[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100424840":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":44,"studyPopulation":44,"armGroups":51,"interventions":61,"overallOfficials":44,"centralContacts":44,"locations":71,"responsibleParty":93,"collaborators":97,"id":103,"slug":44,"hasResults":104,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":104,"sex":110,"minAge":111,"maxAge":112,"enrollmentInfo":113,"targetDuration":44,"studyType":116,"phases":117,"briefSummary":119,"conditions":120,"keywords":122,"overallStatus":73,"whyStopped":44,"lastUpdateSubmitDate":125,"lastUpdatePostDateStruct":126,"startDateStruct":129,"completionDateStruct":131,"leadSponsor":133,"locationsCount":134},{"fullName":5,"class":6},"Tartu University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":34,"otherOutcomes":44},[9,13,16,18,21,24,27,29,31],{"measure":10,"description":11,"timeFrame":12},"Excess weight loss %","Calculated loss of the excess weight","10 years",{"measure":14,"description":15,"timeFrame":12},"Impact on type 2 diabetes mellitus","Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %",{"measure":14,"description":17,"timeFrame":12},"Outcome of type 2 diabetes mellitus after the surgery, measured in usage of medication (same dosage, decreased dosage, insulin to peroral, ended all medication)",{"measure":19,"description":20,"timeFrame":12},"Impact on hypertensive disease","Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)",{"measure":22,"description":23,"timeFrame":12},"Impact on total cholesterol","Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol\u002FL).",{"measure":25,"description":26,"timeFrame":12},"Impact on hyperlipidemia","Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol\u002FL)",{"measure":25,"description":28,"timeFrame":12},"Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol\u002FL)",{"measure":25,"description":30,"timeFrame":12},"Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol\u002FL)",{"measure":32,"description":33,"timeFrame":12},"Impact on hyperlipidemias","Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides",[35,38,41],{"measure":36,"description":37,"timeFrame":12},"Nutritional deficiencies: anemia","% of subjects having hemoglobin below sex adjusted reference (g\u002FL) and ferritin below sex adjusted references (ug\u002FL)",{"measure":39,"description":40,"timeFrame":12},"Nutritional deficiencies","Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol\u002FL)",{"measure":42,"description":43,"timeFrame":12},"GERD","% of subjects reporting reflux disease symptoms and\u002For PPI usage after the surgery",null,{"allocation":46,"interventionModel":47,"interventionModelDescription":44,"primaryPurpose":48,"observationalModel":44,"timePerspective":44,"maskingInfo":49},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":50,"maskingDescription":44,"whoMasked":44},"NONE",[52,58],{"label":53,"type":54,"description":44,"interventionNames":55},"Women","ACTIVE_COMPARATOR",[56,57],"Procedure: One-anastomosis gastric bypass","Procedure: Long biliary limb Roux gastric bypass",{"label":59,"type":54,"description":44,"interventionNames":60},"Men",[56,57],[62,67],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":44},"PROCEDURE","One-anastomosis gastric bypass","One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)",[59,53],{"type":63,"name":68,"description":69,"armGroupLabels":70,"otherNames":44},"Long biliary limb Roux gastric bypass","Other group is planned to receive a long biliary limb Roux gastric bypass",[59,53],[72],{"facility":5,"status":73,"city":74,"state":44,"zip":75,"country":76,"countryCode":77,"cosmosGeoPoint":78,"geoPoint":83,"contacts":84},"RECRUITING","Tartu","50406","Estonia","EE",{"type":79,"coordinates":80},"Point",[81,82],26.72509,58.38062,{"lat":82,"lon":81},[85,90],{"name":86,"role":87,"phone":88,"phoneExt":44,"email":89},"Eva-Maria Kikkas, Dr","CONTACT","+37258162720","evamariakikkas@gmail.com",{"name":91,"role":87,"phone":44,"phoneExt":44,"email":92},"Toomas Sillakivi, Dr, PhD","toomas.sillakivi@kliinikum.ee",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":44,"oldOrganization":44},"PRINCIPAL_INVESTIGATOR","Eva-Maria Kikkas","Doctor and Teaching staff",[98,100],{"name":99,"class":6},"North Estonia Medical Centre",{"name":101,"class":102},"Fertilitas (private clinic)","UNKNOWN","100424840",false,"NCT04812132","RCT Comparing OAGB and Long Limb Roux Gastric Bypass","A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.","OAGBvsLLbypass","Inclusion Criteria:\n\n* BMI over 35 and obesity related disease\n* BMI over 40\n* age between 18-60 years\n* agrees to participate in the study\n\nExclusion Criteria:\n\n* age under 18 years or over 60 years\n* abundant adhesions discovered during the surgery\n* active upper gastrointestinal ulcer disease\n* prior bariatric surgery\n* active symptomatic reflux disease\n* active psychiatric disease (eg psychosis)","ALL","18 Years","60 Years",{"count":114,"type":115},500,"ESTIMATED","INTERVENTIONAL",[118],"NA","A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass.\n\nWe plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea.\n\nOther outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life.\n\nThere are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts.\n\nThere are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.",[121],"Obesity",[123,68,124,121],"OAGB","Metabolic surgery","2021-03-21",{"date":127,"type":128},"2021-03-23","ACTUAL",{"date":130,"type":128},"2021-01-01",{"date":132,"type":115},"2036-12-31",{"name":5,"class":6},1]