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NCT Number: NCT02240576

Possible Manifestation of Rhinitis After Nasal Fracture

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UZ Leuven ENT

Leuven, Vlaams Brabant, 3000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Comparison of the incidence of IR after nasal fracture in the patient population with the incidence of IR in the control group.

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2026
First posted
Sep 15, 2014
Registry last updated
Jul 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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