Hydronephrosis in Children
Conditions
Keywords
hydronephrosis
Brief summary
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.
Interventions
OTHERUltrasonography with oral hydration
Before, 30 min and 90 min following oral hydration
RADIATIONScintigraphy
Sponsors
University Hospital, Strasbourg, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No
Inclusion criteria
* child of 30 days old or less * unilateral or bilateral hydronephrosis (pelvis \> 5mm )
Exclusion criteria
* complex uropathy * diuretic administration 6 hours prior to ultrasonography or scintigraphy * oral feeding trouble
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | The secondary 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 hydration and scintigraphy results. The independent surgeon will only be given data from the clinical exam and the ultrasonography with oral hydration, he will make a decision aposteriori. 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) |
Countries
France
Outcome results
None listed