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临床试验/NCT01350466
NCT01350466已完成不适用

Prospective Study Investigating the Role of Occupational Exposure on Sinus Surgery Outcome

Universitaire Ziekenhuizen KU Leuven0 个研究点目标入组 200 人开始时间: 2011年8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
200

研究概览

简要总结

The pathophysiology of chronic rhinosinusitis (CRS) is complex and involves several immune, infectious and anatomic factors. When medical therapy fails, functional endoscopic sinus surgery (FESS) is the therapy of choice. From literature it is known that 10% of patients that undergo FESS, need revision surgery within the 3 years following initial surgery. Causes of failure are multiple and not fully understood.

As is the case in patients suffering from occupational rhinitis (OR), a subgroup of patients with severe and/or therapy resistent rhinosinusitis may suffer from mucosal pathology induced by occupational factors as well. No data are currently available on how these factors may contribute to the disease manifestation, whereas negligence of these factors as potential causes of disease may lead to the chronicity of rhinosinusitis, aggravate the mucosal condition and even give rise to the induction of bronchial symptoms. There exists no documentation on the role of the occupational agents on chronic sinus disease.

This prospective study aims at providing data about the exposure levels of patients that undergo sinus surgery and correlate them with both subjective and objective postoperative parameters. This will be done by providing a questionnaire that was developed at our department to all patients that are planned for sinus surgery at the participating centers. This questionnaire asks for medical history, current sinonasal symptoms, professional history and recreational occupation. An extensive list of occupational agents is given and patients are asked to indicate those that they encounter at work or during recreational activities. This will be followed by an extensive clinical investigation including nasal endoscopy. These investigations (questionnaire and clinical examination) will be repeated at 3 months and 12 months after surgery.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for sinus surgery because of recurrent acute sinusitis or chronic sinusitis with or without nasal polyps.
  • Age > 18 and < 65 years
  • Signed informed consent
  • Willingness and capability to fill in questionnaire.

排除标准

  • Patient with diagnosed cystic fibrosis or primary ciliary dysfunction syndrome
  • Patients that undergo FESS for antrochoanal polyp
  • Patient that undergo FESS for a malignant process
  • Patient that are diagnosed with sarcoidosis or any type of vasculitis

研究者

申办方类型
Other

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