- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01777425
Long-term Control in Rhinosinusitis After Functional Endoscopic Sinus Surgery (FESS)
Long-term Control in Rhinosinusitis After FESS: Cross-sectional Observational Study on Control in Rhinosinusitis at a Mean Interval of 3 Years After FESS
Studieoversikt
Status
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Vlaams Brabant
-
Leuven, Vlaams Brabant, Belgia, 3000
- UZ Leuven ORL
-
-
Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgia, 3000
- UZ Leuven
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patients that have undergone bilateral ESS for inflammatory sinonasal disease, without additional sino-nasal surgery after the ESS.
- Age > 18 and < 75 years.
- Written informed consent
- Dutch, French or English speaking patients
Exclusion Criteria:
- Unilateral ESS
- Benign and malignant tumor disease
- Patient with a psychiatric, addictive, or any disorder of which the investigators feel at the time of evaluation for participation in the study that this may compromise the ability to give truly informed consent for participation in this study or provide reliable information on the questionnaire
- Lack of knowledge of Dutch, French or English
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
|---|
|
rhinosinusitis patients
patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Control Status of Patients With Rhinosinusitis
Tidsramme: 3 years after FESS
|
1. Percentage of patients with rhinosinusitis that are fully controlled, partly controlled and uncontrolled according to the new european position paper on rhinosinusitis (EPOS) definitions at a mean interval of 3 years after endoscopic sinus surgery.
|
3 years after FESS
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Control Nasal Endoscopy
Tidsramme: 3 years after ESS
|
Evaluating of difference in control if nasal endoscopy is performed three years after ESS.
|
3 years after ESS
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Visual Analogue Scale (VAS), Sinonasal Outcome Test (SNOT22) and Short Form (36) Health Survey (SF36) Score Three Years After ESS in Controlled, Partially Controlled and Uncontrolled Group
Tidsramme: three years after ESS
|
VAS scores: a measurement of patient's subjective evaluation by indicating a position on a line between two endpoints. Patients will score eight individual symptoms on a scale from 0 until 10, being 0 no trouble and 10 maximum trouble. Finally a mean symptom score will be calculated per symptom. The SNOT-22 questionnaire is a validated 22 item questionnaire. patients indicate how much they are affected in eight different areas and identify the 5 most important items. The SNOT-22 total score can range from 0 to 110, with higher scores representing worse quality of life. Perceived health status can be evaluated by the 36-item short-form (SF-36). It consists of 36 items covering eight domains. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability |
three years after ESS
|
Samarbeidspartnere og etterforskere
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 082012
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