Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome

Study Overview
=================
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.

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

Conditions
-----------------
Empty Nose Syndrome

Intervention / Treatment
-----------------
* Procedure: Nasal surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients receiving nose surgery<br>Patients in need of nose surgery, before and after surgery; or only after successful surgery, then with or without Empty Nose Syndrome. | Procedure: Nasal surgery<br> <br> * Other names: Removal of turbinates and septum parts;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional nasal surgery, Empty Nose Syndrome (ENS)