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Enrolling by invitationNCT05840874AVPEDUpdated May 16, 2023

Complications of Enterocystoplasty in Children

An observational study in Complications of Surgical Procedure, Neurogenic Bladder and Spina Bifida, sponsored by Dr Christelle DESTINVAL. Enrolling by invitation at 1 site in France. Open to participants aged 0 Years to 17 Years. Per ClinicalTrials.gov, last updated 2023-05-16.

Sponsored by Dr Christelle DESTINVAL · Observational

From the registry’s dates

  • Primary completion was expected by May 2023, 3 years 5 months ago, but the record still lists the study as enrolling by invitation.
Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
90
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

  • Complications of Surgical Procedure
  • Neurogenic Bladder
  • Spina Bifida
  • Child, Only

Keywords

  • Augmentation Enterocystoplasty
  • Surgical Complications
  • Children
  • 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 planned enrollment of 90 is above the median of 71 across 57 observational studies indexed under Urinary Bladder, Neurogenic.

Browse Urinary Bladder, Neurogenic studies →

Lead sponsor

This is the only study on the registry with Dr Christelle DESTINVAL as lead sponsor.

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
Case-only
Time perspective
Retrospective
Enrollment
90 participants (estimated)
Patient registry
No
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
  • ULorraine
    Nancy, 54000, 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

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2023 (actual). Primary completion is estimated for May 2023, 2 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2023
First posted
May 3, 2023
StartActual
Mar 1, 2023
Primary completionEst.
May 31, 2023
CompletionEst.
May 31, 2023
Last update
May 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05840874
Lead sponsor
Dr Christelle DESTINVAL
Responsible party
Dr Christelle DESTINVAL (Principal Investigator, University of Lorraine) — Sponsor-investigator
First posted
May 3, 2023
Start date
Mar 1, 2023
Primary completion
May 31, 2023 (estimated)
Completion
May 31, 2023 (estimated)
Last update
May 16, 2023

Oversight

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

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No contact was published for this record. The registry link below has the sponsor’s details.

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