{
  "FullStudy":{
    "Rank":217906,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01515293",
          "OrgStudyIdInfo":{
            "OrgStudyId":"HUV-APP-MDFB"
          },
          "Organization":{
            "OrgFullName":"Hospital Universitario Virgen de la Arrixaca",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Single Incision Versus Conventional Laparoscopic Appendectomy",
          "OfficialTitle":"Prospective Randomised Study Comparing Single Incision Transumbilical Versus Conventional Laparoscopic Appendectomy"
        },
        "StatusModule":{
          "StatusVerifiedDate":"May 2011",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"September 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2010",
            "PrimaryCompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"January 23, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"January 24, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Dolores Frutos Bernal",
            "ResponsiblePartyInvestigatorTitle":"Dolores Frutos HUV Arrixaca",
            "ResponsiblePartyInvestigatorAffiliation":"Hospital Universitario Virgen de la Arrixaca"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Hospital Universitario Virgen de la Arrixaca",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of this study is to compare the short-term outcomes of single-incision and conventional laparoscopic appendectomy.",
          "DetailedDescription":"Appendicitis is the most common abdominal emergency. The treatment is surgical and single incision laparoscopic surgery (SILS) involves performing laparoscopic surgery through a single transumbilical point, in an attempt to improve the results of laparoscopic surgery."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Appendicitis"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"184",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Single Incision Laparoscopic Appendectomy",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Single Incision Laparoscopic Appendectomy"
                  ]
                }
              },{
                "ArmGroupLabel":"Conventional appendectomy",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"Conventional appendectomy",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Conventional appendectomy"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Single Incision Laparoscopic Appendectomy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Single Incision Laparoscopic Appendectomy"
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"Conventional appendectomy",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Conventional appendectomy"
                  ]
                }
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with suspected acute appendicitis\n\nExclusion Criteria:\n\nPerforated appendicitis",
          "Gender":"All",
          "MinimumAge":"12 Years",
          "StdAgeList":{
            "StdAge":[
              "Child",
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"23386239",
                "ReferenceType":"derived",
                "ReferenceCitation":"Frutos MD, Abrisqueta J, Lujan J, Abellan I, Parrilla P. Randomized prospective study to compare laparoscopic appendectomy versus umbilical single-incision appendectomy. Ann Surg. 2013 Mar;257(3):413-8. doi: 10.1097/SLA.0b013e318278d225."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000001064",
                "ConditionMeshTerm":"Appendicitis"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "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":"D000002429",
                "ConditionAncestorTerm":"Cecal Diseases"
              },{
                "ConditionAncestorId":"D000007410",
                "ConditionAncestorTerm":"Intestinal Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M1112",
                "ConditionBrowseLeafName":"Surgical Wound",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M2957",
                "ConditionBrowseLeafName":"Appendicitis",
                "ConditionBrowseLeafAsFound":"Appendicitis",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "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":"M4262",
                "ConditionBrowseLeafName":"Cecal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M9027",
                "ConditionBrowseLeafName":"Intestinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC26",
                "ConditionBrowseBranchName":"Wounds and Injuries"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC01",
                "ConditionBrowseBranchName":"Bacterial and Fungal Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC06",
                "ConditionBrowseBranchName":"Digestive System Diseases"
              }
            ]
          }
        }
      }
    }
  }
}