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Chronic Rhinosinusitis Classification Proposal

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02822781
Enrollment
100
Registered
2016-07-04
Start date
2015-11-01
Completion date
2016-07-21
Last updated
2017-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NASAL SURGICAL PROCEDURES, RHINOPLASTY

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

Interventions

OTHERNo 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.

Sponsors

Fondation Hôpital Saint-Joseph
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Assessment of change of the SNOT 22 score with a significant improvement from a minimal decrease of 10 pointsDay1, Month 6Assessment of change of the SNOT 22 score with a significant improvement from a minimal decrease of 10 points

Secondary

MeasureTime frame
Assessment of change of endoscopic nasal in consultationDay1, Month 6

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026