Aspirin Sensitivity, Asthma, Nasal Polyps, Sinusitis, Chronic
Conditions
Brief summary
This randomized study compares operative techniques in chronic rhinosinusitis with polyposis (CRSwNP) surgery. It aims to evaluate outcomes in asthma and CRSwNP, safety and costs. The investigators want to see if patients with certain clinical and/or genetic predispositions will benefit from extended surgery. They also aim to find biomarkers for detection and management models for of severe airway inflammation and to further develop markers for progressive disease forms.
Detailed description
Please see study protocol
Interventions
PROCEDUREExtended endoscopic sinus surgery
ESS of all sinuses
PROCEDURELimited endoscopic sinus surgery
Partial ethmoidectomy
Sponsors
Helsinki University Central Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient not responding to conservative treatment of 3 months of nasal steroid drops * Nasal polyp score ≥ 4/8 * SNOT-22 ≥ 30 * Lund-Mackay CT score ≥ 14 * One previous endoscopic sinus surgery or at least one peroral corticosteroid course or at least 3 courses of antibiotics within 2 years
Exclusion criteria
* Age \<18 years, age \> 65 years * Complication of CRS (f.e. mucocele, invasive fungal rhinosinusitis) * Other diagnosis than CRSwNP (inverted papilloma, antrochoanal polyp etc.) * Previous external sinus surgery or Draf 3 procedure (or indication for external approaches or Draf 3 * Bleeding diathesis * Pregnancy/ breastfeeding * Cystic fibrosis * Primary ciliary dyskinesia (PCD) * Sarcoidosis * Granulomatosis with polyangitis (GPA) * Eosinophilic granulomatosis with polyangitis (EGPA) * Immunosupression (diagnosed Spesific Antibody Deficiency (SAD), common variable immunodeficiency (CVI), HIV or use of biologicals/immunosuppressive medication) * Immunotherapy * Daily use of systemic corticosteroids * Communication problems (f.e. neurological/psychiatric disease, language skills) * Unlikely to comply * Other severe disease * Inability to be operated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sino-nasal outcome test (SNOT-22) | Baseline, Post-intervention every 3 months during 2 years | Change from baseline in patient symptoms as measured by the Sino-Nasal Outcomes Test (SNOT-22) survey. Scores are measured from 0-5 in a 22 item validated survey. Total scores range from 0-110 with higher scores indicating greater burden of sinonasal symptoms. |
Countries
Finland, Netherlands
Outcome results
None listed