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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05861024
Other study ID # ULorilith
Secondary ID 2023PI005
Status Completed
Phase
First received
Last updated
Start date November 20, 2022
Est. completion date April 10, 2023

Study information

Verified date May 2023
Source University of Lorraine
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 bladder procedures..)


Description:

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


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Bladder Augmentation
Bladder Augmentation using bowel loop (ileal or sigmoid loop)

Locations

Country Name City State
France ULorraine Vandœuvre-lès-Nancy Grand-Est

Sponsors (1)

Lead Sponsor Collaborator
University of Lorraine

Country where clinical trial is conducted

France, 

References & Publications (3)

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

Outcome

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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