Clinical trial NCT03673969: Mini Gastric Bypass vs Roux enY Gastric Bypass
Official title: Mini Gastric Bypass vs Roux enY Gastric Bypass
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastric Bypass
Keywords: Mini Gastric Bypass
Roux En-Y Gastric Bypass
Bariatric surgery
Type 2 diabetes
Lead sponsor: Doncaster And Bassetlaw Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Excess weight loss
timeFrame: 2 years post surgery
Secondary outcomes:
measure: Type 2 diabetes remission
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Morbidity
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Mortality
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Operative time
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Length of stay
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Readmission rate
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Lipid profile
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Malnutrition
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Liver failure
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Gastro-oesophageal reflux
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Upper GI cancer
timeFrame: 6 months, 2 years, 5 years and 10 years
measure: Diarrhoea
timeFrame: 6 months, 2 years, 5 years and 10 years
Other outcomes:
Locations:
city: Doncaster
country: United Kingdom
facility: Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
References: