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| Name | Class |
|---|---|
| Ziekenhuisgroep Twente | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| non-Banded Mini Gastric Bypass | Active Comparator | Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placement of MiniMizer Gastric Ring | Device | Insertion of MiniMizer Gastric Ring in addition to the normal MGB-OAGB |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Body Weight Change 5 years after surgery | Percentage total body weight change 5 years after the procedure | 5 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Percentage Excess Weight (%EWL) 5 years after surgery | Change in Percentage Excess Weight (%EWL) | 5 years |
| Change in (existing) co-morbidities 5 years after surgery | Change in severity of obesity-related co-morbidities: Type 2 Diabetes Mellitus (changes in HbA1c or use of antidiabetic medication), Hypertension (changes in bloodpressure or changes in use of antihypertensives), Osteo-arthritis (changes in VAS-score or use of analgesia drugs) , Hyperlipidemia (changes in HDL/LDL ratio, triglycerides or use of statine drugs), Obstructive Sleep Apnea syndrome (changes in use of CPEP treatment or changes is apneu hypopneu idex), and Gastro-Esophageal Reflux Disease (Changes in outcomes of GERD-HR questionnnaire which scoring scale runs from 0 (asymptomatic) to 50 (complete prohibitive) or changes in use of protonpompinhibitors) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marc J van Det, MD PhD | Contact | +31887087878 | m.vdet@zgt.nl | |
| Maureen Tissink, MD | Contact | +31887087878 | m.tissink@zgt.nl |
| Name | Affiliation | Role |
|---|---|---|
| Marc J van Det, MD PhD | ZiekenhuisGroup Twente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ziekenhuisgroep Twente | Recruiting | Almelo | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40085187 | Derived | 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. |
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Individual Participant data will not be shared.
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Non-blinded prospective randomized controlled single center trial.
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| Normal MGB-OAGB | Procedure | No insertion of Minimizer Gastric Ring in addition to the normal MGB-OAGB |
|
| 5 years |
| Outcome measurement of SF-36 questionnaire | Evalution of changes in outcome of SF-36 Questionnaire 5 years after surgery. Scoring scale is described between 0 (lowest) and 100 (highest) to evaluate patient's welfare | 5 years |
| Outcome measurement of OBESI-Q questionnaire | Evalution of changes in outcome of OBESI-Q Questionnaire 5 years after surgery. Scoring scale is described between 0 (lowest) and 100 (highest) to evaluate patient's welfare | 5 years |
| Dumping Syndrome | The presence and severity of complains related to Dumping Syndrome in participants (yes or no) | 5 years |
| Complications | The occurrence of short- and long-term complications of the minimizer ring | 5 years |