ClinicalTrials.gg
CompletedNCT06733194AVPEDUpdated Dec 13, 2024

Complications of Bladder Augmentation in Children

An observational study in Neurogenic Bladder Disorder, Spina Bifida and Complications of Surgical Procedures or Medical Care, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2024-12-13.

Sponsored by University Hospital, Clermont-Ferrand · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
87
Ages
0 Years to 17 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Neurogenic Bladder Disorder
  • Spina Bifida
  • Complications of Surgical Procedures or Medical Care
  • Child, Only
  • Bladder Dysfunction

Keywords

  • Bladder Augmentation
  • Enterocystoplasty
  • Surgical Complications
  • Child
  • Retrospective Study
03

In context

Urinary Bladder, Neurogenic

189 studies on the registry are indexed under Urinary Bladder, Neurogenic; 40 are open to participants now.

This study's enrollment of 87 is above the median of 71 across 57 observational studies indexed under Urinary Bladder, Neurogenic.

Browse Urinary Bladder, Neurogenic studies →

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 859 studies on the registry; 179 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
0 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Children with dysfunctional bladder

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients who underwent a enterocystoplasty before 18 years old

Exclusion criteria

Exclusion Criteria:

  • Patients who underwent a enterocystoplasty after 18 years old
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
87 participants (actual)
Patient registry
No

Groups and cohorts

  • Group I

    Patients who underwent an ileocystoplasty

  • Group S

    Patients who underwent a sigmoidocystoplasty

06

What researchers measure

Primary outcomes

  1. Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty

    Observational study

    Time frame: 38 years

Secondary outcomes

  1. Impact of the participants' age on the occurrence of complications depending on the type of enterocystoplasty

    Observational study

    Time frame: 38 years

  2. Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty

    Observational study

    Time frame: 38 years

  3. Impact of the participants' type of neurogenic bladder on the occurrence of complications depending on the type of enterocystoplasty

    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

    Time frame: 38 years

07

Study locations

1 site
  • Clermont-Ferrand University Hospital
    Clermont-Ferrand, Auvergne 63003, France
08

References and documents

Publications

  • Molina CA, Lima GJ, Cassini MF, Andrade MF, Facincani I, Tucci Junior S. Complications after bladder augmentation in children. Acta Cir Bras. 2016;31 Suppl 1:8-12. doi: 10.1590/S0102-86502016001300003. PubMed 27142898 ↗

Individual participant data

Plan to share: No — In the name of anonymization we won't share individual participant data

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06733194
Responsible party
Destinval Christelle (Dr., University Hospital, Clermont-Ferrand) — Principal investigator
First posted
Dec 13, 2024
Start date
Nov 1, 2020
Primary completion
Dec 31, 2022
Completion
Jan 1, 2023
Last update
Dec 13, 2024

Study contacts

Christelle Destinval
principal investigator · University Hospital, Clermont-Ferrand

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.

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