Mini Gastric Bypass vs Roux enY Gastric Bypass

Study Overview
=================
Brief Summary
-----------------
The primary aim of this research project is to assess the safety and efficacy of the MGB operation in the UK

Detailed Description
-----------------
The main aim of this project is to develop an ideal bariatric/metabolic surgery operation. The ideal features are highly safe operation, revisable, reversible, extremely effective, short operative time, short hospital stay, cost-effective, no long-term complications and acceptable to the patients. Mini Gastric Bypass/One Anastomosis Gastric Bypass MGB/OAGB is relatively a new bariatric /metabolic surgery operation that is increasing in popularity and currently more than 60,000 operations are performed worldwide. Only 125 MGB operations are published from UK. No previous RCT to date in the UK to test the new operation although RCT was done in Taiwan 2005 and showed that MGB is not inferior to the Roux EnY Gastric Bypass RYGB. This research project is assessing the outcomes of this operation and opening the doors to understand its effects and how it works compared to the standard RYGB. The possible development in the project is to study the hormonal changes after the MGB.

Official Title
-----------------
Mini Gastric Bypass vs Roux enY Gastric Bypass

Conditions
-----------------
Gastric Bypass

Intervention / Treatment
-----------------
* Procedure: Gastric bypass


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: They have a BMI of 40 kg/m2 or more, or between 35 kg/m2 and 40 kg/m2 and other significant disease (for example, type 2 diabetes or high blood pressure) that could be improved if they lost weight. All appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss. The person has been receiving or will receive intensive management in a tier 3 service. The person is generally fit for anaesthesia and surgery. The person commits to the need for long-term follow-up Exclusion Criteria: Not meeting the eligibility criteria Under 18s

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

Accepts Healthy Volunteers
-----------------
No

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MGB<br>Mini gastric bypass | Procedure: Gastric bypass<br>* Surgical method of gastric bypass<br>|
| Active Comparator: Roux enY gastric bypass<br>Roux enY gastric bypass | Procedure: Gastric bypass<br>* Surgical method of gastric bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess weight loss | Amount of weight lost | 2 years post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Type 2 diabetes remission | Type 2 diabetes remission | 6 months, 2 years, 5 years and 10 years | 
| Morbidity | Morbidity | 6 months, 2 years, 5 years and 10 years | 
| Mortality | Mortality | 6 months, 2 years, 5 years and 10 years | 
| Operative time | Operative time | 6 months, 2 years, 5 years and 10 years | 
| Length of stay | Length of stay | 6 months, 2 years, 5 years and 10 years | 
| Readmission rate | Readmission rate | 6 months, 2 years, 5 years and 10 years | 
| Lipid profile | Lipid profile | 6 months, 2 years, 5 years and 10 years | 
| Malnutrition | Malnutrition | 6 months, 2 years, 5 years and 10 years | 
| Liver failure | Liver failure | 6 months, 2 years, 5 years and 10 years | 
| Gastro-oesophageal reflux | Gastro-oesophageal reflux | 6 months, 2 years, 5 years and 10 years | 
| Upper GI cancer | Upper GI cancer | 6 months, 2 years, 5 years and 10 years | 
| Diarrhoea | Diarrhoea | 6 months, 2 years, 5 years and 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mini Gastric Bypass, Roux En-Y Gastric Bypass, Bariatric surgery, Type 2 diabetes