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

September 13, 2021 updated by: Safia Saleh Abdellattef, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The rate of Eustachian tube dysfunction with nasal polyp
Time Frame: 2years
2years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2021

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

May 1, 2023

Study Registration Dates

First Submitted

March 21, 2021

First Submitted That Met QC Criteria

September 13, 2021

First Posted (Actual)

September 23, 2021

Study Record Updates

Last Update Posted (Actual)

September 23, 2021

Last Update Submitted That Met QC Criteria

September 13, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • FESS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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