Nctid:
NCT06616662
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-03"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012003", "term"=>"Rectal Fistula"}, {"id"=>"D000005402", "term"=>"Fistula"}], "ancestors"=>[{"id"=>"D000020763", "term"=>"Pathological Conditions, Anatomical"}, {"id"=>"D000007412", "term"=>"Intestinal Fistula"}, {"id"=>"D000016154", "term"=>"Digestive System Fistula"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000012002", "term"=>"Rectal Diseases"}], "browseLeaves"=>[{"id"=>"M14850", "name"=>"Recurrence", "relevance"=>"LOW"}, {"id"=>"M8532", "name"=>"Fistula", "asFound"=>"Fistula", "relevance"=>"HIGH"}, {"id"=>"M14845", "name"=>"Rectal Fistula", "asFound"=>"Perianal Fistula", "relevance"=>"HIGH"}, {"id"=>"M22519", "name"=>"Pathological Conditions, Anatomical", "relevance"=>"LOW"}, {"id"=>"M10446", "name"=>"Intestinal Fistula", "relevance"=>"LOW"}, {"id"=>"M18616", "name"=>"Digestive System Fistula", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>257}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2018-07-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-07-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-25", "studyFirstSubmitDate"=>"2024-09-23", "studyFirstSubmitQcDate"=>"2024-09-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-27", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2021-07-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"healing rate", "timeFrame"=>"three years", "description"=>"incidence of healing in both approaches"}], "secondaryOutcomes"=>[{"measure"=>"incontinence", "timeFrame"=>"three years", "description"=>"incidence of incontinence after both approaches"}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["perianal fistula,flap,ligation"], "conditions"=>["Perianal Fistula"]}, "descriptionModule"=>{"briefSummary"=>"a study that detect the most suitable surgical techniques for treating transsphincteric fistula", "detailedDescription"=>"we compared between LIFT and MAF in elderly with PAF"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"two hundred and fifty seven elderly patient with PAF", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* elderly persons with PAF\n\nExclusion Criteria:\n\n* recurrent fistula\n* associated autoimmune diseases"}, "identificationModule"=>{"nctId"=>"NCT06616662", "briefTitle"=>"Transsphincteric Fistula Management Using LIFT and MAF", "organization"=>{"class"=>"OTHER_GOV", "fullName"=>"Zagazig University"}, "officialTitle"=>"Comparative Outcomes of Ligation of the Intersphincteric Fistula Tract and Mucosal Advancement Flap Techniques in Elderly Patients with Transsphincteric Perianal Fistulas: Recurrence, Incontinence and Risk Factors", "orgStudyIdInfo"=>{"id"=>"perianal fistula"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"LIFT", "interventionNames"=>["Procedure: LIFT"]}, {"label"=>"MAF", "interventionNames"=>["Procedure: MAF"]}], "interventions"=>[{"name"=>"MAF", "type"=>"PROCEDURE", "description"=>"use mucosal advancement flap to treat PAF", "armGroupLabels"=>["MAF"]}, {"name"=>"LIFT", "type"=>"PROCEDURE", "description"=>"use LIFT surgery for treating PAF", "armGroupLabels"=>["LIFT"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"44511", "city"=>"Zagazig", "state"=>"Sharkia", "country"=>"Egypt", "facility"=>"Faculty of Medicine Zagazig University", "geoPoint"=>{"lat"=>30.58768, "lon"=>31.502}}], "overallOfficials"=>[{"name"=>"Tamer. A.A.M. Habeeb", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Zagazig University"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Zagazig University", "class"=>"OTHER_GOV"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"prof of general and laparoscopic surgery", "investigatorFullName"=>"Tamer.A.A.M.Habeeb", "investigatorAffiliation"=>"Zagazig University"}}}}
