Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome

Not Applicable

Completed

• Conditions: Empty Nose Syndrome
• Interventions: Procedure: Nasal surgery

• Registration Number: NCT02230423
• Lead Sponsor: University of Zurich

Brief 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).

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-04-28
• Study First Submitted QC: 2014-08-29
• Study First Posted: 2014-09-03
• Study Start: 2015-05
• Primary Completion: 2018-04
• Study Completion: 2018-05
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-11
• Last Update Posted: 2018-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients receiving nose surgery	Nasal surgery	Patients in need of nose surgery, before and after surgery; or only after successful surgery, then with or without "Empty Nose Syndrome".

Primary Outcome Measures

Name	Time	Method
Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression	Up to 1 year post-surgery

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Zurich University Hospital; 🇨🇭 Zurich, Switzerland