{
  "FullStudy":{
    "Rank":218271,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510496",
          "OrgStudyIdInfo":{
            "OrgStudyId":"GENDOLCAT"
          },
          "Organization":{
            "OrgFullName":"Fundacion IMIM",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy: Analysis of Risk Factors and Association With Genetic Polymorphisms",
          "OfficialTitle":"Transition From Acute to Chronic Pain After Inguinal Hernia, Hysterectomy and Thoracotomy : Analysis of Risk Factors and Association With Genetic Polymorphisms"
        },
        "StatusModule":{
          "StatusVerifiedDate":"December 2015",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2009"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"December 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"July 2014",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"December 23, 2011",
          "StudyFirstSubmitQCDate":"January 11, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 16, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"December 29, 2015",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"December 30, 2015",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Antonio Montes",
            "ResponsiblePartyInvestigatorTitle":"MD",
            "ResponsiblePartyInvestigatorAffiliation":"Fundacion IMIM"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Fundacion IMIM",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The treatment of postoperative pain continues to be inadequate in the investigators practice setting.\n\nInadequate pain treatment not only contributes to postoperative complications in the short term but can also be a factor that favors the development of chronic postoperative pain and diminishes long-term quality of life. Risk factors that can lead to a transition to chronic pain need to be analyzed."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Chronic Postoperative Pain"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Chronic pain",
              "genetic polymorphisms",
              "postoperative pain"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Observational",
          "DesignInfo":{
            "DesignObservationalModelList":{
              "DesignObservationalModel":[
                "Cohort"
              ]
            },
            "DesignTimePerspectiveList":{
              "DesignTimePerspective":[
                "Prospective"
              ]
            }
          },
          "BioSpec":{
            "BioSpecRetention":"Samples With DNA",
            "BioSpecDescription":"Sample collection Five milliliters of venous blood will be extracted from each patient with chronic pain; control samples will come from a DNA bank. All patients must have given their written consent to testing and storage.\n\n- Plasma DNA will be extracted with a BioRobot EZ1 Workstation (Qiagen)."
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"3979",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Patients who had inguinal herniorraphy.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Inguinal herniorraphy."
                  ]
                }
              },{
                "ArmGroupLabel":"Patients who had hysterectomy.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Hysterectomy."
                  ]
                }
              },{
                "ArmGroupLabel":"Patients who had thoracotomy.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Thoracotomy ."
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Inguinal herniorraphy.",
                "InterventionDescription":"Inguinal herniorraphy (non laparoscopic).",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Patients who had inguinal herniorraphy."
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"Hysterectomy.",
                "InterventionDescription":"Hysterectomy: Vaginal and abdominal.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Patients who had hysterectomy."
                  ]
                }
              },{
                "InterventionType":"Procedure",
                "InterventionName":"Thoracotomy .",
                "InterventionDescription":"Thoracotomy (non laparoscopic).",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Patients who had thoracotomy."
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Evaluation of chronic postsurgical pain.",
                "PrimaryOutcomeDescription":"After 3 months a physical examination will take place and after 12 months a follow-up will be reported by phone.",
                "PrimaryOutcomeTimeFrame":"After 3 and 12 months of surgery."
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Predictive factors of chronic postsurgical pain.",
                "SecondaryOutcomeDescription":"Preoperative (psychological factors, preoperative pain, pharmacologic treatment) intraoperative (surgical technic, type of anaestesia) and postoperative(posoperative pain, surgical complications and treatment of postoperative pain).",
                "SecondaryOutcomeTimeFrame":"After 3 and 12 months of surgery."
