Comparison of the efficacy of septoplasty with non –surgical management in improving nasal obstruction in patients with deviated nasal septum- A randomized clinical trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- We expect surgical correction of deviated nasal septum by septoplasty to improve the nasal obstruction better than non-surgical management
研究概览
简要总结
Septoplasty , the surgical correction of deviated nasal septum , is one of the most common ENT surgeries in adults. Currently , the main indication to perform septoplasty is nasal obstruction due to deviated nasal septum. However , the effectiveness of septoplasty in relieving nasal obstruction remains uncertain. The objective of this study is to compare the efficacy of septoplasty with non surgical management in improving nasal obstruction in patients with deviated nasal septum both objectively with NASAL PEAK INSPIRATORY FLOW (NPIF) and subjectively with VISUAL ANALOGUE SCALE (VAS) , SINO NASAL OUTCOME TEST 22 ( SNOT-22) and NASAL OBSTRUCTION SYMPTOM EVALUATION ( NOSE) scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients above 18 years of age with nasal obstruction due to DNS.
排除标准
- •Patients with a history of previous septal surgery
- •Septoplasty done for indications other than deviated nasal septum
- •Patients with a strong preference to surgery will be excluded from the study.
结局指标
主要结局
We expect surgical correction of deviated nasal septum by septoplasty to improve the nasal obstruction better than non-surgical management
时间窗: 1, 3, 6 months post treatment
次要结局
- We expect surgical correction of deviated nasal septum by septoplasty to improve the nasal obstruction better than non-surgical management both subjectively with peak nasal inspiratory flow and objectively with visual analogue scale , sino nasal outcome test-22, nasal obstruction symptom evaluation scales(140)