Clinical Trial: Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children. Is it Useful for Diagnosis and Follow up?

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 Summary:
Sponsor: University Hospital, Strasbourg, France

Current Primary Outcome: Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care [ Time Frame: 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)


Original Primary Outcome: Same as current

Current Secondary Outcome: Similarity between the decision of the treating surgeon and the independent surgeon about the subject's medical care [ Time Frame: 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)


Original Secondary Outcome: Same as current

Information By: University Hospital, Strasbourg, France

Dates:
Date Received: February 18, 2014
Date Started: May 2014
Date Completion: November 2016
Last Updated: October 1, 2015
Last Verified: October 2015