An interventional study of Ultrasonography with oral hydration and Scintigraphy in Hydronephrosis in Children, sponsored by University Hospital, Strasbourg, France. Withdrawn at 1 site in France. Open to participants aged Up to 30 Days. Per ClinicalTrials.gov, last updated 2015-10-02.
Sponsored by University Hospital, Strasbourg, France · Not applicable, Interventional, and Diagnostic
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.
55 studies on the registry are indexed under Hydronephrosis; 9 are open to participants now.
Browse Hydronephrosis studies →University Hospital, Strasbourg, France is the lead sponsor of 999 studies on the registry; 358 are open to participants now.
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Exclusion Criteria:
Ultrasonography before, 30 min and 90 min following hydratation.
Other: Ultrasonography with oral hydration · Radiation: Scintigraphy
Before, 30 min and 90 min following oral hydration
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)
Time frame: V2 (Age of 6 months)
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)
Time frame: Between V0 (age: 30 days ) and V2 (age: 6 months)
This study is withdrawn, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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