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Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

Primary Purpose

Acute Renal Failure, Anuria, Obstructive Uropathy

Status

Unknown status

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

initial urinary drainage

direct ureteroscopy

About this trial

This is an interventional treatment trial for Acute Renal Failure focused on measuring anuria, children, ureteroscopy, initial urinary drainage, ureteric stones

Eligibility Criteria

undefined - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Cairo University HospitalsRecruiting
Cairo University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

initial urinary drainage

direct ureteroscopy

Arm Description

initial urinary drainage to stabilize renal functions before ureteroscopy

direct ureteroscopy without initial urinary drainage

Outcomes

Primary Outcome Measures

Return to normal creatinine

period for return to normal creatinine in both groups

stone free status

success in removal of ureteric stones using ureteroscopy

operative and early post operative complications

Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever

Secondary Outcome Measures

ureteric stricture

occurrence of ureteric stricture as a delayed complication

period to reach stone free status bilaterally

period to reach stone free status bilaterally after the treatment of the contralateral side

number of times of exposure to general anesthesia

number of times of exposure to general anesthesia during successive interventions to clear stones bilaterally

Full Information

NCT ID

NCT02139059

First Posted

May 13, 2014

Last Updated

February 2, 2015

Sponsor

Cairo University

1. Study Identification

Unique Protocol Identification Number

NCT02139059

Brief Title

Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

June 2014 (undefined)

Primary Completion Date

August 2015 (Anticipated)

Study Completion Date

December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cairo University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Renal Failure, Anuria, Obstructive Uropathy, Ureteric Stones

Keywords

anuria, children, ureteroscopy, initial urinary drainage, ureteric stones

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

initial urinary drainage

Arm Type

Active Comparator

Arm Description

initial urinary drainage to stabilize renal functions before ureteroscopy

Arm Title

direct ureteroscopy

Arm Type

Active Comparator

Arm Description

direct ureteroscopy without initial urinary drainage

Intervention Type

Procedure

Intervention Name(s)

initial urinary drainage

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

direct ureteroscopy

Intervention Description

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 Measure Information:

Title

Return to normal creatinine

Description

period for return to normal creatinine in both groups

Time Frame

1 week

Title

stone free status

Description

success in removal of ureteric stones using ureteroscopy

Time Frame

1 week

Title

operative and early post operative complications

Description

Hematuria, Extravasation (perforation), mucosal complications, stone migration, failure of ureteric access, fever

Time Frame

1 week

Secondary Outcome Measure Information:

Title

ureteric stricture

Description

occurrence of ureteric stricture as a delayed complication

Time Frame

6 months

Title

period to reach stone free status bilaterally

Description

period to reach stone free status bilaterally after the treatment of the contralateral side

Time Frame

6 months

Title

number of times of exposure to general anesthesia

Description

number of times of exposure to general anesthesia during successive interventions to clear stones bilaterally

Time Frame

6 months

10. Eligibility

Sex

All

Maximum Age & Unit of Time

12 Years

Accepts Healthy Volunteers

Eligibility 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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mohammed S ElSheemy, A Professor

Phone

01006117755

mohammedshemy@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mohammed S ElSheemy, A professor

Organizational Affiliation

Cairo University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cairo University Hospitals

City

Cairo

ZIP/Postal Code

12222

Country

Egypt

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mohammed S ElSheemy, A Professor

Facility Name

Cairo University Hospitals

City

Cairo

ZIP/Postal Code

12222

Country

Egypt

Individual Site Status

Not yet recruiting

12. IPD Sharing Statement

Learn more about this trial

Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

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