NCT02240576

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Dec 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress95%
Dec 2014Dec 2026

First Submitted

Initial submission to the registry

September 9, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 15, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

July 10, 2024

Status Verified

July 1, 2024

Enrollment Period

3 years

First QC Date

September 9, 2014

Last Update Submit

July 9, 2024

Conditions

Nasal Fracture

Keywords

surgery for nasal fracture

Outcome Measures

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.

    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

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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 Gasthuisberg.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Leuven ENT

Leuven, Vlaams Brabant, 3000, Belgium

Location

Study Officials

  • Peter Hellings, Prof Dr

    UZ Leuven

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2014

First Posted

September 15, 2014

Study Start

December 1, 2014

Primary Completion

December 1, 2017

Study Completion (Estimated)

December 1, 2026

Last Updated

July 10, 2024

Record last verified: 2024-07

Locations

BE(1)