Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- surgical outcome
研究概览
简要总结
The objectives of this study would be to determine the most effective treatment for children with PCRS and asthma who fail medical management.
详细描述
This prospective, randomized study would involve children age 6-12 with symptoms of both PCRS and asthma. Their symptoms would first be managed medically with standard medical therapy. In the event they fail medical management, patients would then be randomized to two treatment arms, either adenoidectomy alone or adenoidectomy with ESS. CT scan of the sinuses would then be obtained to evaluate the extent of sinus disease and aid in preoperative planning in those patients undergoing ESS. Sinus mucosa thickening seen on CT is also integral in the diagnosis of PCRS, according to consensus statements published by the American Academy of Otolaryngology. At each visit patient's symptoms would be measured with the SN-5, a validated questionnaire for tracking PCRS.
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
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria:
- •Age 6-12 at time of study enrollment. Presence of chronic sinusitis: >90 days 2 or more symptoms of purulent rhinorrhea, nasal obstruction, facial pressure/pain, or cough with corresponding endoscopic and/or CT findings in a patient 18 years or younger.
- •Presence of asthma, as documented in the medical record by the patient's pediatrician and/or pulmonologist
排除标准
- •Exclusion criteria include previous sinus surgery, previous adenoidectomy, or presence of cystic fibrosis, antrochoanal polyp, immunodeficiency, or fungal infection.
结局指标
主要结局
surgical outcome
时间窗: 1 year
次要结局
未报告次要终点