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| Name | Class |
|---|---|
| Universiteit Antwerpen | OTHER |
| Gasthuis Zusters Antwerpen | OTHER |
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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).
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:
Secondary outcome
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| External septorhinoplasty | Procedure | 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. |
| 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:
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants eligible for external septorhinoplasty will consecutively be enrolled in the study according to CONSORT guidelines
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Frank Declau, MD, PhD | Contact | +3232831500 | nko@telenet.be |
| Name | Affiliation | Role |
|---|---|---|
| Frank Declau, MD, PhD | Universiteit Antwerpen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept. Otorhinolaryngology, H&N Surgery | Recruiting | Antwerp | 2018 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33506453 | Background | Pingnet L, Verkest V, Fransen E, Declau F. Dutch Translation and Validation of the FACE-Q Rhinoplasty Module. Facial Plast Surg. 2021 Jun;37(3):296-301. doi: 10.1055/s-0040-1721099. Epub 2021 Jan 27. | |
| Background | Valérie Verkest, Laura Pİngnet, Erik Fransen, Frank Declau. Analysis of functional and aesthetic outcomes in external septorhinoplasty: study protocol. B-ENT 2020; 16: 45-50 DOI: 10.5152/B-ENT.2020.19125 | ||
| 33945612 |
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| ID | Term |
|---|---|
| D015508 | Nasal Obstruction |
| ID | Term |
|---|---|
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
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| 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 |
| 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 |
| Background |
| Declau F, Pingnet L, Verkest V, Hansen T. Cross-Cultural Evaluation of the Dutch FACE-Q Rhinoplasty Questionnaires Using Rasch Analysis. Aesthet Surg J. 2021 Nov 12;41(12):NP1916-NP1930. doi: 10.1093/asj/sjab217. |
| 35114725 | Background | Verkest V, Pingnet L, Fransen E, Declau F. Multidimensionality of Patient-Reported Outcome Measures in Rhinoplasty Satisfaction. Facial Plast Surg. 2022 Oct;38(5):468-476. doi: 10.1055/a-1760-1422. Epub 2022 Feb 3. |
| 35022839 | Background | Verkest V, Pingnet L, Fransen E, Declau F. Piezo-assisted Turbinoplasty Versus Partial Turbinectomy in External Septorhinoplasty: A Prospective Comparative Study in 100 Patients. Aesthetic Plast Surg. 2022 Jun;46(3):1323-1331. doi: 10.1007/s00266-021-02662-0. Epub 2022 Jan 13. |
| Background | Pingnet L, Verkest V , Saltychev M , Most SP , Declau F. Translation and Validation of the Standardized Cosmesis and Health Nasal Outcomes Survey in Dutch. B-ENT 2022; 18: 170-175. doi: 10.5152/B-ENT.2022.22910. |
| D012120 |
| Respiration Disorders |
| D010038 | Otorhinolaryngologic Diseases |