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OpenTrials
Completed

NCT Number: NCT06733194

Complications of Bladder Augmentation in Children

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.

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Key information

Conditions

Neurogenic Bladder Disorder Bladder Dysfunction Child, Only Complications of Surgical Procedures or Medical Care Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Nervous System Malformations Neural Tube Defects Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Spina Bifida Spinal Dysraphism Urinary Bladder Diseases Urinary Bladder, Neurogenic Urogenital Diseases Urologic Diseases

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, 63003, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent a enterocystoplasty before 18 years old

Exclusion criteria

  • Patients who underwent a enterocystoplasty after 18 years old

Treatment and study plan

Primary outcomes

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

    Time frame: 38 years

    Observational study

Secondary outcomes

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

    Time frame: 38 years

    Observational study

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

    Time frame: 38 years

    Observational study

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

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Registry information

Official study title

Surgical Complications After Bladder Augmentation in Children: a Retrospective Study About 87 Patients

Acronym: AVPED

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
Dec 13, 2024
Registry last updated
Dec 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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