Nctid:
NCT06614296
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>100}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2024-04-03", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-08-02", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-27", "studyFirstSubmitDate"=>"2024-09-24", "studyFirstSubmitQcDate"=>"2024-09-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-10-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-26", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-07-25", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Unscheduled readmission", "timeFrame"=>"1 year", "description"=>"Unscheduled readmission refers to a patient who was unplanned or unexpected return to the hospital after CLIF discharged from a previous hospitalization."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Spine Degeneration"], "conditions"=>["Spine Degeneration"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to learn about the readmission related to Crenel Lateral Interbody Fusion (CLIF). The main question it aims to answer is:\n\nWhat are the risk factors for readmission after CLIF surgery?"}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients (\\>18 years old) with spinal degeneration undergoing CLIF surgery, including both unscheduled and scheduled readmissions.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with spinal degeneration undergoing CLIF surgery\n\nExclusion Criteria:\n\n* Under the age of 18"}, "identificationModule"=>{"nctId"=>"NCT06614296", "briefTitle"=>"Unscheduled Hospital Readmission After Crenel Lateral Interbody Fusion", "organization"=>{"class"=>"OTHER", "fullName"=>"Second Affiliated Hospital, School of Medicine, Zhejiang University"}, "officialTitle"=>"Factors and Experiences Associated with Unscheduled Hospital Readmission After Crenel Lateral Interbody Fusion", "orgStudyIdInfo"=>{"id"=>"2024-0165"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Unscheduled readimission", "description"=>"Unscheduled readimission after CLIF", "interventionNames"=>["Procedure: Crenel lateral interbody fusion plus second stage surgery"]}, {"label"=>"Scheduled readimission", "description"=>"Scheduled readimission after CLIF", "interventionNames"=>["Procedure: Crenel Lateral Interbody Fusion"]}], "interventions"=>[{"name"=>"Crenel Lateral Interbody Fusion", "type"=>"PROCEDURE", "otherNames"=>["Lateral Lumbar Interbody Fusion"], "description"=>"The Crenel Lateral Interbody Fusion (CLIF) is a surgical technique developed by the Department of Spine Surgery at the Second Affiliated Hospital of Zhejiang University School of Medicine. Building on the traditional Lateral Lumbar Interbody Fusion technique, this series of technical improvements overcomes the shortcomings of previous surgical methods, enhancing the safety, operability, and effectiveness of the surgery while reducing complications.", "armGroupLabels"=>["Scheduled readimission"]}, {"name"=>"Crenel lateral interbody fusion plus second stage surgery", "type"=>"PROCEDURE", "description"=>"The patient was first admitted to undergo CLIF surgery and was discharged after the operation. The patient will return to the hospital for a second surgery at the scheduled time.", "armGroupLabels"=>["Unscheduled readimission"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"310000", "city"=>"Hangzhou", "state"=>"Zhejiang", "country"=>"China", "facility"=>"2nd Affiliated Hospital, School of Medicine, Zhejiang University", "geoPoint"=>{"lat"=>30.29365, "lon"=>120.16142}}]}, "ipdSharingStatementModule"=>{"infoTypes"=>["STUDY_PROTOCOL"], "ipdSharing"=>"YES"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Second Affiliated Hospital, School of Medicine, Zhejiang University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
