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).
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
Study Type
OBSERVATIONAL
Enrollment
750
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.
Dept. Otorhinolaryngology, H&N Surgery
Antwerp, Belgium
RECRUITINGMeasurement 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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)
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Change between pre- and postoperative results of Utrecht questionnaire.
Time frame: 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).
Time frame: 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.
Time frame: 12 months
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.
Time frame: 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.
Time frame: 12 months