LITAVPED: Urinary Calculi After Bladder Augmentation in Children

Sponsor

University of Lorraine (Other)

Overall Status

Completed

CT.gov ID

NCT05861024

Collaborator

(none)

Enrollment

Location

4.6

Actual Duration (Months)

6.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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..)

Condition or Disease	Intervention/Treatment	Phase
Calculi, Urinary Neurogenic Bladder Spina Bifida Child, Only	Other: Bladder Augmentation

Detailed Description

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

Study Design

Study Type:

Observational

Actual Enrollment :

29 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Management of Urinary Calculi After Bladder Augmentation in Children

Actual Study Start Date :

Nov 20, 2022

Actual Primary Completion Date :

Jan 31, 2023

Actual Study Completion Date :

Apr 10, 2023

Arms and Interventions

Arm	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)

Arm

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)

Outcome Measures

Primary Outcome Measures

Rate of participants with urinary calculi [Through study completion, an average of 2 years]
After bladder augmentation
Location of urinary calculi in the participants [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 Outcome Measures

Time frame between surgery and occurence of urinary calculi in the participants [Through study completion, an average of 2 years]
After bladder augmentation
Management of urinary calculi after bladder augmentation in the participants [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.
Risk factors of urinary calculi after bladder augmentation in the participants [Through study completion, an average of 2 years]
Age, sex, type of bladder augmentation...