NCT05053906

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

September 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

September 23, 2021

Status Verified

September 1, 2021

Enrollment Period

1.4 years

First QC Date

March 21, 2021

Last Update Submit

September 13, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • The rate of Eustachian tube dysfunction with nasal polyp

    2years

Interventions

EndoscopeDEVICE

effect of FESS on eustachian tube function

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Patient Who have been diagnosed to have nasal polypi Both unilateral and bilateral before doing FESS

You may not qualify if:

  • children Patient. Patients with craniofacial abnormalities or active infection Patients with suspected nasal and nasopharyngeal tumour Patients with nasal and ear surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 24691503BACKGROUND
  • 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.

    PMID: 28758602BACKGROUND

MeSH Terms

Interventions

Endoscopes

Intervention Hierarchy (Ancestors)

Diagnostic EquipmentEquipment and SuppliesSurgical Equipment

Central Study Contacts

Safia Sh Abd-Ellattef, 3

CONTACT

Mohamed Ad Mahmoud, 2

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

March 21, 2021

First Posted

September 23, 2021

Study Start

November 1, 2021

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

September 23, 2021

Record last verified: 2021-09