- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT05053906
Effect of Functional Endoscopic Sinus Surgery On Eustachian Tube Function in Patients With Nasal Polypi
This study is conducted to :
Correlate the incidence of ETD with nasal polypi. To evaluate the effects of functional endoscopic sinus surgery on eustachian tube function in patients with nasal polypi
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Eustachian tube dysfunction (ETD) is a frequently applied diagnosis, used when abnormal ET function is believed to underlie any of a wide range of symptoms or middle ear (ME) abnormalities. Two distinct forms of the disorder are recognised, representing different ends of the spectrum of ET function: 1)obstructive ETD (OETD), in which tubal opening or patency is reduced, and 2) patulous ETD (PETD), in which the ET is too open. It has been suggested that some patients with OETD have either predominantly active dysfunction (failure of muscle-controlled opening), or passive dysfunction (failure of pressure-related opening).
There are several explanations to account for the ET dysfunction associated with nasal diseases:
- Mechanical obstruction of ET orifice may occur due to nasal mass.
- Increased secretions from seromucous glands in the pharyngeal portion of ET may accumulate and block the tube.
- Lymphatic stasis due to edema of the submucosa of the tube resulting in compromise of the lumen may produce ET dysfunction.
- Further increase in hydrostatic pressure result in the accumulation of ME fluid by transudative process.
- Tubal dysfunction may be related to deficiency of surfactant that is thought to facilitate tubal opening. It has been postulated that this material is inactivated by inflammation.
ETD symptoms will decrease post-endoscopic sinus surgery to a level comparable with a non-CRS population The use of the ETDQ-7 has the potential to enhance clinical care by highlighting the impact of ETD as well as guiding and evaluating appropriate management. Further prospective testing of
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiekontakt
- Navn: Safia Sh Abd-Ellattef, 3
- Telefonnummer: 01033111172
- E-post: safeyasaleh21@gmail.com
Studer Kontakt Backup
- Navn: Mohamed Ad Mahmoud, 2
- Telefonnummer: 01067835980
- E-post: drsalem@aun.edu.eg
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patient Who have been diagnosed to have nasal polypi Both unilateral and bilateral before doing FESS
Exclusion Criteria:
- children Patient. Patients with craniofacial abnormalities or active infection Patients with suspected nasal and nasopharyngeal tumour Patients with nasal and ear surgery
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Potensielle
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
The rate of Eustachian tube dysfunction with nasal polyp
Tidsramme: 2years
|
2years
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Generelle publikasjoner
- Csakanyi Z, Katona G, Konya D, Mohos F, Sziklai I. Middle ear gas pressure regulation: the relevance of mastoid obliteration. Otol Neurotol. 2014 Jul;35(6):944-53. doi: 10.1097/MAO.0000000000000282.
- Ilan O, Marcus EL, Cohen Y, Farkash T, Levy R, Sasson A, Adelman C. Eustachian tube dysfunction leading to middle-ear pathology in patients on chronic mechanical ventilation. J Laryngol Otol. 2017 Sep;131(9):817-822. doi: 10.1017/S0022215117001554. Epub 2017 Jul 31.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Forventet)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- FESS
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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