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

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

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.

Study Overview

• Status: Terminated
• Conditions: Obesity
• Intervention / Treatment: Other: RYGB; Other: OAGB/MGB

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Hessen
    • Offenbach, Hessen, Germany, 63069
      • Sana Klinikum Offenbach

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RYGB-group; Patients who undergo laparoscopic RYGB (150 cm alimentary limb, 50 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50	Other: RYGB; laparoscopic RYGB
Experimental: OAGB/MGB-group; Patients who undergo laparoscopic OAGB/MGB (200 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50	Other: OAGB/MGB; laparoscopic OAGB/MGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
complications	complications classified next to Clavien-Dindo	up to 2 years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
mortality	death up to 2 years after surgery	up to 2 years after surgery
remission of type 2 diabetes mellitus	HbA1c < 6.5% without medication	up to 2 years after surgery
remission of hypertonus	blood pressure < 140/90 mmHg without medication	up to 2 years after surgery
gastro-esophageal reflux disease	GERD-HRGL Heartburn Scale	up to 2 years after surgery
remission of sleep apnea	presence/absence of CPAP	up to 2 years after surgery
remission of hypertrigliceridemia	triglyceride < 200mg/dl without medication	up to 2 years after surgery
remission of hypercholesterinemia	cholesterin < 155 mg/dl without medication	up to 2 years after surgery
quality of life questionnaire	changing in quality of life measured by questionnaire	up to 2 years after surgery
weight loss	postoperative excess weight loss in %	up to 2 years after surgery
operation time	operation time during surgery in minutes	operation time during surgery in minutes
malnutrition 1	postoperative malnutrition: protein < 64 g/l	up to 2 years after surgery
malnutrition 2	postoperative malnutrition: albumin < 35 g/l	up to 2 years after surgery
malnutrition 3	postoperative malnutrition: ferritin (< 30 µg/l)	up to 2 years after surgery
malnutrition 4	postoperative malnutrition: vitamin E < 12 µmol/l	up to 2 years after surgery
malnutrition 5	postoperative malnutrition: vitamin K < 90 ng/l	up to 2 years after surgery
malnutrition 6	postoperative malnutrition: vitamin 25-OH- Vitamin D3 < 50 nmol/l	up to 2 years after surgery
malnutrition 7	postoperative malnutrition: vitamin A < 1.05 µmol/l	up to 2 years after surgery
malnutrition 8	postoperative malnutrition: vitamin B12 < 145 pmol/l	up to 2 years after surgery
revisional surgery	revisional surgery during follow up	up to 2 years after surgery

Collaborators and Investigators

• Sponsor: Sana Klinikum Offenbach
• Investigators: Study Chair: Sonja Chiappetta, MD, Sana Klinikum Offenbach

Publications and helpful links

General Publications

• Chevallier JM, Arman GA, Guenzi M, Rau C, Bruzzi M, Beaupel N, Zinzindohoue F, Berger A. One thousand single anastomosis (omega loop) gastric bypasses to treat morbid obesity in a 7-year period: outcomes show few complications and good efficacy. Obes Surg. 2015 Jun;25(6):951-8. doi: 10.1007/s11695-014-1552-z.
• Jammu GS, Sharma R. A 7-Year Clinical Audit of 1107 Cases Comparing Sleeve Gastrectomy, Roux-En-Y Gastric Bypass, and Mini-Gastric Bypass, to Determine an Effective and Safe Bariatric and Metabolic Procedure. Obes Surg. 2016 May;26(5):926-32. doi: 10.1007/s11695-015-1869-2.
• Musella M, Apers J, Rheinwalt K, Ribeiro R, Manno E, Greco F, Cierny M, Milone M, Di Stefano C, Guler S, Van Lessen IM, Guerra A, Maglio MN, Bonfanti R, Novotna R, Coretti G, Piazza L. Efficacy of Bariatric Surgery in Type 2 Diabetes Mellitus Remission: the Role of Mini Gastric Bypass/One Anastomosis Gastric Bypass and Sleeve Gastrectomy at 1 Year of Follow-up. A European survey. Obes Surg. 2016 May;26(5):933-40. doi: 10.1007/s11695-015-1865-6.
• Guenzi M, Arman G, Rau C, Cordun C, Moszkowicz D, Voron T, Chevallier JM. Remission of type 2 diabetes after omega loop gastric bypass for morbid obesity. Surg Endosc. 2015 Sep;29(9):2669-74. doi: 10.1007/s00464-014-3987-7. Epub 2015 Jan 1.
• Lee WJ, Yu PJ, Wang W, Chen TC, Wei PL, Huang MT. Laparoscopic Roux-en-Y versus mini-gastric bypass for the treatment of morbid obesity: a prospective randomized controlled clinical trial. Ann Surg. 2005 Jul;242(1):20-8. doi: 10.1097/01.sla.0000167762.46568.98.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 1, 2020

Study Registration Dates

• First Submitted: February 5, 2017
• First Submitted That Met QC Criteria: February 5, 2017
• First Posted (Estimate): February 7, 2017

Study Record Updates

• Last Update Posted (Estimate): January 16, 2023
• Last Update Submitted That Met QC Criteria: January 13, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Roux-en Y gastric bypass; One-anastomosis gastric bypass; Mini-gastric bypass; metabolic surgery
• Other Study ID Numbers: FF 74/2016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No