NCT01054521已完成不适用
A Randomized Comparison Study of Temperature-controlled and Bipolar Radiofrequency for Inferior Turbinate Reduction in Patients With Chronic Rhinitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 2
- 主要终点
- Visual Analog scale scores of nasal obstructive symptom.
研究概览
简要总结
Currently, there are several alternative treatments for patients with chronic rhinitis (CR) who failed medication. Although, most of the researches have been focusing on temperature-controlled RF (TCRF), the cost is a major limitation for applying it worldwide. The investigators objective of this study is to compare the subjective and objective outcomes of Bipolar RF (BRF) with the more popular TCRF for CR treatment. The investigators hypothesized that both have equivalent outcomes but with less operative time and potentially at lower cost.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults with snoring and chronic nasal obstruction.
- •Respond to topical decongestant but not respond to nasal steroids, oral anti-histamine and oral decongestant
- •Consent to the protocol.
排除标准
- •Chronic active sinusitis, severe Deviated nasal septum (DNS), nasal polyps, sinonasal tumor, previous sinonasal surgery or head neck irradiation.
- •Uncontrolled bleeding disorders, hypertension, or cardiovascular diseases
- •Not complete the protocol
结局指标
主要结局
Visual Analog scale scores of nasal obstructive symptom.
时间窗: Up to 1 year follow-up
次要结局
- VAS scores of nasal discharge, sneezing, hyposmia, postnasal drip(Up to 1 year follow-up)
- Postoperative crust, mucociliary transportation time (MTT), minimal cross sectional area (MCA), total nasal volume (VOL), nasal airway resistance (NAR) at 75 Pa(Up to 1 year follow-up)
研究者
研究点 (2)
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