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临床试验/NCT06082193
NCT06082193招募中不适用

Olfactory Cleft Stenosis and Obstruction on Paranasal Sinus CT Scan in Pre Septo Rhinoplasty Patients Without Respiratory Mucosa Pathology : Normal Variants or Pathologic Findings ?

Central Hospital, Nancy, France2 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2023年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
75
试验地点
2
主要终点
Olfactory cleft stenosis or obstruction

研究概览

简要总结

This retrospective studed included patients referred to our institution between December 2013 and december 2021 for septoplasty or septorhinoplasty. All patients underwent pre operatory paranasal sinus CT scan and olfactory test. Olfacory cleft stenosis will be quoted as none (less than 1/3 contact between nasal septum and ethmoïd turbinates), partial (1/3-2/3 contact between nasal septum and turbinates) or total (more than 2/3 contact between nasal septum and turbinates), as well as Olfactory Cleft obstruction as none (opacification less than 1/3 of olfactory cleft), partial (1/3-2/3 opacification) or complete (more than 2/3 opacification).

详细描述

In this retrospective study, We will include every patients over 18 years old who had a septoplasty or septorhinoplasty between December 2013 and December 2021 and who underwent paranasal CT scan and olfactory test (sniffin stick test).

The patients will be find thanks to social security code GAMA007 for septoplastie, GAMA 004, 010 for septorhinoplasty and olfactometry GJQP001.

The patients with mucosa pathology on CT scan or with record of chronic respiratory rhinitis, septum perforation or a pathology that can alter the olfaction on the consultation report will be excluded.

Olfactory measurements were performed before surgery using the threshold and identification subtests of Sniffin Stick Test. Olfactory status will be classified by taking into account the normative data provided by Hummel et al and the real identification score. The patients will be classified as normosmic if the threshold and the identification score is superior the tenth percentile. If not, they will be classified as anosmic if both score are 0 and hyposmic otherwise.

2 experienced radiologists will perform the measures on paranasal sinus CT. They will be blinded to olfactory results.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

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

  • Patients over 18 years old who underwent paranasal sinus CT and olfactory test before septoplasty or septorhinoplasty

排除标准

  • Respiratory mucosa pathology on CT (polyposis, opacification of the maxillary sinuses, ethmoid cells, frontal sinus, sphenoidal sinus, sinonasal tumor)
  • septal perforation
  • chronic respiratory rhinitis (allergic, vasomotor, mucoviscidosis)
  • pathologie that can alter olfaction (multiple sclerosis, meningioma, post infection such as COVID)

结局指标

主要结局

Olfactory cleft stenosis or obstruction

时间窗: 1 day

Measures will classify as none, partial or total stenosis or obstruction

次要结局

  • Impact of olfactory cleft stenosis or obstruction(1 day)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Principal Investigator
主要研究者

JANKOWSKI Roger

Professor

Central Hospital, Nancy, France

研究点 (2)

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