Nctid:
NCT06227988
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-01"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000008107", "term"=>"Liver Diseases"}], "ancestors"=>[{"id"=>"D000004066", "term"=>"Digestive System Diseases"}], "browseLeaves"=>[{"id"=>"M11107", "name"=>"Liver Diseases", "asFound"=>"Liver Disease", "relevance"=>"HIGH"}, {"id"=>"M4509", "name"=>"Ascites", "relevance"=>"LOW"}, {"id"=>"M6010", "name"=>"Cholelithiasis", "relevance"=>"LOW"}, {"id"=>"M24980", "name"=>"Cholecystolithiasis", "relevance"=>"LOW"}, {"id"=>"M25095", "name"=>"Gallstones", "relevance"=>"LOW"}, {"id"=>"M8883", "name"=>"Gastrointestinal Diseases", "relevance"=>"LOW"}, {"id"=>"M7255", "name"=>"Digestive System Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Digestive System Diseases", "abbrev"=>"BC06"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000008110", "term"=>"Liver Extracts"}], "ancestors"=>[{"id"=>"D000006397", "term"=>"Hematinics"}], "browseLeaves"=>[{"id"=>"M11110", "name"=>"Liver Extracts", "asFound"=>"Examination", "relevance"=>"HIGH"}, {"id"=>"M4949", "name"=>"Bilirubin", "relevance"=>"LOW"}, {"id"=>"M9485", "name"=>"Hematinics", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Hematinics", "abbrev"=>"Hemat"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"PROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>53}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2023-06-20", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-07-30", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-19", "studyFirstSubmitDate"=>"2024-01-19", "studyFirstSubmitQcDate"=>"2024-01-19", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-29", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-07-30", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score", "timeFrame"=>"2 years", "description"=>". For comparison between prediction scores receiver operative curves will be used."}], "secondaryOutcomes"=>[{"measure"=>"To assess potential differences in prediction accuracy between VOCAL-Penn and MELD for 30 and 90-day mortality", "timeFrame"=>"2 years", "description"=>"For subgroup analysis comparison between groups independent sample T test will be used.\n\nused."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Fluid buildup in the belly (ascites)", "Gallstones.", "Muscle loss."], "conditions"=>["CHRONIC LIVER DISEASE"]}, "descriptionModule"=>{"briefSummary"=>"4a. Primary To assess postoperative mortality at 30 and 90 days using the VOCAL PENN score\n\n4b. Secondary To assess potential differences in prediction accuracy between VOCAL-Penn and MELD for 30 and 90-day mortality", "detailedDescription"=>"For each patient and surgery,we will be collecting detailed pre-operative data regarding demographics (age, sex, body mass index, surgery category, comorbidities (diabetes mellitus, hypertension), and pertinent laboratory values (sodium, creatinine, total bilirubin, the international normalized ratio \\[INR\\], albumin, platelet count.) The etiology of liver disease will be classified.\n\nTo ensure that laboratory data accurately reflected the pre-operative state, only those from within 30 days prior to surgery will be considered For each patient VOCAL PENN score, MELD score, and Mayo score will be calculated using an online calculator."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "maximumAge"=>"65 years", "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"1. STUDY POPULATION Data of 53 patients with liver disease who undergoing surgery of interest will be included\n2. DESIGN AND DURATION OF THE STUDY\n\nProspective observational study Duration 2 years", "healthyVolunteers"=>true, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with established cirrhosis Patients who had not received liver transplantation and who underwent surgery of interest were included These surgery categories will be the same as those used in the original VOCAL-Penn derivation study and will include the open abdominal, laparoscopic abdominal, and abdominal wall.\n\nExclusion Criteria:\n\n* Patients with insufficient pre-operative data to compute the VOCAL-Penn score, Mayo risk score, or MELD-Na score will be excluded.