A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass. We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea. Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life. There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts. There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
500
One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)
Other group is planned to receive a long biliary limb Roux gastric bypass
Tartu University Hospital
Tartu, Estonia
RECRUITINGExcess weight loss %
Calculated loss of the excess weight
Time frame: 10 years
Impact on type 2 diabetes mellitus
Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %
Time frame: 10 years
Impact on type 2 diabetes mellitus
Outcome of type 2 diabetes mellitus after the surgery, measured in usage of medication (same dosage, decreased dosage, insulin to peroral, ended all medication)
Time frame: 10 years
Impact on hypertensive disease
Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)
Time frame: 10 years
Impact on total cholesterol
Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).
Time frame: 10 years
Impact on hyperlipidemia
Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)
Time frame: 10 years
Impact on hyperlipidemia
Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L)
Time frame: 10 years
Impact on hyperlipidemia
Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)
Time frame: 10 years
Impact on hyperlipidemias
Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides
Time frame: 10 years
Nutritional deficiencies: anemia
% of subjects having hemoglobin below sex adjusted reference (g/L) and ferritin below sex adjusted references (ug/L)
Time frame: 10 years
Nutritional deficiencies
Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol/L)
Time frame: 10 years
GERD
% of subjects reporting reflux disease symptoms and/or PPI usage after the surgery
Time frame: 10 years
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