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NCT Number: NCT03925389

Outcome Analysis in 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).

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Key information

Conditions

Rhinoplasty Airway Obstruction Esthetics Nasal Obstruction Nose Diseases Otorhinolaryngologic Diseases Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dept. Otorhinolaryngology, H&N Surgery

Antwerp, 2018, Belgium

Location status: Recruiting

Location contact

Frank Declau, MD, PhD

CONTACT

[email protected]

+3232831500

Laura Pingnet, MD

SUB_INVESTIGATOR

Valérie Verkest, MD

SUB_INVESTIGATOR

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Measurement of pre- and postoperative changes in aesthetic satisfaction using FACE-Q (TM) questionnaire

    Time frame: 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).

  2. Measurement of pre- and postoperative changes in nasal obstruction using NOSE questionnaire

    Time frame: 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).

  3. Measurement of pre- and postoperative changes in nasal obstruction using acoustic rhinometry

    Time frame: 12 months

    Change between pre- and postoperative acoustic rhinometry:

    •AR (acoustic rhinometry): minimal cross-sectional area (cm2) (MCA) is measured for each nostril separately.

  4. Measurement of pre- and postoperative changes in nasal obstruction using peak nasal inspiratory flow:

    Time frame: 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.

  5. Measurement of pre- and postoperative changes in nasal obstruction using rhinomanometry

    Time frame: 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).

  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)

    Time frame: 12 months

    Change between pre- and postoperative results of Utrecht questionnaire.

  7. Measurement of pre- and postoperative changes in aesthetic satisfaction and nasal obstruction using the SCHNOS Questionnaire

    Time frame: 12 months

    Change between pre- and postoperative results of SCHNOS questionnaire. 10 items scale from 0 (no problem) to 5 (severe problem).

  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)

    Time frame: 12 months

    Change between pre- and postoperative results of BDD questionnaire.

Secondary outcomes

  1. Correlation between NOSE questionnaire and nasal functional tests

    Time frame: 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.

  2. Correlation between change of nasal functional tests and surgical methods

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Frank Declau, MD, PhD

CONTACT

[email protected]

+3232831500

Sponsors and collaborators

Lead sponsor

FRANK DECLAU

Other

Collaborators

  • Gasthuis Zusters Antwerpen
  • Universiteit Antwerpen

Registry information

Official study title

Functional and Aesthetic Outcome Analysis in External Septorhinoplasty

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Apr 24, 2019
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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