CRSwNP nasal polyps
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 strategy
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Bilateral CRSwNP (nasal polyps) * >17 years * indication for endoscopic sinus surgery (primary or revision) as judged by their ENT surgeon
Exclusion criteria
Exclusion criteria: * pregnancy * inability to comply with study protocol, * systemic diseases affecting the nose (e.g., Wegener*s, granulomatosis, sarcoid, primary ciliary dyskinesia, cystic fibrosis, * antrochoanal polyps (benign polyps originating from the mucosa of the maxillary sinus). * inverted papilloma and malignant polyps. * acute upper or lower respiratory tract infections within 2 weeks before the inclusion visit), * use of systemic corticosteroids within 4 weeks before the inclusion visit * need of continuous systemic corticosteroids treatment for other disease than CRSwNP * systemic diseases preventing participation in the study, * inability to be operated * medical or surgical treatments influencing the study.
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 |
|---|---|
| Secondary study parameters/endpoints include 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 (0 * no polyps, 1-confined to middle meatus, 2-below middle turbinate. 3- massive polyposis) * 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) Baseline data collection for the RCT include Most of the measurements described above. On top of that we will collect the following measurements: * CT scan (Lund-Mackay score) * If surgery is performed a surgical report indicating which sinus are opened and what was found there (surgical report with standard items) will be made * Laboratory results including total IgE and serum eosinophils * Earlier sinus surgery with dates and estimation of extent (based on CT scan) * S | — |
Countries
Netherlands
Outcome results
None listed