Nctid:
NCT06236282
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000012004", "term"=>"Rectal Neoplasms"}], "ancestors"=>[{"id"=>"D000015179", "term"=>"Colorectal Neoplasms"}, {"id"=>"D000007414", "term"=>"Intestinal Neoplasms"}, {"id"=>"D000005770", "term"=>"Gastrointestinal Neoplasms"}, {"id"=>"D000004067", "term"=>"Digestive System Neoplasms"}, {"id"=>"D000009371", "term"=>"Neoplasms by Site"}, {"id"=>"D000009369", "term"=>"Neoplasms"}, {"id"=>"D000004066", "term"=>"Digestive System Diseases"}, {"id"=>"D000005767", "term"=>"Gastrointestinal Diseases"}, {"id"=>"D000007410", "term"=>"Intestinal Diseases"}, {"id"=>"D000012002", "term"=>"Rectal Diseases"}], "browseLeaves"=>[{"id"=>"M14846", "name"=>"Rectal Neoplasms", "asFound"=>"Rectal Cancer", "relevance"=>"HIGH"}, {"id"=>"M17890", "name"=>"Colorectal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M10448", "name"=>"Intestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8886", "name"=>"Gastrointestinal Neoplasms", "relevance"=>"LOW"}, {"id"=>"M7256", "name"=>"Digestive System Neoplasms", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"M10444", "name"=>"Intestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M14844", "name"=>"Rectal Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Neoplasms", "abbrev"=>"BC04"}, {"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"COHORT"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>93}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2012-05-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-03-31", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-23", "studyFirstSubmitDate"=>"2024-01-08", "studyFirstSubmitQcDate"=>"2024-01-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2022-12-31", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Operation time", "timeFrame"=>"0 week", "description"=>"To determine whether the use of articulated device can shorten total operative time"}], "secondaryOutcomes"=>[{"measure"=>"Long-term Survival", "timeFrame"=>"2 year", "description"=>"2 year recurrence free survival and 2 year overall survival"}, {"measure"=>"Anastomotic leakage (postop outcome)", "timeFrame"=>"4 weeks", "description"=>"anastomotic leakage within one month"}, {"measure"=>"TME quality (Operative outcome)", "timeFrame"=>"0 weeks", "description"=>"Quality of total mesorectal excision to compare quality of surgery"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Rectal Cancer"]}, "descriptionModule"=>{"briefSummary"=>"This study aimed to assess efficacy of ArtiSential® in reducing laparoscopic rectal cancer surgery duration. We retrospectively reviewed the data of patients who underwent laparoscopic low or ultralow anterior resection for primary mid-to-low rectal cancer, performed by a single surgeon in 2012-2022. Patients were divided into groups, use group vs. non-use group, based on the use or non-use of the ArtiSential®. The total mesorectal excision quality and resection margin status did not differ between the groups. ArtiSential® reduced operative time without impairing surgical quality or oncologic outcomes."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["CHILD", "ADULT", "OLDER_ADULT"], "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"Patients who underwent laparoscopic resection for mid-to low rectal cancer located within 10 cm of the anal verge, performed by a single experienced surgeon between 2012 and 2022.", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* mid-to-low rectal caner (witing 10cm of the anal verge)\n* laparoscopic surgery\n\nExclusion Criteria:\n\n* combined surgery\n* recurrent rectal cancer surgery"}, "identificationModule"=>{"nctId"=>"NCT06236282", "briefTitle"=>"ArtiSential® for Rectal Cancer Surgery", "organization"=>{"class"=>"OTHER", "fullName"=>"Seoul National University Hospital"}, "officialTitle"=>"Safety and Efficacy of Flexible Articulated Instrument (ArtiSential®) in Laparoscopic Surgery for Rectal Cancer", "orgStudyIdInfo"=>{"id"=>"2208-0071346"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"ArtiSential® Use", "description"=>"Laparoscopic low anterior resection, with use of both straight devices and articulated devices", "interventionNames"=>["Device: ArtiSential®"]}, {"label"=>"ArtiSential® Non-Use", "description"=>"Laparoscopic low anterior resection, with use of straight devices only"}], "interventions"=>[{"name"=>"ArtiSential®", "type"=>"DEVICE", "description"=>"Articulated laparoscopic device made by Livsmed Co, South Korea.", "armGroupLabels"=>["ArtiSential® Use"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Seoul", "country"=>"Korea, Republic of", "facility"=>"Seoul National University Hospital", "geoPoint"=>{"lat"=>37.566, "lon"=>126.9784}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"UNDECIDED"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Seoul National University Hospital", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
