{
  "FullStudy":{
    "Rank":218079,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01513005",
          "OrgStudyIdInfo":{
            "OrgStudyId":"PI10-PR.-REGIMBEAU"
          },
          "SecondaryIdInfoList":{
            "SecondaryIdInfo":[
              {
                "SecondaryId":"2010-A01178-31",
                "SecondaryIdType":"Other Identifier",
                "SecondaryIdDomain":"ID-RCB"
              }
            ]
          },
          "Organization":{
            "OrgFullName":"Centre Hospitalier Universitaire, Amiens",
            "OrgClass":"OTHER"
          },
          "BriefTitle":"Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery",
          "OfficialTitle":"Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study",
          "Acronym":"GASTRAMBU"
        },
        "StatusModule":{
          "StatusVerifiedDate":"February 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"May 2011"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"May 2012",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"May 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 19, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"February 4, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"February 5, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Centre Hospitalier Universitaire, Amiens",
            "LeadSponsorClass":"OTHER"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"No"
        },
        "DescriptionModule":{
          "BriefSummary":"The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery.",
          "DetailedDescription":"The purpose of this study is to investigate whether the patients with morbid obesity requiring a surgical approach by Laparoscopic Sleeve Gastrectomy could be operated according to a \"day-case surgery\" modality.\n\nThe sequence of this study is the following:\n\npatients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests.\nmedical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed.\nduring a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study\nafter obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit.\nthe following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...)\nthe 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up.\nfollow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Obesity"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Laparoscopic Sleeve Gastrectomy",
              "obesity management"
            ]
          }
        },
        "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":"Laparoscopic Sleeve Gastrectomy",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Procedure: Laparoscopic Sleeve Gastrectomy"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Procedure",
                "InterventionName":"Laparoscopic Sleeve Gastrectomy",
                "InterventionDescription":"the operative technique consists in few steps:\n\nposition of 4 trocars and insertion of a nasogastric tube\ndissection and mobilization of the greater curvature of the stomach\npreparation of the stomach for division\ngastric partition\nextraction of the gastric remnant\npostoperative surveillance",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Laparoscopic Sleeve Gastrectomy"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"unexpected admission rate",
                "PrimaryOutcomeDescription":"the unexpected admission rate corresponds to the number of overnight hospitalization i.e. the number of patients not treated considering a Day-Case Surgery.",
                "PrimaryOutcomeTimeFrame":"the day following the surgery"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"readmission rate",
                "SecondaryOutcomeDescription":"the readmission rate is defined as the number of readmission with conventional hospitalization",
                "SecondaryOutcomeTimeFrame":"one year"
              },{
                "SecondaryOutcomeMeasure":"unexpected consultation rate",
                "SecondaryOutcomeDescription":"the unexpected consultation rate corresponds to the number of consultations after the Laparoscopic Sleeve Gastrectomy because of a postoperative outcome (adverse event, pain...)",
                "SecondaryOutcomeTimeFrame":"one year"
              },{
                "SecondaryOutcomeMeasure":"reoperation rate",
                "SecondaryOutcomeTimeFrame":"one year"
              },{
                "SecondaryOutcomeMeasure":"overall length of stay",
                "SecondaryOutcomeDescription":"the overall length of stay corresponds to the duration of all hospitalizations i.e. between the surgical procedure and the end of follow up.",
                "SecondaryOutcomeTimeFrame":"one year"
              },{
                "SecondaryOutcomeMeasure":"per operative outcomes",
                "SecondaryOutcomeDescription":"the per operative outcomes include each event observed during the surgical procedure",
                "SecondaryOutcomeTimeFrame":"one year"
              },{
                "SecondaryOutcomeMeasure":"postoperative outcomes",
                "SecondaryOutcomeDescription":"the postoperative outcomes include all outcomes reported during the follow-up period",
                "SecondaryOutcomeTimeFrame":"one year"
              },{
                "SecondaryOutcomeMeasure":"efficiency of Laparoscopic Sleeve Gastrectomy",
                "SecondaryOutcomeDescription":"the efficiency of Laparoscopic Sleeve Gastrectomy is evaluated with the BAROS questionnaire",
                "SecondaryOutcomeTimeFrame":"six months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nsufficient understanding\ngood observance of medical prescription\navailability of a responsible adult for the first operative night\npatients living nearby the hospital (1 h maximum away)\ntelephonic accessibility\nbetween 18 and 60 years old adults\nbody mass index less than 60 kg/m2\nobesity requiring bariatric surgery\nsurgery validated by an obesity-related staff\n\nExclusion Criteria:\n\npatient under administrative or legal protection\nobesity without HAS criteria\ncardiovascular comorbidity\npulmonary comorbidity\ncurative anticoagulant therapy\nbad diabetes control\nbody mass index higher than 60 kg/m2",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "MaximumAge":"60 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Jean-Marc REGIMBEAU, MD,phD",
                "OverallOfficialAffiliation":"CHU Amiens",
                "OverallOfficialRole":"Principal Investigator"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"North Universitary Hospital",
                "LocationCity":"Amiens",
                "LocationZip":"80054",
                "LocationCountry":"France"
              }
            ]
          }
        },
        "ReferencesModule":{
          "ReferenceList":{
            "Reference":[
              {
                "ReferencePMID":"21769286",
                "ReferenceType":"background",
                "ReferenceCitation":"Péquignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6."
              },{
                "ReferencePMID":"20971049",
                "ReferenceType":"background",
                "ReferenceCitation":"Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016."
              },{
                "ReferencePMID":"19902316",
                "ReferenceType":"background",
                "ReferenceCitation":"Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10."
              },{
                "ReferencePMID":"19081482",
                "ReferenceType":"background",
                "ReferenceCitation":"Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30."
              },{
                "ReferencePMID":"18696169",
                "ReferenceType":"background",
                "ReferenceCitation":"Fuks D, Dumont F, Berna P, Verhaeghe P, Sinna R, Sabbagh C, Demuynck F, Yzet T, Delcenserie R, Bartoli E, Regimbeau JM. Case report-complex management of a postoperative bronchogastric fistula after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Feb;19(2):261-264. doi: 10.1007/s11695-008-9643-3. Epub 2008 Aug 12."
              },{
                "ReferencePMID":"27687352",
                "ReferenceType":"derived",
                "ReferenceCitation":"Badaoui R, Alami Chentoufi Y, Hchikat A, Rebibo L, Popov I, Dhahri A, Antoun G, Regimbeau JM, Lorne E, Dupont H. Outpatient laparoscopic sleeve gastrectomy: first 100 cases. J Clin Anesth. 2016 Nov;34:85-90. doi: 10.1016/j.jclinane.2016.03.026. Epub 2016 May 3."
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000009765",
                "ConditionMeshTerm":"Obesity"
              }
            ]
          },
          "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"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M11284",
                "ConditionBrowseLeafName":"Obesity",
                "ConditionBrowseLeafAsFound":"Obesity",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M23894",
                "ConditionBrowseLeafName":"Overnutrition",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M11267",
                "ConditionBrowseLeafName":"Nutrition Disorders",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M24773",
                "ConditionBrowseLeafName":"Overweight",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M3696",
                "ConditionBrowseLeafName":"Body Weight",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC18",
                "ConditionBrowseBranchName":"Nutritional and Metabolic Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              }
            ]
          }
        }
      }
    }
  }
}