Effect of Extraesophageal Reflux on Inferior Nasal Turbinates Hypertrophy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 6
- 主要终点
- Severity of extraesophageal reflux using oropharyngeal pH monitoring
研究概览
简要总结
The study examines the severity of extraesophageal reflux using oropharyngeal pH monitoring in patients with varying degrees of lower turbinates hypertrophy.
详细描述
Hypertrophy of the lower turbinates causes obstruction of the nasal breathing with several health risks and a significant reduction in quality of life. Mouth breathing is non-physiological. When breathing through the mouth, the air is not purified, warmed, or humidified. This results in more frequent respiratory infections, drying of the airways, burning in the throat and causes snoring and sleep apnoea overnight. Also, nasal obstruction leads to a significant reduction in quality of life. Conservative treatment with topically applied corticosteroids is often without effect and surgical reduction of the lower turbinates under local or general anesthesia is necessary. The operation is another discomfort for the patient and is not without risks.
The pathogenesis of lower turbinates hypertrophy is multifactorial. Currently, extraesophageal reflux (EER) is considered to be a possible factor as well. The role of EER in chronic rhinosinusitis, especially in difficult-to-treat conditions, has been investigated in the past, and EER would likely be a possible co-factor. The relationship between hypertrophic lower turbinates and EER has not been studied yet.
The primary outcome/goal of the study:
To examine the severity of extraesophageal reflux using oropharyngeal pH monitoring in patients with varying degrees of lower turbinates hypertrophy.
Other goals:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
No masking is being used in this study
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years
- •patients indicated for oropharyngeal pH-metry (Restech) with suspected extraesophageal reflux
- •patients with 2nd - 4th degree hypertrophy of the lower turbinates (according to Camacho Classification)
排除标准
- •patients with chronic rhinosinusitis with polyps
- •patients who have had an acute upper respiratory tract infection in the last 8 weeks
- •patients after previous surgery in the nasal cavity and nasopharynx
- •patients after radiotherapy in the head and neck area
- •non tolerance of pH catheter
结局指标
主要结局
Severity of extraesophageal reflux using oropharyngeal pH monitoring
时间窗: 24 hours
The primary outcome measure of the study is to examine the severity of extraesophageal reflux using oropharyngeal pH monitoring in patients with varying degrees of lower turbinates hypertrophy, assessed on the RYAN score.
次要结局
未报告次要终点