An interventional study of Septoplasty in Surgical Procedure, Unspecified, sponsored by Chang Gung Memorial Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-06-21.
Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Treatment
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
Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
patients will receive septoplasty together with Le Fort I osteotomy
Procedure: Septoplasty
patient will only receive Le Fort I osteotomy
Changes in symptom severity and health-related quality of life in sinonasal conditions
Sino-Nasal Outcome Test 22(SNOT-22) questionnaire will be used
Time frame: before surgery and 24 months after surgery
Changes in nasal patency and congestion
Acoustic rhinometry will be used
Time frame: before surgery and 24 months after surgery
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
Rhinomanometry will be used
Time frame: before surgery and 24 months after surgery
Changes of causative allergens
RAST examination will be used
Time frame: before surgery and 24 months after surgery
This study is status unknown, as verified in Apr 2013. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Chang Gung Memorial Hospital