Effect of Functional Endoscopic Sinus Surgery On Eustachian Tube Function in Patients With Nasal Polypi

Functional Endoscopic Sinus Surgery Clinical Trial

Official title:

Effect of Functional Endoscopic Sinus Surgery On Eustachian Tube Function in Patients With Nasal Polypi

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05053906
• Other study ID #: FESS
• Status: Not yet recruiting
• Start date: November 1, 2021
• Est. completion date: May 1, 2023

Study information

• Verified date: September 2021
• Source: Assiut University
• Contact: Safia Sh Abd-Ellattef, 3
• Phone: 01033111172
• Email: safeyasaleh21[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 1, 2023
• Est. primary completion date: April 1, 2023
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Functional Endoscopic Sinus Surgery

Intervention

Device:
• Endoscope
effect of FESS on eustachian tube function

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of Eustachian tube dysfunction with nasal polyp		2years