RCT Comparing OAGB and Long Limb Roux Gastric Bypass

A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04812132

Acronym

OAGBvsLLbypass

Enrollment

500

Registered

2021-03-23

Start date

2021-01-01

Completion date

2036-12-31

Last updated

2021-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

OAGB, Long biliary limb Roux gastric bypass, Metabolic surgery, Obesity

Brief summary

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.

Interventions

PROCEDUREOne-anastomosis gastric bypass

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

PROCEDURELong biliary limb Roux gastric bypass

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
Impact on hyperlipidemias	10 years	Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides
Impact on hypertensive disease	10 years	Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)
Impact on total cholesterol	10 years	Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).
Impact on hyperlipidemia	10 years	Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)
Excess weight loss %	10 years	Calculated loss of the excess weight
Impact on type 2 diabetes mellitus	10 years	Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %

Secondary

Measure	Time frame	Description
Nutritional deficiencies	10 years	Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol/L)
GERD	10 years	% of subjects reporting reflux disease symptoms and/or PPI usage after the surgery
Nutritional deficiencies: anemia	10 years	% of subjects having hemoglobin below sex adjusted reference (g/L) and ferritin below sex adjusted references (ug/L)

Countries

Estonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026