The Role of Turbinectomy in Rhinoseptoplasty: a Randomized Clinical Trial With Evaluation of Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Quality of life related to nasal obstruction
研究概览
简要总结
Research Question: Performing partial turbinectomy associated with rhinoseptoplasty is responsible for an increase in quality of life related to nasal obstruction when compared to no intervention in rhinoseptoplasty inferior turbinate?
- Population: patients eligible for functional rhinoseptoplasty and / or aesthetic
- Intervention: surgery, turbinectomy of inferior turbinates
- Comparison: the absence of intervention in inferior turbinates
- Primary endpoint: Quality of life related to nasal obstruction
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
- Single (Participant)
入排标准
- 年龄范围
- 6 Months 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligible patients to rhinoseptoplasty
- •Patients who agreed to participate
排除标准
- •Presence of symptoms of nasal obstruction in the absence of septal deviation, poor support of the nasal tip or clamping of the nasal valve;
- •Presence of hypertrophic and obstructive inferior turbinates;
- •Presence of sinonasal tumors;
- •Patients undergoing treatment of other concomitant rhinoplasty entities such as inflammatory sinus pathology, adenoid hypertrophy, septal perforation, otoplasty and blepharoplasty.
研究组 & 干预措施
Rhinoseptoplasty and turbinectomy
Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.
干预措施: Rhinoseptoplasty (Procedure)
Rhinoseptoplasty and turbinectomy
Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.
干预措施: Partial turbinectomy (Procedure)
Rhinoseptoplasty and turbinectomy
Patients submitted to rhinoseptoplasty associated to Endoscopic partial turbinectomy.
干预措施: Endoscopic partial turbinectomy (Procedure)
Rhinoseptoplasty
Patients submitted only to rhinoseptoplasty, without turbinectomy procedure.
干预措施: Rhinoseptoplasty (Procedure)
结局指标
主要结局
Quality of life related to nasal obstruction
时间窗: 3 months
Quality of life will be evaluated by the WHOQOL-BREF instrument, that comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
次要结局
- Topical Nasal Corticosteroids(3 MONTHS)
- Nasal sneezing(3 MONTHS)
- Nasal Rhinorrhea(3 MONTHS)
- Nasal Pruritis(3 MONTHS)
- Allergic Conjunctivitis(3 months)
- Oral antihistamine(3 months)