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

Chang Gung Medical Foundation logo

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

  • 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

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

Trial contacts and locations

1

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Central trial contact

Yu-Fang Liao, PHD

Data sourced from clinicaltrials.gov

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