chronic rhinosinusitis with nasal polyps
Conditions
Interventions
subjects are randomized between limited or extended ESS
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - 18-65 years of age - having chronic rhinosinusitis with nasal polyps with an indication for surgery - 1 oral corticosteroid course / 3 antibiotic courses in the past 2 years; or at least 1 previous sinus surgery
Exclusion criteria
Exclusion criteria: - complications of chronic rhinosinusitis warranting surgery - indication for or previous extensive surgery (external approaches or draf III) - bleeding diathesis - pregnancy / breast feeding - underlying diseases such as CF, PCD, GPA, eGPA, sarcoidosis, HIV, CVID - use of immunosuppressive or immunomodulatory medication (biologicals, daily oral corticosteroids)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main endpoint is the difference in the disease-specific patient reported outcome measurement *SNOT-22* scores between the limited and extended groups 1 and 2 years after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| Furthermore, differences in (additional) medication use, reinterventions, objective and subjective measures of control of CRSwNP and of asthma, safety indicators and medical costs (both direct and indirect) will be compared in order to better counsel patients for either limited or extended surgical procedures | — |
Countries
Netherlands
Outcome results
None listed