Trigeminal Endonasal Perception: A Predictor for Septoplasty Outcome

October 11, 2018 updated by: University of Zurich

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Zurich University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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".
Procedure: Nasal surgery
Other Names:
  • Septoplasty
  • Turbinoplasty
  • Removal of turbinates and septum parts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 1 year post-surgery

Secondary Outcome Measures

Outcome 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
Time Frame: Up to 1 year post-op
Up to 1 year post-op

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Zurich

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

April 28, 2014

First Submitted That Met QC Criteria

August 29, 2014

First Posted (Estimate)

September 3, 2014

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 11, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM_31_01_2014
  • KEK-ZH-Nr: 2013-0545 (Other Identifier: Zurich Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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