Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02230423

Enrollment

140

Registered

2014-09-03

Start date

2015-05-31

Completion date

2018-05-31

Last updated

2018-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Empty Nose Syndrome

Keywords

Functional nasal surgery, Empty Nose Syndrome (ENS)

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.

Interventions

PROCEDURENasal surgery

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 99 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026