Complications of Enterocystoplasty in Children

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

• Registration Number: NCT05840874
• Lead Sponsor: Dr Christelle DESTINVAL

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.

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 Timeline

• Study Start: 2023-03-01
• Study First Submitted: 2023-04-06
• Study First Submitted QC: 2023-04-28
• Status Verified: 2023-05
• Study First Posted: 2023-05-03
• Last Update Submitted: 2023-05-14
• Last Update Posted: 2023-05-16
• Primary Completion: 2023-05-31
• Study Completion: 2023-05-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• patients who underwent a enterocystoplasty before 18 years old

Exclusion Criteria

• patients who underwent a enterocystoplasty after 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty	38 years	Observational study

Secondary Outcome Measures

Name	Time	Method
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
Impact of the participants' age on the occurrence of complications depending on the type of enterocystoplasty	38 years	Observational study
Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty	38 years	Observational study

Trial Locations

Locations (1)

ULorraine; 🇫🇷 Nancy, France