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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sino-nasal outcome test (SNOT-22)
Timeframe: Baseline, Post-intervention every 3 months during 2 years