Ureteral Stents Versus Percutaneous Nephrostomy for Initial Urinary Drainage

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2013-09-30

Brief Summary

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To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children

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Detailed Description

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To compare percutaneous nephrostomy (PCN) versus double J stent (JJ) as an initial urinary drainage in children with obstructive calcular anuria and acute renal failure due to ureteric calculi to identify selection criteria for initial urinary drainage method to improve drainage, to decrease complications and to facilitate subsequent definitive clearance of stones as this comparison is lacking in literature

Conditions

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Children Obstructive Uropathy Acute Renal Failure Ureteric Stones

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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percutaneous nephrostomy

percutaneous nephrostomy insertion (6-8 Fr in size) for initial urinary drainage followed by definitive stone management.

Group Type ACTIVE_COMPARATOR

percutaneous nephrostomy insertion

Intervention Type PROCEDURE

The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.

Definitive stone management

Intervention Type PROCEDURE

(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.

Bilateral double J ureteric stents

double J ureteric stent insertion (4.8-6 Fr JJ in size) for initial urinary drainage followed by definitive stone management.

Group Type ACTIVE_COMPARATOR

bilateral double J ureteric stent

Intervention Type PROCEDURE

The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.

Definitive stone management

Intervention Type PROCEDURE

(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.

Interventions

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percutaneous nephrostomy insertion

The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.

Intervention Type PROCEDURE

bilateral double J ureteric stent

The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.

Intervention Type PROCEDURE

Definitive stone management

(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.

Intervention Type PROCEDURE

Other Intervention Names

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PCN insertion nephrostomy insertion JJ DSM

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

Exclusion Criteria

* Patients with grade 0-1 hydronephrosis
* fever, pyonephrosis or sepsis.
* any contraindication to both methods of drainage (urinary diversion, urethral stricture or uncontrolled coagulopathy).

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No