Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sinusitis, Chronic
- Sponsor
- Helsinki University Central Hospital
- Enrollment
- 97
- Locations
- 3
- Primary Endpoint
- Sino-nasal outcome test (SNOT-22)
- Status
- Completed
- Last Updated
- last year
Overview
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
Investigators
Paula Virkkula
Chief Physician in Rhinology
Helsinki University Central Hospital
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Sino-nasal outcome test (SNOT-22)
Time Frame: 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.