Obesity
Conditions
Keywords
Roux-en Y gastric bypass, One-anastomosis gastric bypass, Mini-gastric bypass, metabolic surgery
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.
Interventions
OTHERRYGB
laparoscopic RYGB
OTHEROAGB/MGB
laparoscopic OAGB/MGB
Sponsors
Sana Klinikum Offenbach
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
envelope randomization
Intervention model description
prospective randomized controlled trial: RYGB (group A) vs OAGB/MGB (group B)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| complications | up to 2 years after surgery | complications classified next to Clavien-Dindo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| remission of type 2 diabetes mellitus | up to 2 years after surgery | HbA1c \< 6.5% without medication |
| remission of hypertonus | up to 2 years after surgery | blood pressure \< 140/90 mmHg without medication |
| gastro-esophageal reflux disease | up to 2 years after surgery | GERD-HRGL Heartburn Scale |
| remission of sleep apnea | up to 2 years after surgery | presence/absence of CPAP |
| remission of hypertrigliceridemia | up to 2 years after surgery | triglyceride \< 200mg/dl without medication |
| remission of hypercholesterinemia | up to 2 years after surgery | cholesterin \< 155 mg/dl without medication |
| quality of life questionnaire | up to 2 years after surgery | changing in quality of life measured by questionnaire |
| weight loss | up to 2 years after surgery | postoperative excess weight loss in % |
| operation time | operation time during surgery in minutes | operation time during surgery in minutes |
| mortality | up to 2 years after surgery | death up to 2 years after surgery |
| malnutrition 2 | up to 2 years after surgery | postoperative malnutrition: albumin \< 35 g/l |
| malnutrition 3 | up to 2 years after surgery | postoperative malnutrition: ferritin (\< 30 µg/l) |
| malnutrition 4 | up to 2 years after surgery | postoperative malnutrition: vitamin E \< 12 µmol/l |
| malnutrition 5 | up to 2 years after surgery | postoperative malnutrition: vitamin K \< 90 ng/l |
| malnutrition 6 | up to 2 years after surgery | postoperative malnutrition: vitamin 25-OH- Vitamin D3 \< 50 nmol/l |
| malnutrition 7 | up to 2 years after surgery | postoperative malnutrition: vitamin A \< 1.05 µmol/l |
| malnutrition 8 | up to 2 years after surgery | postoperative malnutrition: vitamin B12 \< 145 pmol/l |
| revisional surgery | up to 2 years after surgery | revisional surgery during follow up |
| malnutrition 1 | up to 2 years after surgery | postoperative malnutrition: protein \< 64 g/l |
Countries
Germany
Outcome results
None listed