Complications of Enterocystoplasty in Children (AVPED)

May 14, 2023 updated by: Dr Christelle DESTINVAL

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

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

Enrolling by invitation

Conditions

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 (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nancy, France, 54000
        • ULorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 38 years
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
Time Frame: 38 years
Observational study
38 years
Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty
Time Frame: 38 years
Observational study
38 years
Impact of the participants' type of neurogenic bladder on the occurrence of complications depending on the type of enterocystoplasty
Time Frame: 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
38 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dr Christelle DESTINVAL

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2023

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

April 28, 2023

First Posted (Actual)

May 3, 2023

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 14, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULorraine
  • 2021PI090 (Registry Identifier: DRCI)

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Child, Only

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Burundi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe