Mini Gastric Bypass vs Roux enY Gastric Bypass

Mini Gastric Bypass vs Roux enY Gastric Bypass

Sponsors

Lead Sponsor: Doncaster And Bassetlaw Hospitals NHS Foundation Trust

Source 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.

Overall Status Withdrawn
Start Date February 1, 2019
Completion Date July 24, 2019
Primary Completion Date July 24, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Excess weight loss 2 years post surgery
Secondary Outcome
Measure Time Frame
Type 2 diabetes remission 6 months, 2 years, 5 years and 10 years
Morbidity 6 months, 2 years, 5 years and 10 years
Mortality 6 months, 2 years, 5 years and 10 years
Operative time 6 months, 2 years, 5 years and 10 years
Length of stay 6 months, 2 years, 5 years and 10 years
Readmission rate 6 months, 2 years, 5 years and 10 years
Lipid profile 6 months, 2 years, 5 years and 10 years
Malnutrition 6 months, 2 years, 5 years and 10 years
Liver failure 6 months, 2 years, 5 years and 10 years
Gastro-oesophageal reflux 6 months, 2 years, 5 years and 10 years
Upper GI cancer 6 months, 2 years, 5 years and 10 years
Diarrhoea 6 months, 2 years, 5 years and 10 years
Condition
Intervention

Intervention Type: Procedure

Intervention Name: Gastric bypass

Description: Surgical method of gastric bypass

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Location
Facility: Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
Location Countries

United Kingdom

Verification Date

July 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Number Of Arms 2
Arm Group

Label: MGB

Type: Active Comparator

Description: Mini gastric bypass

Label: Roux enY gastric bypass

Type: Active Comparator

Description: Roux enY gastric bypass

Acronym MGB vs RYGB
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Masking Description: Participant will not know the arm prior to surgery, but will be made aware of it afterward

Source: ClinicalTrials.gov