Outcome Analysis in Septorhinoplasty

Last updated: March 24, 2025
Sponsor: FRANK DECLAU
Overall Status: Active - Recruiting

Phase

N/A

Condition

Nasal Obstruction

Acute Rhinitis

Treatment

External septorhinoplasty

Clinical Study ID

NCT03925389
FDSV02
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • at least 18 years old

  • Patients eligible for external septorhinoplasty: patients seen in consultationbecause of nasal obstruction were evaluated. Patients who had symptoms of nasalobstruction for at least 1 year that were the result of an identifiable anatomicalcause such as septal deviation, turbinate hypertrophy, internal valve collapse, orexternal valve collapse were included in the study.

Exclusion

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

Study Design

Total Participants: 750
Treatment Group(s): 1
Primary Treatment: External septorhinoplasty
Phase:
Study Start date:
May 07, 2019
Estimated Completion Date:
December 10, 2025

Study 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

Connect with a study center

  • Dept. Otorhinolaryngology, H&N Surgery

    Antwerp, 2018
    Belgium

    Active - Recruiting

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