Condition category
Ear, Nose and Throat
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
14/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.fess.nl

Contact information

Type

Scientific

Primary contact

Prof W.J. Fokkens

ORCID ID

Contact details

Academic Medical Center
Amsterdam
Department of Otorhinolaryngology
Room A2-234
P.O. Box 22660
Almere
1100 DD
Netherlands
+31 (0)20 5663789
W.J.Fokkens@amc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR558

Study information

Scientific title

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

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

01/01/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

160

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

Trial participating centre

Academic Medical Center, Amsterdam
Almere
1100 DD
Netherlands

Sponsor information

Organisation

Academic Medical Centre (AMC) (Netherlands)

Sponsor details

ENT Department
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Academic Medical Centre (AMC) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes