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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.
Study design: A prospective non blinded single centre randomized controlled trial.
Sudy population: The study population will exist of patients eligible for MGB-OAGB surgery. Patients are invited to participate if Body Mass Index (BMI) ≥ 35kg/m2 with a comorbidity related to morbid obesity, or a BMI exceeding 40kg/m2.
Intervention: Insertion of the MiniMizer Ring around the gastric pouch in addition to the 'standard' MGB-OAGB.
Main study parameters/endpoints:
Primary Objective:
%TBWL 5 years after surgery.
Secondary Objectives:
Percentage Excess Weight Loss (%EWL) 5 years after surgery.
Decrease or reduction of comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints).
Improvement of quality of life: SF-36 and OBESI-Q questionnaires.
Incidence and severity of dumping syndrome.
Incidence and severity of reflux symptoms: GERD-HRQoL questionnaire.
Incidence and complications due to silicone band.
Measurement of objectives are before surgery and six times after surgery combined with the standard postoperative care for patients who undergo bariatric surgery:
Expected advantages of bOLGB versus OLGB:
Possible disadvantages of bOLGB versus OLGB:
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210 participants in 2 patient groups
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Central trial contact
Maureen Tissink, MD; Marc J van Det, MD PhD
Data sourced from clinicaltrials.gov
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