RhinoplastyNCT03925389
Outcome Analysis in Septorhinoplasty
An observational study of Rhinoplasty and Nasal Obstruction, run by FRANK DECLAU at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rhinoplasty, Nasal Obstruction, Esthetics
- What is being tested?
- External septorhinoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 750 participants
- Where
- 1 siteBelgium
- Study dates
- 7 May 2019to 10 Dec 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants eligible for external septorhinoplasty will consecutively be enrolled in the study according to CONSORT guidelines
Who may be able to join
- 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.
Who cannot join
- < 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Dept. Otorhinolaryngology, H&N Surgery
Antwerp, 2018
Frank Declau, MD, PhD, +3232831500, nko@telenet.be
Valérie Verkest, MD
About this study
Official title: Functional and Aesthetic Outcome Analysis in External Septorhinoplasty
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).
Read the 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
- Conditions
- Rhinoplasty, Nasal Obstruction, Esthetics
- Being tested
- External septorhinoplasty
- Keywords
- Nasal function, Septorhinoplasty, Patient-reported outcome, Rhinomanometry, Acoustic Rhinometry, Peak Nasal Inspiratory Flow, Esthetics
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External septorhinoplastyProcedure or surgery
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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 12 months
Secondary outcomes (2)
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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start7 May 2019
- Primary completion10 Dec 2025 (estimated)
- Study completion10 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for RhinoplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FRANK DECLAU
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen, Gasthuis Zusters Antwerpen
- Responsible party
- Sponsor-investigator, FRANK DECLAU, Universiteit Antwerpen
- Investigators
- Frank Declau, MD, PhD, Principal investigator, Universiteit Antwerpen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03925389
- Sponsor's protocol ID
- FDSV02
- Status last verified
- Mar 2025
- First submitted
- 13 Apr 2019
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 33506453Valérie 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
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.
PubMed 33945612Verkest 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.
PubMed 35114725Verkest 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.
PubMed 35022839Pingnet 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.