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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

Outcome Analysis in Septorhinoplasty

Clinicaltrials.gov identifier NCT03925389

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted July 8, 2019

Study Description

Brief summary:

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).

  • Condition or Disease:Rhinoplasty
    Nasal Obstruction
    Esthetics
  • Intervention/Treatment: Procedure: External septorhinoplasty
  • Phase: N/A
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) 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

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 30 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Functional and Aesthetic Outcome Analysis in External Septorhinoplasty
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: December 2020
  • Estimated Study Completion Date: December 2020
Outcome Measures
  • Primary Outcome Measures: 1. 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).
  • 2. 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).
  • 3. 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.
  • 4. 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.
  • 5. 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).
  • Secondary Outcome Measures: 1. 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.
  • 2. 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.
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • 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
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

Contacts and Locations
Contacts

Contact: Frank Declau, MD, PhD +3232831500 nko@telenet.be

Locations

Belgium
Dept. Otorhinolaryngology, H&N Surgery
Antwerp

Sponsors and Collaborators

FRANK DECLAU

Universiteit Antwerpen

Gasthuis Zusters Antwerpen

Investigators

Principal Investigator: Frank Declau, MD, PhD Universiteit Antwerpen

More Information
  • Responsible Party: FRANK DECLAU
  • ClinicalTrials.gov Identifier: NCT03925389 History of Changes
  • Other Study ID Numbers: FDSV02
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: July 8, 2019
  • Last Verified: July 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by FRANK DECLAU: Patient-reported outcome
    Rhinomanometry
    Acoustic Rhinometry
    Peak Nasal Inspiratory Flow
    Esthetics
    Nasal function
    Septorhinoplasty
  • Additional relevant MeSH terms: Nasal Obstruction