Chronic Rhinosinusitis Classification Proposal

RHINOPLASTY Clinical Trial

Official title:

Chronic Rhinosinusitis Classification Proposal: Evaluation of the Severity and the Effectiveness of Medical and Surgical Treatments

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02822781
• Other study ID #: CLASSIFICATION RSC
• Status: Completed
• Phase: N/A
• First received: June 30, 2016
• Last updated: September 7, 2017
• Start date: November 1, 2015
• Est. completion date: July 21, 2016

Study information

• Verified date: September 2017
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Chronic rhinosinusitis (CRS) is a debilitating disease that remains (smell, nasal patency, flow) because currently treatment protocols available to us are with a limited efficacy. The assessment of the response to surgical treatment protocols and monitoring the become of patients treated with only drugs should allow investigators to identify the predictive patient's profile for the response. With this prospective data, this study would allow investigators to make a classification of Chronic rhinosinusitis.

Description:

Chronic rhinosinusitis (CRS) is a debilitating disease that remains (smell, nasal patency, flow) because currently treatment protocols available to us are with a limited efficacy.

For many years, practitioners have tried to identify a universal therapeutic protocol. It turns out that no treatment (functional endoscopic surgery, antifungal therapy, medical treatment with antibiotics / corticosteroids) does not resolve all of the symptoms and their effectiveness is variable from one patient to another.

The most plausible explanation is that the term "rhinosinusitis" includes various different pathophysiological mechanism entities, requiring different treatment. Like certain skin or lung diseases, chronic inflammation of the sinuses may have different origins, allergic or extrinsic (infectious). It is therefore important to determine the type of inflammation responsible for adapting the management.

First, it is important to determine from all forms of CRS (with or without polyps), those associated with allergic inflammation and infectious ones. The presence or absence of polyps does not appear to be a determining factor of the type of inflammation. However, the criteria

• allergy and asthma - could provide guidance to an allergic mechanism.

The study aims to distinguish different phenotypes CRS according to clinical, anatomical criteria and biological criteria. Clinical classification obtained would assess and predict more finely treatment response and target according to the phenotype, the best supported. Surgery is one of the therapeutic options in the treatment of rhinosinusitis, but the term satisfaction of healing and patient comfort is variable, a finer and precise distribution of patients will allow us to better predict the success of the surgery and therefore the offer targeted patients.

Primary objective :

To assess the response to surgical treatment of rhinosinusitis and the outcome of these patients in order to highlight predictors of success of surgery.

Secondary objectives:

Assess chronic rhinosinusitis phenotype by score SNOT 22 (importance of symptoms) which assesses the average severity of different groups Assessing the future of non-operated patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 21, 2016
• Est. primary completion date: April 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with bilateral chronic rhinosinusitis evolving for more than 3 months with diffuse sinus opacities scanner.

Exclusion Criteria:

• Rhino Sinusitis unilateral

• Background total or functional ethmoidectomy (but not polypectomy)

• immunodeficiency or immunosuppression in patients

Related Conditions & MeSH terms

• NASAL SURGICAL PROCEDURES
• RHINOPLASTY

Intervention

Other:
• No intervention
There is no intervention. The patients will receive common questionnaire usually used by doctors (SNOT 22). Some Data to describe the population are collected then.

Locations

Country	Name	City	State
France	Fondation Ophtalmologique Adolphe de Rothschild	Paris	Ile-de-France
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France
France	L'Institut Arthur vernes	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of change of the SNOT 22 score with a significant improvement from a minimal decrease of 10 points	Assessment of change of the SNOT 22 score with a significant improvement from a minimal decrease of 10 points	Day1, Month 6
Secondary	Assessment of change of endoscopic nasal in consultation		Day1, Month 6