Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

NCT02139059 — Not applicable, Unknown, 50 participants, Cairo University

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

Registry	NCT02139059
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	50 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Acute Renal Failure, Anuria, Obstructive Uropathy, Ureteric Stones
Interventions	initial urinary drainage, direct ureteroscopy (Procedure)
Dates	start 2014-06-01, primary completion 2015-08-01 (estimated), completion 2015-12-01 (estimated), first posted 2014-05-15, last updated 2015-02-03
Locations	2 sites in Egypt

-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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
initial urinary drainage	Active comparator	Procedure: initial urinary drainage	initial urinary drainage to stabilize renal functions before ureteroscopy
direct ureteroscopy	Active comparator	Procedure: direct ureteroscopy	direct ureteroscopy without initial urinary drainage

initial urinary drainage (Procedure): 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 (Procedure): 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.

+Outcome measures

Primary outcomes

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

Secondary outcomes

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

+Eligibility

Sex: All, ages: any to 12 Years

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.

+Locations (2)

Facility	City	Country	Status
Cairo University Hospitals	Cairo	Egypt	Recruiting
Cairo University Hospitals	Cairo	Egypt	Not yet recruiting

+Investigators

Mohammed S ElSheemy, A professor, Principal investigator, Cairo University