Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

Not Applicable

• Conditions: Acute Renal Failure; Obstructive Uropathy; Anuria; Ureteric Stones
• Interventions: Procedure: initial urinary drainage; Procedure: direct ureteroscopy

• Registration Number: NCT02139059
• Lead Sponsor: Cairo University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-14
• Study First Posted: 2014-05-15
• Study Start: 2014-06
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-02
• Last Update Posted: 2015-02-03
• Primary Completion: 2015-08
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
initial urinary drainage	initial urinary drainage	initial urinary drainage to stabilize renal functions before ureteroscopy
direct ureteroscopy	direct ureteroscopy	direct ureteroscopy without initial urinary drainage

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cairo University Hospitals; 🇪🇬 Cairo, Egypt