External septorhinoplasty in Nasal Obstruction and Rhinoplasty and Esthetics - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Procedure: External septorhinoplasty

Detailed 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 Type

Observational

Enrollment (Estimated)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Frank Declau, MD, PhD
Phone Number: +3232831500
Email: nko@telenet.be

Study Locations

Belgium
- - Antwerp, Belgium, 2018
    - Recruiting
    - Dept. Otorhinolaryngology, H&N Surgery
    - Contact:
      
      Frank Declau, MD, PhD
      
      Phone Number: +3232831500
      
      Email: nko@telenet.be
    - Sub-Investigator:
      
      Valérie Verkest, MD
    - Sub-Investigator:
      
      Laura Pingnet, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants eligible for external septorhinoplasty will consecutively be enrolled in the study according to CONSORT guidelines

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of pre- and postoperative changes in aesthetic satisfaction using FACE-Q (TM) questionnaire Time Frame: 12 months	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
Measurement of pre- and postoperative changes in nasal obstruction using NOSE questionnaire Time Frame: 12 months	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
Measurement of pre- and postoperative changes in nasal obstruction using acoustic rhinometry Time Frame: 12 months	Change between pre- and postoperative acoustic rhinometry: •AR (acoustic rhinometry): minimal cross-sectional area (cm2) (MCA) is measured for each nostril separately.	12 months
Measurement of pre- and postoperative changes in nasal obstruction using peak nasal inspiratory flow: Time Frame: 12 months	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
Measurement of pre- and postoperative changes in nasal obstruction using rhinomanometry Time Frame: 12 months	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
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) Time Frame: 12 months	Change between pre- and postoperative results of Utrecht questionnaire.	12 months
Measurement of pre- and postoperative changes in aesthetic satisfaction and nasal obstruction using the SCHNOS Questionnaire Time Frame: 12 months	Change between pre- and postoperative results of SCHNOS questionnaire. 10 items scale from 0 (no problem) to 5 (severe problem).	12 months
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) Time Frame: 12 months	Change between pre- and postoperative results of BDD questionnaire.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation between NOSE questionnaire and nasal functional tests Time Frame: 12 months	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
Correlation between change of nasal functional tests and surgical methods Time Frame: 12 months	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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

FRANK DECLAU

Collaborators

Universiteit Antwerpen

Gasthuis Zusters Antwerpen

Investigators

Principal Investigator: Frank Declau, MD, PhD, Universiteit Antwerpen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
Valérie Verkest, Laura Pİngnet, 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
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.
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.
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.
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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 7, 2019

Primary Completion (Estimated)

December 10, 2025

Study Completion (Estimated)

December 10, 2025

Study Registration Dates

First Submitted

April 13, 2019

First Submitted That Met QC Criteria

April 19, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

FDSV02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Outcome Analysis in Septorhinoplasty

Functional and Aesthetic Outcome Analysis in External Septorhinoplasty