Mini Gastric Bypass vs Roux enY Gastric Bypass

Not Applicable

Withdrawn

• Conditions: Gastric Bypass
• Interventions: Procedure: Gastric bypass

• Registration Number: NCT03673969
• Lead Sponsor: Doncaster And Bassetlaw Hospitals NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2018-09-13
• Study First Submitted QC: 2018-09-14
• Study First Posted: 2018-09-17
• Study Start: 2019-02-01
• Status Verified: 2019-07
• Primary Completion: 2019-07-24
• Study Completion: 2019-07-24
• Last Update Submitted: 2019-07-24
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MGB	Gastric bypass	Mini gastric bypass
Roux enY gastric bypass	Gastric bypass	Roux enY gastric bypass

Primary Outcome Measures

Name	Time	Method
Excess weight loss	2 years post surgery	Amount of weight lost

Secondary Outcome Measures

Name	Time	Method
Mortality	6 months, 2 years, 5 years and 10 years	Mortality
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
Readmission rate	6 months, 2 years, 5 years and 10 years	Readmission rate
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
Length of stay	6 months, 2 years, 5 years and 10 years	Length of stay
Lipid profile	6 months, 2 years, 5 years and 10 years	Lipid profile
Malnutrition	6 months, 2 years, 5 years and 10 years	Malnutrition
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

Trial Locations

Locations (1)

Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust; 🇬🇧 Doncaster, South Yorkshire, United Kingdom