Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial

Study Overview
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Brief Summary
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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

Official Title
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Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial

Conditions
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Surgical Procedure, Unspecified

Intervention / Treatment
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* Procedure: Septoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Septoplasty<br>patients will receive septoplasty together with Le Fort I osteotomy | Procedure: Septoplasty<br> <br> |
| No Intervention: No septoplasty<br>patient will only receive Le Fort I osteotomy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in symptom severity and health-related quality of life in sinonasal conditions | Sino-Nasal Outcome Test 22(SNOT-22) questionnaire will be used | before surgery and 24 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in nasal patency and congestion | Acoustic rhinometry will be used | 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 | Rhinomanometry will be used | before surgery and 24 months after surgery | 
| Changes of causative allergens | RAST examination will be used | before surgery and 24 months after surgery |