Ped-Urolithia: Stone Disease of the Urinary Tract in Children: Clinical Presentation, Diagnostic Methods, Therapeutic Management, Evolution and Prognosis

Sponsor
University Hospital, Strasbourg, France (Other)
Overall Status
Recruiting
CT.gov ID
NCT06032364
Collaborator
(none)
140
1
12
11.6

Study Details

Study Description

Brief Summary

The incidence of stone disease of the urinary tract in children is increasingly increasing with a remarkable economic impact for its management.

This incidence is variable according to race, geographic region, socio-economic status and dietary habits.

Oxalo-calcium stones are the most common but the biochemical nature of urinary stones varies depending on the region where those of a phosphatic nature are characterized by a higher incidence in Europe.

The diagnosis is confirmed by imaging. The unprepared abdomen (ASP) has low diagnostic accuracy. The scanner is the reference tool but remains an irradiating examination.

Risk factors for disease recurrence include primarily the presence of an underlying urinary metabolic abnormality and young age. Urinary metabolic abnormalities vary from one study to another.

The understanding of lithogenesis, its evaluation as well as the therapeutic options is essential for adequate and adapted management in the pediatric population.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    140 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Stone Disease of the Urinary Tract in Children: Clinical Presentation, Diagnostic Methods, Therapeutic Management, Evolution and Prognosis
    Actual Study Start Date :
    Aug 23, 2023
    Anticipated Primary Completion Date :
    Aug 23, 2024
    Anticipated Study Completion Date :
    Aug 23, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Study of the modalities of the therapeutic management of children with urinary stones, retrospective description of the evolutionary aspects and the risk factors associated with recurrence. [Files analysed retrospectively from January 01, 2010 to December 31, 2022 will be examined]

      This study is retrospective on already existing data

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    1 Year to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:
    • Patients aged less than 18 years.

    • Both sexes.

    • Subjects presenting with lithiasis of the urinary tree in one of the two departments concerned between 01/01/2010 and 12/31/2022

    • Subject not opposing, after information, the reuse of their data for the purposes of this research.

    • Holders of parental authority who do not object, after being informed, to the reuse of their child's data for the purposes of this research.

    Exclusion criteria:
    • Subject or holder of parental authority having expressed opposition to participating in the study.

    • Non-usable patient files: insufficient data.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Service de Pédiatrie 1 - CHU de Strasbourg - France Strasbourg France 67091

    Sponsors and Collaborators

    • University Hospital, Strasbourg, France

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Strasbourg, France
    ClinicalTrials.gov Identifier:
    NCT06032364
    Other Study ID Numbers:
    • 9020
    First Posted:
    Sep 13, 2023
    Last Update Posted:
    Sep 13, 2023
    Last Verified:
    Aug 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Strasbourg, France
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 13, 2023