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Primary Versus Deferred Ureteroscopy for Calculus Anuria in Children

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04980079
Enrollment
60
Registered
2021-07-28
Start date
2021-04-01
Completion date
2021-12-30
Last updated
2021-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ureter Obstruction

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.

Interventions

PROCEDUREPrimary 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

PROCEDUREdeferred ureteroscopy URS

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

Sponsors

South Valley University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
1 Years to 12 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
renal functionone month .improvement in creatinine level mg/dl urea level mg/dl

Secondary

MeasureTime frameDescription
the stone-free ratesone monthThe clinical outcomes of the procedures including the perioperative complications : * of perforation * of infection * of residual stones * of the stone-free rates

Countries

Egypt

Contacts

Primary Contactmostafa mostafa, B.sc
mostafaalsoghier@yahoo.com01069432827

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026