An interventional study of Laparoscopic one anastomosis gastric bypass and A shape-memory ring for adjustable gastric banding in Obesity, sponsored by University Medical Center, Kazakhstan. Withdrawn at 1 site in Kazakhstan. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-05-15.
Sponsored by University Medical Center, Kazakhstan · Not applicable, Interventional, and Treatment
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 ]
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
Browse Obesity studies →University Medical Center, Kazakhstan is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Procedure: Laparoscopic one anastomosis gastric bypass · Device: A shape-memory ring for adjustable gastric banding
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.
Procedure: Laparoscopic one anastomosis gastric bypass
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.
A shape-memory ring (SMR) use for adjustable gastric banding. SMR is placed around the gastric pouch above the gastro-entero-anastomosis.
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.
Time frame: Baseline, at 12, 24, 36 months after surgery
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2021 (actual). Primary completion is estimated for Apr 2024, 36 months after the start.
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This study is withdrawn, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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University Medical Center, Kazakhstan