Complications of Bladder Augmentation in Children (AVPED)

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

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.

Study Overview

• Status: Completed
• Conditions: Child, Only; Spina Bifida; Bladder Dysfunction; Neurogenic Bladder Disorder; Complications of Surgical Procedures or Medical Care

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 Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• France
  • Auvergne
    • Clermont-Ferrand, Auvergne, France, 63003
      • Clermont-Ferrand University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Children with dysfunctional bladder

Description

Inclusion Criteria:

• Patients who underwent a enterocystoplasty before 18 years old

Exclusion Criteria:

• Patients who underwent a enterocystoplasty after 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group I; Patients who underwent an ileocystoplasty
Group S; Patients who underwent a sigmoidocystoplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty	Observational study	38 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of the participants' age on the occurrence of complications depending on the type of enterocystoplasty	Observational study	38 years
Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty	Observational study	38 years
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

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Christelle Destinval, University Hospital, Clermont-Ferrand

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: December 10, 2024
• First Submitted That Met QC Criteria: December 10, 2024
• First Posted (Estimated): December 13, 2024

Study Record Updates

• Last Update Posted (Estimated): December 13, 2024
• Last Update Submitted That Met QC Criteria: December 10, 2024
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Child; Retrospective Study; Surgical Complications; Bladder Augmentation; Enterocystoplasty
• Additional Relevant MeSH Terms: Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Congenital Abnormalities; Nervous System Malformations; Neural Tube Defects; Spinal Dysraphism; Urinary Bladder, Neurogenic; Urinary Bladder Diseases
• Other Study ID Numbers: M24DC1102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: In the name of anonymization we won't share individual participant data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No