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Currently, you can access the following clinical trials being conducted worldwide:
Clinicaltrials.gov identifier NCT03925389
Recruitment Status Recruiting
First Posted April 24, 2019
Last update posted July 8, 2019
A prospective observational cohort study that measures pre- and postoperative outcome of septorhinoplasty by means of patient-related outcome measures (PROMS: NOSE and FACE-Q) as well as with functional tests (NAR, AR, PNIF).
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
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- 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.
- < 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
Contact: Frank Declau, MD, PhD +3232831500 email@example.com
Dept. Otorhinolaryngology, H&N Surgery
Gasthuis Zusters Antwerpen
Principal Investigator: Frank Declau, MD, PhD Universiteit Antwerpen