RCT Comparing OAGB and Long Limb Roux Gastric Bypass (OAGBvsLLbypass)

Tartu University Hospital

Status: Enrolling

Conditions: Obesity

Treatments: Procedure: One-anastomosis gastric bypass; Procedure: Long biliary limb Roux gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT04812132

TartuUH

Details and patient eligibility

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Women

Active Comparator group

Treatment:

Procedure: Long biliary limb Roux gastric bypass

Procedure: One-anastomosis gastric bypass

Men

Active Comparator group

Treatment:

Procedure: Long biliary limb Roux gastric bypass

Procedure: One-anastomosis gastric bypass