Comparison of Total Tubeless Mini-PCNL Versus Tubeless Mini-PCNL : A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL
研究概览
简要总结
Limited literature has focused on the use of totally tubeless mini-percutaneous nephrolithotomy (Mini-PCNL) for the treatment of large renal stones.
This Randomized Controlled trial aims to compare complication and safety of Mini-PCNL between total tubeless and tubeless Mini-PCNL.
详细描述
After being informed about study and potential risks, all patient giving written informed consent with undergo a mini-PCNL operation. Patient who meet the eligibility requirements will be randomized in a single-blind manner (patient) in a 1:1 ratio to total tubeless mini-PCNL or tubeless mini-PCNL.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
盲法说明
All eligible patients will be provided with an explanation of the research and invited to participate.
Patient will participate or not depends on whether they not meet the surgical exclusion criteria. If they meet the criteria, they will not participate in the research. If they not meet the criteria, they will be randomly assigned to one of the groups.
Patients will not be informed of the treatment intervention in advance
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
- •Patients diagnosed with kidney stones with a size ranging from 20 to 40 millimeters.
- •Patients have undergone mini-PCNL, unilateral
- •Absence of urinary tract infections before surgery.
- •No urological congenital abnormality
- •No coagulopathy
排除标准
- •Presence of residual stones after the surgery, fragments larger than 4 millimeters.
- •Patients with a single functioning kidney
- •Complicated cases, including:
- •massive bleeding in the upper tract during surgery
- •Severe collecting systems injury during surgery
- •Severe UPJ mucosa swelling considered unsafe by the physician, requiring the placement of a DJ stent or nephostomy tube
- •Participants who decline or request withdrawal from the research study.
结局指标
主要结局
incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL
时间窗: from post operative day 0 to day 45
The main objective is to study the incidence of complications between total tubeless mini-pcnl and tubeless mini-PCNL
次要结局
- The secondary objective is to assess the surgical outcomes between total tubeless mini-pcnl and tubeless mini-PCNL(from post operative day 0 to day 45)
研究者
Thanakorn Sirajarus
Principal Investigator
Mahidol University