The Role of Perioperative Systemic Steroids in Patients With Chronic Rhinosinusitis Without Polyps (CRSsNP)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- Lund Kennedy Endoscopy Score Over Time
研究概览
简要总结
While oral steroids have been shown to be effective in the management of patients with chronic rhinosinusitis with polyps, its role in treating chronic rhinosinusitis without polyps (CRSsNP) is ambiguous. Despite a lack of strong clinical evidence to suggest a benefit in this disease state, steroids are often prescribed as a component of post-operative care after sinus surgery for patients without polyps. Oral steroids carry with them significant adverse effects, and should be prescribed thoughtfully. The aims of this study are to determine if oral steroids in the peri-operative period improves patient outcomes in CRS without polyps.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •CRSsNP as defined by Clinical Practice Guideline (Update) on Adult Sinusitis
- •scheduled to undergo endoscopic sinus surgery
排除标准
- •chronic rhinosinusitis with polyps (CRSwNP)
- •Aspirin exacerbated respiratory disease
- •Cystic fibrosis
- •Immunosuppressive states (Human immunodeficiency virus, transplant)
- •Oral steroid use within 30 days of surgery
研究组 & 干预措施
Prednisone
Provided oral steroid and topical steroid
干预措施: Flonase (Drug)
Placebo
Provided oral placebo and topical steroid
干预措施: Flonase (Drug)
Prednisone
Provided oral steroid and topical steroid
干预措施: Prednisone (Drug)
结局指标
主要结局
Lund Kennedy Endoscopy Score Over Time
时间窗: Baseline, 1, week, 1 month, 3 months, and 6 months
The Lund-Kennedy score is a validated scale by which clinicians grade the endoscopic appearance of the sinonasal cavity for sinusitis patients. There are 5 parameters rated on a scale of 0-2 for each side of the nose, for a maximum total score of 20 points. Higher scores represent a worse endoscopic appearance.
Sino-nasal Outcome Test (SNOT-22) Over Time
时间窗: Baseline, 1, week, 1 month, 3 months, and 6 months
SNOT-22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.
次要结局
未报告次要终点
研究者
Julia Noel
Principal Investigator
Stanford University