Possible Manifestation of Rhinitis After Nasal Fracture

Active, not recruiting

• Conditions: Nasal Fracture

• Registration Number: NCT02240576
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-09-09
• Study First Submitted QC: 2014-09-11
• Study First Posted: 2014-09-15
• Study Start: 2014-12
• Primary Completion: 2017-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 310

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

Inclusion criteria of the control group:

• Presence of problem on vocal cords without previous nasal fracture
• Surgery of the vocal cords under general anaesthesia in 2005-2013

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group.	at least 1 year after surgery	Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group.; outcome measurement: percentage of participants

Trial Locations

Locations (1)

UZ Leuven ENT; 🇧🇪 Leuven, Vlaams Brabant, Belgium