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RhinoplastyNCT03925389

Outcome Analysis in Septorhinoplasty

An observational study of Rhinoplasty and Nasal Obstruction, run by FRANK DECLAU at 1 site in Belgium.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
Are there results?
Not yet: the study is under way

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.

Frank Declau, MD, PhD contact

+3232831500

nko@telenet.be

Belgium1 site, 1 recruiting

  • Dept. Otorhinolaryngology, H&N Surgery

    Antwerp, 2018

    Frank Declau, MD, PhD, +3232831500, nko@telenet.be

    Valérie Verkest, MD

    Recruiting

Other trials in Belgium

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
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.

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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)

  1. 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

  2. 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.

  1. First posted24 Apr 2019
  2. Study start7 May 2019
  3. Primary completion10 Dec 2025 (estimated)
  4. Study completion10 Dec 2025 (estimated)

Resources

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)
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 33506453

  • 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

  • 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 33945612

  • 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.

    PubMed 35114725

  • 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.

    PubMed 35022839

  • 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.

Questions about this trial

What is this clinical trial studying?

An observational study of Rhinoplasty and Nasal Obstruction, run by FRANK DECLAU at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Frank Declau, MD, PhD (+3232831500, nko@telenet.be), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Measurement of pre- and postoperative changes in aesthetic satisfaction using FACE-Q (TM) questionnaire (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03925389, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.

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