Surgical Procedure, Unspecified
Conditions
Brief summary
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
Interventions
PROCEDURESeptoplasty
Sponsors
Chang Gung Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Taiwanese adults with dentofacial deformities (DFD) 2. Have documented nasal obstruction and a hypertrophied inferior turbinate on the contralateral side of the septal deviation 3. Will undergo bimaxillary surgery including 1-piece Le Fort I osteotomy for DFD at the Craniofacial Center between 2012 and 2013
Exclusion criteria
1. Previous OGS or nasal surgery 2. Patients with nasal polyposis, rhinosinusitis or neoplasia 3. Patients with clefts or craniofacial anomaly 4. Patients with adenoid hypertrophy, nasal valve collapse, uncontrolled asthma or tobacco use 5. Noncompliance for test 6. Noncompliance to test schedule 7. Won't sign informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in symptom severity and health-related quality of life in sinonasal conditions | before surgery and 24 months after surgery | Sino-Nasal Outcome Test 22(SNOT-22) questionnaire will be used |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in nasal patency and congestion | before surgery and 24 months after surgery | Acoustic rhinometry will be used |
| 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 | Rhinomanometry will be used |
| Changes of causative allergens | before surgery and 24 months after surgery | RAST examination will be used |
Countries
Taiwan
Contacts
Primary ContactYu-Fang Liao, PHD
Outcome results
None listed