Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

Study Overview
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Brief Summary
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To compare staged ureteroscopy following initial urinary drainage versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure in children.

Detailed Description
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To compare staged ureteroscopy following initial urinary drainage and stabilization of renal functions using percutaneous nephrostomy or double J stent versus direct ureteroscopy without initial urinary drainage in the treatment of obstructive calcular anuria with acute renal failure due to ureteric calculi in children.

Official Title
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Staged Ureteroscopy After Initial Urinary Drainage Versus Direct Ureteroscopy in the Treatment of Pediatric Obstructive Calcular Anuria

Conditions
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Anuria, Acute Renal Failure, Obstructive Uropathy, Ureteric Stones

Intervention / Treatment
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* Procedure: initial urinary drainage
* Procedure: direct ureteroscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: children ≤12 years old presenting with Obstructive Anuria and Acute Renal Failure due to bilateral ureteric stones suitable for ureteroscopy. Exclusion Criteria: Fever, pyonephrosis or sepsis. unstable patients are stabilized first by dialysis.

Ages Eligible for Study
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Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: initial urinary drainage<br>initial urinary drainage to stabilize renal functions before ureteroscopy | Procedure: initial urinary drainage<br>* initial urinary drainage is done using nephrostomy or double J stent to stabilize renal functions. this is followed several days later by definitive ureteroscopy.<br>|
| Active Comparator: direct ureteroscopy<br>direct ureteroscopy without initial urinary drainage | Procedure: direct ureteroscopy<br>* direct ureteroscopy is done without initial urinary drainage and before return to normal chemistry. this is followed follow-up of renal functions for several days before treatment of the contralateral side.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to normal creatinine | period for return to normal creatinine in both groups | 1 week | 
| stone free status | success in removal of ureteric stones using ureteroscopy | 1 week | 
| operative and early post operative complications | Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ureteric stricture | occurrence of ureteric stricture as a delayed complication | 6 months | 
| period to reach stone free status bilaterally | period to reach stone free status bilaterally after the treatment of the contralateral side | 6 months | 
| number of times of exposure to general anesthesia | number of times of exposure to general anesthesia during successive interventions to clear stones bilaterally | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anuria, children, ureteroscopy, initial urinary drainage, ureteric stones