Clinical trial NCT05053906: Effect of Functional Endoscopic Sinus Surgery On Eustachian Tube Function in Patients With Nasal Polypi
Official title: Effect of Functional Endoscopic Sinus Surgery On Eustachian Tube Function in Patients With Nasal Polypi
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Endoscopic Sinus Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-09-23
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients planned for FESS who have nasal polypi will undergo a complete history and physical examination (including otoscopy and palpation of the face and temporomandibular joints), pre-operative nasal endoscopy, computed tomography (CT) of the paranasal sinuses , completion of the Eustachian Tube Dysfunction questionnaires -7 and tempanometry. And Postoperative : nasal endoscopy, , completion of the Eustachian Tube Dysfunction questionnaires -7 and tempanometry

Brief 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

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: The rate of Eustachian tube dysfunction with nasal polyp
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
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.