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

Surgical Procedure, Unspecified Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01883687
• Other study ID #: 102-0546C
• Status: Not yet recruiting
• Phase: N/A
• First received: May 23, 2013
• Last updated: June 19, 2013
• Start date: June 2013
• Est. completion date: April 2017

Study information

• Verified date: April 2013
• Source: Chang Gung Memorial Hospital
• Contact: Yu-Fang Liao, PHD
• Phone: +886-3-3196200
• Email: yufang[@]cgmh.org.tw
• Is FDA regulated: No
• Health authority: Taiwan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2017
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Surgical Procedure, Unspecified

Intervention

Procedure:
• Septoplasty

Locations

Country	Name	City	State
Taiwan	Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Changes in nasal patency and congestion	Acoustic rhinometry will be used	before surgery and 24 months after surgery	No
Secondary	Changes of nasal airway volume		before surgery and 24 months after surgery	No
Secondary	Changes in transnasal pressure and airway resistance and pressure-flow characteristics	Rhinomanometry will be used	before surgery and 24 months after surgery	No
Secondary	Changes of causative allergens	RAST examination will be used	before surgery and 24 months after surgery	No