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F.E.S.: 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.


- candidate number1910
- NTR NumberNTR558
- ISRCTNISRCTN87577685
- Date ISRCTN created14-feb-2006
- date ISRCTN requested13-jan-2006
- Date Registered NTR5-jan-2006
- Secondary IDsN/A 
- Public TitleF.E.S.: 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.
- Scientific TitleFESS 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.
- ACRONYMF.E.S.
- hypothesisFESS is effective: giving significant reduction of symptoms. The indication for FESS must be based on the symptoms of the patient and its duration, CT scan abnormalities and/or nasal endoscopic abnormalities, and a history of adequate conservative treatment.
- Healt Condition(s) or Problem(s) studiedChronische rhinosinusitis, Nasal polyps
- Inclusion criteria1.Males or females aged 18 years old can participate. 2.Diagnosis CRS with/without NP (definition according to 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: -RSOM-31 (add score of magnitude of questions 1,2,4,22 result > 9) -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 criteria1. 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 (cyclosporine, -blocker, ACE inhibitors, 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 1-jan-2006
- planned closingdate1-jan-2008
- Target number of participants160
- InterventionsThe intervention to be investigated is FESS: Functional Endoscopic Sinus Surgery. One treatment arm will receive FESS plus a standardised form of medical treatment. The control group will receive standardised medical treatment. The standardised medical treatment is topical steroids for mild CRS (without NP). in moderate/severe disease a long-term antibiotic is added. The therapy for NP will be corticosteroids. For mild NP a spray, for moderate disease: spray and drops, and for severe disease: oral steroids with drops. Specific details are in the protocol.
- Primary outcomeThe primary outcome measure is a validated disease-specific quality of life questionnaire: SNOT-20.
- Secondary outcomeThe 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.
- Timepoints
- Trial web sitehttp://www.fess.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. Dr. W.J. Fokkens
- CONTACT for SCIENTIFIC QUERIESProf. Dr. W.J. Fokkens
- Sponsor/Initiator Academic Medical Center (AMC), Department of Ear- Nose and Throat (ENT)
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Ear- Nose and Throat (ENT)
- PublicationsN/A
- Brief summaryFunctional Endoscopic Sinus Surgery (FESS) is a well-accepted component of the management of chronic rhinosinusitis (CRS) with or without nasal polyps (NP). Evidence level III studies show success rates of FESS between 85-95% improvement. Eventhough FESS is often performed, 10.000/year in the Netherlands, evidence level I is lacking. The relevance of CRS/NP follows the high prevalence and the high impact on quality of life, which results in significant costs. In a prospective, multi centre, randomised controlled trial the efficacy and cost-effectiveness of Functional Endoscopic Sinus Surgery (FESS) plus medical treatment is studied and compared to ongoing medical treatment. Patients having the common condition chronic rhinosinusitis with or without nasal polyps with its severe impact on the quality of life are eligible if they are refractory to the regular medical treatment and have an indication for FESS. One treatment arm will receive FESS plus a standardised form of medical treatment. The control group will receive standardised medical treatment. The primary outcome measures is a validated rhinosinusitis specific quality of life questionnaire: Sinonasal Outcome test (4). A sample size of 77 in each group (154 in total) will have 80% power to detect a difference in means of 0.5 assuming that the common standard deviation is 1.1 using a two group t-test with a 0.05 two-sided significance level (4). The treatment arms will be stopped and evaluated at the time-point of 3 months. For the long-term follow-up evaluation of FESS the total duration of this study will be 1 year. After checking the assumptions of normality and constant variance an unpaired t-test will be performed to compare the means in the 2 groups. The economic evaluation of FESS is designed as a cost-effectiveness study, with primary economic outcome expressed as cost difference per CRS-severity-adjusted life time. Costs are distinguished in direct medical and non-medical costs, and indirect costs; they will be estimated according to current methodology and national guidelines (12). Days of sick leave and the EuroQoL questionnaires (generic health) will be used. The trial start-up will take a half year, inclusion-period 1 year, trial duration 1 year and analysing the results another half year, which leads to a total planned study duration of 3 years.
- Main changes (audit trail)
- RECORD5-jan-2006 - 6-mrt-2006


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