Obesity
Conditions
Keywords
Obesity, Bariatric surgery, Ring with shape memory, One anastomosis gastric bypass
Brief summary
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.
Detailed description
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: * BMI from 30 to 50 kg / m2; * Ages Eligible for Study: 18 Years to 55 Years Outcome Measures: Change of body mass index \[ Time Frame: Baseline, at 12, 24, 36 months after surgery \]
Interventions
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.
DEVICEA shape-memory ring for adjustable gastric banding
A shape-memory ring (SMR) use for adjustable gastric banding. SMR is placed around the gastric pouch above the gastro-entero-anastomosis.
Sponsors
University Medical Center, Kazakhstan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Clinical diagnosis of Obesity; 2. BMI from 30 to 50 kg / m2.
Exclusion criteria
1. Insulin-dependent diabetes; 2. BMI less than 30 kg / m2 and more than 50 kg / m2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of body mass index | Baseline, at 12, 24, 36 months after surgery | 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. |
Countries
Kazakhstan
Outcome results
None listed