NCT06579924尚未招募不适用
Re-usable Versus Disposable Rigid Nephroscope During Mini-PCNLs When Treating Large-burden Kidney Stones: an Feasibility Randomised Controlled Trial
The First Affiliated Hospital of Guangzhou Medical University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Stone free rate
研究概览
简要总结
A feasibility randomised controlled trials comparing re-usable versus disposable nephroscope when treating kidney stones during mini-PCNLs
详细描述
Study Participants Patients undergoing minimally-invasive PCNLs with intention to treat renal low- to medium-burden renal stones.
Inclusion Criteria
- Patients undergoing mini PCNL to treat renal stones with a cumulative stone diameter 2-5 cm and completing at least a 3 month's follow-up
- Cases performed by surgeons beyond their learning curves
- Patients aged > 18
- Unenhanced CT scan carried out within 3 months pre-operatively
- Post-operative follow-up carried out according to our study protocol, with NCCT carried out within 2-3 months after surgery
- ASA 1-2
- Patients with normal weight (BMI: 18-25)
- Participant is willing and able to give informed consent to the proposed surgical treatment and agreeing to be enrolled in the study.
Exclusion Criteria
The participant may not enter the study if ANY of the following apply:
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 (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing mini PCNL to treat renal stones with a cumulative stone diameter 2-5 cm and completing at least a 3 month's follow-up
- •Cases performed by surgeons beyond their learning curves
- •Patients aged > 18
- •Unenhanced CT scan carried out within 3 months pre-operatively
- •Post-operative follow-up carried out according to our study protocol, with NCCT carried out within 2-3 months after surgery
- •Patients with normal weight (BMI: 18-25)
- •Participant is willing and able to give informed consent to the proposed surgical treatment and agreeing to be enrolled in the study.
排除标准
- •Contraindications to surgical treatment
- •PCNL performed for proximal ureteric stones
- •Urinary tract with abnormal anatomy
- •Obese patients
- •Patients with pyonephrosis
- •Patients on anticoaugulants
- •Preoperative CT scan not within 3 months before surgery
- •Pregnant patients
- •Patients younger than 18 years of age
结局指标
主要结局
Stone free rate
时间窗: 90 days post-op
ability of used scope in determining a complete stone clearance, or absence of clinically significant residual fragments
次要结局
- complication rate(30 days post-op)
- adequacy of used instrument(intra-operative assessment)
研究者
Guohua Zeng
Professor
The First Affiliated Hospital of Guangzhou Medical University
研究点 (1)
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