Outcome Analysis in Septorhinoplasty

Nasal Obstruction Clinical Trial

Official title:

Functional and Aesthetic Outcome Analysis in External Septorhinoplasty

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03925389
• Other study ID #: FDSV02
• Status: Recruiting
• Start date: May 7, 2019
• Est. completion date: December 10, 2024

Study information

• Verified date: November 2023
• Source: Universiteit Antwerpen
• Contact: Frank Declau, MD, PhD
• Phone: +3232831500
• Email: nko[@]telenet.be
• Is FDA regulated: No
• Study type: Observational

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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 10, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Esthetics
• Nasal Obstruction
• Rhinoplasty

Intervention

Procedure:
• External septorhinoplasty
A surgical procedure to repair defects or deformities of both the nasal septum and the external nasal pyramid through an external incision at the columella.

Locations

Country	Name	City	State
Belgium	Dept. Otorhinolaryngology, H&N Surgery	Antwerp

Sponsors (3)

Lead Sponsor	Collaborator
FRANK DECLAU	Gasthuis Zusters Antwerpen, Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

References & Publications (6)

Declau F, Pingnet L, Verkest V, Hansen T. Cross-Cultural Evaluation of the Dutch FACE-Q Rhinoplasty Questionnaires Using Rasch Analysis. Aesthet Surg J. 2021 Nov 12;41(12):NP1916-NP1930. doi: 10.1093/asj/sjab217. — View Citation

Pingnet L, Verkest V , Saltychev M , Most SP , Declau F. Translation and Validation of the Standardized Cosmesis and Health Nasal Outcomes Survey in Dutch. B-ENT 2022; 18: 170-175. doi: 10.5152/B-ENT.2022.22910.

Pingnet L, Verkest V, Fransen E, Declau F. Dutch Translation and Validation of the FACE-Q Rhinoplasty Module. Facial Plast Surg. 2021 Jun;37(3):296-301. doi: 10.1055/s-0040-1721099. Epub 2021 Jan 27. — View Citation

Valérie Verkest, Laura PIngnet, Erik Fransen, Frank Declau. Analysis of functional and aesthetic outcomes in external septorhinoplasty: study protocol. B-ENT 2020; 16: 45-50 DOI: 10.5152/B-ENT.2020.19125

Verkest V, Pingnet L, Fransen E, Declau F. Multidimensionality of Patient-Reported Outcome Measures in Rhinoplasty Satisfaction. Facial Plast Surg. 2022 Oct;38(5):468-476. doi: 10.1055/a-1760-1422. Epub 2022 Feb 3. — View Citation

Verkest V, Pingnet L, Fransen E, Declau F. Piezo-assisted Turbinoplasty Versus Partial Turbinectomy in External Septorhinoplasty: A Prospective Comparative Study in 100 Patients. Aesthetic Plast Surg. 2022 Jun;46(3):1323-1331. doi: 10.1007/s00266-021-02662-0. Epub 2022 Jan 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of pre- and postoperative changes in aesthetic satisfaction using FACE-Q (TM) questionnaire	Change between pre- and postoperative results of FACE-Q questionnaire.; • FACE-Q (TM): Two items of the FACE-Q (TM) instrument (satisfaction with nose and satisfaction with nostrils) are used: Subscale 'Satisfaction of the nostrils': score from 0 (very unsatisfied) to 100 (very satisfied).; Subscale 'Satisfaction of the nose': score from 0 (very unsatisfied) to 100 (very satisfied).	12 months
Primary	Measurement of pre- and postoperative changes in nasal obstruction using NOSE questionnaire	Change between pre- and postoperative results of NOSE questionnaire.; • NOSE (Nasal Obstruction and Septoplasty Effectiveness Scale): scale from 0 (no nasal obstruction) to 100 (severe nasal obstruction).	12 months
Primary	Measurement of pre- and postoperative changes in nasal obstruction using acoustic rhinometry	Change between pre- and postoperative acoustic rhinometry: •AR (acoustic rhinometry): minimal cross-sectional area (cm2) (MCA) is measured for each nostril separately.	12 months
Primary	Measurement of pre- and postoperative changes in nasal obstruction using peak nasal inspiratory flow:	Change between pre- and postoperative peak nasal inspiratory flow: •PNIF (peak nasal inspiratory flow): peak nasal inspiratory flow (l/min) is measured for each nostril separately.	12 months
Primary	Measurement of pre- and postoperative changes in nasal obstruction using rhinomanometry	Change between pre- and postoperative rhinomanometry : •NAR(nasal anterior rhinomanometry) : nasal airflow at 150 Pa is recorded for each nostril separately (ml/sec).	12 months
Primary	Measurement of pre- and postoperative changes in aesthetic satisfaction Utrecht Questionnaire: 6 items scale: - 5 items with Likert scale from 5 (not at all) to 25 very (often) - 1 item: VAS score from 0 (very ugly) to 10 (very nice)	Change between pre- and postoperative results of Utrecht questionnaire.	12 months
Primary	Measurement of pre- and postoperative changes in aesthetic satisfaction and nasal obstruction using the SCHNOS Questionnaire	Change between pre- and postoperative results of SCHNOS questionnaire. 10 items scale from 0 (no problem) to 5 (severe problem).	12 months
Primary	Measurement of pre- and postoperative changes in aesthetic satisfaction using the BDD (Body Dysmorphic Disorder) Questionnaire. 7 items scale: item 1-2 : dichotomous (yes/no) Item 3-6: 1(mild) to 5 (extreme) Item 7: dichotomous (yes/no)	Change between pre- and postoperative results of BDD questionnaire.	12 months
Secondary	Correlation between NOSE questionnaire and nasal functional tests	Correlation between: NOSE (Nasal Obstruction and Septoplasty Effectiveness Scale): scale from 0 (no nasal obstruction) to 100 (severe nasal obstruction).; and: NAR(nasal active rhinomanometry) : nasal airflow at 150 Pa is recorded for each nostril separately (ml/sec).; PNIF (peak nasal inspiratory flow): peak nasal inspiratory flow (l/min) is measured for each nostril separately.; AR (acoustic rhinometry): minimal cross-sectional area (cm2) (MCA) is measured for each nostril.	12 months
Secondary	Correlation between change of nasal functional tests and surgical methods	NAR(nasal active rhinomanometry) : nasal airflow at 150 Pa is recorded for each nostril separately (ml/sec).; PNIF (peak nasal inspiratory flow): peak nasal inspiratory flow (l/min) is measured for each nostril separately.; AR (acoustic rhinometry): minimal cross-sectional area (cm2) (MCA) is measured for each nostril.; and: surgical data acquired from the operative report from each patient: technical procedures undertaken to improve nasal obstruction by addressing the anatomic structures that comprise the internal and/or external nasal valves.	12 months