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

Obesity Clinical Trial

— MGBvsRYGB  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03045679
• Other study ID #: FF 74/2016
• Status: Terminated
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: December 1, 2020

Study information

• Verified date: January 2023
• Source: Sana Klinikum Offenbach
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 1, 2020
• Est. primary completion date: December 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• RYGB
laparoscopic RYGB
• OAGB/MGB
laparoscopic OAGB/MGB

Locations

Country	Name	City	State
Germany	Sana Klinikum Offenbach	Offenbach	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Sana Klinikum Offenbach

Country where clinical trial is conducted

Germany, 

References & Publications (5)

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 — View Citation

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. — View Citation

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 — View Citation

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.0000167762.465 — View Citation

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: t — View Citation

Outcome

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