Clinical Benefit and cost effectiveness of endoscopic sinus surgery (ESS) in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP)

Completed

• Conditions: CRSwNP; nasal polyps; 10046304

• Registration Number: NL-OMON47166
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 238

Inclusion Criteria

* Bilateral CRSwNP (nasal polyps)
* >17 years
* indication for endoscopic sinus surgery (primary or revision) as judged by their ENT surgeon

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary clinical endpoint is HRQol in CRSwNP patients, measured by the<br /><br>SNOT-22 at 12 months follow-up. HRQol is a<br /><br>frequently used clinical endpoint in CRS clinical trials.</p><br>