Outcome Analysis in Septorhinoplasty

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-07

Study Completion Date

2025-12-10

Brief Summary

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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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Detailed Description

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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

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Rhinoplasty Nasal Obstruction Esthetics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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External septorhinoplasty

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No