{
  "FullStudy":{
    "Rank":217917,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515150",
          "OrgStudyIdInfo":{
            "OrgStudyId":"P-VOD"
          },
          "Organization":{
            "OrgFullName":"Uppsala University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis",
          "OfficialTitle":"Management of Patients With Uncomplicated Diverticulitis as Out-patient and Without Antibiotics",
          "Acronym":"P-VOD"
        },
        "StatusModule":{
          "StatusVerifiedDate":"January 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"February 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"August 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 23, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 26, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Uppsala University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Previous multicentre study NCT 01008488 indicates that a patient with CT-proven uncomplicated diverticulitis has a very low risk (1.4%) of developing severe complications such as perforations or abscesses. The question is whether or not hospitalization is necessary, and if patients in that case could return home without antibiotics.\n\nThe purpose of this study is to evaluate if out-patients managements in uncomplicated colonic diverticulitis is possible without readmission or complications.",
          "DetailedDescription":"At the emergency room all patients with computed tomography verified acute uncomplicated diverticulitis will be asked about participation in the study. If They accept the participation, They will be send home with pain relief medicine. Every morning a nurse from our colorectal unit call the patient asking about the condition. The patients will have a visit at the surgery unit within 10 days."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Colonic Diverticulitis"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "diverticulitis",
              "Out-patient management",
              "Antibiotics"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "PatientRegistry":"No",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"161",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Out-patients in diverticulitis",
                "ArmGroupDescription":"All patient with acute uncomplicated diverticulitis how accept participation in the study will be enrolled in the study."
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Number of admission and complications among participant within three months follow-up.",
                "PrimaryOutcomeTimeFrame":"Three months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"To evaluate reason of hospital admission, late complications, need of bowel rest and costs",
                "SecondaryOutcomeTimeFrame":"Three months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAdults (age above 18 years, acute abdominal pain (Duration< 3 days), abdominal tenderness, elevated inflammatory parameters, CT- scan sign of uncomplicated diverticulitis(without sign of abscess or free air).\n\nExclusion Criteria:\n\ndiffuse peritonitis sepsis or abscess, drying Patients who are unable to intake of fluids orally, severe pain with need of repeated parenteral morphine treatment, immunological deficient patients incl. steroid treatment, pregnancy, dementia, patients who need hospitalization of other reasons",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"95 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"Patients with CT- scan varified acute uncomplicated diverticulitis how are abel to underwent out-patients managment",
          "SamplingMethod":"Probability Sample"
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Mats Enlund, Ass. Prof",
                "OverallOfficialAffiliation":"Centre of Clinical Research of Uppsala University, Västmanlands Hospital Västerås",
                "OverallOfficialRole":"Study Chair"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Colorectal unit, department of surgery Västmanland Hospital Västerås",
                "LocationCity":"Västerås",
                "LocationState":"Västmanland",
                "LocationZip":"72189",
                "LocationCountry":"Sweden"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000004238",
                "ConditionMeshTerm":"Diverticulitis"
              },{
                "ConditionMeshId":"D000004239",
                "ConditionMeshTerm":"Diverticulitis, Colonic"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000076385",
                "ConditionAncestorTerm":"Diverticular Diseases"
              },{
                "ConditionAncestorId":"D000059413",
                "ConditionAncestorTerm":"Intraabdominal Infections"
              },{
                "ConditionAncestorId":"D000007239",
                "ConditionAncestorTerm":"Infection"
              },{
                "ConditionAncestorId":"D000005759",
                "ConditionAncestorTerm":"Gastroenteritis"
              },{
                "ConditionAncestorId":"D000005767",
                "ConditionAncestorTerm":"Gastrointestinal Diseases"
              },{
                "ConditionAncestorId":"D000004066",
                "ConditionAncestorTerm":"Digestive System Diseases"
              },{
                "ConditionAncestorId":"D000043963",
                "ConditionAncestorTerm":"Diverticulosis, Colonic"
              },{
                "ConditionAncestorId":"D000003108",
                "ConditionAncestorTerm":"Colonic Diseases"
              },{
                "ConditionAncestorId":"D000007410",
                "ConditionAncestorTerm":"Intestinal Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M5997",
                "ConditionBrowseLeafName":"Diverticulitis",
                "ConditionBrowseLeafAsFound":"Diverticulitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5998",
                "ConditionBrowseLeafName":"Diverticulitis, Colonic",
                "ConditionBrowseLeafAsFound":"Colonic Diverticulitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5999",
                "ConditionBrowseLeafName":"Diverticulum",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M1603",
                "ConditionBrowseLeafName":"Diverticular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8866",
                "ConditionBrowseLeafName":"Infection",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4951",
                "ConditionBrowseLeafName":"Communicable Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M28052",
                "ConditionBrowseLeafName":"Intraabdominal Infections",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7458",
                "ConditionBrowseLeafName":"Gastroenteritis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M7466",
                "ConditionBrowseLeafName":"Gastrointestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M5838",
                "ConditionBrowseLeafName":"Digestive System Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23801",
                "ConditionBrowseLeafName":"Diverticulosis, Colonic",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M4919",
                "ConditionBrowseLeafName":"Colonic Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9027",
                "ConditionBrowseLeafName":"Intestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}