Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes in symptom severity and health-related quality of life in sinonasal conditions
研究概览
简要总结
Objectives: The aims of this study are (1) to define the effectiveness of functional nasal surgery during Le Fort I osteotomy on nasal obstruction through objective as well as subjective evaluations, (2) to determine guideline for concomitant functional nasal surgery with Le Fort I osteotomy, and (3) to explore possible mechanisms by which functional nasal surgery may reduce nasal obstruction severity.
Design: A prospective, single-blnd, randomized trial. Setting: Chang Gung Craniofacial Center and Department of Otolaryngology (ENT). Patients: A total of 80 Taiwanese patients with unilateral cleft lip and palate and dentofacial deformity (age >16 for females, >18 for males; 40 in experimental and 40 in control groups) Interventions: In the experimental group, all patients will receive Le Fort I osteotomy and septoplasty. In the control group, all patients will receive Le Fort I osteotomy only.
Measurements: All patients will undergo history taking, clinical examination, radioallergosorbent (RAST) examination (before surgery), standard questionnaire and image examination before surgery, one week, 1, 3, 6, 12 and 24 months after surgery. To reduce radiation exposure, cone-beam CT will only be performed before surgery and one week, 12 and 24 months after surgery.
Data Analysis: Independent t and chi-squared tests, correlation coefficients and repeated measures analysis of variance (ANOVA) will be used. Statistical significance is assumed for a p value of less than 0.05.
Key Words: cleft lip palate, nasal septum deviation, Le Fort I osteotomy, septoplasty, effectiveness
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Taiwanese adults with dentofacial deformities (DFD)
- •Have documented nasal obstruction and a hypertrophied inferior turbinate on the contralateral side of the septal deviation
- •Will undergo bimaxillary surgery including 1-piece Le Fort I osteotomy for DFD at the Craniofacial Center between 2012 and 2013
排除标准
- •Previous OGS or nasal surgery
- •Patients with nasal polyposis, rhinosinusitis or neoplasia
- •Patients with clefts or craniofacial anomaly
- •Patients with adenoid hypertrophy, nasal valve collapse, uncontrolled asthma or tobacco use
- •Noncompliance for test
- •Noncompliance to test schedule
- •Won't sign informed consent
结局指标
主要结局
Changes in symptom severity and health-related quality of life in sinonasal conditions
时间窗: before surgery and 24 months after surgery
Sino-Nasal Outcome Test 22(SNOT-22) questionnaire will be used
次要结局
- Changes in nasal patency and congestion(before surgery and 24 months after surgery)
- Changes of nasal airway volume(before surgery and 24 months after surgery)
- Changes in transnasal pressure and airway resistance and pressure-flow characteristics(before surgery and 24 months after surgery)
- Changes of causative allergens(before surgery and 24 months after surgery)