Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children

Not Applicable

• Conditions: Ureter Obstruction
• Interventions: Procedure: Primary ureterscopy URS; Procedure: deferred ureteroscopy URS

• Registration Number: NCT04980079
• Lead Sponsor: South Valley University

Brief Summary

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

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 Timeline

• Study Start: 2021-04-01
• Status Verified: 2021-07
• Study First Submitted: 2021-07-14
• Study First Submitted QC: 2021-07-17
• Last Update Submitted: 2021-07-17
• Study First Posted: 2021-07-28
• Last Update Posted: 2021-07-28
• Primary Completion: 2021-11-15
• Study Completion: 2021-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A -undergo primary ureteroscopy URS	Primary ureterscopy URS	Thirty children with calicular anuria will undergo primary ureteroscopy URS
the group B(30 patients) will undergo deferred ureteroscopy URS	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

Primary Outcome Measures

Name	Time	Method
renal function	one month .	improvement in creatinine level mg/dl urea level mg/dl

Secondary Outcome Measures

Name	Time	Method
the stone-free rates	one month	The clinical outcomes of the procedures including the perioperative complications : * of perforation; * of infection; * of residual stones; * of the stone-free rates

Trial Locations

Locations (1)

Mostafa; 🇪🇬 Luxor, Egypt