CRS: Chronische Rhinosinusitis NP: Nasal Polyps
Conditions
Interventions
The intervention to be investigated is FESS: Functional Endoscopic Sinus Surgery. One treatment arm will receive FESS plus a standardised form of medical treatment. The control group will receive stan
Sponsors
None
Eligibility
Inclusion criteria
Inclusion criteria: 1.Males or females aged 18 years old can participate. 2.Diagnosis CRS with/without NP (definition according to EPOS) 3.Prior treatment as defined in the treatment scheme of the protocol for at least 12 weeks 4.No prior sinus surgery 5.Indication for FESS, both criteria must be met: -RSOM-31 (add score of magnitude of questions 1,2,4,22 result > 9) -CT score > 3 on 1 side at least, judged on a CT-scan made prior to visit 1 and made less than 4 months ago; Lund/Mackay scoring; 6. Written informed consent.
Exclusion criteria
Exclusion criteria: 1. Cystic fibrosis; 2. Gross immunodeficiency (congenital or acquired); 3. Congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD); 4. Non-invasive fungal balls and invasive fungal disease; 5. Systemic vasculitis and granulomatous diseases; 6. Patients who have any serious or unstable concurrent disease; 7. Any structural nasal abnormalities (other than polyps or chronic sinusitis), e.g. severe nasal septum deviation; 8. Rhinosurgery during the past 6 weeks; 9. Systemic steroids 4 weeks before the study; 10. Medication affecting nasal mucosa (cyclosporine, ß-blocker, ACE inhibitors, NSAIDs, reserpine, guanethidinge, phenolomine, methyldopa, alfa-adrenoceptor antagonist and chlorpromazine); 11. Medication other than trial medication; 12. Females who are pregnant or lactating; 13. Inability to follow the instructions within this protocol or known inability to attend ALL clinical visits within the intervals stated.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is a validated disease-specific quality of life questionnaire: SNOT-20. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoint is re-evaluation of the indication for FESS. Another secondary endpoint will be the standardised evaluation of the nasendoscopy and the CT-scan. For the efficiency assessment 2 secondary endpoints will be evaluated: days of sick-leave and a work-productivity questionnaire. | — |
Contacts
Public ContactW.J. Fokkens
Academic Medical Center (AMC), Department of Otorhinolaryngology, Room A2-234, P.O. Box 22660
Outcome results
None listed