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Completed

NCT Number: NCT02230423

Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome

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).

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Key information

Conditions

Empty Nose Syndrome

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zurich University Hospital

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal surgery

Procedure

Other names: Septoplasty, Turbinoplasty, Removal of turbinates and septum parts

Primary outcomes

  1. Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression

    Time frame: Up to 1 year post-surgery

Secondary outcomes

  1. 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

    Time frame: Up to 1 year post-op

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 3, 2014
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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