Nctid:
NCT06229587
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002972", "term"=>"Cleft Palate"}], "ancestors"=>[{"id"=>"D007569", "term"=>"Jaw Abnormalities"}, {"id"=>"D007571", "term"=>"Jaw Diseases"}, {"id"=>"D009140", "term"=>"Musculoskeletal Diseases"}, {"id"=>"D019767", "term"=>"Maxillofacial Abnormalities"}, {"id"=>"D019465", "term"=>"Craniofacial Abnormalities"}, {"id"=>"D009139", "term"=>"Musculoskeletal Abnormalities"}, {"id"=>"D009057", "term"=>"Stomatognathic Diseases"}, {"id"=>"D009056", "term"=>"Mouth Abnormalities"}, {"id"=>"D009059", "term"=>"Mouth Diseases"}, {"id"=>"D018640", "term"=>"Stomatognathic System Abnormalities"}, {"id"=>"D000013", "term"=>"Congenital Abnormalities"}], "browseLeaves"=>[{"id"=>"M6207", "name"=>"Cleft Palate", "asFound"=>"Cleft Palate", "relevance"=>"HIGH"}, {"id"=>"M12", "name"=>"Congenital Abnormalities", "relevance"=>"LOW"}, {"id"=>"M10599", "name"=>"Jaw Abnormalities", "relevance"=>"LOW"}, {"id"=>"M10601", "name"=>"Jaw Diseases", "relevance"=>"LOW"}, {"id"=>"M12097", "name"=>"Musculoskeletal Diseases", "relevance"=>"LOW"}, {"id"=>"M21671", "name"=>"Maxillofacial Abnormalities", "relevance"=>"LOW"}, {"id"=>"M21420", "name"=>"Craniofacial Abnormalities", "relevance"=>"LOW"}, {"id"=>"M12096", "name"=>"Musculoskeletal Abnormalities", "relevance"=>"LOW"}, {"id"=>"M12017", "name"=>"Stomatognathic Diseases", "relevance"=>"LOW"}, {"id"=>"M12016", "name"=>"Mouth Abnormalities", "relevance"=>"LOW"}, {"id"=>"M12019", "name"=>"Mouth Diseases", "relevance"=>"LOW"}, {"id"=>"M20727", "name"=>"Stomatognathic System Abnormalities", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Musculoskeletal Diseases", "abbrev"=>"BC05"}, {"name"=>"Mouth and Tooth Diseases", "abbrev"=>"BC07"}, {"name"=>"Diseases and Abnormalities at or Before Birth", "abbrev"=>"BC16"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>40}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-04", "completionDateStruct"=>{"date"=>"2024-03-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-04-29", "studyFirstSubmitDate"=>"2024-01-01", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-04-30", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-02-28", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"speech assessement", "timeFrame"=>"3years", "description"=>"Nasopharyngoscopic examination of the cleft patients after repair with Furlow with buccinator flap allowing assessment of the grade of velopharyngeal closure during speech"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Cleft Palate"]}, "descriptionModule"=>{"briefSummary"=>"Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done. Middle ear function was assessed by clinical otoscopic examination and by tympanometry to detect the presence or absence of middle ear effusion and the need for tympanostomy tubes. Speech outcomes were assessed using perceptual speech assessment for the degree of hypernasality, compensatory misarticulation and speech intelligibility. Nasopharyngoscopic examination of the patients was done for visualization of the velopharyngeal port, allowing assessment of the pattern and grade of velopharyngeal closure during speech and the presence or absence of a velopharyngeal gap"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD"], "maximumAge"=>"7 years", "minimumAge"=>"3 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* - Age 3 to 7 years\n* 1ry cleft repair by furrolow with buccal myomucosal flap\n* Non syndromic previously treated children\n* Cleft repaired by the same surgeon\n\nExclusion Criteria:\n\n* - Syndromic patient\n* Cleft palate repair by any technique except furlow with buccal myomucosal flap"}, "identificationModule"=>{"nctId"=>"NCT06229587", "briefTitle"=>"Furlow With Buccinator and Velopharyngeal Function", "organization"=>{"class"=>"OTHER", "fullName"=>"Fayoum University"}, "officialTitle"=>"Speech and Middle Ear Outcomes Following Primary Cleft Palate Repair by Furlow Z-plasty Technique With a Buccinator Myomucosal Flap", "orgStudyIdInfo"=>{"id"=>"13"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"furlow with buccinator arm", "interventionNames"=>["Procedure: furlow with buccinator flap"]}], "interventions"=>[{"name"=>"furlow with buccinator flap", "type"=>"PROCEDURE", "description"=>"Assessment of speech and the middle ear function of patients between the age of 3 and 7 years surgically treated by ARC (Furlow z-palatoplasty with a buccinator myomucosal flap) was done", "armGroupLabels"=>["furlow with buccinator arm"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Giza", "country"=>"Egypt", "facility"=>"Hearing Institution", "geoPoint"=>{"lat"=>30.00808, "lon"=>31.21093}}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Fayoum University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"principle investigator", "investigatorFullName"=>"Shaimaa Mohsen", "investigatorAffiliation"=>"Fayoum University"}}}}
