Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-01-04 @ 6:25 PM
Study NCT ID:
NCT00651092
Status:
UNKNOWN
Last Update Posted:
2008-04-02
First Post:
2008-03-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2008-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-03', 'completionDateStruct': {'date': '2010-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2008-04-01', 'studyFirstSubmitDate': '2008-03-30', 'studyFirstSubmitQcDate': '2008-04-01', 'lastUpdatePostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'quality of life', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'rhinomanometry, saccharine test, nasal endoscopy', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['turbinectomy'], 'conditions': ['Bilateral Inferior Turbinates Hypertrophy']}, 'referencesModule': {'references': [{'pmid': '11089995', 'type': 'RESULT', 'citation': 'Fradis M, Golz A, Danino J, Gershinski M, Goldsher M, Gaitini L, Malatskey S, Armush W. Inferior turbinectomy versus submucosal diathermy for inferior turbinate hypertrophy. Ann Otol Rhinol Laryngol. 2000 Nov;109(11):1040-5. doi: 10.1177/000348940010901109.'}, {'pmid': '1999659', 'type': 'RESULT', 'citation': "Williams HO, Fisher EW, Golding-Wood DG. 'Two-stage turbinectomy': sequestration of the inferior turbinate following submucosal diathermy. J Laryngol Otol. 1991 Jan;105(1):14-6. doi: 10.1017/s0022215100114707."}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to compare endoscopic submucosal inferior turbinectomy to blunt turbinectomy in terms of subjective and objective parameters.', 'detailedDescription': 'The two methods of nasal inferior turbinectomy are well popularized and in use for long periods of time. Endoscopic submucosal inferior turbinectomy is performed in our hospital and blunt turbinectomy is performed usually in privat clinics outside the hospital where there is no endoscopic equipment. We will examine both subjective (QOL questionaire) and objective parameters(rhinomanometry- a non invasive method to evaluate nasal airflow, saccharine test, nasal endoscopy) in our comparison of the outcome of these two methods.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients above 18 years\n\nExclusion Criteria:\n\n* can not answer a written questionaire'}, 'identificationModule': {'nctId': 'NCT00651092', 'briefTitle': 'Inferior Submucosal Turbinectomy Versus Blunt Turbinectomy for Inferior Turbinate Hypertrophy', 'organization': {'class': 'OTHER', 'fullName': 'Soroka University Medical Center'}, 'officialTitle': 'to Compare Two Well Popularized Methods of Inferior Nasal Turbinectomy', 'orgStudyIdInfo': {'id': 'sor466208ctil'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A1', 'description': 'since the two methods of turbinectomy are in used on a regular basis there is no way to perform double blind study- both the surgeon and the patients are well aware of the operation they are about to go. we just compare several parameters in patients who are anyway about to undergo an operation in a specific method that is used by their surgeon', 'interventionNames': ['Procedure: bilateral nasal inferior turbinectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'A2', 'description': 'the resection of the inferior turbinates will be performed endonasally with an endoscopical instruments', 'interventionNames': ['Procedure: endoscopic submucosal resection of the inferior turbinates']}], 'interventions': [{'name': 'bilateral nasal inferior turbinectomy', 'type': 'PROCEDURE', 'otherNames': ['inferior conchectomy'], 'description': 'the operation is performed endonasally under general or local anesthesia, the inferior turbinates are resected and removed', 'armGroupLabels': ['A1']}, {'name': 'endoscopic submucosal resection of the inferior turbinates', 'type': 'PROCEDURE', 'otherNames': ['submucosal conchectomy'], 'description': 'surgery of the inferior turbinates- endonasally with endoscopic instruments and by performing submucosal resection of the nasal turbinates', 'armGroupLabels': ['A2']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'nili segal, md', 'role': 'CONTACT', 'email': 'segalna@012.net.il', 'phone': '+972544268202'}, {'name': 'moshe puterman, md', 'role': 'CONTACT', 'email': 'puterman@netvision.net.il', 'phone': '+97286400521'}], 'overallOfficials': [{'name': 'nili segal, md', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'soroka university medical center beer sheva israel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Soroka University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Dr nili segal', 'oldOrganization': 'soroke university medical center'}}}}