Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

Acute Renal Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02139059
• Other study ID #: 61179
• Status: Recruiting
• Phase: N/A
• First received: May 13, 2014
• Last updated: February 2, 2015
• Start date: June 2014
• Est. completion date: December 2015

Study information

• Verified date: February 2015
• Source: Cairo University
• Contact: Mohammed S ElSheemy, A Professor
• Phone: 01006117755
• Email: mohammedshemy[@]yahoo.com
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 12 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Anuria
• Obstructive Uropathy
• Ureteral Calculi
• Ureteric Stones
• Ureterolithiasis

Intervention

Procedure:
• initial urinary drainage
initial urinary drainage is done using nephrostomy or double J stent to stabilize renal functions. this is followed several days later by definitive ureteroscopy.
• direct ureteroscopy
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.

Locations

Country	Name	City	State
Egypt	Cairo University Hospitals	Cairo
Egypt	Cairo University Hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Return to normal creatinine	period for return to normal creatinine in both groups	1 week	Yes
Primary	stone free status	success in removal of ureteric stones using ureteroscopy	1 week	No
Primary	operative and early post operative complications	Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever	1 week	Yes
Secondary	ureteric stricture	occurrence of ureteric stricture as a delayed complication	6 months	Yes
Secondary	period to reach stone free status bilaterally	period to reach stone free status bilaterally after the treatment of the contralateral side	6 months	No
Secondary	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	Yes