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
| ISRCTN | ISRCTN87577685 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87577685 |
| Secondary identifying numbers | NTR558 |
- Submission date
- 14/02/2006
- Registration date
- 14/02/2006
- Last edited
- 14/08/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Prof W.J. Fokkens
Scientific
Scientific
Academic Medical Center, Amsterdam
Department of Otorhinolaryngology
Room A2-234
P.O. Box 22660
Almere
1100 DD
Netherlands
| Phone | +31 (0)20 5663789 |
|---|---|
| W.J.Fokkens@amc.nl |
Study information
| Study design | Multicentre randomised open label active controlled parallel group trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | FES |
| Study hypothesis | FESS is effective: giving significant reduction of symptoms. The indication for FESS must be based on the symptoms of the patient and its duration, computed tomography (CT) scan abnormalities and/or nasal endoscopic abnormalities, and a history of adequate conservative treatment. |
| Ethics approval(s) | Received from local medical ethics committee |
| Condition | Chronic rhinosinusitis (CRS), nasal polyps (NP) |
| Intervention | The intervention to be investigated is Functional Endoscopic Sinus Surgery (FESS). 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 therapy is a spray, for moderate disease therapy is a spray and drops, and for severe disease therapy is oral steroids with drops. Specific details are in the protocol. |
| Intervention type | Other |
| Primary outcome measure | The primary outcome measure is a validated disease-specific quality of life questionnaire: SNOT-20. |
| Secondary outcome measures | 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. |
| Overall study start date | 01/01/2006 |
| Overall study end date | 01/01/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 160 |
| Participant 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 |
| Participant 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 |
| Recruitment start date | 01/01/2006 |
| Recruitment end date | 01/01/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Academic Medical Center, Amsterdam
Almere
1100 DD
Netherlands
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
ENT Department
P.O. Box 22660
Amsterdam
1100 DD
Netherlands
"ROR" |
https://ror.org/03t4gr691 |
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Funders
Funder type
Hospital/treatment centre
Academic Medical Centre (AMC) (Netherlands)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
