NCT05840874

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 6, 2023

Completed
27 days until next milestone

First Posted

Study publicly available on registry

May 3, 2023

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2023

Completed
Last Updated

May 16, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

April 6, 2023

Last Update Submit

May 14, 2023

Conditions

Keywords

Augmentation EnterocystoplastySurgical ComplicationsChildrenRetrospective 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

Eligibility Criteria

Age0 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ULorraine

Nancy, 54000, 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: 27142898BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, NeurogenicSpinal Dysraphism

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeural Tube DefectsNervous System MalformationsCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 6, 2023

First Posted

May 3, 2023

Study Start

March 1, 2023

Primary Completion

May 31, 2023

Study Completion

May 31, 2023

Last Updated

May 16, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

In the name of anonymization we won't share individual participant data

Locations