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

Study Overview

• Status: Unknown
• Conditions: Surgical Procedure, Unspecified
• Intervention / Treatment: Procedure: Septoplasty

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Septoplasty; patients will receive septoplasty together with Le Fort I osteotomy	Procedure: Septoplasty
NO_INTERVENTION: No septoplasty; patient will only receive Le Fort I osteotomy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Yu-Fang Liao, PHD, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (ANTICIPATED): April 1, 2016
• Study Completion (ANTICIPATED): April 1, 2017

Study Registration Dates

• First Submitted: May 23, 2013
• First Submitted That Met QC Criteria: June 19, 2013
• First Posted (ESTIMATE): June 21, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): June 21, 2013
• Last Update Submitted That Met QC Criteria: June 19, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: 102-0546C