Outcome Analysis in Septorhinoplasty
- Conditions
- Nasal ObstructionEstheticsRhinoplasty
- Registration Number
- NCT03925389
- Lead Sponsor
- FRANK DECLAU
- Brief Summary
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
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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 750
- 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.
- < 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Measurement of pre- and postoperative changes in nasal obstruction using NOSE questionnaire 12 months 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).Measurement of pre- and postoperative changes in nasal obstruction using peak nasal inspiratory flow: 12 months 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.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) 12 months Change between pre- and postoperative results of Utrecht questionnaire.
Measurement of pre- and postoperative changes in aesthetic satisfaction and nasal obstruction using the SCHNOS Questionnaire 12 months Change between pre- and postoperative results of SCHNOS questionnaire. 10 items scale from 0 (no problem) to 5 (severe problem).
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) 12 months Change between pre- and postoperative results of BDD questionnaire.
Measurement of pre- and postoperative changes in nasal obstruction using acoustic rhinometry 12 months Change between pre- and postoperative acoustic rhinometry:
•AR (acoustic rhinometry): minimal cross-sectional area (cm2) (MCA) is measured for each nostril separately.Measurement of pre- and postoperative changes in aesthetic satisfaction using FACE-Q (TM) questionnaire 12 months 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).Measurement of pre- and postoperative changes in nasal obstruction using rhinomanometry 12 months Change between pre- and postoperative rhinomanometry :
•NAR(nasal anterior rhinomanometry) : nasal airflow at 150 Pa is recorded for each nostril separately (ml/sec).
- Secondary Outcome Measures
Name Time Method Correlation between NOSE questionnaire and nasal functional tests 12 months 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.Correlation between change of nasal functional tests and surgical methods 12 months 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.
Trial Locations
- Locations (1)
Dept. Otorhinolaryngology, H&N Surgery
🇧🇪Antwerp, Belgium