NCT01455948终止不适用
Canadian Health Economics, Health Outcome, and Effectiveness Comparison of Treatment of the Frontal Sinus Ostium and Recess and Other Sinuses With Functional Endoscopic Sinus Surgery (FESS) or Balloon Sinuplasty in Patients With Chronic Sinusitis (CRS)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 15
- 主要终点
- The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.
研究概览
简要总结
The economic, patient related outcome, and effectiveness of balloon sinuplasty in the treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare environment is not known at this time. This study will evaluate the impact of balloon sinuplasty and traditional FESS treatment on CRS patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
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
- 否
入选标准
- •Documented diagnosis of unilateral or bilateral Chronic Rhinosinusitis based on the European Position Paper on Rhinosinusitis and Nasal Polyps (2) with at least frontal and maxillary sinus involvement
- •Documented failed medical treatment of CRS
- •Eighteen (18) to sixty-five (65) years of age
- •Employed in full time position or equivalent
- •Planned FESS for treatment of CRS
- •Must have an American Society of Anesthesiologists physical status of P3 classification or less
- •Able to provide informed consent by signing the informed consent document at the screening visit prior to any study activities
- •Able to read and understand English
排除标准
- •Previous sinonasal surgery
- •Cystic Fibrosis
- •Diagnosed immotile cilia syndrome
- •Samter's Triad
- •Diagnosed immunodeficiency syndrome
- •Diagnosed fungal sinusitis
- •Concurrent septoplasty or turbinate surgery
- •Diagnosed recurrent acute sinusitis
- •Current smoker
- •Presence of grade 2 or greater nasal polyps
- •Sinonasal tumors or obstructive lesions
- •History of substance or alcohol abuse within the past 12 months
- •Investigator's opinion that the subject should not be in the study such as any conditions that could compromise the wellbeing of the patient or integrity of the study or prevent the patient from meeting or performing study requirements
- •Participation in a research study 30 days prior to surgery
结局指标
主要结局
The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.
时间窗: 6 months
次要结局
- Health outcome of patients in the two treatment groups.(6 months)
- Effectiveness of the two treatment groups in relieving symptomology of CRS.(6 months)
研究者
研究点 (15)
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