Mini Gastric Bypass vs Roux enY Gastric Bypass

Gastric Bypass Clinical Trial

— MGB vs RYGB  

Official title:

Mini Gastric Bypass vs Roux enY Gastric Bypass

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03673969
• Other study ID #: 0945 2018 NCTS
• Status: Withdrawn
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 24, 2019

Study information

• Verified date: July 2019
• Source: Doncaster And Bassetlaw Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 24, 2019
• Est. primary completion date: July 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Bypass

Intervention

Procedure:
• Gastric bypass
Surgical method of gastric bypass

Locations

Country	Name	City	State
United Kingdom	Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust	Doncaster	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Doncaster And Bassetlaw Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Excess weight loss	Amount of weight lost	2 years post surgery
Secondary	Type 2 diabetes remission	Type 2 diabetes remission	6 months, 2 years, 5 years and 10 years
Secondary	Morbidity	Morbidity	6 months, 2 years, 5 years and 10 years
Secondary	Mortality	Mortality	6 months, 2 years, 5 years and 10 years
Secondary	Operative time	Operative time	6 months, 2 years, 5 years and 10 years
Secondary	Length of stay	Length of stay	6 months, 2 years, 5 years and 10 years
Secondary	Readmission rate	Readmission rate	6 months, 2 years, 5 years and 10 years
Secondary	Lipid profile	Lipid profile	6 months, 2 years, 5 years and 10 years
Secondary	Malnutrition	Malnutrition	6 months, 2 years, 5 years and 10 years
Secondary	Liver failure	Liver failure	6 months, 2 years, 5 years and 10 years
Secondary	Gastro-oesophageal reflux	Gastro-oesophageal reflux	6 months, 2 years, 5 years and 10 years
Secondary	Upper GI cancer	Upper GI cancer	6 months, 2 years, 5 years and 10 years
Secondary	Diarrhoea	Diarrhoea	6 months, 2 years, 5 years and 10 years