Complications of Enterocystoplasty in Children

Child, Only Clinical Trial

— AVPED  

Official title:

Surgical Complications of Enterocystoplasty in Children: A Retrospective Monocentric Study About 39 Cases

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05840874
• Other study ID #: ULorraine
• Secondary ID: 2021PI090
• Status: Enrolling by invitation
• Start date: March 1, 2023
• Est. completion date: May 31, 2023

Study information

• Verified date: May 2023
• Source: University of Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 90
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 17 Years

Eligibility

Inclusion Criteria:

• patients who underwent a enterocystoplasty before 18 years old

Exclusion Criteria:

• patients who underwent a enterocystoplasty after 18 years old

Related Conditions & MeSH terms

• Child, Only
• Neurogenic Bladder
• Spina Bifida
• Spinal Dysraphism
• Urinary Bladder, Neurogenic

Locations

Country	Name	City	State
France	ULorraine	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Dr Christelle DESTINVAL

Country where clinical trial is conducted

France, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty	Observational study	38 years
Secondary	Impact of the participants' age on the occurrence of complications depending on the type of enterocystoplasty	Observational study	38 years
Secondary	Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty	Observational study	38 years
Secondary	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	38 years