Clinical trial NCT03045679: One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: Roux-en Y gastric bypass
One-anastomosis gastric bypass
Mini-gastric bypass
metabolic surgery
Lead sponsor: Sana Klinikum Offenbach
Sponsor class: OTHER
First posted: 2017-02-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled trial: RYGB (group A) vs OAGB/MGB (group B)
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: complications
timeFrame: up to 2 years after surgery
Secondary outcomes:
measure: mortality
timeFrame: up to 2 years after surgery
measure: remission of type 2 diabetes mellitus
timeFrame: up to 2 years after surgery
measure: remission of hypertonus
timeFrame: up to 2 years after surgery
measure: gastro-esophageal reflux disease
timeFrame: up to 2 years after surgery
measure: remission of sleep apnea
timeFrame: up to 2 years after surgery
measure: remission of hypertrigliceridemia
timeFrame: up to 2 years after surgery
measure: remission of hypercholesterinemia
timeFrame: up to 2 years after surgery
measure: quality of life questionnaire
timeFrame: up to 2 years after surgery
measure: weight loss
timeFrame: up to 2 years after surgery
measure: operation time
timeFrame: operation time during surgery in minutes
measure: malnutrition 1
timeFrame: up to 2 years after surgery
measure: malnutrition 2
timeFrame: up to 2 years after surgery
measure: malnutrition 3
timeFrame: up to 2 years after surgery
measure: malnutrition 4
timeFrame: up to 2 years after surgery
measure: malnutrition 5
timeFrame: up to 2 years after surgery
measure: malnutrition 6
timeFrame: up to 2 years after surgery
measure: malnutrition 7
timeFrame: up to 2 years after surgery
measure: malnutrition 8
timeFrame: up to 2 years after surgery
measure: revisional surgery
timeFrame: up to 2 years after surgery
Other outcomes:
Locations:
city: Offenbach
country: Germany
facility: Sana Klinikum Offenbach
state: Hessen
Study officials:
affiliation: Sana Klinikum Offenbach
name: Sonja Chiappetta, MD
role: STUDY_CHAIR
References:
citation: 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.
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/s11695-015-1869-2.
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: 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.
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.
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.0000167762.46568.98.