Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome

NCT ID: NCT02230423

Last Updated: 2018-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

140 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Empty Nose Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Patients receiving nose surgery

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

Group Type EXPERIMENTAL

Nasal surgery

Intervention Type PROCEDURE

Interventions

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Nasal surgery

Intervention Type PROCEDURE

Other Intervention Names

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Septoplasty Turbinoplasty Removal of turbinates and septum parts

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael Soyka, Dr.med.

Role: PRINCIPAL_INVESTIGATOR

Zurich University Hospital

Locations

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Zurich University Hospital

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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KEK-ZH-Nr: 2013-0545

Identifier Type: OTHER

Identifier Source: secondary_id

SM_31_01_2014

Identifier Type: -

Identifier Source: org_study_id

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