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| Name | Class |
|---|---|
| North Estonia Medical Centre | OTHER |
| Fertilitas (private clinic) | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women | Active Comparator |
| |
| Men | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| One-anastomosis gastric bypass | Procedure | One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Excess weight loss % | Calculated loss of the excess weight | 10 years |
| Impact on type 2 diabetes mellitus | Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c % | 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) | 10 years |
| Impact on hypertensive disease | Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended) | 10 years |
| Impact on total cholesterol | Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L). | 10 years |
| Impact on hyperlipidemia | Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L) | 10 years |
| Impact on hyperlipidemia | Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L) | 10 years |
| Impact on hyperlipidemia |
| Measure | Description | Time Frame |
|---|---|---|
| Nutritional deficiencies: anemia | % of subjects having hemoglobin below sex adjusted reference (g/L) and ferritin below sex adjusted references (ug/L) | 10 years |
| Nutritional deficiencies | Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol/L) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tartu University Hospital | Recruiting | Tartu | 50406 | Estonia |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Long biliary limb Roux gastric bypass | Procedure | Other group is planned to receive a long biliary limb Roux gastric bypass |
|
Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)
| 10 years |
| Impact on hyperlipidemias | Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides | 10 years |
| 10 years |
| GERD | % of subjects reporting reflux disease symptoms and/or PPI usage after the surgery | 10 years |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |