Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children

Ureter Obstruction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04980079
• Other study ID #: calculus anuria in children
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: December 30, 2021

Study information

• Verified date: July 2021
• Source: South Valley University
• Contact: mostafa mostafa, B.sc
• Phone: 01069432827
• Email: mostafaalsoghier[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 30, 2021
• Est. primary completion date: November 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Calculi
• Ureter Obstruction
• Ureteral Obstruction

Intervention

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
• deferred ureteroscopy URS
insertion of a double -J stent or percutaneous nephrostomy (PCN) at first , then a deferred ureteroscopy URS will be done .

Locations

Country	Name	City	State
Egypt	Mostafa	Luxor

Sponsors (1)

Lead Sponsor	Collaborator
South Valley University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	renal function	improvement in creatinine level mg/dl urea level mg/dl	one month .
Secondary	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