Outcome Analysis in Septorhinoplasty

Study Overview
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Brief Summary
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A prospective observational cohort study that measures pre- and postoperative outcome of septorhinoplasty by means of patient-related outcome measures (PROMS: NOSE, FACE-Q, Utrecht Questionnaire, SCHNOS and BDDQ-AS) as well as with functional tests (NAR, AR, PNIF).

Detailed Description
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Introduction: In an ENT setting, septorhinoplasty is frequently performed for both functional and aesthetic reasons. Therefore, pre- and postoperative evaluation of patients' 'total' satisfaction regarding their nasal appearance and functional result is paramount. Objectives: To measure the pre- and postoperative functional and aesthetic outcome in patients undergoing an external septorhinoplasty. Design, setting, participants: A prospective observational, longitudinal outcome cohort study in a single private hospital centre is set up. All participants are patients undergoing an external septorhinoplasty for functional and aesthetic reasons. Exposures: The Nasal Obstruction Symptom Evaluation scale (NOSE), Utrecht questionnaire, the FACE-Q Satisfaction With Nose, FACE-Q Satisfaction With Nostrils, SCHNOS score and BDDQ-AS score, are administered to patients preoperatively and at 3, 6 and 12 months postoperatively. Also functional tests (nasal anterior rhinomanometry (NAR), Peak nasal inspiratory flow (PNIF) and acoustic rhinometry (AR) will be performed preoperatively and postoperatively at 6 and 12 months. Patient demographics, nasal history, and outcomes will be analyzed. Main outcome and measures: The primary outcome will measure longitudinal postoperative changes in nasal obstruction and aesthetic satisfaction: Change between pre- and postoperative results of NOSE and FACE-Q questionnaires, Utrecht questionnaire, SCHNOS and BDDQ-AS score (time frame: at inclusion and at 3, 6 and 12 months postoperatively) Change between pre- and postoperative values of NAR, PNIF and acoustic rhinometry (time frame: at inclusion and at 6 and 12 months postoperatively) Secondary outcome Correlation between PROMS and functional tests Correlation between change in functional tests and the surgical methods used

Official Title
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Functional and Aesthetic Outcome Analysis in External Septorhinoplasty

Conditions
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Rhinoplasty, Nasal Obstruction, Esthetics

Intervention / Treatment
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* Procedure: External septorhinoplasty


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: at least 18 years old Patients eligible for external septorhinoplasty: patients seen in consultation because of nasal obstruction were evaluated. Patients who had symptoms of nasal obstruction for at least 1 year that were the result of an identifiable anatomical cause such as septal deviation, turbinate hypertrophy, internal valve collapse, or external valve collapse were included in the study. Exclusion Criteria: < 18 years mental or physical incapacity to answer the questionnaires nasal fracture or surgery in the past year nasal cocaine use in the past year

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: External septorhinoplasty|A surgical procedure to repair defects or deformities of both the nasal septum and the external nasal pyramid through an external incision at the columella.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of pre- and postoperative changes in aesthetic satisfaction using FACE-Q (TM) questionnaire | Change between pre- and postoperative results of FACE-Q questionnaire. • FACE-Q (TM): Two items of the FACE-Q (TM) instrument (satisfaction with nose and satisfaction with nostrils) are used: Subscale 'Satisfaction of the nostrils': score from 0 (very unsatisfied) to 100 (very satisfied). Subscale 'Satisfaction of the nose': score from 0 (very unsatisfied) to 100 (very satisfied). | 12 months | 
| Measurement of pre- and postoperative changes in nasal obstruction using NOSE questionnaire | Change between pre- and postoperative results of NOSE questionnaire. • NOSE (Nasal Obstruction and Septoplasty Effectiveness Scale): scale from 0 (no nasal obstruction) to 100 (severe nasal obstruction). | 12 months | 
| Measurement of pre- and postoperative changes in nasal obstruction using acoustic rhinometry | Change between pre- and postoperative acoustic rhinometry: •AR (acoustic rhinometry): minimal cross-sectional area (cm2) (MCA) is measured for each nostril separately. | 12 months | 
| Measurement of pre- and postoperative changes in nasal obstruction using peak nasal inspiratory flow: | Change between pre- and postoperative peak nasal inspiratory flow: •PNIF (peak nasal inspiratory flow): peak nasal inspiratory flow (l/min) is measured for each nostril separately. | 12 months | 
| Measurement of pre- and postoperative changes in nasal obstruction using rhinomanometry | Change between pre- and postoperative rhinomanometry : •NAR(nasal anterior rhinomanometry) : nasal airflow at 150 Pa is recorded for each nostril separately (ml/sec). | 12 months | 
| Measurement of pre- and postoperative changes in aesthetic satisfaction Utrecht Questionnaire: 6 items scale: - 5 items with Likert scale from 5 (not at all) to 25 very (often) - 1 item: VAS score from 0 (very ugly) to 10 (very nice) | Change between pre- and postoperative results of Utrecht questionnaire. | 12 months | 
| Measurement of pre- and postoperative changes in aesthetic satisfaction and nasal obstruction using the SCHNOS Questionnaire | Change between pre- and postoperative results of SCHNOS questionnaire. 10 items scale from 0 (no problem) to 5 (severe problem). | 12 months | 
| Measurement of pre- and postoperative changes in aesthetic satisfaction using the BDD (Body Dysmorphic Disorder) Questionnaire. 7 items scale: item 1-2 : dichotomous (yes/no) Item 3-6: 1(mild) to 5 (extreme) Item 7: dichotomous (yes/no) | Change between pre- and postoperative results of BDD questionnaire. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between NOSE questionnaire and nasal functional tests | Correlation between: NOSE (Nasal Obstruction and Septoplasty Effectiveness Scale): scale from 0 (no nasal obstruction) to 100 (severe nasal obstruction). and: NAR(nasal active rhinomanometry) : nasal airflow at 150 Pa is recorded for each nostril separately (ml/sec). PNIF (peak nasal inspiratory flow): peak nasal inspiratory flow (l/min) is measured for each nostril separately. AR (acoustic rhinometry): minimal cross-sectional area (cm2) (MCA) is measured for each nostril. | 12 months | 
| Correlation between change of nasal functional tests and surgical methods | NAR(nasal active rhinomanometry) : nasal airflow at 150 Pa is recorded for each nostril separately (ml/sec). PNIF (peak nasal inspiratory flow): peak nasal inspiratory flow (l/min) is measured for each nostril separately. AR (acoustic rhinometry): minimal cross-sectional area (cm2) (MCA) is measured for each nostril. and: surgical data acquired from the operative report from each patient: technical procedures undertaken to improve nasal obstruction by addressing the anatomic structures that comprise the internal and/or external nasal valves. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nasal function, Septorhinoplasty, Patient-reported outcome, Rhinomanometry, Acoustic Rhinometry, Peak Nasal Inspiratory Flow, Esthetics