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临床试验/NCT03374124
NCT03374124Unknown不适用

The Surgical Prognosis Based Diagnostic Strategy for Eosinophilic Chronic Rhinosinusitis: A Retrospective Study

Jianbo Shi1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年1月最近更新:
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
nasal symptoms

研究概览

简要总结

Previous studies have demonstrated that the eosinophilic inflammation of nasal mucosa is associated with the uncontrolled condition of chronic rhinosinusitis after surgery. However, the definition of the eosinophilic chronic rhinosinusitis is not very clear. Japanese researchers have designed a scoring system to diagnose eosinophilic chronic rhinosinusitis. In this study, the investigators hope to examine the practicability of this scoring system and have a better knowledge of eosinophilic chronic rhinosinusitis in china.The retrospective study was conducted in a tertiary hospital. Participants received functional endoscopic sinus surgery more than 1 years were called back for evaluation. A diagnosis cut off value of eosinophil count was determined by the surgery prognosis. Then different factors were compared between participants with eosinophilic CRS and those with non-eosinophilic CRS to establish the appropriated diagnosis approach for eosinophilic CRS.

详细描述

The retrospective study was conducted in a tertiary hospital. Participants received functional endoscopic sinus surgery more than 1 years were called back for evaluation. A diagnosis cut off value of eosinophil count was determined by the surgery prognosis. Then different factors were compared between participants with eosinophilic CRS and those with non-eosinophilic CRS to establish the appropriated diagnosis approach for eosinophilic CRS.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of chronic rhinosinusitis according to European position paper of rhinosinusitis and nasal polyps 2007.

排除标准

  • Immunodeficiency diseases, history of head and/or facial trauma, cancer or organ transplant recipients.
  • Pregnancy or lactation.
  • Acute respiratory tract infection within one month before the study.
  • Patients without pathological samples.
  • Antrochoanal polyp and cyst of the paranasal sinuses.

结局指标

主要结局

nasal symptoms

时间窗: through study completion, an average of 2 year

presence of bothersome congestion or rhinorrhea or olfactory loss or headache.(VAS more than 7 points).

endoscopic appearance indicate the uncontrol of CRS

时间窗: through study completion, an average of 2 year

The presence of diseased mucosa (nasal polyps, mucopurulent secretions,and/or inflamed mucosa) under endoscopy. (Lund-kennedy endoscopic score: Polyp≥1 or Oedema≥2 or Discharge≥2; 0-Absence of polyps;1-polyps in middle meatus only;2-polyps beyond middle meatus but not blocking the nose completely;3-polyps completely obstructing the nose. Oedema: 0-absent; 1-mild; 2-severe.Discharge: 0-no discharge; 1-clear, thin discharge; 2-thick, purulent discharge.)

次要结局

未报告次要终点

研究者

发起方
Jianbo Shi
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jianbo Shi

Professor

First Affiliated Hospital, Sun Yat-Sen University

研究点 (1)

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