Nctid:
NCT06227871
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000000038", "term"=>"Abscess"}, {"id"=>"D000018784", "term"=>"Abdominal Abscess"}, {"id"=>"D000010181", "term"=>"Pancreatic Cyst"}, {"id"=>"D000010185", "term"=>"Pancreatic Fistula"}, {"id"=>"D000005402", "term"=>"Fistula"}, {"id"=>"D000009336", "term"=>"Necrosis"}, {"id"=>"D000057868", "term"=>"Anastomotic Leak"}, {"id"=>"D000014947", "term"=>"Wounds and Injuries"}], "ancestors"=>[{"id"=>"D000020763", "term"=>"Pathological Conditions, Anatomical"}, {"id"=>"D000010335", "term"=>"Pathologic Processes"}, {"id"=>"D000013492", "term"=>"Suppuration"}, {"id"=>"D000007239", "term"=>"Infections"}, {"id"=>"D000007249", "term"=>"Inflammation"}, {"id"=>"D000011183", "term"=>"Postoperative Complications"}, {"id"=>"D000003560", "term"=>"Cysts"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000010182", "term"=>"Pancreatic Diseases"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000016154", "term"=>"Digestive System Fistula"}], "browseLeaves"=>[{"id"=>"M17685", "name"=>"Wounds and Injuries", "asFound"=>"Injury", "relevance"=>"HIGH"}, {"id"=>"M12284", "name"=>"Necrosis", "asFound"=>"Necrosis", "relevance"=>"HIGH"}, {"id"=>"M8532", "name"=>"Fistula", "asFound"=>"Fistula", "relevance"=>"HIGH"}, {"id"=>"M6765", "name"=>"Cysts", "relevance"=>"LOW"}, {"id"=>"M28891", "name"=>"Anastomotic Leak", "asFound"=>"Anastomotic Leak", "relevance"=>"HIGH"}, {"id"=>"M37", "name"=>"Abscess", "asFound"=>"Abscess", "relevance"=>"HIGH"}, {"id"=>"M13101", "name"=>"Pancreatic Cyst", "asFound"=>"Pancreas Cyst", "relevance"=>"HIGH"}, {"id"=>"M6", "name"=>"Abdominal Injuries", "relevance"=>"LOW"}, {"id"=>"M20845", "name"=>"Abdominal Abscess", "asFound"=>"Abdominal Abscess", "relevance"=>"HIGH"}, {"id"=>"M13105", "name"=>"Pancreatic Fistula", "asFound"=>"Pancreas; Fistula", "relevance"=>"HIGH"}, {"id"=>"M22519", "name"=>"Pathological Conditions, Anatomical", "relevance"=>"LOW"}, {"id"=>"M16273", "name"=>"Suppuration", "relevance"=>"LOW"}, {"id"=>"M10283", "name"=>"Infections", "relevance"=>"LOW"}, {"id"=>"M6368", "name"=>"Communicable Diseases", "relevance"=>"LOW"}, {"id"=>"M10293", "name"=>"Inflammation", "relevance"=>"LOW"}, {"id"=>"M14065", "name"=>"Postoperative Complications", "relevance"=>"LOW"}, {"id"=>"M13102", "name"=>"Pancreatic Diseases", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M18616", "name"=>"Digestive System Fistula", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Wounds and Injuries", "abbrev"=>"BC26"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Infections", "abbrev"=>"BC01"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M22554", "name"=>"Pancrelipase", "relevance"=>"LOW"}, {"id"=>"M13114", "name"=>"Pancreatin", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Gastrointestinal Agents", "abbrev"=>"Gast"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>31}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2019-11-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-03-01", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-25", "studyFirstSubmitDate"=>"2024-01-17", "studyFirstSubmitQcDate"=>"2024-01-25", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-03-01", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Complication occurrence", "timeFrame"=>"Up to 12 weeks postoperatively", "description"=>"Complications including wound dehiscence, pancreatic duct leak, pancreatic pseudocyst, pancreatic fistula formation, pancreatic necrosis, intra-abdominal abscess, traumatic pancreatitis, anastomotic leak"}], "secondaryOutcomes"=>[{"measure"=>"Associated intra-abdominal injuries", "timeFrame"=>"within 48 hours of admission", "description"=>"concomitant intra-abdominal injuries including pancreatic duck, diaphragm, stomach, liver, kidney, Major vasculature, spleen, duodenum, small bowel, colon, ureter"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Pancreatic trauma", "Penetrating abdominal injury", "Abdominal trauma"], "conditions"=>["Pancreatic Trauma", "Pancreatic Duct Injury", "Pancreas Necrosis", "Pancreas Cyst", "Pancreas; Fistula", "Pancreas Abscess", "Intra-Abdominal Abscess", "Anastomotic Leak", "Pancreas Injury"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this observational study is to compare the presentation, treatment, and outcomes in patients suffering traumatic pancreatic injuries from blunt or penetrating trauma.