Correlation of the Objective and Subjective Measures of t... | NCT03331107

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

NCT03331107

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Apr 27, 2023Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Nasal Obstruction

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 5, 2016Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Jan 1, 2019Actual

First Submitted Date

Oct 24, 2017

First Submission Date that Met QC Criteria

Oct 31, 2017

First Posted Date

Nov 6, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 26, 2023

Last Update Posted Date

Apr 27, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient admitted for septoplasty in Institut Arthur Vernes

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

Condition Browse Module

MeSH Terms

ID	Term
D015508	Nasal Obstruction

Ancestor Terms

ID	Term
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D000402	Airway Obstruction
D012131	Respiratory Insufficiency

Browse Leaves

Not provided

Browse Branches

Not provided