Analyzing outcomes of septorhinoplasty procedures
Functional and Aesthetic Outcome Analysis in External Septorhinoplasty
Universiteit Antwerpen · NCT03925389
This study is trying to see how well septorhinoplasty surgery helps people breathe better and feel happier about their nose over the course of a year.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 750 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universiteit Antwerpen (other) |
| Locations | 1 site (Antwerp) |
| Trial ID | NCT03925389 on ClinicalTrials.gov |
What this trial studies
This observational cohort study evaluates the pre- and postoperative outcomes of patients undergoing external septorhinoplasty for both functional and aesthetic reasons. It utilizes patient-reported outcome measures (PROMs) such as the NOSE and FACE-Q questionnaires, along with functional tests like nasal anterior rhinomanometry and acoustic rhinometry. Participants will be assessed at multiple time points: preoperatively and at 3, 6, and 12 months post-surgery to determine changes in nasal obstruction and aesthetic satisfaction. The study is conducted in a single private hospital setting in Antwerp.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with nasal obstruction due to identifiable anatomical causes who are seeking septorhinoplasty.
Not a fit: Patients under 18, those with recent nasal surgery or fractures, or individuals unable to complete questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of patient satisfaction and functional improvements following septorhinoplasty, leading to better surgical outcomes.
How similar studies have performed: Previous studies have shown that patient-reported outcomes can effectively measure satisfaction and functional improvements in similar surgical procedures.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Antwerp
- Dept. Otorhinolaryngology, H&N Surgery — Antwerp, Belgium (RECRUITING)
Study contacts
- Principal investigator: Frank Declau, MD, PhD — Universiteit Antwerpen
- Study coordinator: Frank Declau, MD, PhD
- Email: nko@telenet.be
- Phone: +3232831500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rhinoplasty, Nasal Obstruction, Esthetics, Nasal function, Septorhinoplasty, Patient-reported outcome, Rhinomanometry, Acoustic Rhinometry