The Banded Mini Gastric Bypass Trial: A Prospective Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Placement of MiniMizer Gastric Ring, Normal MGB-OAGB.
- Who it may be relevant to
- Registry conditions: Bariatric Surgery, Weight Loss, Comorbidities and Coexisting Conditions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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 comorbidities (diabetes mellitus, hypertension, hyperlipidemia, sleep apnoea, and joint complaints). 4. Improvement of quality of life: SF-36 and OBESI-Q questionnaires. 5. Incidence and severity of dumping syndrome. 6. Incidence and severity of reflux symptoms: GERD-HRQoL questionnaire. 7. 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: 1. Increase of weight reduction, and due to that decrease of comorbidities and/or mortality related to overweight. 2. Long term decrease of weight regain. 3. Decrease of incidence of dumping. Possible disadvantages of bOLGB versus OLGB: 1. Band-related complications such as erosion, infection, stenosis, or pouch dilatation. 2. Functional gastro-intestinal complains such as dysphagia and reflux.
Interventions
- Device Placement of MiniMizer Gastric Ring
Insertion of MiniMizer Gastric Ring in addition to the normal MGB-OAGB - Procedure Normal MGB-OAGB
No insertion of Minimizer Gastric Ring in addition to the normal MGB-OAGB
Primary outcome measures
- Total Body Weight Change 5 years after surgery [Time frame: 5 Years]
Secondary outcome measures (6)
- Change in Percentage Excess Weight (%EWL) 5 years after surgery [Time frame: 5 years]
- Change in (existing) co-morbidities 5 years after surgery [Time frame: 5 years]
- Outcome measurement of SF-36 questionnaire [Time frame: 5 years]
- Outcome measurement of OBESI-Q questionnaire [Time frame: 5 years]
- Dumping Syndrome [Time frame: 5 years]
- Complications [Time frame: 5 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- Ziekenhuisgroep Twente — Almelo
Publications
- Tissink M, Verhagen T, Faneyte I, Hazebroek E, Oost S, Timmerman J, Veldhuis A, van Det M. The Banded One-Anastomosis Gastric Bypass Trial (RiMini Trial): Protocol of a Prospective Single-Center Randomized Controlled Trial. Obes Surg. 2025 May;35(5):1854-1859. doi: 10.1007/s11695-025-07751-6. Epub 2025 Mar 14. PMID 40085187
Identifiers
NCT: NCT05472922 · R22.025