Complications of Bladder Augmentation in Children | NCT06733194

Studies
Complications of Bladder Augmentation in Children

NCT06733194

Sponsor

University Hospital, Clermont-Ferrand

Status

Completed

Last Update Posted

Dec 13, 2024Actual

Enrollment

87Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Jan 1, 2023Actual

First Submitted Date

Dec 10, 2024

First Submission Date that Met QC Criteria

Dec 10, 2024

First Posted Date

Dec 13, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 10, 2024

Last Update Posted Date

Dec 13, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Destinval Christelle, Dr., University Hospital, Clermont-FerrandPrincipal Investigator

Lead Sponsor

University Hospital, Clermont-FerrandOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

87Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group I		Patients who underwent an ileocystoplasty
Group S		Patients who underwent a sigmoidocystoplasty

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent a enterocystoplasty before 18 years old

Exclusion Criteria:

Patients who underwent a enterocystoplasty after 18 years old

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

0 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Children with dysfunctional bladder

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christelle Destinval	University Hospital, Clermont-Ferrand	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clermont-Ferrand University Hospital		Clermont-Ferrand	Auvergne	63003	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27142898	Background	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.

ID	Term
D001750	Urinary Bladder, Neurogenic
D016135	Spinal Dysraphism

ID	Term
D009461	Neurologic Manifestations
D009422	Nervous System Diseases
D001745	Urinary Bladder Diseases
D014570	Urologic Diseases