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Completed

NCT Number: NCT07371494

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

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult patients (≥18 years of age).
  • Patients with renal stones measuring ≤20 mm in maximal diameter on preoperative imaging.
  • No prior surgical or interventional procedure during the same hospital admission.
  • Ability and willingness to provide written informed consent.

Exclusion criteria

  • Pregnancy.
  • Coagulation disorders or bleeding diathesis contraindicating surgery.
  • Contraindications to either Super-mini Percutaneous Nephrolithotomy (SMP) or Flexible Ureteroscopy (fURS).
  • Patients undergoing SMP or fURS for ureteral stones that migrated back into the kidney.

Treatment and study plan

Super-Mini Percutaneous Nephrolithotomy

Procedure

Surgical removal of renal stones using super-mini PCNL technique

flexible ureteroscopy

Procedure

Endoscopic treatment of renal stones using flexible ureteroscope

Primary outcomes

  1. Stone-free rate (SFR)

    Time frame: 1 month after surgery

    Stone-free rate was defined as the absence of residual stone fragments >4 mm in maximal diameter on postoperative imaging. Stone-free status was assessed using plain abdominal radiography (KUB) on postoperative day 1 and non-contrast computed tomography (CT) at 1 month after surgery. The stone-free rate was determined based on the 1-month CT findings.

Sponsors and collaborators

Lead sponsor

Hanoi Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 28, 2026
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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