Delayed or Direct Ureteroscopy in the Treatment of Pediatric Calcular Anuria

NCT ID: NCT02139059

Last Updated: 2015-02-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Acute Renal Failure; Anuria; Obstructive Uropathy; Ureteric Stones

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

initial urinary drainage

initial urinary drainage to stabilize renal functions before ureteroscopy

Group Type: ACTIVE_COMPARATOR

initial urinary drainage

Intervention Type: 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

direct ureteroscopy without initial urinary drainage

Group Type: ACTIVE_COMPARATOR

direct ureteroscopy

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

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.

• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

mohammed said elsheemy

Associte professor of urology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammed S ElSheemy, A professor

Role: PRINCIPAL_INVESTIGATOR

Cairo University

Locations

Cairo University Hospitals

Cairo, , Egypt

Site Status: RECRUITING

Cairo University Hospitals

Cairo, , Egypt

Site Status: NOT_YET_RECRUITING

Countries

Egypt

Central Contacts

Mohammed S ElSheemy, A Professor

Role: CONTACT

mohammedshemy@yahoo.com

01006117755

Other Identifiers

61179

Identifier Type: -

Identifier Source: org_study_id