Bariatric Surgery, Comorbidities and Coexisting Conditions, Weight Loss
Conditions
Keywords
MGB-OAGB, MiniMizer Ring, banded bypass
Brief summary
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
DEVICEPlacement of MiniMizer Gastric Ring
Insertion of MiniMizer Gastric Ring in addition to the normal MGB-OAGB
PROCEDURENormal MGB-OAGB
No insertion of Minimizer Gastric Ring in addition to the normal MGB-OAGB
Sponsors
Ziekenhuisgroep Twente
Marc van Det
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Non-blinded prospective randomized controlled single center trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Body Weight Change 5 years after surgery | 5 Years | Percentage total body weight change 5 years after the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in (existing) co-morbidities 5 years after surgery | 5 years | 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) |
| Outcome measurement of SF-36 questionnaire | 5 years | 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 |
| Change in Percentage Excess Weight (%EWL) 5 years after surgery | 5 years | Change in Percentage Excess Weight (%EWL) |
| Dumping Syndrome | 5 years | The presence and severity of complains related to Dumping Syndrome in participants (yes or no) |
| Complications | 5 years | The occurrence of short- and long-term complications of the minimizer ring |
| Outcome measurement of OBESI-Q questionnaire | 5 years | 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 |
Countries
Netherlands
Contacts
Primary ContactMarc J van Det, MD PhD
Backup ContactMaureen Tissink, MD
Outcome results
None listed