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Hospital changed in 2019, no recruitment performed
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| OAGB/MGB-group | Experimental | Patients who undergo laparoscopic OAGB/MGB (200 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RYGB | Other | laparoscopic RYGB |
| |
| OAGB/MGB |
| Measure | Description | Time Frame |
|---|---|---|
| complications | complications classified next to Clavien-Dindo | up to 2 years after surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sonja Chiappetta, MD | Sana Klinikum Offenbach | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sana Klinikum Offenbach | Offenbach | Hesse | 63069 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25585612 | Result | 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. | |
| 26337694 | Result |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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prospective randomized controlled trial: RYGB (group A) vs OAGB/MGB (group B)
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envelope randomization
| Other |
laparoscopic OAGB/MGB |
|
| 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 |
| 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. |
| 26341086 | 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. |
| 25552228 | 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. |
| 15973097 | 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. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |