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

April 26, 2023 updated by: Groupe Hospitalier Paris Saint Joseph

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

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

Study Locations

  • France
    • Ile-de-France
      • Paris, Ile-de-France, France, 75014
        • Groupe Hospitalier Paris Saint Joseph

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

patient admitted for septoplasty in Institut Arthur Vernes

Description

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 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
Nose Obstruction symptom Evaluation
Time Frame: 3 months
scale about nose obstruction filled up by the patient
3 months
nasal resistance to airflow
Time Frame: 3 months
3 months

Collaborators and Investigators

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

Sponsor

Groupe Hospitalier Paris Saint Joseph

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)

December 5, 2016

Primary Completion (Actual)

December 31, 2017

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

October 24, 2017

First Submitted That Met QC Criteria

October 31, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

April 27, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SEPTORHINO

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.

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