V0 (age: 30 days ) and V2 (age: 6 months))