Rhinosinusitis (rhinosinusistis) surgery (chirurgie) drug treatment ( medicamenteuze behandeling) nasal polyps (neuspoliepen)
Conditions
Interventions
Eligible patients will be randomly assigned in a 1:1 ratio to one of both interventions:
1. a surgical strategy consisting of ESS in addition to drug treatment. Those assigned to the surgical strateg
Sponsors
Amsterdam Medical Centre, Department of Ear-, Nose- and Throat (ENT)
Eligibility
Inclusion criteria
Inclusion criteria: Informed consent Bilateral CRSwNP (nasal polyps) Age >17 years Indication for endoscopic sinus surgery (primary or revision) as judged by their ENT surgeon
Exclusion criteria
Exclusion criteria: 1. Inability to comply with study protocol 2. Septal surgery without ESS 3. Polypectomy without ethmoidectomy 4. Turbinate surgery 5. Radical surgery 6. Denker surgery/ Draf III 7. Surgery for mucokeles 8. Systemic diseases affecting the nose (e.g., Wegener’s, granulomatosis, sarcoid, primary ciliary dyskinesia, cystic fibrosis) 9. Antrochoanal polyps (benign polyps originating from the mucosa of the maxillary sinus). 10. Inverted papilloma and malignant polyps. 11. Acute upper or lower respiratory tract infections within 2 weeks before the inclusion visit), 12. Use of systemic corticosteroids within 4 weeks before the inclusion visit 13. Need of continuous systemic corticosteroids treatment for other disease than CRSwNP 14. Systemic diseases preventing participation in the study ( e.g. severe cardiovascular/pulmonary illness, malignancy, auto-immune disorders) 15. Pregnancy 16. Inability to be operated 17. Medication: B-blocker, systemic corticosteroid use, ACE-inhibitors 18. Aspirin intolerance 19. Alcohol/drug abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary clinical endpoint is HRQol in CRSwNP patients, measured by the SNOT-22 at 12 months follow-up. HRQol is a frequently used clinical endpoint in CRS clinical trials. | — |
Secondary
| Measure | Time frame |
|---|---|
| The effectiveness of ESS in addition to drug treatment as compared to drug treatment alone in adults with CRSwNP in the short (3-6 months) and long (12 - 24 months) term, in terms of: • Generic HRQoL (EQ-5D-5L) • Disease specific HRQoL and symptoms (SNOT-22) • Endoscopic assessment of the nose (Endoscopic assessment of the nasal cavity, graded using the Lildholt scale) Endoscopic assessment of the nose (Lund-Kennedy endoscopy scores and Modified Lund Mackay Postoperative Endoscopy Score) • Olfactory function (Sniffin Sticks) • Nasal obstruction (PNIF) • Daily records cards (DRC) will be provided 2 weeks before until 2 weeks after a visit to the clinic to record daily symptoms, medication use, adverse events, healthcare resource use and related health care costs • CRS disease control (EPOS CRS control test, NOSE test) • Asthma control in the subgroup of patients with asthma (Asthma Control Test) • Symptomatic exacerbations requiring further treatment including ESS identified using diaries and medical notes • Adverse effects of drug and surgical treatment and readmissions identified using diaries and medical notes • Healthcare resource use and related health care costs including patient time and travel costs, out-of-pocket expenditure, time off education, work and usual activities using repeated questionnaires and diaries (DRC) | — |
Contacts
Public ContactW.J. Fokkens
Academic Medical Center (AMC), Department of Otorhinolaryngology, Room A2-234, P.O. Box 22660
Outcome results
None listed