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

S

Sana Klinikum Offenbach

Status

Terminated

Conditions

Obesity

Treatments

Other: OAGB/MGB
Other: RYGB

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

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

Exclusion criteria

  • obesity surgery in the anamnesis
  • visceral surgery in the anamnesis (excluding appendectomy and cholecystectomy)

Trial design

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

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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