Urinary Calculi After Bladder Augmentation in Children (LITAVPED)

May 16, 2023 updated by: Dr Christelle DESTINVAL, University of Lorraine

Management of Urinary Calculi After Bladder Augmentation in Children

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..)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study the data of patients younger than 18 years old, who underwent a bladder augmentation, complicated by urinary calculi.

Study Type

Observational

Enrollment (Actual)

29

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
    • Grand-Est
      • Vandœuvre-lès-Nancy, Grand-Est, France, 54500
        • 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

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients operated in our center

Description

Inclusion Criteria:

  • Patients younger than 18 years old, with urinary calculi, after bladder augmentation

Exclusion Criteria:

  • Patients older than 18 years old, with urinary calculi, after bladder augmentation

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ileocystoplasty
Urinary Calculi After Ileocystoplasty in Children
Other: Bladder Augmentation
Bladder Augmentation using bowel loop (ileal or sigmoid loop)
Sigmoidocystoplasty
Urinary Calculi After Sigmoidocystoplasty in Children
Other: Bladder Augmentation
Bladder Augmentation using bowel loop (ileal or sigmoid loop)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of participants with urinary calculi
Time Frame: Through study completion, an average of 2 years
After bladder augmentation
Through study completion, an average of 2 years
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.
Through study completion, an average of 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time frame between surgery and occurence of urinary calculi in the participants
Time Frame: Through study completion, an average of 2 years
After bladder augmentation
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
Age, sex, type of bladder augmentation...
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
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.
Through study completion, an average of 2 years

Collaborators and Investigators

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

Sponsor

University of Lorraine

Investigators

  • Principal Investigator: Christelle Destinval, MD, University of Lorraine

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)

November 20, 2022

Primary Completion (Actual)

January 31, 2023

Study Completion (Actual)

April 10, 2023

Study Registration Dates

First Submitted

April 13, 2023

First Submitted That Met QC Criteria

May 14, 2023

First Posted (Actual)

May 16, 2023

Study Record Updates

Last Update Posted (Actual)

May 18, 2023

Last Update Submitted That Met QC Criteria

May 16, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ULorilith
  • 2023PI005 (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 the investigators 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.

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