Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children

Primary Versus Deferred Ureteroscopy for Management of Calculus Anuria in Children: A Prospective Randomized Study

To evaluate the role of both primary and deferred URS in the management of calculus anuria concerning the feasibility, clinical outcome, and cost-effectiveness in children in a comparative study

Study Overview

• Status: Recruiting
• Conditions: Ureter Obstruction
• Intervention / Treatment: Procedure: Primary ureterscopy URS; Procedure: deferred ureteroscopy URS

Detailed Description

Thirty group B (30) patients will be admitted to do urinary drainage through the insertion of a JJ stent or percutaneous nephrostomy (PCN) at first , then a deferred URS will be done children will undergo primary URS( group A ) and in. Ureteral dilatation will be done when the stone size exceeds 10 mm to facilitate the extraction of the fragments. Ureteroscopic lithotripsy will be done using a 6.5:7.5 Fr semi-rigid ureteroscope and holmium laser. The ureteric stent will last for one week after lithotripsy. Postoperatively, the patients in both groups will monitored for post obstructive diuresis, fever, hematuria, and extent of renal function improvement.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mostafa Mostafa, B.sc; Phone Number: 01069432827; Email: mostafaalsoghier@yahoo.com

Study Locations

• Egypt
  • Luxor, Egypt, 85951
    • Recruiting
    • Mostafa
    • Contact: Mostafa Mostafa, B.sc; Phone Number: 01069432827; Email: mostafaalsoghier@yahoo.com
    • Contact: asmaa mostafa, MD; Phone Number: 010144437474; Email: lalamohamed@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Children ˂12 years with calculus anuria.
• Clinically stable (serum creatinine < 3.5 mg/dl, blood urea < 100 mg/dl,serum potassium level < 7 milliequivalent /L and /or ph of blood > 7.1)
• All the patients free of sepsis.

Exclusion Criteria:

• Unstable children (serum creatinine ≥ 3.5 mg/dl, blood urea ≥ 100 mg/dl, serum potassium ≥ 7 milliequivalent/l, and/or blood pH ≤ 7.1, signs of acidosis, sepsis, or fluid retention).
• Children with underlying urological structural abnormalities

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: group A -undergo primary ureteroscopy URS; Thirty children with calicular anuria will undergo primary ureteroscopy URS	Procedure: Primary ureterscopy URS; Ureteral dilatation will be done when the stone size exceeds 10 mm to facilitate the extraction of the fragments. Ureteroscopic lithotripsy will be done using a 6.5:7.5 Fr semi-rigid ureteroscope and holmium laser. The ureteric stent will last for one week after lithotripsy; Other Names: URSureteroscopy
Active Comparator: the group B(30 patients) will undergo deferred ureteroscopy URS; group B (30) patients will be admitted to do urinary drainage through the insertion of a double-J stent or percutaneous nephrostomy (PCN) at first , then a deferred ureteroscopy URS will be done	Procedure: deferred ureteroscopy URS; insertion of a double -J stent or percutaneous nephrostomy (PCN) at first , then a deferred ureteroscopy URS will be done .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
renal function	improvement in creatinine level mg/dl urea level mg/dl	one month .

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the stone-free rates	The clinical outcomes of the procedures including the perioperative complications : of perforation; of infection; of residual stones; of the stone-free rates	one month

Collaborators and Investigators

• Sponsor: South Valley University
• Investigators: Study Director: Mostafa abdelrazek, MD, SVU

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Anticipated): November 15, 2021
• Study Completion (Anticipated): December 30, 2021

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: July 17, 2021
• First Posted (Actual): July 28, 2021

Study Record Updates

• Last Update Posted (Actual): July 28, 2021
• Last Update Submitted That Met QC Criteria: July 17, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Ureteral Diseases; Calculi; Ureteral Obstruction
• Other Study ID Numbers: calculus anuria in children

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No