NCT02695602终止不适用
Prospective Randomized Trial Comparing Microdebrider-Assisted Inferior Turbinoplasty (MAIT) vs Submucous Resection (SMR)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients
研究概览
简要总结
This is a prospective, patient blinded, randomized, clinical trial enrolling patients with symptoms and signs of nasal obstruction related to enlarged inferior turbinates. The purpose of this study is to compare two different surgical methods, both of which are already in common use, for the treatment of nasal obstruction in patients with inferior turbinate hypertrophy.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms of chronic nasal obstruction with an exam finding of turbinate hypertrophy, with or without septal deviation will be eligible for the study.
- •Failed medical treatment
- •Have failed medical treatment for at least 1 month, and will be offered surgery
- •Patients having Septoplasty at the same time as their turbinate reduction surgery.
排除标准
- •Patients who have had previous turbinate reduction surgery will be excluded.
- •Patients that have nasal polyps, chronic rhinosinusitis, adenoid hypertrophy, nasal tumors, or any other exam finding that would explain their symptoms of nasal obstruction other than enlarged inferior turbinates with or without septal deviation will be excluded.
- •Patients who are diagnosed with purely bony inferior turbinate hypertrophy as discussed below.
- •Patients on hormone or anticoagulation therapy and those who have a history of head and neck radiation therapy will be excluded.
- •All study candidates will be assessed for external nasal valve collapse via the modified Cottle maneuver, and will be excluded if they exhibit significant external or internal nasal valve collapse as their primary cause of their nasal obstruction.
- •All patients will complete the Visual Analog Scale (VAS) on nasal obstruction before and after decongestion at their preoperative visit. Patients that fail to report a score less than 5 after decongestion are likely to have bony rather than soft tissue hypertrophy. In these patients MAIT is unlikely to be an adequate surgical option, and they would derive a greater amount of benefit from SMR. Therefore these patients will be excluded from the study, and offered only SMR.
结局指标
主要结局
Change in Nasal Obstruction Symptom Evaluation (NOSE) Score in MAIT vs SMR treated patients
时间窗: 3 years post-operative
Measure of pain on the Visual Analog Scale
时间窗: 3 years post-operative
次要结局
未报告次要终点
研究者
研究点 (1)
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