Child, Only Clinical Trial
— LITAVPEDOfficial title:
Management of Urinary Calculi After Bladder Augmentation in Children
Verified date | May 2023 |
Source | University of Lorraine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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..)
Status | Completed |
Enrollment | 29 |
Est. completion date | April 10, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | |
Gender | All |
Age group | N/A to 17 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | ULorraine | Vandœuvre-lès-Nancy | Grand-Est |
Lead Sponsor | Collaborator |
---|---|
University of Lorraine |
France,
Mathoera RB, Kok DJ, Nijman RJ. Bladder calculi in augmentation cystoplasty in children. Urology. 2000 Sep 1;56(3):482-7. doi: 10.1016/s0090-4295(00)00663-4. — View Citation
Salama AK, Misseri R, Hollowell N, Hahney B, Whittam B, Kaefer M, Cain MP, Rink RC, Szymanski KM. Incidence of nephrolithiasis after bladder augmentation in people with spina bifida. J Pediatr Urol. 2021 Aug;17(4):521.e1-521.e7. doi: 10.1016/j.jpurol.2021.03.012. Epub 2021 Mar 19. — View Citation
Szymanski KM, Misseri R, Whittam B, Lingeman JE, Amstutz S, Ring JD, Kaefer M, Rink RC, Cain MP. Bladder stones after bladder augmentation are not what they seem. J Pediatr Urol. 2016 Apr;12(2):98.e1-6. doi: 10.1016/j.jpurol.2015.06.021. Epub 2015 Sep 25. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of participants with urinary calculi | After bladder augmentation | Through study completion, an average of 2 years | |
Primary | 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. | Through study completion, an average of 2 years | |
Secondary | Time frame between surgery and occurence of urinary calculi in the participants | After bladder augmentation | Through study completion, an average of 2 years | |
Secondary | 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. | Through study completion, an average of 2 years | |
Secondary | Risk factors of urinary calculi after bladder augmentation in the participants | Age, sex, type of bladder augmentation... | Through study completion, an average of 2 years |
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