Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-31 @ 3:53 PM
Study NCT ID:
NCT05053906
Status:
UNKNOWN
Last Update Posted:
2021-09-23
First Post:
2021-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Functional Endoscopic Sinus Surgery On Eustachian Tube Function in Patients With Nasal Polypi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019723', 'term': 'Endoscopes'}], 'ancestors': [{'id': 'D019719', 'term': 'Diagnostic Equipment'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D013523', 'term': 'Surgical Equipment'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2021-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-13', 'studyFirstSubmitDate': '2021-03-21', 'studyFirstSubmitQcDate': '2021-09-13', 'lastUpdatePostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of Eustachian tube dysfunction with nasal polyp', 'timeFrame': '2years'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Functional Endoscopic Sinus Surgery']}, 'referencesModule': {'references': [{'pmid': '24691503', 'type': 'BACKGROUND', '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.'}, {'pmid': '28758602', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'This study is conducted to :\n\nCorrelate 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', 'detailedDescription': '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).\n\nThere are several explanations to account for the ET dysfunction associated with nasal diseases:\n\n* Mechanical obstruction of ET orifice may occur due to nasal mass.\n* Increased secretions from seromucous glands in the pharyngeal portion of ET may accumulate and block the tube.\n* Lymphatic stasis due to edema of the submucosa of the tube resulting in compromise of the lumen may produce ET dysfunction.\n* Further increase in hydrostatic pressure result in the accumulation of ME fluid by transudative process.\n* 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.\n\nETD 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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient Who have been diagnosed to have nasal polypi Both unilateral and bilateral before doing FESS\n\nExclusion Criteria:\n\n* children Patient. Patients with craniofacial abnormalities or active infection Patients with suspected nasal and nasopharyngeal tumour Patients with nasal and ear surgery'}, 'identificationModule': {'nctId': 'NCT05053906', 'briefTitle': 'Effect of Functional Endoscopic Sinus Surgery On Eustachian Tube Function in Patients With Nasal Polypi', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Functional Endoscopic Sinus Surgery On Eustachian Tube Function in Patients With Nasal Polypi', 'orgStudyIdInfo': {'id': 'FESS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Endoscope', 'type': 'DEVICE', 'description': 'effect of FESS on eustachian tube function'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Safia Sh Abd-Ellattef, 3', 'role': 'CONTACT', 'email': 'safeyasaleh21@gmail.com', 'phone': '01033111172'}, {'name': 'Mohamed Ad Mahmoud, 2', 'role': 'CONTACT', 'email': 'drsalem@aun.edu.eg', 'phone': '01067835980'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer', 'investigatorFullName': 'Safia Saleh Abdellattef', 'investigatorAffiliation': 'Assiut University'}}}}