Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial
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|ClinicalTrials.gov Identifier: NCT01883687|
Recruitment Status : Unknown
Verified April 2013 by Chang Gung Memorial Hospital.
Recruitment status was: Not yet recruiting
First Posted : June 21, 2013
Last Update Posted : June 21, 2013
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
|Condition or disease||Intervention/treatment||Phase|
|Surgical Procedure, Unspecified||Procedure: Septoplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Functional Nasal Surgery at the Time of Le Fort I Osteotomy: A Prospective, Single-blind, Randomized Trial|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||April 2017|
patients will receive septoplasty together with Le Fort I osteotomy
No Intervention: No septoplasty
patient will only receive Le Fort I osteotomy
- Changes in symptom severity and health-related quality of life in sinonasal conditions [ Time Frame: before surgery and 24 months after surgery ]Sino-Nasal Outcome Test 22(SNOT-22) questionnaire will be used
- Changes in nasal patency and congestion [ Time Frame: before surgery and 24 months after surgery ]Acoustic rhinometry will be used
- Changes of nasal airway volume [ Time Frame: before surgery and 24 months after surgery ]
- Changes in transnasal pressure and airway resistance and pressure-flow characteristics [ Time Frame: before surgery and 24 months after surgery ]Rhinomanometry will be used
- Changes of causative allergens [ Time Frame: before surgery and 24 months after surgery ]RAST examination will be used
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01883687
|Contact: Yu-Fang Liao, PHD||+886-3-3196200 ext email@example.com|
|Chang Gung Memorial Hospital|
|Contact: Yu-Fang Liao, PHD +886-3-3196200 ext 3500|
|Principal Investigator: Yu-Fang Liao, PHD|
|Study Director:||Yu-Fang Liao, PHD||Chang Gung Memorial Hospital|