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Lack of funding to progress the study
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The primary aim of this research project is to assess the safety and efficacy of the MGB operation in the UK
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MGB | Active Comparator | Mini gastric bypass |
|
| Roux enY gastric bypass | Active Comparator | Roux enY gastric bypass |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gastric bypass | Procedure | Surgical method of gastric bypass |
|
| Measure | Description | Time Frame |
|---|---|---|
| Excess weight loss | Amount of weight lost | 2 years post surgery |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust | Doncaster | South Yorkshire | DN2 5LT | United Kingdom |
Final report and findings will be appropriately disseminated following completion of the study
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015390 | Gastric Bypass |
| ID | Term |
|---|---|
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
| D000073319 | Obesity Management |
| D013812 | Therapeutics |
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Participant will not know the arm prior to surgery, but will be made aware of it afterward
| 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 |
| D004700 | Endocrine System Diseases |
| D005763 |
| Gastroenterostomy |
| D000714 | Anastomosis, Surgical |
| D013514 | Surgical Procedures, Operative |
| D013505 | Digestive System Surgical Procedures |