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with given inform consent, aged mor than 18 years, who undergo scheduled surgery of one of the following types: inguinal hernia (men), hysterectomy, thoracotomy (men).\n\nExclusion Criteria:\n\nPatients aged less than 18 years,\nPatients requiring reoperation because of surgical complications.",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          },
          "StudyPopulation":"All spanish patients who undergo scheduled surgery of one of the following types: inguinal herniorrhaphy, hysterectomy, toracothomy.",
          "SamplingMethod":"Non-Probability Sample"
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Hospital Municipal de Badalona",
                "LocationCity":"Badalona",
                "LocationState":"Barcelona",
                "LocationZip":"08911",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Universitari Germans Trias i Pujol",
                "LocationCity":"Badalona",
                "LocationState":"Barcelona",
                "LocationZip":"08916",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital de San Bernabé",
                "LocationCity":"Berga",
                "LocationState":"Barcelona",
                "LocationZip":"08600",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital de Granollers",
                "LocationCity":"Granollers",
                "LocationState":"Barcelona",
                "LocationZip":"08400",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Universitari de Bellvitge",
                "LocationCity":"L'Hospitalet de Llobregat",
                "LocationState":"Barcelona",
                "LocationZip":"08907",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital General de Manresa",
                "LocationCity":"Manresa",
                "LocationState":"Barcelona",
                "LocationZip":"08240",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital de Mataro",
                "LocationCity":"Mataro",
                "LocationState":"Barcelona",
                "LocationZip":"08304",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Parc Tauli",
                "LocationCity":"Sabadell",
                "LocationState":"Barcelona",
                "LocationZip":"08208",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Mutua de Terrassa",
                "LocationCity":"Terrassa",
                "LocationState":"Barcelona",
                "LocationZip":"08221",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Universitari Mutua de Terrassa",
                "LocationCity":"Terrassa",
                "LocationState":"Barcelona",
                "LocationZip":"08227",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital de Viladecans",
                "LocationCity":"Viladecans",
                "LocationState":"Barcelona",
                "LocationZip":"08840",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital de Santa Caterina",
                "LocationCity":"Salt",
                "LocationState":"Girona",
                "LocationZip":"17190",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Sant Joan de Reus",
                "LocationCity":"Reus",
                "LocationState":"Tarragona",
                "LocationZip":"43201",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Lluís Alcanyís de Xàtiva",
                "LocationCity":"Xàtiva",
                "LocationState":"València",
                "LocationZip":"46800",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital del Mar",
                "LocationCity":"Barcelona",
                "LocationZip":"08003",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital de l'Esperança",
                "LocationCity":"Barcelona",
                "LocationZip":"08024",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital de la Santa Creu i Sant Pau",
                "LocationCity":"Barcelona",
                "LocationZip":"08025",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Sagrat Cor",
                "LocationCity":"Barcelona",
                "LocationZip":"08029",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Universitari Vall d'Hebron",
                "LocationCity":"Barcelona",
                "LocationZip":"08035",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Clínic i Provincial de Barcelona",
                "LocationCity":"Barcelona",
                "LocationZip":"08036",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital del Sant Boi",
                "LocationCity":"Barcelona",
                "LocationZip":"08830",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Universitari Doctor Josep Trueta de Girona",
                "LocationCity":"Girona",
                "LocationZip":"17007",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Santa Maria",
                "LocationCity":"Lleida",
                "LocationZip":"25198",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Clínico de Valencia",
                "LocationCity":"Valencia",
                "LocationZip":"46010",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital General Universitario de Valencia",
                "LocationCity":"Valencia",
                "LocationZip":"46014",
                "LocationCountry":"Spain"
              },{
                "LocationFacility":"Hospital Universitari de la Fe",
                "LocationCity":"Valencia",
                "LocationZip":"46026",
                "LocationCountry":"Spain"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"25985024",
                "ReferenceType":"derived",
                "ReferenceCitation":"Montes A, Roca G, Sabate S, Lao JI, Navarro A, Cantillo J, Canet J; GENDOLCAT Study Group. Genetic and Clinical Factors Associated with Chronic Postsurgical Pain after Hernia Repair, Hysterectomy, and Thoracotomy: A Two-year Multicenter Cohort Study. Anesthesiology. 2015 May;122(5):1123-41. doi: 10.1097/ALN.0000000000000611."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000010149",
                "ConditionMeshTerm":"Pain, Postoperative"
              },{
                "ConditionMeshId":"D000059350",
                "ConditionMeshTerm":"Chronic Pain"
              },{
                "ConditionMeshId":"D000006552",
                "ConditionMeshTerm":"Hernia, Inguinal"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000011183",
                "ConditionAncestorTerm":"Postoperative Complications"
              },{
                "ConditionAncestorId":"D000010335",
                "ConditionAncestorTerm":"Pathologic Processes"
              },{
                "ConditionAncestorId":"D000010146",
                "ConditionAncestorTerm":"Pain"
              },{
                "ConditionAncestorId":"D000009461",
                "ConditionAncestorTerm":"Neurologic Manifestations"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              },{
                "ConditionAncestorId":"D000006547",
                "ConditionAncestorTerm":"Hernia"
              },{
                "ConditionAncestorId":"D000020763",
                "ConditionAncestorTerm":"Pathological Conditions, Anatomical"
              },{
                "ConditionAncestorId":"D000046449",
                "ConditionAncestorTerm":"Hernia, Abdominal"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M8208",
                "ConditionBrowseLeafName":"Hernia",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M8213",
                "ConditionBrowseLeafName":"Hernia, Inguinal",
                "ConditionBrowseLeafAsFound":"Inguinal Hernia",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M11652",
                "ConditionBrowseLeafName":"Pain, Postoperative",
                "ConditionBrowseLeafAsFound":"Postoperative Pain",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M28029",
                "ConditionBrowseLeafName":"Chronic Pain",
                "ConditionBrowseLeafAsFound":"Chronic Pain",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M11649",
                "ConditionBrowseLeafName":"Pain",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M12648",
                "ConditionBrowseLeafName":"Postoperative Complications",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M10987",
                "ConditionBrowseLeafName":"Neurologic Manifestations",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M21103",
                "ConditionBrowseLeafName":"Pathological Conditions, Anatomical",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24262",
                "ConditionBrowseLeafName":"Hernia, Abdominal",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC10",
                "ConditionBrowseBranchName":"Nervous System Diseases"
              }
            ]
          }
        }
      }
    }
  }
}