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Clinical Efficacy of Mini-PCNLversus RIRS for the Management of Upper Urinary Tract Calculus (1-2.5 cm)

A

Ain Shams University

Status

Completed

Conditions

Stone, Kidney

Treatments

Procedure: mini-PCNL procedure
Procedure: RIRS procedure

Study type

Interventional

Funder types

Other

Identifiers

NCT06031103
Pediatric renal stones

Details and patient eligibility

About

The goal of this [ type of study:]prospective randomized clinical trial. The main question is to compare the outcomes of mini-percutaneous nephrolithotomy (m-PCNL) and retrograde intrarenal surgery (RIRS) in treating upper urinary tract calculus in children ≤ 10 years.

Full description

With the increase in morbidity and incidence of pediatric kidney stone disease, childhood urolithiasis has become a significant health problem worldwide, especially in developing countries. Children with urinary calculi are at high risk for recurrent stone formation and may require multiple surgical interventions.

In recent decades, with the improvement of miniaturization of surgical equipment, the management of pediatric kidney stone disease has changed dramatically. As a result of these improvements, minimally invasive techniques, such as percutaneous nephrolithotomy (PCNL) and retrograde intrarenal surgery (RIRS) are alternative treatment options for children with upper urinary tract calculus.

Extracorporeal shock wave lithotripsy (ESWL) has been used for the treatment of upper urinary tract calculus < 2 cm. but, The significantly lower stone-free rates (SFR) of SWL as compared to the PCNL and RIRS, requirement for anesthesia, the possibility of parenchymal damage to the growing kidney and the need for additional sessions are the significant limitations of SWL

Mini-percutaneous nephrolithotomy (Mini-PCNL) is an adjustment of the standard PCNL procedure after the development of small-caliber instruments that has several advantages such as a smaller skin incision, smaller tract size, and less bleeding. However, mini-PCNL may cause severe complications because of fragile parenchyma, small caliber collecting system, and mobile kidney in pediatric patients.

with the persistent advancement of endoscopic instruments and flexible ureteroscope, the examination of the upper urinary tract has become more feasible, and retrograde intrarenal surgery (RIRS) can effectively compete with PCNL. However, the outcomes of the use of flexible ureteroscope in the pediatric population such as the risk of ureteral injury, stone-free rate especially in large stones (more than 2 cm), need for the ancillary procedure, the need to indwell double-J stent in advance and high cost of instrument and maintenance remain largely unknown, resulting in controversy about the clinical safety and efficacy of PCNL and RIRS in the treatment of upper urinary tract calculus.

In the current study, the investigators aimed to compare RIRS and mini-PCNL by evaluating The operative and postoperative outcomes for children ≤10 years of age with upper urinary tract calculus (1-2.5 cm).

Enrollment

60 patients

Sex

All

Ages

1 month to 10 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • This study will include all children (age < 10 years) who undergo Mini-PCNL or RIRS with stone size (1_2.5 cm) for upper urinary tract stones

Exclusion criteria

  • Children with urinary tract infections until treated
  • Children with ureteral stricture
  • Congenital urological anomalies
  • Previous urological surgery

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups

childhood urolithiasis treated with mini PCNL Procedure
Active Comparator group
Description:
pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure
Treatment:
Procedure: mini-PCNL procedure
childhood urolithiasis treated with RIRS Procedure
Active Comparator group
Description:
pediatric patients with upper urinary tract calculus treated with mini-PCNL procedure
Treatment:
Procedure: RIRS procedure

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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