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Completed

NCT Number: NCT06734403

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..)

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Key information

Conditions

Calculi, Urinary Calculi Child, Only Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Nervous System Diseases Nervous System Malformations Neural Tube Defects Neurogenic Bladder Disorder Neurologic Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Signs and Symptoms Spina Bifida Spinal Dysraphism Urinary Bladder Diseases Urinary Bladder, Neurogenic Urinary Calculi Urogenital Diseases Urolithiasis Urologic Diseases

Age range

0 year–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital, Clermont-Ferrand

Clermont-Ferrand, Auvergne, 63003, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bladder Augmentation

Other

Bladder Augmentation using bowel loop (ileal or sigmoid loop)

Primary outcomes

  1. 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

  2. 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.

Secondary outcomes

  1. 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

    Time frame between surgery and occurence of urinary calculi in the participants After bladder augmentation

  2. 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.

  3. 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...

Sponsors and collaborators

Lead sponsor

University Hospital, Clermont-Ferrand

Other

Collaborators

  • Central Hospital, Nancy, France

Registry information

Official study title

Management of Patients Who Had Urolithiasis After Bladder Augmentation in Childhood

Acronym: LITAPED

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2024
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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