Hydronephrosis in Children Clinical Trial
Official title:
Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children. Is it Useful for Diagnosis and Follow up?
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.
| Status | Withdrawn |
| Enrollment | 0 |
| Est. completion date | November 2016 |
| Est. primary completion date | November 2016 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | N/A to 30 Days |
| Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| France | Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care | 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) |
V2 (Age of 6 months) | No |
| Secondary | Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care | 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) |
Between V0 (age: 30 days ) and V2 (age: 6 months) | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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N/A |