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临床试验/NCT07371494
NCT07371494已完成不适用

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

Hanoi Medical University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2024年1月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
72
试验地点
1
主要终点
Stone-free rate (SFR)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

SMP group

Experimental

干预措施: Super-mini Percutaneous Nephrolithotomy (Procedure)

fURS group

Experimental

干预措施: Flexible Ureteroscopy (Procedure)

结局指标

主要结局

Stone-free rate (SFR)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Hanoi Medical University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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