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临床试验/NCT03163134
NCT03163134终止不适用

Lumbar Drain After Endoscopic Surgery of the Skull Base

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2011年2月3日最近更新:
适应症
干预措施

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

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

No Intervention

Group of patients that did not receive a lumbar drain after surgery

Lumbar Drain Group

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paul Gardner

Associate Professor

University of Pittsburgh

研究点 (2)

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