Possible Manifestation of Rhinitis After Nasal Fracture

Nasal Fracture Clinical Trial

Official title:

Possible Manifestation of Rhinitis After Nasal Fracture

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02240576
• Other study ID #: nose fracture study
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2014
• Last updated: December 2, 2015
• Start date: December 2014
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 310
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Fractures, Bone
• Nasal Fracture

Locations

Country	Name	City	State
Belgium	UZ Leuven ENT	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group.	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	at least 1 year after surgery	No