Neurogenic Bladder DisorderAVPEDNCT06733194
Complications of Bladder Augmentation in Children
An observational study of Neurogenic Bladder Disorder and Spina Bifida, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Neurogenic Bladder Disorder, Spina Bifida, Complications of Surgical Procedures or Medical Care
- How many people
- 87 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2020to 1 Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Children with dysfunctional bladder
Who may be able to join
- Patients who underwent a enterocystoplasty before 18 years old
Who cannot join
- Patients who underwent a enterocystoplasty after 18 years old
Trial locations and contacts
1 site in 1 country.
France1 site
Clermont-Ferrand University Hospital
Clermont-Ferrand, Auvergne, 63003
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Urinary Bladder, Neurogenic, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Patients who underwent an ileocystoplasty | |
| Group S | Patients who underwent a sigmoidocystoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty
Observational study
Measured: 38 years
Secondary outcomes (3)
Impact of the participants' age on the occurrence of complications depending on the type of enterocystoplasty
Observational study
Measured: 38 years
Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty
Observational study
Measured: 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
Measured: 38 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start1 Nov 2020
- Primary completion31 Dec 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Bladder DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Destinval Christelle, University Hospital, Clermont-Ferrand
- Investigators
- Christelle Destinval, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06733194
- Sponsor's protocol ID
- M24DC1102
- Acronym
- AVPED
- Status last verified
- Jan 2023
- First submitted
- 10 Dec 2024
- Last updated
- 13 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: In the name of anonymization we won't share individual participant data
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.
PubMed 27142898
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surgical Complications After Bladder Augmentation in Children: a Retrospective Study About 87 Patients
- ClinicalTrials.gov ID
- NCT06733194
- Acronym / sponsor ID
- AVPED / M24DC1102
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 13 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | – | –Patients who underwent an ileocystoplasty |
| Group S | – | –Patients who underwent a sigmoidocystoplasty |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children with dysfunctional bladder
Key inclusion criteria (1 listed)
- Patients who underwent a enterocystoplasty before 18 years old
Key exclusion criteria (1 listed)
- Patients who underwent a enterocystoplasty after 18 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty
Time frame: 38 years
Observational study
3 secondary outcomes
Impact of the participants' age on the occurrence of complications depending on the type of enterocystoplasty
Time frame: 38 years
Impact of the participants' sex on the occurrence of complications depending on the type of enterocystoplasty
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2024.
- Background: PubMed 27142898Molina 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.
- Individual participant dataSharing planned: No. In the name of anonymization we won't share individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christelle Destinval principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurogenic Bladder Disorder and Spina Bifida, run by University Hospital, Clermont-Ferrand at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical complications of bladder augmentation in children depending on the type of enterocystoplasty (time frame: 38 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06733194, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2024.