Calculi, UrinaryLITAPEDNCT06734403
Urinary Calculi After Bladder Augmentation in Children
An observational study of Calculi, Urinary and Neurogenic Bladder Disorder, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
The goal of this observational study is to analyse the occurence of urinary calculi after bladder augmentation in children: location of the calculi (kidney or bladder) type of bladder augmentation with higher rate of urinary calculi and why Find risk factors of urinary calculi in bladder augmentation (age, sex, other… Read more about this study
- Who is it for?
- Ages 0 to 17 years
- Conditions the study is for
- Calculi, Urinary, Neurogenic Bladder Disorder, Spina Bifida
- What is being tested?
- Bladder Augmentation
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 20 Nov 2022to 10 Apr 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: Patients younger than 18 years old, with urinary calculi, after bladder augmentation.
Who may be able to join
- Patients younger than 18 years old, with urinary calculi, after bladder augmentation
Who cannot join
- Patients older than 18 years old, with urinary calculi, after bladder augmentation
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital, Clermont-Ferrand
Clermont-Ferrand, Auvergne, 63003
About this study
Official title: Management of Patients Who Had Urolithiasis After Bladder Augmentation in Childhood
The goal of this observational study is to analyse the occurence of urinary calculi after bladder augmentation in children:
- location of the calculi (kidney or bladder)
- type of bladder augmentation with higher rate of urinary calculi and why
- Find risk factors of urinary calculi in bladder augmentation (age, sex, other bladder procedures..)
Read the detailed description
Study the data of patients younger than 18 years old, who underwent a bladder augmentation, complicated by urinary calculi.
- Being tested
- Bladder Augmentation
- Keywords
- Urinary Calculus, Bladder Augmentation, Child, Retrospective Study
- Medical subject headings
- Urinary Calculi, Urinary Bladder, Neurogenic, Spinal Dysraphism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bladder AugmentationOther
Bladder Augmentation using bowel loop (ileal or sigmoid loop)
| Study group | Role | What they receive |
|---|---|---|
| Ileocystoplasty | Urinary Calculi After Ileocystoplasty in Children Receives: Other: Bladder Augmentation | |
| Sigmoidocystoplasty | Urinary Calculi After Sigmoidocystoplasty in Children Receives: Other: Bladder Augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of participants with urinary calculi
Rate of participants with urinary calculi After bladder augmentation
Measured: Through study completion, an average of 2 years
Location of urinary calculi in the participants
After bladder augmentation, urinary calculi can be seen on postoperative imaging such as abdominal ultrasound, CT scan, and MRI. The different locations of these calculi can be the kidneys, the ureters, the bladder, or the urethra. Each patient who has had urinary calculi will be reported, and the location of the calculi will be specified depending on the imaging results.
Measured: Through study completion, an average of 2 years
Secondary outcomes (3)
Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation
Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation
Measured: Through study completion, an average of 2 years
Management of urinary calculi after bladder augmentation in the participants
3 main procedures help getting rid off urinary calculi: extracorporeal lithotripsy, endoscopic surgery or laparotomy. The patients were divided depending on the procedure that was used to remove the urinary calculi.
Measured: Through study completion, an average of 2 years
Risk factors of urinary calculi after bladder augmentation in the participants
Age, sex, type of bladder augmentation...
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start20 Nov 2022
- Primary completion31 Jan 2023
- Study completion10 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Calculi, UrinaryStudies of the same condition, open and under way.
- 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Responsible party
- Principal investigator, Destinval Christelle, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734403
- Sponsor's protocol ID
- M24DC1104
- Acronym
- LITAPED
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 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 the investigators won't share individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Patients Who Had Urolithiasis After Bladder Augmentation in Childhood
- ClinicalTrials.gov ID
- NCT06734403
- Acronym / sponsor ID
- LITAPED / M24DC1104
- Keywords
- Urinary Calculus, Bladder Augmentation, Child, Retrospective Study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Collaborators
- Central Hospital, Nancy, France
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 10 Apr 2023 (actual)
- First posted
- 16 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 analyse the occurence of urinary calculi after bladder augmentation in children:
- location of the calculi (kidney or bladder)
- type of bladder augmentation with higher rate of urinary calculi and why
- Find risk factors of urinary calculi in bladder augmentation (age, sex, other bladder procedures..)
Detailed description
Study the data of patients younger than 18 years old, who underwent a bladder augmentation, complicated by urinary calculi.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ileocystoplasty | – | Other: Bladder AugmentationUrinary Calculi After Ileocystoplasty in Children |
| Sigmoidocystoplasty | – | Other: Bladder AugmentationUrinary Calculi After Sigmoidocystoplasty in Children |
Who may qualify
- Ages
- 0 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients younger than 18 years old, with urinary calculi, after bladder augmentation.
Key inclusion criteria (1 listed)
- Patients younger than 18 years old, with urinary calculi, after bladder augmentation
Key exclusion criteria (1 listed)
- Patients older than 18 years old, with urinary calculi, after bladder augmentation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bladder AugmentationBladder Augmentation using bowel loop (ileal or sigmoid loop) | Other | Ileocystoplasty, Sigmoidocystoplasty |
Primary outcome
Rate of participants with urinary calculi
Time frame: Through study completion, an average of 2 years
Rate of participants with urinary calculi After bladder augmentation
Location of urinary calculi in the participants
Time frame: Through study completion, an average of 2 years
After bladder augmentation, urinary calculi can be seen on postoperative imaging such as abdominal ultrasound, CT scan, and MRI. The different locations of these calculi can be the kidneys, the ureters, the bladder, or the urethra. Each patient who has had urinary calculi will be reported, and the location of the calculi will be specified depending on the imaging results.
3 secondary outcomes
Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation
Time frame: Through study completion, an average of 2 years
Management of urinary calculi after bladder augmentation in the participants
Time frame: Through study completion, an average of 2 years
Risk factors of urinary calculi after bladder augmentation in the participants
Time frame: Through study completion, an average of 2 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 16 Dec 2024.
- Individual participant dataSharing planned: No. In the name of anonymization the investigators 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Calculi, Urinary and Neurogenic Bladder Disorder, 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 16 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?
Rate of participants with urinary calculi (time frame: Through study completion, an average of 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2024.