{ "FullStudy":{ "Rank":218047, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01513421", "OrgStudyIdInfo":{ "OrgStudyId":"281/10" }, "Organization":{ "OrgFullName":"Centre Hospitalier Universitaire Vaudois", "OrgClass":"OTHER" }, "BriefTitle":"Active Versus Non Active Drainage for the Treatment of Infected Intra-abdominal Collection", "OfficialTitle":"Active Versus Non Active Drainage for the Treatment of Infected Intra-abdominal Collection: a Randomized Prospective Trial" }, "StatusModule":{ "StatusVerifiedDate":"January 2012", "OverallStatus":"Unknown status", "LastKnownStatus":"Recruiting", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"January 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"January 2013", "PrimaryCompletionDateType":"Anticipated" }, "CompletionDateStruct":{ "CompletionDate":"January 2014", "CompletionDateType":"Anticipated" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 17, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 20, 2012", "StudyFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"January 20, 2012", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"January 23, 2012", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Principal Investigator", "ResponsiblePartyInvestigatorFullName":"Dr. Emmanuel Melloul", "ResponsiblePartyInvestigatorTitle":"Surgeon, M.D.", "ResponsiblePartyInvestigatorAffiliation":"Centre Hospitalier Universitaire Vaudois" }, "LeadSponsor":{ "LeadSponsorName":"Centre Hospitalier Universitaire Vaudois", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The Percutaneous drainage of symptomatic intra-abdominal collection (primary or secondary to surgery)is the treatment of choice in the absence of peritonitis signs. In critically ill patients, this procedure allows to avoid or postpone surgery. In these settings, the percutaneous drain can be either in Active Vacuum Pressure or in Free drainage. However, no prospective trials has assessed the efficiency of these two modalities of drainage in cases of infected intra-abdominal collections. The investigators aimed then to prospectively analyzed the efficiency (in term of infectious control) of drainage under active vacuum pressure vs. free drainage for the treatment of infected intra-abdominal collections." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Surgery", "Pancreatitis", "Diverticulitis", "Appendicitis" ] }, "KeywordList":{ "Keyword":[ "Infected", "Intra-abdominal", "Collection", "Drainage", "Percutaneous" ] } }, "DesignModule":{ "StudyType":"Observational", "DesignInfo":{ "DesignObservationalModelList":{ "DesignObservationalModel":[ "Cohort" ] }, "DesignTimePerspectiveList":{ "DesignTimePerspective":[ "Prospective" ] } }, "EnrollmentInfo":{ "EnrollmentCount":"100", "EnrollmentType":"Anticipated" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Active vacuum pressure drainage", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Percutaneous drainage of intra-abdominal collection" ] } },{ "ArmGroupLabel":"Free drainage", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Procedure: Percutaneous drainage of intra-abdominal collection" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Procedure", "InterventionName":"Percutaneous drainage of intra-abdominal collection", "InterventionDescription":"Percutaneous drainage of infected intra-abdominal collection Under computed tomography or ultrasound guidance.\n\nProcedures perform by a board certified interventional radiologist", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Active vacuum pressure drainage", "Free drainage" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Intra-abdominal drainage", "Postoperative collection" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"time of drainage", "PrimaryOutcomeTimeFrame":"90 days after drianage" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Control of infection", "SecondaryOutcomeTimeFrame":"up to 7 days after drainage" },{ "SecondaryOutcomeMeasure":"Timing of antibiotherapy", "SecondaryOutcomeTimeFrame":"up to 15 days after drainage" },{ "SecondaryOutcomeMeasure":"Hospital stay", "SecondaryOutcomeTimeFrame":"up to 90 days after drainage" },{ "SecondaryOutcomeMeasure":"Morbidity related to the procedure", "SecondaryOutcomeTimeFrame":"up to 90 days after drainage" },{ "SecondaryOutcomeMeasure":"in-hospital mortality", "SecondaryOutcomeTimeFrame":"up to 90 days after the drainage" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nInfected intra-abdominal collection requiring a percutaneous drainage after surgery or due to a primary intra-abdominal infectious disease (e.g. diverticulitis, appendicitis)\nage over 18 years old\nintra-abdominal collections >5 cm in diameter