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

Study Overview
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Brief Summary
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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: Increase of weight reduction, and due to that decrease of comorbidities and/or mortality related to overweight. Long term decrease of weight regain. Decrease of incidence of dumping. Possible disadvantages of bOLGB versus OLGB: Band-related complications such as erosion, infection, stenosis, or pouch dilatation. Functional gastro-intestinal complains such as dysphagia and reflux.

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

Conditions
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Bariatric Surgery, Weight Loss, Comorbidities and Coexisting Conditions

Intervention / Treatment
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* Device: Placement of MiniMizer Gastric Ring
* Procedure: Normal MGB-OAGB


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Non-blinded prospective randomized controlled single center trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Banded Mini Gastric Bypass<br>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) | Device: Placement of MiniMizer Gastric Ring<br>* Insertion of MiniMizer Gastric Ring in addition to the normal MGB-OAGB<br>|
| Active Comparator: non-Banded Mini Gastric Bypass<br>Patients are treated for morbid obesity with a Mini gastric bypass (MGB-OAGB) | Procedure: Normal MGB-OAGB<br>* No insertion of Minimizer Gastric Ring in addition to the normal MGB-OAGB<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Body Weight Change 5 years after surgery | Percentage total body weight change 5 years after the procedure | 5 Years | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MGB-OAGB, MiniMizer Ring, banded bypass