[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100475591":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":45,"responsibleParty":61,"collaborators":65,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":71,"acronym":72,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":26,"enrollmentInfo":76,"targetDuration":26,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":87,"overallStatus":47,"whyStopped":26,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Ziekenhuisgroep Twente","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Banded Mini Gastric Bypass","EXPERIMENTAL","Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Gastric Ring (Bariatric Solutions GmbH, Stein am Rhein Switzerland)",[13],"Device: Placement of MiniMizer Gastric Ring",{"label":15,"type":16,"description":17,"interventionNames":18},"non-Banded Mini Gastric Bypass","ACTIVE_COMPARATOR","Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB)",[19],"Procedure: Normal MGB-OAGB",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Placement of MiniMizer Gastric Ring","Insertion of MiniMizer Gastric Ring in addition to the normal MGB-OAGB",[9],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"PROCEDURE","Normal MGB-OAGB","No insertion of Minimizer Gastric Ring in addition to the normal MGB-OAGB",[15],[33],{"name":34,"affiliation":35,"role":36},"Marc J van Det, MD PhD","ZiekenhuisGroup Twente","PRINCIPAL_INVESTIGATOR",[38,42],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+31887087878","m.vdet@zgt.nl",{"name":43,"role":39,"phone":40,"phoneExt":26,"email":44},"Maureen Tissink, MD","m.tissink@zgt.nl",[46],{"facility":5,"status":47,"city":48,"state":26,"zip":26,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Almelo","Netherlands","NL",{"type":52,"coordinates":53},"Point",[54,55],6.6625,52.35667,{"lat":55,"lon":54},[58,59],{"name":34,"role":39,"phone":40,"phoneExt":26,"email":41},{"name":60,"role":39,"phone":40,"phoneExt":26,"email":44},"Maureen W Tissik, MD",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"SPONSOR_INVESTIGATOR","Marc van Det","principal investigator",[66],{"name":5,"class":6},"100475591","the-banded-mini-gastric-bypass-trial-a-prospective-randomized-controlled-trial-100475591",false,"NCT05472922","The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial","RiMini","Inclusion Criteria:\n\n* Patients meet IFSO criteria for Bariatric Surgery\n* Age 18 and above\n\nExclusion Criteria:\n\n* Previous Bariatric surgery\n* Inability to read and understand written information\n* Any genetic condition that can hamper the acceptance of medical advice\n* chronic bowel disease\n* Severe kidney of liver disease\n* Pregnancy at the start or during the research period\n* Patients with pre-existing therapy refractory GERD\n* Patients with an allergy to silicone","ALL","18 Years",{"count":77,"type":78},210,"ESTIMATED","INTERVENTIONAL",[81],"NA","Rationale: Investigate if there is a significant weight reduction expressed in total body weight loss percentage (%TBWL) in patients 5 years after surgery, whom underwent a mini gastric bypass (MGB-OAGB) with addition of the implantation of a MiniMizer Ring.\n\nStudy design: A prospective non blinded single centre randomized controlled trial.\n\nSudy population: The study population will exist of patients eligible for MGB-OAGB surgery. Patients are invited to participate if Body Mass Index (BMI) ≥ 35kg\u002Fm2 with a comorbidity related to morbid obesity, or a BMI exceeding 40kg\u002Fm2.\n\nIntervention: Insertion of the MiniMizer Ring around the gastric pouch in addition to the 'standard' MGB-OAGB.\n\nMain study parameters\u002Fendpoints:\n\nPrimary Objective:\n\n1. %TBWL 5 years after surgery.\n\n   Secondary Objectives:\n2. Percentage Excess Weight Loss (%EWL) 5 years after surgery.\n3. Decrease or reduction of comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints).\n4. Improvement of quality of life: SF-36 and OBESI-Q questionnaires.\n5. Incidence and severity of dumping syndrome.\n6. Incidence and severity of reflux symptoms: GERD-HRQoL questionnaire.\n7. Incidence and complications due to silicone band.\n\nMeasurement of objectives are before surgery and six times after surgery combined with the standard postoperative care for patients who undergo bariatric surgery:\n\nExpected advantages of bOLGB versus OLGB:\n\n1. Increase of weight reduction, and due to that decrease of comorbidities and\u002For mortality related to overweight.\n2. Long term decrease of weight regain.\n3. Decrease of incidence of dumping.\n\nPossible disadvantages of bOLGB versus OLGB:\n\n1. Band-related complications such as erosion, infection, stenosis, or pouch dilatation.\n2. Functional gastro-intestinal complains such as dysphagia and reflux.",[84,85,86],"Bariatric Surgery","Weight Loss","Comorbidities and Coexisting Conditions",[88,89,90],"MGB-OAGB","MiniMizer Ring","banded bypass","2022-07-20",{"date":93,"type":94},"2022-07-25","ACTUAL",{"date":96,"type":94},"2022-07-01",{"date":98,"type":78},"2028-07-01",{"name":63,"class":6},1]