Olfaction and Inflammation in Chronic Rhinosinusitis With Nasal Polyps

Centre Hospitalier Universitaire de Saint Etienne3 enrolled

Overview

Impaired olfaction is one of the major complaints of patients with nasosinus polyposis, with nasal obstruction. In case of failure of medical treatment for patients with polyposis nasosinusal, they may use endoscopic surgery nasosinusal. Before surgery, 73% are hyposmic or anosmic, compared to 43% after surgery. Persistence of hyposmia or anosmia despite the removal of polyps can be explained by mechanisms inflammatory in the mucous membrane of the olfactory cleft. In addition, studies in mice have shown a degeneration of primary olfactory neurons at the level of the olfactory mucosa in connection with directly with TNF alpha, a pro-inflammatory molecule.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Nasal Polyps Chronic Rhinosinusitis With Nasal Polyps Olfaction Disorders

Interventions

Sniffin Stick TestDIAGNOSTIC_TEST

The test consists of odorous rods that are presented to the patient's nose. It consists of 3 parts different, with 3 sets of corresponding sticks: an olfactory threshold test, an olfactory discrimination test and an olfactory identification test. The final score, out of 48, is the sum of the olfactory threshold, discrimination and identification scores. Normal test values are defined as greater than the tenth percentile of the general population, so the test result is compared to reference values on a chart to determine whether the patient is normosmic, hyposmic or anosmic.

numerical evaluation scale for olfactionOTHER

numerical rating scale from 0 (no smell) to 10 (perfect smell)

numerical evaluation scale for nasal obstructionOTHER

numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)

nasal outcome testOTHER

list of symptoms and social/emotional consequences of rhino-sinusitis. 16 questions that the patient must code from "no problem" to "serious problem" over the last 15 days

dosage of 17 cytokinesBIOLOGICAL

dosage of 17 cytokines : G-CSF, GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p70), IL-13, IL-17A, MCP-1 (MCAF), MIP-1β,TNF-α

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria for patients : * Patients with nasosinus polyposis requiring nasosinus surgery * Patient affiliated or entitled to a social security * signed consent Inclusion Criteria for control group : * Patients with an indication for septoplasty * Patient affiliated or entitled to a social security * signed consent Exclusion Criteria for patients : * Patients with nasosinus polyposis secondary to another disease * Patients with hyposmia or anosmia prior to naso-sinus polyposis * Patients with diagnosed neurodegenerative disease * Patients who are mentally or physically unable to perform olfactory tests * Patients on anti-TNF-alpha therapy, long-term oral corticosteroid therapy, or other immunomodulatory therapy. Exclusion Criteria for control group : * Patients with nasosinus polyposis * Patients with chronic rhino-sinusitis * Patients with hyposmia or anosmia * Patients with diagnosed neurodegenerative disease * Patients who are mentally or physically unable to perform olfactory tests * Patients on anti-TNF-alpha therapy, long-term oral corticosteroid therapy, or other immunomodulatory therapy.

Outcomes

Primary Outcomes

expression rate of TNF-alpha in biopsies

The main evaluation criterion is based on two variables: the expression rate of TNF-alpha in olfactory slit biopsies and the Sniffin Stick test score.

Time frame: 2 months

Sniffin Stick test score

The main evaluation criterion is based on two variables: the expression rate of TNF-alpha in olfactory slit biopsies and the Sniffin Stick test score. Sniffin Stick test score : The final score, out of 48, is the sum of the olfactory threshold (out of 16), discrimination (out of 16) and identification (out of 16) scores. Normal test values are defined as greater than the tenth percentile of the general population, so the test result is compared to reference values on a chart to determine whether the patient is normosmic, hyposmic or anosmic.

Time frame: 2 months

Secondary Outcomes

Olfactory Cleft Endoscopic Score

measured at control and patients. 5 endoscopic feature to be completed : * discharge : 0= none or scant clear/thin drainage (normal) ; 1= more abundant, thicker clear/white drainage (not normal but not purulent) ; 2= thicker, more abundant, discolored/purulent drainage. * polyps : 0= none ; 1= discrete polyps partially narrowing/blocking the olfactory cleft (\<50%) ; 2= discrete polyps completely narrowing/blocking the olfactory cleft (\>50%). * edema : 0= none ; 1= swelling partially narrowing/blocking the olfactory cleft (\<50%) ; 2= swelling completely narrowing/blocking the olfactory cleft (\>50%). * crusting : 0= none ; 1= mild ; 2= severe * scarring : 0= none ; 1= mild ; 2= severe

Time frame: 2 months

expression rate of TNF-alpha in polyps