Clinical trial

RCT Comparing OAGB and Long Limb Roux Gastric Bypass

Recruiting now · Not applicable · 1 countries · Registry ID NCT04812132

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 60 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

Inclusion Criteria: * BMI over 35 and obesity related disease * BMI over 40 * age between 18-60 years * agrees to participate in the study Exclusion Criteria: * age under 18 years or over 60 years * abundant adhesions discovered during the surgery * active upper gastrointestinal ulcer disease * prior bariatric surgery * active symptomatic reflux disease * active psychiatric disease (eg psychosis)

Treatments and study arms

One-anastomosis gastric bypass

Procedure

One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)

Long biliary limb Roux gastric bypass

Procedure

Other group is planned to receive a long biliary limb Roux gastric bypass

Primary outcomes

Excess weight loss %10 years

Calculated loss of the excess weight

Impact on type 2 diabetes mellitus10 years

Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %

Impact on type 2 diabetes mellitus10 years

Outcome of type 2 diabetes mellitus after the surgery, measured in usage of medication (same dosage, decreased dosage, insulin to peroral, ended all medication)

Impact on hypertensive disease10 years

Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)

Impact on total cholesterol10 years

Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).

Impact on hyperlipidemia10 years

Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)

Impact on hyperlipidemia10 years

Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L)

Impact on hyperlipidemia10 years

Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Tartu University Hospital🌐 Tartu, Estonia

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Eva-Maria Kikkas, DrContact

Email · Call +37258162720

Toomas Sillakivi, Dr, PhDContact