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

NCT03045679 | Terminated

• 1 other identifier: FF 74/2016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obesity

Keywords

Roux-en Y gastric bypass; One-anastomosis gastric bypass; Mini-gastric bypass; metabolic surgery

Outcome Measures

Primary Outcomes (1)

• complications

  complications classified next to Clavien-Dindo

  up to 2 years after surgery

Secondary Outcomes (19)

• mortality

  up to 2 years after surgery

• remission of type 2 diabetes mellitus

  up to 2 years after surgery

• remission of hypertonus

  up to 2 years after surgery

• gastro-esophageal reflux disease

  up to 2 years after surgery

• remission of sleep apnea

  up to 2 years after surgery

Study Arms (2)

RYGB-group

EXPERIMENTAL

Patients who undergo laparoscopic RYGB (150 cm alimentary limb, 50 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50

Other: RYGB

OAGB/MGB-group

EXPERIMENTAL

Patients who undergo laparoscopic OAGB/MGB (200 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50

Other: OAGB/MGB

Interventions

RYGB OTHER

laparoscopic RYGB

RYGB-group

OAGB/MGB OTHER

laparoscopic OAGB/MGB

OAGB/MGB-group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Sana Klinikum Offenbach: lead

Study Sites (1)

Sana Klinikum Offenbach

Offenbach, Hesse, 63069, Germany

Location

Related 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. 2015 Jun;25(6):951-8. doi: 10.1007/s11695-014-1552-z.

  PMID: 25585612 RESULT

• 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.

  PMID: 26337694 RESULT

• 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.

  PMID: 26341086 RESULT

• 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.

  PMID: 25552228 RESULT

• 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.

  PMID: 15973097 RESULT

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sonja Chiappetta, MD

  Sana Klinikum Offenbach

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: envelope randomization
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator: Dr. Sonja Chiappetta

Model Details: prospective randomized controlled trial: RYGB (group A) vs OAGB/MGB (group B)

Study Record Dates

• First Submitted: February 5, 2017
• First Posted: February 7, 2017
• Study Start: January 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: January 17, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)