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TSC-URO: Voiding Disorders in Children After Sacrococcygeal Teratoma Resection

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT05182853
Collaborator
(none)
8
Enrollment
1
Location
5.5
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sacrococcygeal teratomas are the most common neonatal tumors and require rapid and complete resection. Tumor nerve compression and pelvic surgical sequelae may lead to many and varied voiding disorders. Data concerning long-term vesico-sphincteric disorders are conflicting. Some studies find good functional results [Cozzi et al., 2008; Draper et al., 2009]. However other authors reveal neurologic bladder with detrusor sphincter dyssynergia [Hambraeus et al., 2018] and rise concerned about long-term renal function [Khanna et al., 2019; Rehfuss et al., 2020] even in the absence of clinical voiding disorders. Most of studies include young patients with other malformations such as anorectal malformations or dysraphisms which may impact the results. The main objective is to assess bladder dysfunction in children aged 6 to 18 years after isolated sacrococcygeal teratoma resection.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    8 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Voiding Disorders in Children After Sacrococcygeal Teratoma Resection
    Actual Study Start Date :
    Jun 16, 2021
    Actual Primary Completion Date :
    Sep 30, 2021
    Actual Study Completion Date :
    Dec 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Presence of voiding disorders [Day 1]

      Presence of voiding disorders will be assessed by the scale: Dysfonctional voiding scoring system

    Secondary Outcome Measures

    1. Presence of defecation disorders [Day 1]

      The Presence of defecation disorders will be assessed by the scale: Bristol stool scale

    2. Presence of secondary neurological bladder [Day 1]

      the Presence of secondary neurological bladder will be assessed by the uroflowmetry

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 18 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Children aged 6 to 18

    • history of sacrococcygeal teratoma resection

    Exclusion criteria:

    • Associated anorectal malformation

    • Associated neurological pathology

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University hospital of Montpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Principal Investigator: Sarah GARNIER, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT05182853
    Other Study ID Numbers:
    • RECHMPL21_0377
    First Posted:
    Jan 10, 2022
    Last Update Posted:
    Jan 11, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    Teratoma
    sacrococcygeal region
    urinary incontinence
    neurogenic bladder
    children
    Additional relevant MeSH terms:
    Teratoma
    Urinary Bladder, Neurogenic

    Study Results

    No Results Posted as of Jan 11, 2022