Does the Addition of Batten Grafting Improve Nasal Outcomes in Patients Undergoing Septoplasty and Turbinate Reduction? A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 5
- 主要终点
- Nasal Obstruction Symptom Evaluation (NOSE) score
研究概览
简要总结
The objective of this study is to compare the effectiveness of batten grafts plus septoplasty and turbinate reduction (intervention arm) compared to septoplasty and turbinate reduction alone (control arm), both in terms of subjective and objective assessments.
详细描述
One of the most common reasons to pursue nasal surgery is for nasal obstruction caused by a septal deviation. Otolaryngologists frequently perform septoplasties to improve nasal obstruction due to septal deviation, leading to improved airflow and decrease office visits and medication use. Concurrently with septal deviations, the inferior turbinate tends to become hypertrophied on the contralateral side potentially causing additional nasal obstruction. While septal deviations and inferior turbinate hypertrophy are more anatomical causes of nasal obstruction, there are also other types that vary depending on nasal airflow, such as nasal valve collapse. One way to surgically correct such dynamic nasal obstruction includes alar batten grafts. These grafts are not meant to change the anatomy of the nose, but instead, function to support the weakened lateral wall. Expanding the current septoplasty procedure to include batten grafts as well as inferior turbinate reduction could possibly improve long-term outcomes, especially reducing future surgeries.
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
- 是
入选标准
- •Patients should satisfy all the following criteria to be considered eligible for randomization:
- •Be age 18 or above
- •Able to provide written informed consent
- •Have an indication for batten graft, septoplasty and turbinate reduction according to prevailing surgical practices.
- •Septal deviation must be present on direct or endoscopic examination
- •Inferior turbinate hypertrophy must be present, direct examination or endoscopic examination
- •Collapse of external nasal valve and/or lateral motion instability must be documented
- •The ENV maye be assessed clinically by observing the alar collapse at baseline or with forced inspiration, Modified cottle may also be performed.
- •In all patients, endoscopic examination should document that the (a) septal deviation, (b) turbinate hypertrophy, and (c) external nasal valve collapse are the primary contributing factors of obstructed breathing.
排除标准
- •Septal perforation
- •History of previous functional rhinoplasty or sinus or septal surgery
- •Patients who are selected for concurrent aesthetic/cosmetic rhinoplasty
- •Untreated allergic rhinitis or allergic rhinitis unresponsive to medical management
- •Patients who have concurrent sinus surgery or polyp removal or concha bullosa resection
结局指标
主要结局
Nasal Obstruction Symptom Evaluation (NOSE) score
时间窗: 12 months
1. The NOSE scale is a scoring scale from 0 to 4 (0 = no problem for quality of life, 4 = a severe problem) under 5 different parameters 2. The sum of 5 different parameters are added up to give a range of possible sums from 0-20. This sum is then multiplied by 5 to give a final score with range 0-100. Ref: Stewart MG, Witsell DL, Smith TL, Weaver EM, Yueh B, Hannley MT. Development and validation of the nasal obstruction symptom evaluation (NOSE) scale. Otolaryngol Head Neck Surg 2004;130:157-163
次要结局
- Lateral Wall Insufficiency (LWI) scores(12 months)
- Peak Inspiratory Flow Rate (PIFR)(12 months)
- Complications and side-effects(12 months)
- Cost-effectiveness (EQ-5D-5L)(12 month)
- Reoperation incidence(12 months)