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

NCT07371494 | Completed

• 1 other identifier: No. 876/GCN-HĐĐĐNCYSH-ĐHYHN
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Stone-free rate (SFR)

  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.

  1 month after surgery

Study Arms (2)

SMP group

EXPERIMENTAL

Procedure: Super-mini Percutaneous Nephrolithotomy

fURS group

EXPERIMENTAL

Procedure: Flexible Ureteroscopy

Interventions

Super-mini Percutaneous Nephrolithotomy PROCEDURE

Surgical removal of renal stones using super-mini PCNL technique

SMP group

Flexible Ureteroscopy PROCEDURE

Endoscopic treatment of renal stones using flexible ureteroscope

fURS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hanoi Medical University: lead

Study Sites (1)

Bach Mai Hospital, Department of Urology

Hanoi, 100000, Vietnam

Location

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2026
• First Posted: January 28, 2026
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 28, 2026

Record last verified: 2026-01

Locations

VN (1)