The 18F Peel-way Sheath Versus the 18F Access Sheath With a Suction-evacuation Function MPCNL for the Management of 2-5cm Size Kidney Stones
2017年6月29日 更新者：Guohua Zeng、The First Affiliated Hospital of Guangzhou Medical University
The 18F Peel-way Sheath Versus the 18F Access Sheath With a Suction-evacuation Function MPCNL for the Management of 2-5cm Size Kidney Stones: A Randomized Controlled Trial
Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of >20mm kidney stones.
Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications.
At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on.
But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness.
Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.
研究概览
详细说明
Percutaneous nephrolithotomy (PNL) has been considered as the first-line choice for the management of >20mm kidney stones.
Microchannel percutaneous nephrolithotomy (Mini PCNL) which takes nephrolithotomy channel size less than or equal to 18, was first used in the treatment of children with kidney stones in 1997, then gradually applied to adult, aims to achieve the similar stone clearance rate as the standard channels, at the same time, reduce the complications.
At present, the use of percutaneous renal surgery in our country is more than 18F plastic peel-away sheath, with the access sheath with a suction-evacuation function was first used by Guohua Zeng and so on.
But there is still a lack of high quality evidence of Evidence-based medical evidence to compare the two kinds of sheath for the safety and effectiveness.
Therefore, this study provides a reliable theoretical basis for the choice of the sheath for the treatment of 2-5cm size Kidney, and ultimately benefit patients with 20mm.
研究类型
介入性
注册 (预期的)
86
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Guangdong
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Guangzhou、Guangdong、中国、510230
- 招聘中
- epartment of Urology, Minimally Invasive Surgery Center, The First Affiliated Hospital of Guangzhou Medical University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients consent for percutaneous renal stone removal
- Age 18 to 70 years
- Normal renal function
- ASA score Ⅰ and Ⅱ
- Renal stones 20-50mm
Exclusion Criteria:
- Patients with solitary kidney
- Uncorrected coagulopathy and active urinary tract infection (UTI)
- Morbid obese patients
- Patients who underwent transplant or urinary diversion
- Congenital abnormalities
- Patients will be excluded from the study if the undergoing standard PNL/mini-perc have purulent fluid in the initial puncture
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他：Group 1
Patients in Group 1 undergo Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath group
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Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath
|
|
其他：Group 2
Patients in Group 2 undergo Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function group
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Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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The renal pelvic pressure
大体时间：During the procedure
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To measure the renal pelvic pressure during mini-PCNL procedure
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During the procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Perioperative complications
大体时间：Intraoperatively or ≤ 1 month postoperatively
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Invaluate perioperative complications by modified Clavien system
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Intraoperatively or ≤ 1 month postoperatively
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2016年1月1日
初级完成 (预期的)
2017年12月1日
研究完成 (预期的)
2017年12月1日
研究注册日期
首次提交
2016年10月27日
首先提交符合 QC 标准的
2017年6月29日
首次发布 (实际的)
2017年7月2日
研究记录更新
最后更新发布 (实际的)
2017年7月2日
上次提交的符合 QC 标准的更新
2017年6月29日
最后验证
2017年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
18F Peel-Way Sheath的临床试验
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Children's Oncology GroupNational Cancer Institute (NCI)招聘中