Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children

South Valley University

Status: Unknown

Conditions: Ureter Obstruction

Treatments: Procedure: deferred ureteroscopy URS; Procedure: Primary ureterscopy URS

Study type: Interventional

Funder types: Other

Identifiers

NCT04980079

calculus anuria in children

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 1 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

group A -undergo primary ureteroscopy URS

Active Comparator group

Description:

Thirty children with calicular anuria will undergo primary ureteroscopy URS

Treatment:

Procedure: Primary ureterscopy URS

the group B(30 patients) will undergo deferred ureteroscopy URS

Active Comparator group

Description:

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

Treatment:

Procedure: deferred ureteroscopy URS