Nctid:
NCT06228027
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D002764", "term"=>"Cholecystitis"}, {"id"=>"D042101", "term"=>"Acalculous Cholecystitis"}, {"id"=>"D041881", "term"=>"Cholecystitis, Acute"}], "ancestors"=>[{"id"=>"D005705", "term"=>"Gallbladder Diseases"}, {"id"=>"D001660", "term"=>"Biliary Tract Diseases"}, {"id"=>"D004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M6005", "name"=>"Cholecystitis", "asFound"=>"Cholecystitis", "relevance"=>"HIGH"}, {"id"=>"M25019", "name"=>"Acalculous Cholecystitis", "asFound"=>"Cholecystitis", "relevance"=>"HIGH"}, {"id"=>"M24988", "name"=>"Cholecystitis, Acute", "asFound"=>"Acute Cholecystitis", "relevance"=>"HIGH"}, {"id"=>"M14065", "name"=>"Postoperative Complications", "relevance"=>"LOW"}, {"id"=>"M8823", "name"=>"Gallbladder Diseases", "relevance"=>"LOW"}, {"id"=>"M4946", "name"=>"Biliary Tract Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"T1150", "name"=>"Cholecystitis", "asFound"=>"Cholecystitis", "relevance"=>"HIGH"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>10000}, "targetDuration"=>"90 Days", "patientRegistry"=>true}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2025-01-01", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-03", "completionDateStruct"=>{"date"=>"2027-04-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-03-07", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-03-12", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2027-01-01", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Mortality", "timeFrame"=>"Jan 2025- Dec 2026", "description"=>"Describe the mortality in the cohort and its causes"}, {"measure"=>"Complications", "timeFrame"=>"Jan 2025- Dec 2026", "description"=>"Describe the mortality in the cohort by Clavien-Dindo's classification"}, {"measure"=>"ACME's prediction of mortality", "timeFrame"=>"Jan 2025- Dec 2026", "description"=>"To describe the prediction in a ROC Curve of ACME Scoring System with C-Statistic"}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Acute Cholecystitis", "Cholecystectomy", "Tokyo Guidelines", "Postoperative Complications", "Mortality", "High-risk patient"], "conditions"=>["Acute Cholecystitis"]}, "descriptionModule"=>{"briefSummary"=>"Acute calculous cholecystitis (ACC) is the second most frequent surgical condition in emergency departments. The recommended treatment is surgical treatment (ST) and the accepted mortality is \\<1%, but in severe and/or fragile patients is higher. Despite the Tokyo Guidelines, there no consensus on who is the unfit patient for ST. A recent study has identified 4 risk factors that predicts the mortality in a 92% of patients (ACME) and could help to develop new guidelines in ACC. The aim of this study is to perfom an external validation of the new simplified scoring system for mortality in ACC.", "detailedDescription"=>"This is a prospective multicenter observational study of 10.000 adults with ACC during 2 consecutive years (2025/2026), including baseline demographic characteristics, comorbidity severity defined as Charlson Comorbidity Index (CCI), ASA Score, Tokyo Guidelines severity classification and the new ACME Scoring system. The primary outcome is to study the prediction of mortality of ACME score. Secondary outcomes include complications following Clavien-Dindo's classification, C-statistic, and ROC Curves."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"PROBABILITY_SAMPLE", "studyPopulation"=>"All the consecutive admisions with an acute calculous cholecystitis, independent on the treatment indicated, during 2025 and 2026.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Acute Calculous Cholecystitis\n\nExclusion Criteria:\n\n* Acute Cholangitis\n* Chronic Cholecystitis\n* Neoplasia\n* Acute Pancreatitis\n* Pregnant"}, "identificationModule"=>{"nctId"=>"NCT06228027", "acronym"=>"ACME_2", "briefTitle"=>"External Validation os the ACME Scoring System", "organization"=>{"class"=>"OTHER", "fullName"=>"Hospital del Mar"}, "officialTitle"=>"Prediction of the Mortality in Acute Calculous Cholecystitis. The ACME Project.", "orgStudyIdInfo"=>{"id"=>"External_ACME Validation"}}, "contactsLocationsModule"=>{"centralContacts"=>[{"name"=>"Ana María González Castillo, PhD", "role"=>"CONTACT", "email"=>"amgonzalezcastillo@gmail.com", "phone"=>"+34665126866"}], "overallOfficials"=>[{"name"=>"Ana María González Castillo, PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Hospital del Mar"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Hospital del Mar", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Doctor", "investigatorFullName"=>"Ana María González Castillo", "investigatorAffiliation"=>"Hospital del Mar"}}}}
