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The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial

RecruitingNAAges 18 Years - anyAllMarc van Det
NCT05472922 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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: 1. %TBWL 5 years after surgery. Secondary Objectives: 2. Percentage Excess Weight Loss (%EWL) 5 years after surgery. 3. Decrease or reduction of com

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients meet IFSO criteria for Bariatric Surgery * Age 18 and above Exclusion Criteria: * Previous Bariatric surgery * Inability to read and understand written information * Any genetic condition that can hamper the acceptance of medical advice * chronic bowel disease * Severe kidney of liver disease * Pregnancy at the start or during the research period * Patients with pre-existing therapy refractory GERD * Patients with an allergy to silicone
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What it tests

  • Placement of MiniMizer Gastric Ring
  • Normal MGB-OAGB
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Where

1 site
Ziekenhuisgroep Twente
Almelo, Netherlands
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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