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

Completed

• Conditions: Chronic rhinosinusitis (CRS), nasal polyps (NP); Ear, Nose and Throat; 1. Chronic sinusitis 2. Nasal polyp

• Registration Number: ISRCTN87577685
• Lead Sponsor: Academic Medical Centre (AMC) (Netherlands)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-02-14
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome measure is a validated disease-specific quality of life questionnaire: SNOT-20.

Secondary Outcome Measures

Name	Time	Method
The secondary endpoint is re-evaluation of the indication for FESS. Another secondary endpoint will be the standardised evaluation of the nasendoscopy and the CT-scan. For the efficiency assessment 2 secondary endpoints will be evaluated: days of sick-leave and a work-productivity questionnaire.