FESS 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…
ID
Bron
Verkorte titel
Aandoening
CRS: Chronische Rhinosinusitis
NP: Nasal Polyps
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome measure is a validated disease-specific quality of life questionnaire: SNOT-20.
Achtergrond van het onderzoek
Functional 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.
Doel van het onderzoek
FESS 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.
Onderzoeksproduct en/of interventie
The 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.
Publiek
Room A2-234,
P.O. Box 22660
W.J. Fokkens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663789
W.J.Fokkens@amc.nl
Wetenschappelijk
Room A2-234,
P.O. Box 22660
W.J. Fokkens
Meibergdreef 9
Amsterdam 1100 DD
The Netherlands
+31 (0)20 5663789
W.J.Fokkens@amc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1.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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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 (cyclosporine, ß-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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL515 |
| NTR-old | NTR558 |
| Ander register | : N/A |
| ISRCTN | ISRCTN87577685 |