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

Chang Gung Medical Foundation

Status: Unknown

Conditions: Surgical Procedure, Unspecified

Treatments: Procedure: Septoplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT01883687

102-0546C

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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80 participants in 2 patient groups

Septoplasty

Experimental group

Description:

patients will receive septoplasty together with Le Fort I osteotomy

Treatment:

Procedure: Septoplasty

No septoplasty

No Intervention group

Description:

patient will only receive Le Fort I osteotomy