\n\nPatients undergoing liver surgeries Patients who received multiple surgeries Those who didn't give consent"}, "identificationModule"=>{"nctId"=>"NCT06227988", "acronym"=>"vocal penn 01", "briefTitle"=>"ASSESSMENT OF SURGICAL RISK IN PATIENTS WITH CHRONIC LIVER DISEASE USING VOCAL PENN SCORE", "organization"=>{"class"=>"OTHER", "fullName"=>"Asian Institute of Gastroenterology, India"}, "officialTitle"=>"ASSESSMENT OF SURGICAL RISK IN PATIENTS WITH CHRONIC LIVER DISEASE USING VOCAL PENN SCORE", "orgStudyIdInfo"=>{"id"=>"Vocal penn score 01"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"patients with liver disease who undergoing surgery", "description"=>"For each patient and surgery, we will be collecting detailed pre-operative data regarding demographics (age, sex, body mass index, surgery category, comorbidities (diabetes mellitus, hypertension), and pertinent laboratory values (sodium, creatinine, total bilirubin, the international normalized ratio \\[INR\\], albumin, platelet count.) The etiology of liver disease will be classified.\n\nTo ensure that laboratory data accurately reflected the pre-operative state, only those from within 30 days prior to surgery will be considered For each patient VOCAL PENN score, MELD score, and Mayo score will be calculated using an online calculator.", "interventionNames"=>["Procedure: patients with liver disease who undergoing surgery", "Procedure: patients with liver disease who do not undergoing surgery"]}, {"label"=>"patients with liver disease who do not undergoing surgery", "description"=>"For each patient and surgery, we will be collecting detailed pre-operative data regarding demographics (age, sex, body mass index, surgery category, comorbidities (diabetes mellitus, hypertension), and pertinent laboratory values (sodium, creatinine, total bilirubin, the international normalized ratio \\[INR\\], albumin, platelet count.) The etiology of liver disease will be classified.\n\nTo ensure that laboratory data accurately reflected the pre-operative state, only those from within 30 days prior to surgery will be considered For each patient VOCAL PENN score, MELD score, and Mayo score will be calculated using an online calculator.", "interventionNames"=>["Procedure: patients with liver disease who undergoing surgery", "Procedure: patients with liver disease who do not undergoing surgery"]}], "interventions"=>[{"name"=>"patients with liver disease who undergoing surgery", "type"=>"PROCEDURE", "description"=>"For each patient and surgery, we will be collecting detailed pre-operative data regarding demographics (age, sex, body mass index, surgery category, comorbidities (diabetes mellitus, hypertension), and pertinent laboratory values (sodium, creatinine, total bilirubin, the international normalized ratio \\[INR\\], albumin, platelet count.) The etiology of liver disease will be classified.\n\nTo ensure that laboratory data accurately reflected the pre-operative state, only those from within 30 days prior to surgery will be considered For each patient VOCAL PENN score, MELD score, and Mayo score will be calculated using an online calculator.", "armGroupLabels"=>["patients with liver disease who do not undergoing surgery", "patients with liver disease who undergoing surgery"]}, {"name"=>"patients with liver disease who do not undergoing surgery", "type"=>"PROCEDURE", "description"=>"For each patient and surgery, we will be collecting detailed pre-operative data regarding demographics (age, sex, body mass index, surgery category, comorbidities (diabetes mellitus, hypertension), and pertinent laboratory values (sodium, creatinine, total bilirubin, the international normalized ratio \\[INR\\], albumin, platelet count.) The etiology of liver disease will be classified.\n\nTo ensure that laboratory data accurately reflected the pre-operative state, only those from within 30 days prior to surgery will be considered For each patient VOCAL PENN score, MELD score, and Mayo score will be calculated using an online calculator.", "armGroupLabels"=>["patients with liver disease who do not undergoing surgery", "patients with liver disease who undergoing surgery"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"500082", "city"=>"Hyderabad", "state"=>"Telangana", "status"=>"RECRUITING", "country"=>"India", "contacts"=>[{"name"=>"Prachiti Gokhe", "role"=>"CONTACT", "email"=>"PRACHITI1331@GMAIL.COM", "phone"=>"8830117645"}, {"name"=>"MAHESH SHETTY", "role"=>"CONTACT", "email"=>"drmaheshgshetty@hotmail.com", "phone"=>"9848225528"}], "facility"=>"Dr Prachiti Gokhe", "geoPoint"=>{"lat"=>17.38405, "lon"=>78.45636}}], "centralContacts"=>[{"name"=>"PRACHITI Gokhe", "role"=>"CONTACT", "email"=>"PRACHITI1331@GMAIL.COM", "phone"=>"8830117645"}, {"name"=>"MAHESH SHETTY", "role"=>"CONTACT", "email"=>"DRMAHESHGSHETTY@HOTMAIL.COM", "phone"=>"9848225528"}], "overallOfficials"=>[{"name"=>"PRACHITI Gokhe", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"AIG HOSPITALS"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Asian Institute of Gastroenterology, India", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
