Gastric Bypass
Conditions
Keywords
Mini Gastric Bypass, Roux En-Y Gastric Bypass, Bariatric surgery, Type 2 diabetes
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.
Interventions
PROCEDUREGastric bypass
Surgical method of gastric bypass
Sponsors
Doncaster And Bassetlaw Hospitals NHS Foundation Trust
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participant will not know the arm prior to surgery, but will be made aware of it afterward
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Excess weight loss | 2 years post surgery | Amount of weight lost |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Gastro-oesophageal reflux | 6 months, 2 years, 5 years and 10 years | Gastro-oesophageal reflux |
| Upper GI cancer | 6 months, 2 years, 5 years and 10 years | Upper GI cancer |
| Diarrhoea | 6 months, 2 years, 5 years and 10 years | Diarrhoea |
| Type 2 diabetes remission | 6 months, 2 years, 5 years and 10 years | Type 2 diabetes remission |
| Morbidity | 6 months, 2 years, 5 years and 10 years | Morbidity |
| Liver failure | 6 months, 2 years, 5 years and 10 years | Liver failure |
| Operative time | 6 months, 2 years, 5 years and 10 years | Operative time |
| Length of stay | 6 months, 2 years, 5 years and 10 years | Length of stay |
| Readmission rate | 6 months, 2 years, 5 years and 10 years | Readmission rate |
| Lipid profile | 6 months, 2 years, 5 years and 10 years | Lipid profile |
| Malnutrition | 6 months, 2 years, 5 years and 10 years | Malnutrition |
| Mortality | 6 months, 2 years, 5 years and 10 years | Mortality |
Countries
United Kingdom
Outcome results
None listed