One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass
NCT ID: NCT03045679
Last Updated: 2023-01-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
100 participants
INTERVENTIONAL
2018-01-01
2020-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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RYGB-group
Patients who undergo laparoscopic RYGB (150 cm alimentary limb, 50 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50
RYGB
laparoscopic RYGB
OAGB/MGB-group
Patients who undergo laparoscopic OAGB/MGB (200 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50
OAGB/MGB
laparoscopic OAGB/MGB
Interventions
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RYGB
laparoscopic RYGB
OAGB/MGB
laparoscopic OAGB/MGB
Eligibility Criteria
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Inclusion Criteria
2. age: 18 - 65 years
3. BMI \> 40 kg/m² or BMI \> 35 kg/m² with obesity related comorbidities
4. informed consent
Exclusion Criteria
2. visceral surgery in the anamnesis (excluding appendectomy and cholecystectomy)
18 Years
65 Years
ALL
Yes
Sponsors
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Sana Klinikum Offenbach
OTHER
Responsible Party
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Sonja Chiappetta, MD
Principal investigator: Dr. Sonja Chiappetta
Principal Investigators
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Sonja Chiappetta, MD
Role: STUDY_CHAIR
Sana Klinikum Offenbach
Locations
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Sana Klinikum Offenbach
Offenbach, Hesse, Germany
Countries
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References
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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.
Other Identifiers
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FF 74/2016
Identifier Type: -
Identifier Source: org_study_id
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