NCT03045679

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

The Evidence of One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass in Metabolic Surgery - a Prospective Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Sana Klinikum Offenbach · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Obesity

Interventions

Type	Name	Description
OTHER	RYGB	laparoscopic RYGB
OTHER	OAGB/MGB	laparoscopic OAGB/MGB

Timeline

• Start date: 2018-01-01
• Primary completion: 2020-12-01
• Completion: 2020-12-01
• First posted: 2017-02-07
• Last updated: 2023-01-17

Locations

1 site across 1 country: Germany