Ultrasonography Sensibilized by Oral Hydration and Hydronephrosis in Children.

NCT02086760 | Withdrawn

• 1 other identifier: 5580
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydronephrosis in Children

Keywords

hydronephrosis

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (1)

Ultrasonography sensibilized by oral hydratation

EXPERIMENTAL

Ultrasonography before, 30 min and 90 min following hydratation.

Other: Ultrasonography with oral hydration; Radiation: Scintigraphy

Interventions

Ultrasonography with oral hydration OTHER

Before, 30 min and 90 min following oral hydration

Ultrasonography sensibilized by oral hydratation

Scintigraphy RADIATION

Ultrasonography sensibilized by oral hydratation

Eligibility Criteria

• Age: Up to 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• child of 30 days old or less
• unilateral or bilateral hydronephrosis (pelvis \> 5mm )

You may not qualify if:

• complex uropathy
• diuretic administration 6 hours prior to ultrasonography or scintigraphy
• oral feeding trouble

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

Service de Chirurgie Pédiatrique - Hôpital de Hautepierre- CHRU Strasbourg

Strasbourg, 67098, France

Location

MeSH Terms

Conditions

Hydronephrosis

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Isabelle LACREUSE, MD

  Hôpitaux Universitaires de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2014
• First Posted: March 13, 2014
• Study Start: May 1, 2014
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: October 2, 2015

Record last verified: 2015-10

Locations

FR (1)