\n\nThe questions this study aims to answer are:\n\n1. Does a statistically significant association exist between pancreatic injury grade and the following individual factors:\n\n * Mortality\n * Morbidity\n * Injury severity score\n2. Is there an association between post-operative pancreatic complications and operation-specific intervention?\n3. Does pancreatic injury score correlate with certain intra-abdominal organ injuries?\n\nParticipants meeting criteria are greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center after presenting to the institution's emergency department as tier 1 or 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patient's greater than 18 years old, with no history of pancreatic surgery who were hospitalized at Kern Medical Center from November 1st, 2019 to March 1st, 2023 after presenting to the institution's emergency department as tier 1 and 2 trauma activations following blunt or penetrating abdominal injury and were diagnosed with pancreatic injury during the same hospitalization.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Hospitalized at Kern Medical Center after presenting to the institution's emergency department as a tier 1 and 2 trauma activation\n* Hospitalized following blunt or penetrating abdominal injury\n* Diagnosed with traumatic pancreatic injury during same admission\n\nExclusion Criteria:\n\n* history of pancreatic surgery\n* Iatrogenic pancreatic injuries"}, "identificationModule"=>{"nctId"=>"NCT06227871", "briefTitle"=>"A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes", "organization"=>{"class"=>"OTHER", "fullName"=>"Kern Medical Center"}, "officialTitle"=>"A Retrospective Analysis of Pancreatic Injuries and Treatment Outcomes", "orgStudyIdInfo"=>{"id"=>"11894"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Penetrating intra-abdominal injury", "description"=>"Patients diagnosed with a pancreatic injury secondary to penetrating intra-abdominal injury subdivided by pancreatic injury grade", "interventionNames"=>["Procedure: Exploratory laparotomy"]}, {"label"=>"Blunt intra-abdominal injury", "description"=>"Patients diagnosed with a pancreatic injury secondary to blunt intra-abdominal injury subdivided by pancreatic injury grade", "interventionNames"=>["Procedure: Exploratory laparotomy"]}], "interventions"=>[{"name"=>"Exploratory laparotomy", "type"=>"PROCEDURE", "description"=>"Exploratory laparotomy with interventions addressing pancreatic injuries Grade 1-5 including pancreatic interventions including subtotal pancreatectomy, distal pancreatectomy, pancreatic ligation, pyloric diversion, or simple drainage of the pancreas.", "armGroupLabels"=>["Blunt intra-abdominal injury", "Penetrating intra-abdominal injury"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"93306", "city"=>"Bakersfield", "state"=>"California", "country"=>"United States", "facility"=>"Kern Medical Center", "geoPoint"=>{"lat"=>35.37329, "lon"=>-119.01871}}], "overallOfficials"=>[{"name"=>"Amber Jones, DO, MPH", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Kern Medical Center"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Kern Medical Center", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"Principal Investigator, DO, MPH", "investigatorFullName"=>"Amber Jones", "investigatorAffiliation"=>"Kern Medical Center"}}}}
