Outcome Analysis in Septorhinoplasty
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Esthetics
- Nasal Obstruction
- Rhinoplasty
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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...
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) and the FACE-Q Satisfaction With Nose, FACE-Q Satisfaction With Nostrils, 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 (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
Tracking Information
- NCT #
- NCT03925389
- Collaborators
- Universiteit Antwerpen
- Gasthuis Zusters Antwerpen
- Investigators
- Principal Investigator: Frank Declau, MD, PhD Universiteit Antwerpen
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