Single-center Randomized Study to Evaluate the Safety and Effectiveness of Direct Puncture of the Caliceal System in Minipercutaneous Nephrolithotripsy (Mini-PCNL)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Body pain
研究概览
简要总结
- A single-center randomized study to evaluate the safety and effectiveness of direct puncture of the caliceal system in mini-percutaneous nephrolithotripsy.
- 60 patients
- Inclusion criteria:
- all patients aged 18 to 70 years who are planning mini-PCNL, ready to consent to the study
- ASA scale 1-3
- Solitary stone up to 2.5 cm
- Single access to the caliceal system
- Exclusion criteria:
- Active infectious process
- Coagulopathies
- Abnormalities of the urinary system
详细描述
All patients will be randomized into 2 groups:
Direct puncture - patients who underwent directive puncture under ultrasound or Rg control. The number of patients is 30 people.
Non-direct puncture - patients who underwent a PCS puncture with retrograde contrast. The number of patients is 30 people.
Patients will be assigned a randomization number that matches their treatment. Block randomization using 10 blocks will be performed by a central randomization organization (www.randomize.net) using a computerized algorithm.
Primary assessed indicators:
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 to 70 years who are scheduled for mini-PCNL, ready to consent to the study
- •ASA scale 1-3
- •Solitary kidney stone up to 2.5 cm
- •One access to the caliceal system
排除标准
- •Active infectious process
- •Coagulopathies
- •Abnormalities of the urinary system
结局指标
主要结局
Body pain
时间窗: 24 hours after operation
Using the Visual Analogue Pain Scale (VAS), pain assessment is planned at 2 hours, 6 hours, 12 hours and 24 hours after surgery
Number of patients with successful direct puncture
时间窗: during the operation (mini-PCNL)
Evaluation of efficacy
Purity of a visual intraoperative field
时间窗: during the operation (mini-PCNL)
Excellent, Moderate, Poor visualization
Puncture duration
时间窗: during the operation (mini-PCNL)
Measurement of puncture duration (in seconds)
次要结局
未报告次要终点