{
  "FullStudy":{
    "Rank":217944,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01514799",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2011_HG_Aleris_limb_length"
          },
          "Organization":{
            "OrgFullName":"Aleris Obesity",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Effects of Long Biliopancreatic Limb vs. Long Alimentary Limb in Superobesity, a Randomized Study",
          "OfficialTitle":"Randomized Study Comparing the Effects of Gastric Bypass Using a Long BP-limb vs. a Long Alimentary Limb in Morbid Obesity"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2020",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"August 29, 2011",
            "StartDateType":"Actual"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"November 20, 2015",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 1, 2020",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 18, 2012",
          "StudyFirstSubmitQCDate":"January 20, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 23, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 24, 2020",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 25, 2020",
            "LastUpdatePostDateType":"Actual"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Aleris Obesity",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Super Obesity, i.e. a BMI above 50, is difficult to treat. Normal gastric bypass surgery is not always enough for proper weight control. Bypassing a longer segment of the gut may be more beneficial. Which part to bypass is not clear.\n\nThe investigators want to compare the effects between preventing a 60 cm proximal (oral) portion of the jejunum from food contact with the effects when preventing a 200 cm part of the jejunum from contact with bile and pancreatic juice.\n\nEndpoints are quality of life, gastrointestinal function, and weight development.",
          "DetailedDescription":"Two variations of gastric bypass are compared:\n\nMethod 1 (test method):A 200 cm BP-limb (distance Treitz to EA) + 150 cm common channel (EA to ileocecal valve) + Roux-Y-limb variable Method 2 (standard method): A 60 cm BP limb + 150 cm Roux-Y-limb + common channel variable.\n\nPatients are evaluated according to the principles of the Scandinavian Obesity surgery registry (SOReg) with the addition of two additional questionnaires.\n\nFU time is set at 5 years."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Morbid Obesity",
              "Weight Loss"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "gastric bypass",
              "morbid obesity",
              "gut function",
              "weight loss"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignInterventionModelDescription":"Randomised study between long and standard biliopancreatic limb in gstric bypass surgery",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"Double",
              "DesignMaskingDescription":"Randomisation in the OR, (closed envelopes, blocks of six) no further info to ward or follow-up unit. No specific info as to randomisation outcome given to patients, all patients follow same protocol.\n\nCode number in operative charts.",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Investigator",
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"140",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"standard length bp limb, long alimentary limb",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"our normal way of doing a gastric bypass 60 cm BP limb",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: gastric bypass"
                  ]
                }
              },{
                "ArmGroupLabel":"Long BP limb",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"200 cm BP limb",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: gastric bypass"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"gastric bypass",
                "InterventionDescription":"two techniques of gastric bypass for studying the effects of making a long BP-limb",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Long BP limb",
                    "standard length bp limb, long alimentary limb"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"body weight reduction",
                "PrimaryOutcomeDescription":"absolute BW reduction, percentage of patients reaching BMI below 30,",
                "PrimaryOutcomeTimeFrame":"5 years"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"gastrointestinal function",
                "SecondaryOutcomeDescription":"SF-36, Op-9, GSRS and TFEQ are used in patient assessed variables",
                "SecondaryOutcomeTimeFrame":"5 years"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nBMI 50-65\nAge 18-55\nConservative attempts at weight reduction failed\n\nExclusion Criteria:\n\nInability to speak and understand the Swedish language\nResidence outside the county of Skåne\nPsychotic disease\nInflammatory bowel disease",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"55 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jan L Hedenbro",
                "OverallOfficialAffiliation":"Lunds Universitets Diabetescentrum",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Aleris Obesity Skåne",
                "LocationCity":"Lund",
                "LocationZip":"SE 222 70",
                "LocationCountry":"Sweden"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"26143297",
                "ReferenceType":"derived",
                "ReferenceCitation":"Nergård BJ, Lindqvist A, Gislason HG, Groop L, Ekelund M, Wierup N, Hedenbro JL. Mucosal glucagon-like peptide-1 and glucose-dependent insulinotropic polypeptide cell numbers in the super-obese human foregut after gastric bypass. Surg Obes Relat Dis. 2015 Nov-Dec;11(6):1237-46. doi: 10.1016/j.soard.2015.03.021. Epub 2015 Apr 2."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000009765",
                "ConditionMeshTerm":"Obesity"
              },{
                "ConditionMeshId":"D000009767",
                "ConditionMeshTerm":"Obesity, Morbid"
              },{
                "ConditionMeshId":"D000015431",
                "ConditionMeshTerm":"Weight Loss"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000044343",
                "ConditionAncestorTerm":"Overnutrition"
              },{
                "ConditionAncestorId":"D000009748",
                "ConditionAncestorTerm":"Nutrition Disorders"
              },{
                "ConditionAncestorId":"D000050177",
                "ConditionAncestorTerm":"Overweight"
              },{
                "ConditionAncestorId":"D000001835",
                "ConditionAncestorTerm":"Body Weight"
              },{
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              },{
                "ConditionAncestorId":"D000001836",
                "ConditionAncestorTerm":"Body Weight Changes"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11284",
                "ConditionBrowseLeafName":"Obesity",
                "ConditionBrowseLeafAsFound":"Obesity",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M11285",
                "ConditionBrowseLeafName":"Obesity, Morbid",
                "ConditionBrowseLeafAsFound":"Morbid Obesity",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M16685",
                "ConditionBrowseLeafName":"Weight Loss",
                "ConditionBrowseLeafAsFound":"Weight Loss",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M3696",
                "ConditionBrowseLeafName":"Body Weight",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M23894",
                "ConditionBrowseLeafName":"Overnutrition",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11267",
                "ConditionBrowseLeafName":"Nutrition Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24773",
                "ConditionBrowseLeafName":"Overweight",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3697",
                "ConditionBrowseLeafName":"Body Weight Changes",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}