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临床试验/NCT02230423
NCT02230423已完成不适用

Trigeminale Endonasale Perzeption, Ein Prädiktor für Das Outcome Einer Septumplastik - Eine Prospektive Kohortenstudie Mit Klinischen Und Biologischen Untersuchungen

University of Zurich2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2015年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
140
试验地点
2
主要终点
Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression

研究概览

简要总结

This study investigates wether patients with increased trigeminal perception threshold and low expression of TRP channels have more often nasal blockage despite functionally successful nasal surgery (TRP channel = transient receptor potential channel).

详细描述

The aim of this study is to find out wether patients with high trigeminal perception threshold (=decreased intranasal sensibility) and low expression of TRP channels of the mucosa suffer more often from impaired nasal breathing after surgery. This could lead to the identification of prognostic factors and therefore prevention of nasal surgery with bad outcome.

Further, differences between patients with empty nose syndrome and asymptomatic patients after extended intranasal surgery, concerning trigeminal perception and TRP channel expression will be investigated.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing a primary septoplasty and/or turbinoplasty
  • Patients suffering from empty nose syndrome after measurably successful nasal surgery
  • Patients with removed turbinates and/or septum, not suffering from ENS (i.e. tumor patients)

排除标准

  • Patients with known neurologic disorders that could compromise perception threshold measurements
  • Patients with known allergies/intolerance to test agents that are used to measure perception thresholds (Cineol=Eucalypt; Menthol, CO2= Carbon Dioxide)
  • Inability to judge or understand the testing or the informed consent

结局指标

主要结局

Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression

时间窗: Up to 1 year post-surgery

次要结局

  • Differences between trigeminal perception threshold as as well as TRP expression levels in patients with postoperative empty nose syndrome and patients with subjectively unimpaired nasal breathing after extended intranasal surgery(Up to 1 year post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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