Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome

Empty Nose Syndrome Clinical Trial

Official title:

Trigeminale Endonasale Perzeption, Ein Prädiktor für Das Outcome Einer Septumplastik - Eine Prospektive Kohortenstudie Mit Klinischen Und Biologischen Untersuchungen

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02230423
• Other study ID #: SM_31_01_2014
• Secondary ID: KEK-ZH-Nr: 2013-
• Status: Completed
• Phase: N/A
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: October 2018
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study investigates wether patients with increased trigeminal perception threshold and low expression of TRP channels have more often nasal blockage despite functionally successful nasal surgery (TRP channel = transient receptor potential channel).

Description:

The aim of this study is to find out wether patients with high trigeminal perception threshold (=decreased intranasal sensibility) and low expression of TRP channels of the mucosa suffer more often from impaired nasal breathing after surgery. This could lead to the identification of prognostic factors and therefore prevention of nasal surgery with bad outcome.

Further, differences between patients with empty nose syndrome and asymptomatic patients after extended intranasal surgery, concerning trigeminal perception and TRP channel expression will be investigated.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: May 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• Patients undergoing a primary septoplasty and/or turbinoplasty

• Patients suffering from empty nose syndrome after measurably successful nasal surgery

• Patients with removed turbinates and/or septum, not suffering from ENS (i.e. tumor patients)

Exclusion Criteria:

• Patients with known neurologic disorders that could compromise perception threshold measurements

• Patients with known allergies/intolerance to test agents that are used to measure perception thresholds (Cineol=Eucalypt; Menthol, CO2= Carbon Dioxide)

• Inability to judge or understand the testing or the informed consent

Related Conditions & MeSH terms

• Empty Nose Syndrome

Intervention

Procedure:
• Nasal surgery

Locations

Country	Name	City	State
Switzerland	Zurich University Hospital	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression		Up to 1 year post-surgery
Secondary	Differences between trigeminal perception threshold as as well as TRP expression levels in patients with postoperative empty nose syndrome and patients with subjectively unimpaired nasal breathing after extended intranasal surgery		Up to 1 year post-op