FES: FESS Effectiveness Study: a multi-centre randomised controlled trial studying the effectiveness of functional endoscopic sinus surgery (FESS) in adult patients with chronic rhinosinusitis/nasal polyps unresponsive to medical therapy

Academic Medical Centre (AMC) (Netherlands)0 个研究点目标入组 160 人开始时间: 2006年2月14日最近更新: 2015年1月13日

适应症

试验速览

暂无简介。

•1. Males or females aged 18 years old can participate
•2. Diagnosis CRS with/without NP (definition according to the European Position Paper on Rhinosinusitis and Nasal Polyposis [EPOS])
•3. Prior treatment as defined in the treatment scheme of the protocol for at least 12 weeks
•4. No prior sinus surgery
•5. Indication for FESS, both criteria must be met:
•5.1. RSOM-31 (add score of magnitude of questions 1, 2, 4, 22 result >9)
•5.2. CT score >3 on 1 side at least, judged on a CT-scan made prior to visit 1 and made less than 4 months ago; Lund/Mackay scoring
•6. Written informed consent

•1. Cystic fibrosis
•2. Gross immunodeficiency (congenital or acquired)
•3. Congenital mucociliary problems e.g. primary ciliary dyskinesia (PCD)
•4. Non-invasive fungal balls and invasive fungal disease
•5. Systemic vasculitis and granulomatous diseases
•6. Patients who have any serious or unstable concurrent disease
•7. Any structural nasal abnormalities (other than polyps or chronic sinusitis) e.g. severe nasal septum deviation
•8. Rhinosurgery during the past 6 weeks
•9. Systemic steroids 4 weeks before the study
•10. Medication affecting nasal mucosa (cyclosporin, ß-blocker, ACE inhibitors, non-steroidal anti-inflammatory drugs [NSAIDs], reserpine, guanethidinge, phenolomine, methyldopa, alfa-adrenoceptor antagonist and chlorpromazine)
•11. Medication other than trial medication
•12. Females who are pregnant or lactating
•13. Inability to follow the instructions within this protocol or known inability to attend ALL clinical visits within the intervals stated

发起方

Academic Medical Centre (AMC) (Netherlands)