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

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

Study Overview

• Status: Withdrawn
• Conditions: Gastric Bypass
• Intervention / Treatment: Procedure: Gastric bypass

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • South Yorkshire
    • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
      • Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: MGB; Mini gastric bypass	Procedure: Gastric bypass; Surgical method of gastric bypass
Active Comparator: Roux enY gastric bypass	Procedure: Gastric bypass; Surgical method of gastric bypass

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Excess weight loss	Amount of weight lost	2 years post surgery

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Doncaster And Bassetlaw Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2019
• Primary Completion (Actual): July 24, 2019
• Study Completion (Actual): July 24, 2019

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 14, 2018
• First Posted (Actual): September 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 26, 2019
• Last Update Submitted That Met QC Criteria: July 24, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Bariatric surgery; Mini Gastric Bypass; Roux En-Y Gastric Bypass
• Other Study ID Numbers: 0945 2018 NCTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Final report and findings will be appropriately disseminated following completion of the study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No