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Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

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ClinicalTrials.gov Identifier: NCT02139059
Recruitment Status : Unknown
Verified February 2015 by mohammed said elsheemy, Cairo University.
Recruitment status was:  Recruiting
First Posted : May 15, 2014
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):
mohammed said elsheemy, 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.

Condition or disease Intervention/treatment Phase
Acute Renal Failure Anuria Obstructive Uropathy Ureteric Stones Procedure: initial urinary drainage Procedure: direct ureteroscopy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Staged Ureteroscopy After Initial Urinary Drainage Versus Direct Ureteroscopy in the Treatment of Pediatric Obstructive Calcular Anuria
Study Start Date : June 2014
Estimated Primary Completion Date : August 2015
Estimated Study Completion Date : December 2015

Arm Intervention/treatment
Active Comparator: initial urinary drainage
initial urinary drainage to stabilize renal functions before ureteroscopy
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.

Active Comparator: direct ureteroscopy
direct ureteroscopy without initial urinary drainage
Procedure: 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.




Primary Outcome Measures :
  1. Return to normal creatinine [ Time Frame: 1 week ]
    period for return to normal creatinine in both groups

  2. stone free status [ Time Frame: 1 week ]
    success in removal of ureteric stones using ureteroscopy

  3. operative and early post operative complications [ Time Frame: 1 week ]
    Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever


Secondary Outcome Measures :
  1. ureteric stricture [ Time Frame: 6 months ]
    occurrence of ureteric stricture as a delayed complication

  2. period to reach stone free status bilaterally [ Time Frame: 6 months ]
    period to reach stone free status bilaterally after the treatment of the contralateral side

  3. number of times of exposure to general anesthesia [ Time Frame: 6 months ]
    number of times of exposure to general anesthesia during successive interventions to clear stones bilaterally



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Ages Eligible for Study:   up to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139059


Contacts
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Contact: Mohammed S ElSheemy, A Professor 01006117755 mohammedshemy@yahoo.com

Locations
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Egypt
Cairo University Hospitals Recruiting
Cairo, Egypt, 12222
Principal Investigator: Mohammed S ElSheemy, A Professor         
Cairo University Hospitals Not yet recruiting
Cairo, Egypt, 12222
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Mohammed S ElSheemy, A professor Cairo University
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Responsible Party: mohammed said elsheemy, Associte professor of urology, Cairo University
ClinicalTrials.gov Identifier: NCT02139059    
Other Study ID Numbers: 61179
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015
Keywords provided by mohammed said elsheemy, Cairo University:
anuria
children
ureteroscopy
initial urinary drainage
ureteric stones
Additional relevant MeSH terms:
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Acute Kidney Injury
Ureteral Calculi
Ureterolithiasis
Anuria
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Ureteral Diseases
Urolithiasis
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Urination Disorders