One-anastomosis Gastric Bypass/Mini-Gastric Bypass Versus Roux-en Y Gastric Bypass

Study Overview
=================
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.

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

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Other: RYGB
* Other: OAGB/MGB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Exclusion Criteria: obesity surgery in the anamnesis visceral surgery in the anamnesis (excluding appendectomy and cholecystectomy)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: prospective randomized controlled trial: RYGB (group A) vs OAGB/MGB (group B)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RYGB-group<br>Patients who undergo laparoscopic RYGB (150 cm alimentary limb, 50 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50 | Other: RYGB<br>* laparoscopic RYGB<br>|
| Experimental: OAGB/MGB-group<br>Patients who undergo laparoscopic OAGB/MGB (200 cm biliopancreatic limb) as a primary surgery in obesity surgery; n = 50 | Other: OAGB/MGB<br>* laparoscopic OAGB/MGB<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications | complications classified next to Clavien-Dindo | up to 2 years after surgery | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Roux-en Y gastric bypass, One-anastomosis gastric bypass, Mini-gastric bypass, metabolic surgery