with signs of infections on imaging\n\nExclusion Criteria:\n\npregnancy\nage< 18 years\nsigns of peritonitis\nIntensive care unit patients", "HealthyVolunteers":"No", "Gender":"All", "MinimumAge":"18 Years", "StdAgeList":{ "StdAge":[ "Adult", "Older Adult" ] }, "StudyPopulation":"In-hospital patients with infected intra-abdominal collection (primary or secondary to surgery)", "SamplingMethod":"Probability Sample" }, "ContactsLocationsModule":{ "CentralContactList":{ "CentralContact":[ { "CentralContactName":"Nicolas Demartines, M.D.", "CentralContactRole":"Contact", "CentralContactPhone":"+41 21 314 24 00", "CentralContactEMail":"nicolas.demartines@chuv.ch" },{ "CentralContactName":"Emmanuel Melloul, M.D.", "CentralContactRole":"Contact", "CentralContactPhone":"+41 21 314 24 00", "CentralContactEMail":"emmanuel.melloul@chuv.ch" } ] }, "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Emmanuel Melloul, M.D.", "OverallOfficialAffiliation":"Department of Visceral surgery (CHUV)", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Nicolas Demartines, M.D.", "OverallOfficialAffiliation":"Department of Visceral surgery (CHUV)", "OverallOfficialRole":"Study Chair" },{ "OverallOfficialName":"Alban Denys, M.D.", "OverallOfficialAffiliation":"Department of Interventional radiology (CHUV)", "OverallOfficialRole":"Study Chair" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Department of Visceral surgery, CHUV", "LocationStatus":"Recruiting", "LocationCity":"Lausanne", "LocationState":"Vaud", "LocationZip":"1011", "LocationCountry":"Switzerland", "LocationContactList":{ "LocationContact":[ { "LocationContactName":"Nicolas Demartines, M.D:", "LocationContactRole":"Contact", "LocationContactPhone":"+41 21 314 24 00", "LocationContactEMail":"nicolas.demartines@chuv.ch" },{ "LocationContactName":"Emmanuel Melloul, M.D.", "LocationContactRole":"Contact", "LocationContactPhone":"+41 21 314 24 00", "LocationContactEMail":"emmanuel.melloul@chuv.ch" },{ "LocationContactName":"Alban Denys, M.D.", "LocationContactRole":"Principal Investigator" },{ "LocationContactName":"Emmanuel Melloul, M.D.", "LocationContactRole":"Principal Investigator" } ] } } ] } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000001064", "ConditionMeshTerm":"Appendicitis" },{ "ConditionMeshId":"D000004238", "ConditionMeshTerm":"Diverticulitis" },{ "ConditionMeshId":"D000010195", "ConditionMeshTerm":"Pancreatitis" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000010182", "ConditionAncestorTerm":"Pancreatic Diseases" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" },{ "ConditionAncestorId":"D000059413", "ConditionAncestorTerm":"Intraabdominal Infections" },{ "ConditionAncestorId":"D000007239", "ConditionAncestorTerm":"Infection" },{ "ConditionAncestorId":"D000005759", "ConditionAncestorTerm":"Gastroenteritis" },{ "ConditionAncestorId":"D000005767", "ConditionAncestorTerm":"Gastrointestinal Diseases" },{ "ConditionAncestorId":"D000002429", "ConditionAncestorTerm":"Cecal Diseases" },{ "ConditionAncestorId":"D000007410", "ConditionAncestorTerm":"Intestinal Diseases" },{ "ConditionAncestorId":"D000076385", "ConditionAncestorTerm":"Diverticular Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M11698", "ConditionBrowseLeafName":"Pancreatitis", "ConditionBrowseLeafAsFound":"Pancreatitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M2957", "ConditionBrowseLeafName":"Appendicitis", "ConditionBrowseLeafAsFound":"Appendicitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M5997", "ConditionBrowseLeafName":"Diverticulitis", "ConditionBrowseLeafAsFound":"Diverticulitis", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M11685", "ConditionBrowseLeafName":"Pancreatic Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M8866", "ConditionBrowseLeafName":"Infection", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4951", "ConditionBrowseLeafName":"Communicable Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M28052", "ConditionBrowseLeafName":"Intraabdominal Infections", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7458", "ConditionBrowseLeafName":"Gastroenteritis", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M4262", "ConditionBrowseLeafName":"Cecal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9027", "ConditionBrowseLeafName":"Intestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5999", "ConditionBrowseLeafName":"Diverticulum", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M1603", "ConditionBrowseLeafName":"Diverticular Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC01", "ConditionBrowseBranchName":"Bacterial and Fungal Diseases" },{ "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" } ] } } } } } }