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Clinical 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).


Clinical Trial 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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03925389
Study type Observational
Source Universiteit Antwerpen
Contact Frank Declau, MD, PhD
Phone +3232831500
Email nko@telenet.be
Status Recruiting
Phase
Start date May 7, 2019
Completion date December 10, 2024

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