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