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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
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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


Condition or disease Intervention/treatment Phase
Surgical Procedure, Unspecified Procedure: Septoplasty Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Changes in nasal patency and congestion [ Time Frame: before surgery and 24 months after surgery ]
    Acoustic rhinometry will be used

  2. Changes of nasal airway volume [ Time Frame: before surgery and 24 months after surgery ]
  3. Changes in transnasal pressure and airway resistance and pressure-flow characteristics [ Time Frame: before surgery and 24 months after surgery ]
    Rhinomanometry will be used

  4. Changes of causative allergens [ Time Frame: before surgery and 24 months after surgery ]
    RAST examination will be used



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Yu-Fang Liao, PHD +886-3-3196200 ext 3500 yufang@cgmh.org.tw

Locations
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Taiwan
Chang Gung Memorial Hospital
Taoyuan, Taiwan
Contact: Yu-Fang Liao, PHD    +886-3-3196200 ext 3500      
Principal Investigator: Yu-Fang Liao, PHD         
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
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Study Director: Yu-Fang Liao, PHD Chang Gung Memorial Hospital
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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT01883687    
Other Study ID Numbers: 102-0546C
First Posted: June 21, 2013    Key Record Dates
Last Update Posted: June 21, 2013
Last Verified: April 2013