Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome
Information source: University of Zurich
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Empty Nose Syndrome
Intervention: Nasal surgery (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: University of Zurich Official(s) and/or principal investigator(s):
Michael Soyka, Dr.med., Principal Investigator, Affiliation: Zurich University Hospital
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).
Clinical Details
Official title: Trigeminale Endonasale Perzeption, Ein Prädiktor für Das Outcome Einer Septumplastik - Eine Prospektive Kohortenstudie Mit Klinischen Und Biologischen Untersuchungen
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Measurement of subjective nasal breathing impairment after surgery depending on trigeminal perception threshold and TRP channel expression
Secondary outcome: 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
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Zurich University Hospital, Zurich 8091, Switzerland; Recruiting
Michael Soyka, Dr.med., Phone: +41 44 255 11 11, Email: michael.soyka@usz.ch
Michael Soyka, Dr.med., Principal Investigator
Additional Information
Starting date: May 2015
Last updated: June 2, 2015
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