One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass

Sana Klinikum Offenbach100 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Obesity

Interventions

RYGBOTHER

laparoscopic RYGB

OAGB/MGBOTHER

laparoscopic OAGB/MGB

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Sana Klinikum Offenbach

Offenbach, Hesse, Germany