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no subject enrolled within one year following EC and IRB approvals.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasonography sensibilized by oral hydratation | Experimental | Ultrasonography before, 30 min and 90 min following hydratation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasonography with oral hydration | Other | Before, 30 min and 90 min following oral hydration |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| V2 (Age of 6 months) |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Isabelle LACREUSE, MD | Hôpitaux Universitaires de Strasbourg | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg | Strasbourg | 67098 | France |
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| ID | Term |
|---|---|
| D006869 | Hydronephrosis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019220 | High-Energy Shock Waves |
| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
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| Scintigraphy | Radiation |
|
| Between V0 (age: 30 days ) and V2 (age: 6 months) |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D055585 |
| Physical Phenomena |