Nctid:
NCT06228261
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000014947", "term"=>"Wounds and Injuries"}, {"id"=>"D000000007", "term"=>"Abdominal Injuries"}], "browseLeaves"=>[{"id"=>"M17685", "name"=>"Wounds and Injuries", "asFound"=>"Trauma", "relevance"=>"HIGH"}, {"id"=>"M6", "name"=>"Abdominal Injuries", "asFound"=>"Abdominal Trauma", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>1000}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"NOT_YET_RECRUITING", "startDateStruct"=>{"date"=>"2024-03-15", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-03-15", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-18", "studyFirstSubmitDate"=>"2024-01-18", "studyFirstSubmitQcDate"=>"2024-01-18", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-12-15", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Complications", "timeFrame"=>"2008-2023", "description"=>"The main outcome measure was the total of complications in patients with a penetrating abdominal trauma assessed by the Clavien-Dindo Classification."}, {"measure"=>"Mortality", "timeFrame"=>"2008-2023", "description"=>"The second main outcome measure was the total of deaths in patients with a penetrating abdominal trauma assessed by preventable or non-preventable deaths."}], "secondaryOutcomes"=>[{"measure"=>"Explorations", "timeFrame"=>"2008-2023", "description"=>"To describe the explorations that has been ordered: eFAST, CT Scan, explorative laparoscopy or laparotomy."}, {"measure"=>"Demographyc description", "timeFrame"=>"2008-2023", "description"=>"Description of the age and gender (Male / Female)"}, {"measure"=>"Physiologic description", "timeFrame"=>"2008-2023", "description"=>"Description of the vitals at arrival (bates per minute, blood pressure)"}, {"measure"=>"Wound and abdominal exploration", "timeFrame"=>"2008-2023", "description"=>"Description of the wound: bleeding, longitude, number of wounds and the abdominal explorations: peritonism or no peritonism."}]}, "oversightModule"=>{"oversightHasDmc"=>true, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Penetrating Trauma", "Trauma surgery", "Explorative laparoscopy", "Trauma laparotomy", "eFAST"], "conditions"=>["Penetrating Abdominal Trauma"]}, "descriptionModule"=>{"briefSummary"=>"Penetrating abdominal trauma (PAT) incidence varies between 3,1-12,8% and it comprises a wide range of injuries with varying patterns on diagnostic imaging. Last guidelines published in 2014 recommend the use of FAST and CXR as the Gold Standard method for evaluating. Computed Tomography (CT) is widely used in stable patients with PAT and it requires intravenous contrast and patient irradiation, leading to additional costs to healthcare services. This study aims to assess the management of PAT in our institution and with its results review the actual protocol.", "detailedDescription"=>"Penetrating abdominal trauma (PAT) incidence varies between 3,1-12,8% and it comprises a wide range of injuries with varying patterns on diagnostic imaging. Last guidelines published in 2014 recommend the use of FAST and CXR as the Gold Standard method for evaluating. Computed Tomography (CT) is widely used in stable patients with PAT and it requires intravenous contrast and patient irradiation, leading to additional costs to healthcare services. This study aims to assess the management of PAT in our institution and with its results review the actual protocol.\n\nA retrospective unicentric study will be conducted on a prospective database of stab wounds at the Department of General Surgery of Hospital del Mar over a 15-year period. The normality of the distribution of quantitative variables will be assessed using the Kolmogorov-Smirnov test. Comparison between qualitative variable groups will be performed using the Chi-square test or Fisher's exact test when appropriate, and non-parametric tests like the Mann-Whitney U test will be used to evaluate the significance of differences in means of quantitative variables. The odds ratios (OR) of predictor variables with outcome variables will be determined."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients with a penetrating trauma in the neck admitted in Hospital del Mar from 2008 to 2023.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* All penetrating trauma patients admitted in the emergency department.\n\nExclusion Criteria:\n\n* All patients with any other diagnostic different from penetrating trauma\n* Blunt trauma patients admitted in the emergency department"}, "identificationModule"=>{"nctId"=>"NCT06228261", "acronym"=>"PAT-HMAR", "briefTitle"=>"Critical Analysis of the Results in the Management of Penetrating Abdominal Trauma in the Past Fifteen Years.", "organization"=>{"class"=>"OTHER", "fullName"=>"Hospital del Mar"}, "officialTitle"=>"Critical Analysis of the Results in the Management of Penetrating Abdominal Trauma in the Past Fifteen Years. Do we Need to Change the Protocol?", "orgStudyIdInfo"=>{"id"=>"Penetrating abdotrauma HMAR"}}, "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"}}}}
