ESS Performed in Operating Room Versus Clinician's Office
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline
研究概览
简要总结
Endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices.
详细描述
In this study, endoscopic sinus surgery will be performed either in the physician's office or in the operating room (OR). Patients treated in the physician's office will have endoscopic sinus surgery performed with the balloon sinuplasty devices. Patients treated in the OR will have endoscopic sinus surgery performed with or without balloon sinuplasty devices. Both primary treatment of sinusitis as well as revision of previously treated sinuses will be allowed. Resource absorption will be evaluated for both venues.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years and greater
- •Both male and female patients eligible
- •Diagnosis of chronic sinusitis that is not responsive to medical management (> 12 weeks of symptoms and failed at least 3 to 6 weeks of appropriate antibiotic therapy as evidenced by presence of disease on CT scan)
- •Planned endoscopic sinus surgery (recommended by investigator, consented to by patient)
排除标准
- •Cystic fibrosis
- •Samter's Triad (Aspirin sensitivity, Asthma, Sinonasal polyposis)
- •Sinonasal tumors or obstructive lesions
- •History of facial trauma that distorts sinus anatomy and precludes access to the sinus ostium
- •Ciliary dysfunction
- •Pregnant females
结局指标
主要结局
Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline
时间窗: 24 weeks
The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline, 1 week, 4 weeks, 24 weeks and 52 weeks post-procedure. The change in SNOT-20 score at each post-procedure time point will be evaluated compared to baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.
次要结局
- Mean Number of Debridements Per Participant (IO Only)(52 weeks)
- Mean Intra-patient Change in SNOT-20 Score at 52 Weeks Post-procedure Compared to Baseline(52 weeks)
- Proportion of Participants With Post-operative Sinus Infections(52 weeks)
- Mean Intra-patient Change in SNOT-20 Score at 1 Week Post-procedure Compared to Baseline(1 week)
- Proportion of Participants Reporting No Pain or Pain of Low Intensity (IO Only)(Day 0)
- Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks](24 weeks)
- Proportion of Participants Rating Procedure as Tolerable (IO Only)(Day 0)
- Proportion of Participants With Revisions (IO Only)(52 weeks)
- Mean Intra-patient Change in SNOT-20 Score at 4 Weeks Post-procedure Compared to Baseline(4 weeks)