Chronic Rhinosinusitis Classification Proposal
- Conditions
- NASAL SURGICAL PROCEDURESRHINOPLASTY
- Registration Number
- NCT02822781
- Lead Sponsor
- Fondation Hôpital Saint-Joseph
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- Patients with bilateral chronic rhinosinusitis evolving for more than 3 months with diffuse sinus opacities scanner.
- Rhino Sinusitis unilateral
- Background total or functional ethmoidectomy (but not polypectomy)
- immunodeficiency or immunosuppression in patients
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of change of the SNOT 22 score with a significant improvement from a minimal decrease of 10 points Day1, Month 6 Assessment of change of the SNOT 22 score with a significant improvement from a minimal decrease of 10 points
- Secondary Outcome Measures
Name Time Method Assessment of change of endoscopic nasal in consultation Day1, Month 6
Trial Locations
- Locations (3)
Groupe Hospitalier Paris Saint Joseph
🇫🇷Paris, Ile-de-France, France
L'Institut Arthur vernes
🇫🇷Paris, Ile-de-France, France
Fondation Ophtalmologique Adolphe de Rothschild
🇫🇷Paris, Ile-de-France, France