One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass
- Conditions
- Obesity
- Registration Number
- NCT03045679
- Lead Sponsor
- Sana Klinikum Offenbach
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 100
- 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
- obesity surgery in the anamnesis
- visceral surgery in the anamnesis (excluding appendectomy and cholecystectomy)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method complications up to 2 years after surgery complications classified next to Clavien-Dindo
- Secondary Outcome Measures
Name Time Method 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
remission of type 2 diabetes mellitus up to 2 years after surgery HbA1c \< 6.5% without medication
gastro-esophageal reflux disease up to 2 years after surgery GERD-HRGL Heartburn Scale
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
mortality up to 2 years after surgery death up to 2 years after surgery
remission of sleep apnea up to 2 years after surgery presence/absence of CPAP
remission of hypercholesterinemia up to 2 years after surgery cholesterin \< 155 mg/dl without medication
malnutrition 2 up to 2 years after surgery postoperative malnutrition: albumin \< 35 g/l
remission of hypertonus up to 2 years after surgery blood pressure \< 140/90 mmHg without medication
malnutrition 1 up to 2 years after surgery postoperative malnutrition: protein \< 64 g/l
malnutrition 5 up to 2 years after surgery postoperative malnutrition: vitamin K \< 90 ng/l
revisional surgery up to 2 years after surgery revisional surgery during follow up
remission of hypertrigliceridemia up to 2 years after surgery triglyceride \< 200mg/dl without medication
malnutrition 6 up to 2 years after surgery postoperative malnutrition: vitamin 25-OH- Vitamin D3 \< 50 nmol/l
malnutrition 8 up to 2 years after surgery postoperative malnutrition: vitamin B12 \< 145 pmol/l
malnutrition 7 up to 2 years after surgery postoperative malnutrition: vitamin A \< 1.05 µmol/l
Trial Locations
- Locations (1)
Sana Klinikum Offenbach
🇩🇪Offenbach, Hessen, Germany
Sana Klinikum Offenbach🇩🇪Offenbach, Hessen, Germany