Surgical Procedure, Unspecified Clinical Trial
Official title:
Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial
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
n/a
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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