{
  "FullStudy":{
    "Rank":218050,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513382",
          "OrgStudyIdInfo":{
            "OrgStudyId":"BAVUGC-2"
          },
          "Organization":{
            "OrgFullName":"Bezmialem Vakif University",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Effectiveness of Methylene Blue Guidance in Total Excision of Pilonidal Sinus.",
          "OfficialTitle":"Does Intraoperative Methylene Blue Guidance in Pilonidal Sinus Surgery Really Effective in Total Excision of the Nest ?",
          "Acronym":"BAVUGC-2"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2016",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2012",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 17, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 23, 2016",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 26, 2016",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Principal Investigator",
            "ResponsiblePartyInvestigatorFullName":"Suleyman Bozkurt",
            "ResponsiblePartyInvestigatorTitle":"Medical Doctor",
            "ResponsiblePartyInvestigatorAffiliation":"Bezmialem Vakif University"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Bezmialem Vakif University",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"Methylene bleu use in pilonidal sinus surgery is not an effective guidance as expected.",
          "DetailedDescription":"To study the potential benefits of intraoperative methylene blue use in pilonidal sinus surgery in detecting the borders of the disease, the histopathologic correlation between the specimen dyed by methylene blue and also the cavity excision specimen not dyed by methylene blue was investigated. The branches that distinctly exceeded the planned dyed excision borders will tried to be detected histopathologically, if any."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Pilonidal Sinus"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Pilonidal sinus",
              "Methylene blue",
              "Histopathology",
              "Surgery"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"30",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Methylene Blue",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"The effect of methylene blue dye in detection and total excision of pilonidal sinus will be studied histopathologically.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Pilonidal sinus excision"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Pilonidal sinus excision",
                "InterventionDescription":"The dyed portion of the excised pilonidal sinus and non-dyed cavity excision specimen will be studied histopathologically to detect any remnant of pilonidal sinus.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Methylene Blue"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Histopathologic detection of any evidence of pilonidal sinus disease in the cavity excision material not dyed by methylene blue",
                "PrimaryOutcomeTimeFrame":"3 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPilonidal sinus disease of the intergluteal region\nPrimary disease without history of drainage\nAges between 18 and 65, both gender\n\nExclusion Criteria:\n\nRecurrent pilonidal sinus disease\nAcute infection with abscess formation and/or purulent copious drainage\nDenial to sign informed consent",
          "HealthyVolunteers":"Accepts Healthy Volunteers",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"65 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Suleyman Bozkurt, M.D.",
                "OverallOfficialAffiliation":"Bezmialem Vakif University, Faculty of Medicine, Department of Surgery",
                "OverallOfficialRole":"Principal Investigator"
              },{
                "OverallOfficialName":"Erhan Aysan, Prof. Dr.",
                "OverallOfficialAffiliation":"Bezmialem Vakif University, Faculty of Medicine, Department of Surgery",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Bezmialem Vakif University, Faculty of Medicine, Department of Surgery",
                "LocationCity":"Istanbul",
                "LocationZip":"34093",
                "LocationCountry":"Turkey"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"17960395",
                "ReferenceType":"result",
                "ReferenceCitation":"Doll D, Novotny A, Rothe R, Kristiansen JE, Wietelmann K, Boulesteix AL, Düsel W, Petersen S. Methylene Blue halves the long-term recurrence rate in acute pilonidal sinus disease. Int J Colorectal Dis. 2008 Feb;23(2):181-7. Epub 2007 Oct 25."
              },{
                "ReferencePMID":"17703314",
                "ReferenceType":"result",
                "ReferenceCitation":"Soll C, Hahnloser D, Dindo D, Clavien PA, Hetzer F. A novel approach for treatment of sacrococcygeal pilonidal sinus: less is more. Int J Colorectal Dis. 2008 Feb;23(2):177-80. Epub 2007 Aug 17."
              },{
                "ReferencePMID":"19330243",
                "ReferenceType":"result",
                "ReferenceCitation":"Mentes O, Oysul A, Harlak A, Zeybek N, Kozak O, Tufan T. Ultrasonography accurately evaluates the dimension and shape of the pilonidal sinus. Clinics (Sao Paulo). 2009;64(3):189-92."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000010864",
                "ConditionMeshTerm":"Pilonidal Sinus"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000003560",
                "ConditionAncestorTerm":"Cysts"
              },{
                "ConditionAncestorId":"D000009369",
                "ConditionAncestorTerm":"Neoplasms"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M12342",
                "ConditionBrowseLeafName":"Pilonidal Sinus",
                "ConditionBrowseLeafAsFound":"Pilonidal Sinus",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M5348",
                "ConditionBrowseLeafName":"Cysts",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}