Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-02-01 @ 3:16 PM
Study NCT ID:
NCT00629694
Status:
COMPLETED
Last Update Posted:
2012-01-23
First Post:
2008-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010034', 'term': 'Otitis Media with Effusion'}, {'id': 'D010033', 'term': 'Otitis Media'}], 'ancestors': [{'id': 'D010031', 'term': 'Otitis'}, {'id': 'D004427', 'term': 'Ear Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000233', 'term': 'Adenoidectomy'}, {'id': 'D008876', 'term': 'Middle Ear Ventilation'}], 'ancestors': [{'id': 'D013517', 'term': 'Otorhinolaryngologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D010030', 'term': 'Ostomy'}, {'id': 'D013506', 'term': 'Otologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-20', 'studyFirstSubmitDate': '2008-02-27', 'studyFirstSubmitQcDate': '2008-02-27', 'lastUpdatePostDateStruct': {'date': '2012-01-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-03-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OM-6', 'timeFrame': 'one year post operative'}], 'secondaryOutcomes': [{'measure': 'tympanogram type B', 'timeFrame': 'one year'}]}, 'conditionsModule': {'keywords': ['adenoidectomy, myringotomy, tubes insertion, otitis media, adenoid hyperthophy'], 'conditions': ['Otitis Media With Effusion']}, 'descriptionModule': {'briefSummary': 'It is not unusual for several children operated for severe adenoid hyperthrophy causing breathing problems to have otitis media with effusion simultaneously. It is unknown whether adenoidectomy, myringotomy and tubes insertion is superior to adenoidectomy and myringotomy alone in terms of otitis media related quality of life and recurrence of otitis media several months after the operation. For this purpose a randomized trial is conducted including children operated for adenoid hyperthrophy and whose otitis media with effusion had caused minimal or no symptoms so far'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '3 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children operated for their adenoid hyperthrophy with an adenoid size of 3 (measured in a scale of 1-3 intraoperatively or from lateral neck x-ray) and otitis media with effusion causing an average air-bone gap of greater than 20db. Children should be otherwise healthy with an ASA score of I and between 3-12 years old of age\n\nExclusion Criteria:\n\n* other health problems especially related with the condition eg cleft palate'}, 'identificationModule': {'nctId': 'NCT00629694', 'briefTitle': "Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy", 'organization': {'class': 'OTHER', 'fullName': "Aghia Sophia Children's Hospital of Athens"}, 'officialTitle': "Adenoidectomy, Myringotomy and Tubes' Insertion vs Adenoidectomy and Myringotomy Alone in Children With Otitis Media With Effusion and Adenoid Hypertrophy", 'orgStudyIdInfo': {'id': '12-01-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'A-T', 'interventionNames': ['Procedure: adenoidectomy, myringotomy, tubes insertion']}, {'type': 'EXPERIMENTAL', 'label': 'A-M', 'interventionNames': ['Procedure: A-M']}], 'interventions': [{'name': 'adenoidectomy, myringotomy, tubes insertion', 'type': 'PROCEDURE', 'description': 'adenoidectomy, myringotomy and tubes insertion (A-T)against adenoidectomy and myringotomy alone (A-M)', 'armGroupLabels': ['A-T']}, {'name': 'A-M', 'type': 'PROCEDURE', 'description': 'adenoidectomy and myringotomy alone', 'armGroupLabels': ['A-M']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Athens', 'country': 'Greece', 'facility': "Department of Otolaryngology-Head and Neck Surgery, Aghia Sophia Children's Hospital of Athens", 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'overallOfficials': [{'name': 'Ioannis M Vlastos, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Aghia Sophia Children's Hospital of Athens"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Aghia Sophia Children's Hospital of Athens", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ioannis Vlastos', 'investigatorAffiliation': "Aghia Sophia Children's Hospital of Athens"}}}}