Mini Gastric Bypass vs Roux enY Gastric Bypass (MGB vs RYGB)

Doncaster And Bassetlaw Hospitals NHS Foundation Trust

Status: Withdrawn

Conditions: Gastric Bypass

Treatments: Procedure: Gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT03673969

0945 2018 NCTS

Details and patient eligibility

About

The primary aim of this research project is to assess the safety and efficacy of the MGB operation in the UK

Full 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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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0 participants in 2 patient groups

MGB

Active Comparator group

Description:

Mini gastric bypass

Treatment:

Procedure: Gastric bypass

Roux enY gastric bypass

Active Comparator group

Description:

Roux enY gastric bypass

Treatment:

Procedure: Gastric bypass