Mini Gastric Bypass vs Roux enY Gastric Bypass

NCT ID: NCT03673969

Last Updated: 2019-07-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-07-24

Brief Summary

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

Detailed Description

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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.

Conditions

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Gastric Bypass

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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MGB

Mini gastric bypass

Group Type ACTIVE_COMPARATOR

Gastric bypass

Intervention Type PROCEDURE

Surgical method of gastric bypass

Roux enY gastric bypass

Roux enY gastric bypass

Group Type ACTIVE_COMPARATOR

Gastric bypass

Intervention Type PROCEDURE

Surgical method of gastric bypass

Interventions

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Gastric bypass

Surgical method of gastric bypass

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Doncaster And Bassetlaw Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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0945 2018 NCTS

Identifier Type: -

Identifier Source: org_study_id

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