A Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass
- Conditions
- Obesity
- Interventions
- Procedure: Laparoscopic one anastomosis gastric bypassDevice: A shape-memory ring for adjustable gastric banding
- Registration Number
- NCT04762849
- Lead Sponsor
- University Medical Center, Kazakhstan
- 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 \[ Time Frame: Baseline, at 12, 24, 36 months after surgery \]
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Clinical diagnosis of Obesity;
- BMI from 30 to 50 kg / m2.
- Insulin-dependent diabetes;
- BMI less than 30 kg / m2 and more than 50 kg / m2.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) Laparoscopic one anastomosis gastric bypass 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 banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) A shape-memory ring for adjustable gastric banding 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 Laparoscopic one anastomosis gastric bypass 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.
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
University medical center
🇰🇿Astana, Kazakhstan