Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)

Study Overview
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Brief Summary
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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
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Please see study protocol

Official Title
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Aggravated Airway Inflammation: Research on Genomics and Optimal Operative Treatment (AirGOs Operative)

Conditions
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Sinusitis, Chronic, Asthma, Nasal Polyps, Aspirin Sensitivity

Intervention / Treatment
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* Procedure: Extended endoscopic sinus surgery
* Procedure: Limited endoscopic sinus surgery


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extended<br>Extended sinus surgery including all sinuses | Procedure: Extended endoscopic sinus surgery<br>* ESS of all sinuses<br>|
| Active Comparator: Limited<br>Limited sinus surgery with partial ethmoidectomy | Procedure: Limited endoscopic sinus surgery<br>* Partial ethmoidectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sino-nasal outcome test (SNOT-22) | 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. | Baseline, Post-intervention every 3 months during 2 years |