Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children

NCT04980079 | Unknown

• 1 other identifier: calculus anuria in children
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Ureter Obstruction

Outcome Measures

Primary Outcomes (1)

• renal function

  improvement in creatinine level mg/dl urea level mg/dl

  one month .

Secondary Outcomes (1)

• the stone-free rates

  one month

Study Arms (2)

group A -undergo primary ureteroscopy URS

ACTIVE COMPARATOR

Thirty children with calicular anuria will undergo primary ureteroscopy URS

Procedure: Primary ureterscopy URS

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

ACTIVE COMPARATOR

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

Interventions

Primary ureterscopy URS PROCEDURE

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

Also known as: URSureteroscopy

group A -undergo primary ureteroscopy URS

deferred ureteroscopy URS PROCEDURE

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

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

Eligibility Criteria

• Age: 1 Year - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Mostafa

Luxor, 85951, Egypt

RECRUITING

MeSH Terms

Conditions

Ureteral Obstruction

Condition Hierarchy (Ancestors)

Ureteral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mostafa abdelrazek, MD

  SVU

  STUDY DIRECTOR

Central Study Contacts

mostafa mostafa, B.sc

CONTACT

01069432827; mostafaalsoghier@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: July 28, 2021
• Study Start: April 1, 2021
• Primary Completion: November 15, 2021
• Study Completion: December 30, 2021
• Last Updated: July 28, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)