Clinical trial NCT03925389: Outcome Analysis in Septorhinoplasty
Official title: Functional and Aesthetic Outcome Analysis in External Septorhinoplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rhinoplasty
Nasal Obstruction
Esthetics
Keywords: Nasal function
Septorhinoplasty
Patient-reported outcome
Rhinomanometry
Acoustic Rhinometry
Peak Nasal Inspiratory Flow
Esthetics
Lead sponsor: Universiteit Antwerpen
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
name: Gasthuis Zusters Antwerpen
First posted: 2019-04-24
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants eligible for external septorhinoplasty will consecutively be enrolled in the study according to CONSORT guidelines

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

Eligibility criteria: 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

Primary outcomes:
measure: Measurement of pre- and postoperative changes in aesthetic satisfaction using FACE-Q (TM) questionnaire
timeFrame: 12 months
measure: Measurement of pre- and postoperative changes in nasal obstruction using NOSE questionnaire
timeFrame: 12 months
measure: Measurement of pre- and postoperative changes in nasal obstruction using acoustic rhinometry
timeFrame: 12 months
measure: Measurement of pre- and postoperative changes in nasal obstruction using peak nasal inspiratory flow:
timeFrame: 12 months
measure: Measurement of pre- and postoperative changes in nasal obstruction using rhinomanometry
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
measure: Measurement of pre- and postoperative changes in aesthetic satisfaction and nasal obstruction using the SCHNOS Questionnaire
timeFrame: 12 months
measure: 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)
timeFrame: 12 months
Secondary outcomes:
measure: Correlation between NOSE questionnaire and nasal functional tests
timeFrame: 12 months
measure: Correlation between change of nasal functional tests and surgical methods
timeFrame: 12 months
Other outcomes:
Locations:
city: Antwerp
country: Belgium
facility: Dept. Otorhinolaryngology, H&N Surgery
Study officials:
affiliation: Universiteit Antwerpen
name: Frank Declau, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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
citation: 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.
citation: 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.
citation: 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.
citation: 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.