NCT03925389

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 13, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 24, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

May 7, 2019

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2025

Completed
Last Updated

March 27, 2025

Status Verified

March 1, 2025

Enrollment Period

6.6 years

First QC Date

April 13, 2019

Last Update Submit

March 24, 2025

Conditions

RhinoplastyNasal ObstructionEsthetics

Keywords

Nasal functionSeptorhinoplastyPatient-reported outcomeRhinomanometryAcoustic RhinometryPeak Nasal Inspiratory FlowEsthetics

Outcome Measures

Primary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • Correlation between NOSE questionnaire and nasal functional tests

    12 months

  • Correlation between change of nasal functional tests and surgical methods

    12 months

Interventions

External septorhinoplastyPROCEDURE

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • \< 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 the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. Otorhinolaryngology, H&N Surgery

Antwerp, 2018, Belgium

RECRUITING

Related Publications (6)

  • 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.

    PMID: 33506453BACKGROUND

  • 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

    BACKGROUND

  • 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.

    PMID: 33945612BACKGROUND

  • 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.

    PMID: 35114725BACKGROUND

  • 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.

    PMID: 35022839BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Nasal Obstruction

Condition Hierarchy (Ancestors)

Nose DiseasesRespiratory Tract DiseasesAirway ObstructionRespiratory InsufficiencyRespiration DisordersOtorhinolaryngologic Diseases

Study Officials

  • Frank Declau, MD, PhD

    Universiteit Antwerpen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Frank Declau, MD, PhD

CONTACT

+3232831500nko@telenet.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Head of Otolaryngology Department, Visiting professor

Study Record Dates

First Submitted

April 13, 2019

First Posted

April 24, 2019

Study Start

May 7, 2019

Primary Completion

December 10, 2025

Study Completion

December 10, 2025

Last Updated

March 27, 2025

Record last verified: 2025-03

Locations

BE(1)