Effects of Septorhinoplasty on Allergic Rhinitis Evolution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Changes from baseline of Airflow rate
研究概览
简要总结
Allergic rhinitis (AR) is a chronic inflammatory disease that affects almost 30% of adult population. Some patients associate septal deviation, main cause of chronic nasal obstruction, and AR. Current literature about AR treatment with septoplasty (STP) is still contradictory, because is thought that patients with AR are not able to appreciate improvement after surgery.
Patients diagnosed with allergic rinitis and septal deviation were evaluated to determined life quality and airflow obstruction evolution after STP.
详细描述
This is a prospective quasi experimental study. After being informed about the study, patients that signed written informed consent were included in the study. In week 0 before surgery, all measurements and questionnaires were performed. 1 month after surgery, measurements were repeated.
After screening, patient´s obstruction was evaluated by anterior rhinomanometry (RNMa), and quality of life scored through ESPRINT scale. ESPRINT is a validated Spanish questionnaire about daily life activity, sleep, psycology and perception of affection by allergic rhinitis. Symtoms were evaluated with visual analogue scale (VAS) and clinical history. Symptoms like sneezing, itchy nose, ocular symptoms and/or nasal obstruction. Also medication (intranasal corticosteroid, antileucotrienos, antihistamines eye drops , antishistamines) frequency use was registered.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical diagnosis of Allergic Rhinitis
- •Diagnosis of nasal obstruction with septal deviation
排除标准
- •Previous nasal surgery
- •Chronic obstructive pulmonary disease
- •Psychiatric disorders
- •Malignant tumors
- •Severe hepatopathy
- •Obstructive sleep apnea
结局指标
主要结局
Changes from baseline of Airflow rate
时间窗: Change from baseline airflow rate (Before treatment) at 1 month after surgery
Rhinomanometre will be used to determine airflow rate changes before surgery (septoplasty) and after it. Rhinomanometre will determine airflow rate in cm3/s and also use a quality scale as normal, mild, severe and very severe
次要结局
- Changes from baseline of symptoms(Changes from baseline (Before treatment) at 1 month after surgery)
- Changes from baseline in quality of life(Changes from baseline (Before treatment) at 1 month after surgery)
研究者
Mario Pérez Sayáns
Proffessor
University of Santiago de Compostela