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AVPED: Complications of Enterocystoplasty in Children

Sponsor
Dr Christelle DESTINVAL (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05840874
Collaborator
(none)
90
Enrollment
1
Location
3
Anticipated Duration (Months)
30.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this observational study is to describe the complications in participants who underwent enterocystoplasty in childhood.

The main question[s] it aims to answer are:

  • what kind of complications are there

  • the kind of complications depending on the type of enterocystoplasty Participants data will be collected in the medical field. There is no comparison group.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    From 1982 to 2020, all patients who had an enterocystoplasty in childhood were collected.

    Complications were numbered depending on the type of enterocystoplasty and the investigators tried to find which risk factors exist.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    90 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Retrospective
    Official Title:
    Surgical Complications of Enterocystoplasty in Children: A Retrospective Monocentric Study About 39 Cases
    Actual Study Start Date :
    Mar 1, 2023
    Anticipated Primary Completion Date :
    May 31, 2023
    Anticipated Study Completion Date :
    May 31, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty [38 years]

      Observational study

    Secondary Outcome Measures

    1. Impact of the participants' age on the occurrence of complications depending on the type of enterocystoplasty [38 years]

      Observational study

    2. Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty [38 years]

      Observational study

    3. Impact of the participants' type of neurogenic bladder on the occurrence of complications depending on the type of enterocystoplasty [38 years]

      Observational study: the participants can have spina bifida, bladder exstrophy, anorectal malformation and if it has an impact on the occurrence of complications depending on the type of enterocystoplasty

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    0 Years to 17 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients who underwent a enterocystoplasty before 18 years old
    Exclusion Criteria:
    • patients who underwent a enterocystoplasty after 18 years old

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 ULorraine Nancy France 54000

    Sponsors and Collaborators

    • Dr Christelle DESTINVAL

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr Christelle DESTINVAL, Principal Investigator, University of Lorraine
    ClinicalTrials.gov Identifier:
    NCT05840874
    Other Study ID Numbers:
    • ULorraine
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dr Christelle DESTINVAL, Principal Investigator, University of Lorraine
    Augmentation Enterocystoplasty
    Surgical Complications
    Children
    Retrospective Study
    Additional relevant MeSH terms:
    Urinary Bladder, Neurogenic
    Spinal Dysraphism

    Study Results

    No Results Posted as of May 3, 2023