{
  "FullStudy":{
    "Rank":218235,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01510977",
          "OrgStudyIdInfo":{
            "OrgStudyId":"2009-0733"
          },
          "Organization":{
            "OrgFullName":"Asan Medical Center",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Second Bowel Preparation for Colonoscopy Failure",
          "OfficialTitle":"The Outcome of a Second Preparation for Colonoscopy After Preparation Failure in the First Procedure: a Prospective Randomized Controlled Study"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2013",
          "OverallStatus":"Terminated",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"November 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"February 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"February 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 9, 2012",
          "StudyFirstSubmitQCDate":"January 17, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 18, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 11, 2013",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 13, 2013",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Jeong-Sik Byeon",
            "ResponsiblePartyInvestigatorTitle":"Clinical Professor",
            "ResponsiblePartyInvestigatorAffiliation":"Asan Medical Center"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Asan Medical Center",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"Colonoscopy is a basic but important tool to diagnose and treat lesions of the colon. Proper colon cleansing is essential for colonoscopy to be performed with a good quality. Inadequate bowel preparation leads to longer colonoscopic insertion time and patient discomfort, as well as inadequate diagnostic yield of colonic lesions. Frequency of colonoscopy failure due to bad bowel preparation is reported to be 0.3% to 6.5 percent, and the rate increases with liver cirrhosis, constipation, dementia, stroke, or administration of tricyclic antidepressants. In case of colonoscopy failure due to bad bowel preparation, the second colonoscopy can be performed with either adding a colon cleansing solution immediately, or it can be performed after a few days with colon cleansing agent together with prokinetics. These different kinds of bowel preparations after first colonoscopy failure have not been compared."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Colonoscopy Failure",
              "Poor Bowel Preparation"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "colonoscopy",
              "bowel preparation"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 4"
            ]
          },
          "DesignInfo":{
            "DesignAllocation":"Randomized",
            "DesignInterventionModel":"Parallel Assignment",
            "DesignPrimaryPurpose":"Diagnostic",
            "DesignMaskingInfo":{
              "DesignMasking":"Single",
              "DesignWhoMaskedList":{
                "DesignWhoMasked":[
                  "Outcomes Assessor"
                ]
              }
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"150",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"PEG",
                "ArmGroupType":"Active Comparator",
                "ArmGroupDescription":"2L of polyethylene glycol addition immediately after first colonoscopy failure",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: polyethylene glycol"
                  ]
                }
              },{
                "ArmGroupLabel":"PEG + bisacodyl",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"One week after initial colonoscopy failure, conventional amount (5L) of polyethylene glycol together with bisacodyl administration",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: polyethylene glycol, Bisacodyl"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"polyethylene glycol, Bisacodyl",
                "InterventionDescription":"After failure of first colonoscopy, bowel preparation with polyethylene glycol and bisacodyl one week after",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "PEG + bisacodyl"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"polyethylene glycol",
                "InterventionDescription":"Immediately after first colonoscopy failure, polyethylene glycol 2L addition",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "PEG"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"second colonoscopy failure due to inadequate bowel preparation (PEG+bisdacodyl group)",
                "PrimaryOutcomeTimeFrame":"one week"
              },{
                "PrimaryOutcomeMeasure":"second colonoscopy failure due to inadequate bowel preparation (PEG group)",
                "PrimaryOutcomeTimeFrame":"within the same day"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nFirst colonoscopy failure due to inadequate bowel preparation\n\nExclusion Criteria:\n\nyounger than 18 years old\npresence of inflammatory bowel disease\npregnant\nlactating\nrefusal",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jeong-Sik Byeon, MD, PhD",
                "OverallOfficialAffiliation":"Asan Medical Center",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Asan Medical Center",
                "LocationCity":"Seoul",
                "LocationZip":"138-736",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000001726",
                "InterventionMeshTerm":"Bisacodyl"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000002400",
                "InterventionAncestorTerm":"Cathartics"
              },{
                "InterventionAncestorId":"D000005765",
                "InterventionAncestorTerm":"Gastrointestinal Agents"
              },{
                "InterventionAncestorId":"D000054368",
                "InterventionAncestorTerm":"Laxatives"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M3590",
                "InterventionBrowseLeafName":"Bisacodyl",
                "InterventionBrowseLeafAsFound":"Bisacodyl",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M26251",
                "InterventionBrowseLeafName":"Laxatives",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M4234",
                "InterventionBrowseLeafName":"Cathartics",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M7464",
                "InterventionBrowseLeafName":"Gastrointestinal Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Gast",
                "InterventionBrowseBranchName":"Gastrointestinal Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        }
      }
    }
  }
}