NCT07371494

Super-Mini Percutaneous Nephrolithotomy Versus Flexible Ureteroscopy for Renal Stones ≤20 mm: A Randomized Controlled Trial

SUPER-MINI PERCUTANEOUS NEPHROLITHOTOMY VERSUS FLEXIBLE URETEROSCOPY FOR RENAL STONES 20 MM OR LESS: A SINGLE-CENTER RANDOMIZED CONTROLLED TRIAL ASSESSING COST - ANALYSIS AND SAFETY IN NORTHERN VIETNAM

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Hanoi Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Kidney stones measuring 20 mm or less are commonly managed using minimally invasive surgical techniques. Two widely used approaches are Super-mini Percutaneous Nephrolithotomy (SMP) and Flexible Ureteroscopy (fURS). Although both techniques are considered effective and safe, they differ in surgical approach, use of disposable equipment, postoperative recovery, and treatment cost. In resource-limited settings, economic considerations may play an important role in treatment selection. This single-center randomized controlled trial was conducted at Bach Mai Hospital, Hanoi, Vietnam, to compare clinical outcomes, safety, and direct medical costs of SMP versus fURS in patients with renal stones ≤20 mm. Eligible patients were randomly assigned in a 1:1 ratio to undergo either SMP or fURS. The primary outcome was the stone-free rate assessed by postoperative imaging. Secondary outcomes included operative time, postoperative complications, length of hospital stay, hemoglobin drop, and total direct treatment cost per case. The results of this study aim to provide evidence to support clinical decision-making for the management of renal stones, particularly in healthcare settings with limited resources.

Conditions

• Renal Calculi (Kidney Stones) ≤ 20 mm

Interventions

Type	Name	Description
PROCEDURE	Super-mini Percutaneous Nephrolithotomy	Surgical removal of renal stones using super-mini PCNL technique
PROCEDURE	Flexible Ureteroscopy	Endoscopic treatment of renal stones using flexible ureteroscope

Timeline

• Start date: 2024-01-01
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2026-01-28
• Last updated: 2026-01-28

Locations

1 site across 1 country: Vietnam