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Background and study aims:
Currently, the gastric bypass is increasingly performed in the version of the mini gastric bypass (MGB). Another name for the procedure: one anastomosis gastric bypass (OAGB). Insufficient weight loss after bariatric surgery or weight gain after surgery is a common big problem in weight loss surgery.
The use of unregulated and uncontrolled bands and rings is not always effective according to previous studies.
This study compares the loss of weight after the laparoscopic banded one anastomosis gastric bypass with the use of a shape-memory ring and standard laparoscopic one anastomosis gastric bypass.
Methods: Adult participants (n=100) are randomly allocated to one of two groups:
Experimental surgical bariatric procedure in the first (A) group: patients (n=50) will undergo the laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) will undergo the laparoscopic one anastomosis gastric bypass (MGB/OAGB group) without band: standard surgery.
All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index.
This study compares the loss of weight after the laparoscopic banded one anastomosis gastric bypass with the use of a shape-memory ring and standard laparoscopic one anastomosis gastric bypass.
Inclusion Criteria:
Outcome Measures: Change of body mass index [ Time Frame: Baseline, at 12, 24, 36 months after surgery ]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) | Experimental | Laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) include the creation of a gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. A ring with shape memory put on the gastric pouch |
|
| laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery | Active Comparator | Laparoscopic one anastomosis gastric bypass (MGB/OAGB) include the creation of a gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparoscopic one anastomosis gastric bypass | Procedure | Laparoscopic one anastomosis gastric bypass include the creation of gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. For the creation of a gastric pouch and gastroenterostomy use a linear stapler. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of body mass index | The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2. | Baseline, at 12, 24, 36 months after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oral Ospanov, Professor | Corporate Foundation "University Medical Center" (UMC) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University medical center | Astana | 010000 | Kazakhstan |
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Participants are randomly allocated to one of two groups:
Experimental surgical bariatric procedure in the first (A) group: patients will undergo the laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR); Active comparator surgical bariatric procedure in the second (B) group: patients will undergo the laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery.
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|
| A shape-memory ring for adjustable gastric banding | Device | A shape-memory ring (SMR) use for adjustable gastric banding. SMR is placed around the gastric pouch above the gastro-entero-anastomosis. |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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