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NCT03331107 Clinical Trial

Correlation of the Objective and Subjective Measures of the Nasal Obstruction Before and After Surgery of the Nasal Septum

Nasal Obstruction Clinical Trial

Official title:
Correlation of the Objective and Subjective Measures of the Nasal Obstruction Before and After Surgery of the Nasal Septum

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03331107
Other study ID # SEPTORHINO
Secondary ID
Status Completed
Phase
First received
Last updated
Start date December 5, 2016
Est. completion date January 1, 2019

Study information
Verified date April 2023
Source Groupe Hospitalier Paris Saint Joseph
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Nasal obstruction is a very subjective sensation but it's also a frequent reason of consultation. Two specific questionnaire NOSE and RhinoQOL were validated; but rhinomanometry value is still a question to debate. As well as the difference between acoustic rhinometry and rhinomanometry. Usually nasal obstruction due to a septal deviation is treated by septoplasty. If the anatomic result can be proved true, the patient's felt would be unsuccessful. The aim of this study is to assess the impact of septoplasty on the nasal obstruction, objectively by rhinometry and subjectively by questionnaire.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date January 1, 2019
Est. primary completion date December 31, 2017
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - age >18 - with medical insurance - programmed for septoplasty - nasal obstruction with septal deviation - accept participation Exclusion Criteria: - nasal sine polyposis - endonasal mass - chronic sinusite - previous nasal surgery

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Groupe Hospitalier Paris Saint Joseph Paris Ile-de-France

Sponsors (1)
Lead Sponsor Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nose Obstruction symptom Evaluation scale about nose obstruction filled up by the patient 3 months
Primary nasal resistance to airflow 3 months
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