One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass (MGBvsRYGB)

Sana Klinikum Offenbach

Status: Terminated

Conditions: Obesity

Treatments: Other: RYGB; Other: OAGB/MGB

Study type: Interventional

Funder types: Other

Identifiers

NCT03045679

FF 74/2016

Details and patient eligibility

About

The aim of this prospective randomized controlled trial is to compare the two procedures One-anastomosis gastric Bypass/Mini-gastric Bypass (OAGB/MGB) and Roux-en Y gastric bypass (RYGB) in relation to intraoperative and postoperative complications (classification of Clavien-Dindo), mortality, metabolic impact (remission of type 2 diabetes mellitus, hypertonus, gastro-esophageal reflux disease, sleep apnea, dyslipidemia, quality of life, operation time, postoperative excess weight loss, malnutrition and re-do/revisonal surgery.

Full description

OAGB/MGB is gaining popularity as a primary surgical treatment for morbid obesity due to reduced operation time, a shorter learning curve, better weight loss, higher metabolic impact and fewer major complications compared to RYGB.

In this prospective randomized controlled trial we want to compare OAGB/MGB and RYGB with a FU of up to 24 month.

Patients with indication for gastric bypass get randomized in group A (RYGB, n = 50) or B (OAGB/MGB, n = 50). FU is performed 1, 3, 6, 12 and 24 month after surgery.

Enrollment: 100 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. primary obesity surgery and indication for gastric bypass
2. age: 18 - 65 years
3. BMI > 40 kg/m² or BMI > 35 kg/m² with obesity related comorbidities
4. informed consent

Exclusion criteria

1. obesity surgery in the anamnesis
2. visceral surgery in the anamnesis (excluding appendectomy and cholecystectomy)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

RYGB-group

Experimental group

Description:

Patients who undergo laparoscopic RYGB (150 cm alimentary limb, 50 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50

Treatment:

Other: RYGB

OAGB/MGB-group

Experimental group

Description:

Patients who undergo laparoscopic OAGB/MGB (200 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50

Treatment:

Other: OAGB/MGB