Clinical trial NCT01883687: Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial
Official title: Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgical Procedure, Unspecified
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2013-06-21
Enrollment: 80
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Changes in symptom severity and health-related quality of life in sinonasal conditions
timeFrame: before surgery and 24 months after surgery
Secondary outcomes:
measure: Changes in nasal patency and congestion
timeFrame: before surgery and 24 months after surgery
measure: Changes of nasal airway volume
timeFrame: before surgery and 24 months after surgery
measure: Changes in transnasal pressure and airway resistance and pressure-flow characteristics
timeFrame: before surgery and 24 months after surgery
measure: Changes of causative allergens
timeFrame: before surgery and 24 months after surgery
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Yu-Fang Liao, PHD
role: STUDY_DIRECTOR
References: