Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.
- Conditions
- Hydronephrosis in Children
- Interventions
- Other: Ultrasonography with oral hydrationRadiation: Scintigraphy
- Registration Number
- NCT02086760
- Lead Sponsor
- University Hospital, Strasbourg, France
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- child of 30 days old or less
- unilateral or bilateral hydronephrosis (pelvis > 5mm )
- complex uropathy
- diuretic administration 6 hours prior to ultrasonography or scintigraphy
- oral feeding trouble
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ultrasonography sensibilized by oral hydratation Scintigraphy Ultrasonography before, 30 min and 90 min following hydratation. Ultrasonography sensibilized by oral hydratation Ultrasonography with oral hydration Ultrasonography before, 30 min and 90 min following hydratation.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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)
Trial Locations
- Locations (1)
Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg
🇫🇷Strasbourg, France