Lumbar Drain After Endoscopic Surgery of the Skull Base
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Number of Participants With Cerebrospinal Fluid (CSF) Leak
研究概览
简要总结
The overall purpose of this study was to assess the necessity of lumbar drain placement after endoscopic endonasal approach (EEA) surgery in reducing cerebrospinal fluid (CSF) leak postoperatively and promote a standardization of its use.
详细描述
In the past, reconstructions were performed using fat grafts or fascia lata for EEA surgery. Considerably high postoperative CSF leaks were reported and were a major cause of concern due CSF fistula increasing risk of infection. Since external lumbar drain can lower CSF pressure and is believed to prevent post operative CSF leak, it was used commonly after EEA. With improvements in EEA skull base reconstructions using a nasal septal flap in the recent years, postoperative CSF leaks have been reported in much lower rates. With this improvement in reconstruction techniques, the use of lumbar drain may not be necessary as it may not significantly lower the risk of CSF leak further. In this prospective randomized study, we will randomize subjects at high risk for CSF leak to either receive a prophylactic lumbar drain or to not receive a prophylactic lumbar drain and compare the rate of CSF leaks and other complications in the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •18 years of age or older
- •Patients undergoing EEA for resection of brain tumors
- •Dural defect greater than 1cm
- •Extensive arachnoid dissection
- •Dissection into a ventricle or cistern
排除标准
- •Less than 18 years of age
- •Spina Bifida
研究组 & 干预措施
No Lumbar Drain Group
Group of patients that did not receive a lumbar drain after surgery
Lumbar Drain Group
Group of patients that received a lumbar drain after surgery
干预措施: Lumbar Drain (Device)
结局指标
主要结局
Number of Participants With Cerebrospinal Fluid (CSF) Leak
时间窗: 1month
Determine the rate of CSF leak in endoscopic endonasal approach (EEA) patients who received lumbar drain placement and EEA patients who did not receive lumbar drain placement.
次要结局
- Number of Participants With Postoperative Complications(1 year)
研究者
Paul Gardner
Associate Professor
University of Pittsburgh
