Health TrialsbyHealthPanel

Outcome Analysis in Septorhinoplasty

ConditionsRhinoplastyNasal ObstructionEsthetics
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFRANK DECLAU

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

< 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 population

Participants eligible for external septorhinoplasty will consecutively be enrolled in the study according to CONSORT guidelines

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • External septorhinoplasty

    Procedure/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.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

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).

Time frame
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).

Time frame
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.

Time frame
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.

Time frame
12 months

Secondary outcomes

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.

Time frame
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.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

FRANK DECLAU

Lead sponsor

Universiteit Antwerpen

Sponsor institution

Universiteit Antwerpen

Collaborator

Gasthuis Zusters Antwerpen

Collaborator

Source ClinicalTrials.gov
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