[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100427913":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":21,"studyPopulation":13,"armGroups":22,"interventions":34,"overallOfficials":45,"centralContacts":49,"locations":57,"responsibleParty":94,"collaborators":13,"id":96,"slug":13,"hasResults":97,"nctId":98,"briefTitle":99,"officialTitle":100,"acronym":101,"eligibilityCriteria":102,"healthyVolunteers":97,"sex":103,"minAge":104,"maxAge":105,"enrollmentInfo":106,"targetDuration":13,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":13,"overallStatus":59,"whyStopped":13,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Flevoziekenhuis","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage excess BMI loss at 2 years (%EBMIL)","Percentage excess BMI loss after 2 years of follow-up","2 years",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":17,"primaryPurpose":18,"observationalModel":13,"timePerspective":13,"maskingInfo":19},"RANDOMIZED","PARALLEL","Randomized controlled trial with 2 groups","TREATMENT",{"masking":20,"maskingDescription":13,"whoMasked":13},"NONE","Rationale: to compare two different types of gastric bypass operations on surgical outcome.\n\nObjective: to compare two established procedures in order to find the optimal procedure in terms of weight loss and metabolic control that is associated with the fewest side-effects and complications, and decreased invasiveness.\n\nStudy design: A multicentre, open label, non-inferiority randomized controlled trial Study population: Patients are eligible for inclusion if their body-mass index (BMI) was 40 kg\u002Fm2 or higher, or 35 kg\u002Fm2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee) and a positive evaluation by our bariatric multidisciplinary team (BMDT) and are aged 18-65.\n\nIntervention: Group 1: One Anastomosis Gastric Bypass with 150cm biliopancreatic limb. Group 2: Roux-en-Y gastric bypass with biliopancreatic limb of 150cm and 75cm alimentary limb.\n\nMain study parameters\u002Fendpoints:\n\nPrimary endpoint:\n\n% Excess BMI loss at two years\n\nSecondary endpoints:\n\nMetabolic status Nutritional status Comorbidity remission QOL Complications or serious adverse events (SAE's)",[23,29],{"label":24,"type":25,"description":26,"interventionNames":27},"OAGB","ACTIVE_COMPARATOR","149 patients receiving one anastomosis gastric bypass (OAGB) with a Biliopancreatic-limb of 150cm",[28],"Procedure: OAGB",{"label":30,"type":25,"description":31,"interventionNames":32},"RYGB","149 patients receiving Roux-en-Y gastric bypass (RYGB) with a Biliopancreatic-limb of 150cm",[33],"Procedure: RYGB",[35,42],{"type":36,"name":24,"description":37,"armGroupLabels":38,"otherNames":39},"PROCEDURE","Simplified gastric bypass procedure",[24],[40,41],"Mini gastric bypass","Omega loop gastric bypass",{"type":36,"name":30,"description":43,"armGroupLabels":44,"otherNames":13},"Roux-en-Y gastric bypass. Standard procedure in the Netherlands",[30],[46],{"name":47,"affiliation":5,"role":48},"Stef JM Smeets, MD PhD","PRINCIPAL_INVESTIGATOR",[50,54],{"name":47,"role":51,"phone":52,"phoneExt":13,"email":53},"CONTACT","0031368688888","ssmeets@flevoziekenhuis.nl",{"name":55,"role":51,"phone":52,"phoneExt":13,"email":56},"Floris Bruinsma, Student","fbruinsma@flevoziekenhuis.nl",[58,77],{"facility":5,"status":59,"city":60,"state":13,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"RECRUITING","Almere Stad","1315RA","Netherlands","NL",{"type":65,"coordinates":66},"Point",[67,68],5.21413,52.37025,{"lat":68,"lon":67},[71,74],{"name":72,"role":51,"phone":13,"phoneExt":13,"email":73},"Floris Bruinsma, MD","florisbruinsma@live.nl",{"name":75,"role":51,"phone":13,"phoneExt":13,"email":76},"Christel Boons, PhD","wetenschapsbureau@flevoziekenhuis.nl",{"facility":78,"status":79,"city":80,"state":13,"zip":81,"country":62,"countryCode":63,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"OLVG","NOT_YET_RECRUITING","Amsterdam","1061AE",{"type":65,"coordinates":83},[84,85],4.88969,52.37403,{"lat":85,"lon":84},[88,91],{"name":89,"role":51,"phone":13,"phoneExt":13,"email":90},"Phillip Dijkhorst, MD","p.j.dijkhorst@olvg.nl",{"name":92,"role":51,"phone":13,"phoneExt":13,"email":93},"Robin Debi","r.a.debi@olvg.nl",{"type":95,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100427913",false,"NCT04852198","Comparing 150cm OAGB With 150cm Biliopancreatic Limb RYGB. A Non-inferiority Trial","A Study on Safety and Efficacy Comparing 150cm One Anastomosis Gastric Bypass With 150cm Biliopancreatic Limb Roux-en-Y Gastric Bypass (Roux-en-WHY?): An Open Label, Multicentre Non-inferiority Randomized Controlled Trial","Roux-en-WHY?","Inclusion Criteria:\n\n* body-mass index (BMI) of 40 kg\u002Fm2 or higher, or 35 kg\u002Fm2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, osteoarthritis of the hip or knee)\n* a positive evaluation by our BMDT\n\nExclusion Criteria:\n\n* Presence of H. Pylori, resistant to eradication therapy\n* chronic diarrhoea\n* history of previous bariatric or extensive abdominal surgery","ALL","18 Years","65 Years",{"count":107,"type":108},298,"ESTIMATED","INTERVENTIONAL",[111],"NA","The purpose of this study is to assess the safety and efficiency of OAGB compared to RYGB",[114,115,116],"Bariatric Surgery Candidate","Obesity","Obesity, Morbid","2024-04-22",{"date":119,"type":120},"2024-04-23","ACTUAL",{"date":122,"type":120},"2021-12-13",{"date":124,"type":108},"2029-11-01",{"name":5,"class":6},2]