Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

February 2, 2015 updated by: mohammed said elsheemy, Cairo University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12222
        • Recruiting
        • Cairo University Hospitals
        • Principal Investigator:
          • Mohammed S ElSheemy, A Professor
      • Cairo, Egypt, 12222
        • Not yet recruiting
        • Cairo University Hospitals

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ureteric stricture
Time Frame: 6 months
occurrence of ureteric stricture as a delayed complication
6 months
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
6 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2014

Primary Completion (Anticipated)

August 1, 2015

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

May 13, 2014

First Submitted That Met QC Criteria

May 14, 2014

First Posted (Estimate)

May 15, 2014

Study Record Updates

Last Update Posted (Estimate)

February 3, 2015

Last Update Submitted That Met QC Criteria

February 2, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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