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临床试验/NCT04124523
NCT04124523已完成不适用

International Opinion Study on Peri-operative Cerebrospinal Fluid Leaks Management After Endoscopic Skull Base Surgery

University Hospital, Montpellier1 个研究点 分布在 1 个国家目标入组 153 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
153
试验地点
1
主要终点
Evaluation of perioperative management of CSF leaks

研究概览

简要总结

Cerebrospinal fluid (CSF) leak is a rare condition. When it involves the ventral skull base, a surgical closure may be achieved using endoscopic skull base surgery techniques. The major principles remain in achieving a watertight closure that can also support the brain (and avoid brain sagging) in case of extensive skull base defects. Surgical techniques are well described. Many clinical factors may influence the successful rate of the reconstruction. However, there is a lack of clinical study on perioperative management of CSF leaks. The purpose of this study is to gather the opinion of skull base surgeons on the post-operative management of patients to avoid CSF leak recurrence.

•Methods: The investigators will collect data from skull base surgeons using an electronic survey questionnaire (Google Form, Google, Mountain View, California, U.S.A.) submitted by e-mail to the members of the French Association of Rhinology, to the European Rhinologic Society, to the French college of neurosurgeons, to the Italian skull base society members, and to the former students of the European endoscopic skull base diploma. This is an anonymous 60-items survey. Questions were classified in eight sections: general questions, material used at the end of the surgical procedure, post-operative resting position, drugs, CSF depletion, post-operative advices, explorations in case of early recurrence of the rhinorrhoea, and follow-up modalities.

•Discussion: The investigators aim to understand the actual practice of skull base surgeons after closure of ventral skull base CSF leaks. This can serve as a basis for conducting clinical studies in the future.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
25 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Evaluation of perioperative management of CSF leaks

时间窗: maximum 2 weeks (during hospitalization)

Evaluation of perioperative management of CSF leaks during hospitalization with 60 items questionnaire (QCM)

次要结局

  • Comparison of practices of surgeons according by specialties(maximum 2 weeks (during hospitalization))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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