Complications of Bladder Augmentation in Children

NCT06733194 | Completed

• 1 other identifier: M24DC1102
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Bladder Disorder; Spina Bifida; Complications of Surgical Procedures or Medical Care; Child, Only; Bladder Dysfunction

Keywords

Bladder Augmentation; Enterocystoplasty; Surgical Complications; Child; Retrospective Study

Outcome Measures

Primary Outcomes (1)

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

  Observational study

  38 years

Secondary Outcomes (3)

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

  38 years

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

  38 years

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

  38 years

Study Arms (2)

Group I

Patients who underwent an ileocystoplasty

Group S

Patients who underwent a sigmoidocystoplasty

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children with dysfunctional bladder

You may qualify if:

• Patients who underwent a enterocystoplasty before 18 years old

You may not qualify if:

• Patients who underwent a enterocystoplasty after 18 years old

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

Clermont-Ferrand University Hospital

Clermont-Ferrand, Auvergne, 63003, France

Location

Related 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.

  PMID: 27142898 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, Neurogenic; Spinal Dysraphism

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neural Tube Defects; Nervous System Malformations; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Christelle Destinval

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 10, 2024
• First Posted: December 13, 2024
• Study Start: November 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: January 1, 2023
• Last Updated: December 13, 2024

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)