Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT04105361
Status:
UNKNOWN
Last Update Posted:
2019-12-27
First Post:
2019-09-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis:A Comparative Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009298', 'term': 'Nasal Polyps'}], 'ancestors': [{'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D011127', 'term': 'Polyps'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2021-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-12-24', 'studyFirstSubmitDate': '2019-09-25', 'studyFirstSubmitQcDate': '2019-09-25', 'lastUpdatePostDateStruct': {'date': '2019-12-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Impact of posterior nasal neurectomy on recurrence rate in allergic rhinosinusitis with nasal polyposis', 'timeFrame': '1 year', 'description': 'Surgical procedure to evaluate the recurrence of nasal polyposis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Nasal Polyps']}, 'referencesModule': {'references': [{'pmid': '1654132', 'type': 'BACKGROUND', 'citation': 'Mengeling WL. Anamnestic immune response of pigs to pseudorabies virus: latent virus reactivation versus direct oronasal and parenteral exposure to virus. J Vet Diagn Invest. 1991 Apr;3(2):133-6. doi: 10.1177/104063879100300205.'}]}, 'descriptionModule': {'briefSummary': 'The study will be conducted to investigate the efficacy of posterior nasal neurectomy in control of recurrence and improvment of allergic symptoms in patients with allergic rhinitis combined with nasal polyposis', 'detailedDescription': 'Allergic rhinitis patients with nasal polyposis will go through FESS combined with posterior nasal neurectomy to detect recurrence rate'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all cases presented to ENT department Assuit University with allergic rhinosinusitis with nasal polyposis\n\nExclusion Criteria:\n\n* refusing enrollment into the study. Pregnant women Refusing surgery Containdication to surgery Patients with aspirin syndrome'}, 'identificationModule': {'nctId': 'NCT04105361', 'briefTitle': 'Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis:A Comparative Study', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Impact of Posterior Nasal Neurectomy With Functional Endoscopic Sinus Surgery for Chronic Rhinosinusitis With Nasal Polyposis :A Comparative Study', 'orgStudyIdInfo': {'id': 'Nasal polyposis'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Study group', 'description': 'We will do posterior nasal neurectomy in patients with allergic rhinitis after FESS in one side of the nose', 'interventionNames': ['Procedure: Posterior neurectomy']}, {'type': 'EXPERIMENTAL', 'label': 'Control group', 'description': 'We will do FESS only in the other side of the nose', 'interventionNames': ['Procedure: Posterior neurectomy']}], 'interventions': [{'name': 'Posterior neurectomy', 'type': 'PROCEDURE', 'description': 'Cut of posterior nasal nerve', 'armGroupLabels': ['Control group', 'Study group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Enas Zarief', 'role': 'CONTACT', 'email': 'Enaa.tharwat23@gmail.com', 'phone': '01226270800'}, {'name': 'Mohamed Gad', 'role': 'CONTACT', 'email': 'Mohamedomar18@yahoo.com', 'phone': '0102 235 0318'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle investigator', 'investigatorFullName': 'ET Zarief', 'investigatorAffiliation': 'Assiut University'}}}}