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临床试验/NCT04784169
NCT04784169Unknown不适用

Free Middle Turbinate Flap for Repair of Low Flow Cerebrospinal Fluid Leak

Wuhan Union Hospital, China1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2021年4月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Number of Participants With Cerebrospinal Fluid (CSF) Leak

研究概览

简要总结

Limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat cerebrospinal fluid (CSF) leak, and the results were inconclusive. The overall purpose of this study was to assess the efficacy and safety of free middle turbinate flap in reparing CSF leak during an endoscopic approach.

详细描述

Cerebrospinal fluid (CSF) rhinorrhea results from an abnormal communication between the sinonasal cavity and the subarachnoid space. It may occur spontaneously or secondary to accidental or iatrogenic trauma. CSF leak is a potentially devastating condition that can lead to ascending meningitis, pneumocephalus, and intracranial abscess. Surgical repair is recommended for most patients with CSF leaks to prevent the potential sequelae.

Multiple graft materials have been employed in the approach, including temporalis fascia, middle turbinate flap, fascia lata, fat, free cartilage or bone, vascularized nasoseptal flap and acellular skin grafts. Among these options, vascular nasoseptal flaps are the most popular materials at present. Limited literature has been reported the use of free middle turbinate flap during an endoscopic approach to treat CSF rhinorrhea, and the results were inconclusive. There were a large number of cases using free middle turbinate flap for CSF rhinorrhea repair in our institution. The purpose of this study was to determine the efficacy and safety of the free middle turbinate flap for repair of CSF rhinorrhea.

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
Triple (Participant, Care Provider, Investigator)

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients undergoing repairing of CSF leak under transsphenoidal approach
  • Dural defect smaller than 1cm
  • No extensive arachnoid dissection
  • No dissection into a ventricle or cistern

排除标准

  • High flow CSF leak

结局指标

主要结局

Number of Participants With Cerebrospinal Fluid (CSF) Leak

时间窗: 1month

次要结局

  • Number of Participants With Postoperative Complications(1 year)

研究者

发起方
Wuhan Union Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qiangping Wang

MD

Wuhan Union Hospital, China

研究点 (1)

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