Possible Manifestation of Rhinitis After Nasal Fracture

NCT ID: NCT02240576

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

310 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2026-12-31

Brief Summary

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We would like to investigate our hypothesis of a higher prevalence of nasal fracture in the history of idiopathic rhinitis (IR) patients compared to healthy controls. Therefore a retrospective analysis of 310 patients with a nasal fracture in the past would be useful to investigate the incidence of IR in this cohort afterwards (5-10 y later).

Detailed Description

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The patient population will be recruited by sending patient questionnaires (form in addendum) to patients who suffered a nasal fracture five to ten years ago (time period 2005-2013) with nose reposition afterwards under general anaesthesia in the chirurgical day care centre (CDC) of university hospital (UZ) Leuven.

The control population (HC) will be recruited by sending a slightly adapted questionnaire (form in addendum) to patients who had surgery of the vocal cords under general anaesthesia in the CDC of UZ Leuven in the same period as the patient group. The control group will be age and sex-matched with the patient group.

Conditions

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Nasal Fracture

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Presence of nasal fracture in 2005-2013 and
* Diagnosis ascertained by a Ear-Nose-Throat (ENT) specialist and
* Followed by nose reposition surgery under general anaesthesia and
* Described in the clinical operation report as "mobile nose bones" OR Available radiography


* Presence of problem on vocal cords without previous nasal fracture
* Surgery of the vocal cords under general anaesthesia in 2005-2013
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Hellings, Prof Dr

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

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UZ Leuven ENT

Leuven, Vlaams Brabant, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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S57183

Identifier Type: -

Identifier Source: org_study_id

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