Gastric BypassMGB vs RYGBNCT03673969
Mini Gastric Bypass vs Roux enY Gastric Bypass
A study testing Gastric bypass in people with Gastric Bypass, run by Doncaster And Bassetlaw Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The primary aim of this research project is to assess the safety and efficacy of the MGB operation in the UK Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Bypass
- What is being tested?
- Gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Feb 2019to 24 Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not meeting the eligibility criteria
- Under 18s
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, South Yorkshire, DN2 5LT
About this study
The primary aim of this research project is to assess the safety and efficacy of the MGB operation in the UK
Read the 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.
- Conditions
- Gastric Bypass
- Being tested
- Gastric bypass
- Keywords
- Mini Gastric Bypass, Roux En-Y Gastric Bypass, Bariatric surgery, Type 2 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric bypassProcedure or surgery
Surgical method of gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| MGB | Active comparator | Mini gastric bypass Receives: Procedure: Gastric bypass |
| Roux enY gastric bypass | Active comparator | Roux enY gastric bypass Receives: Procedure: Gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess weight loss
Amount of weight lost
Measured: 2 years post surgery
Secondary outcomes (12)
Type 2 diabetes remission
Type 2 diabetes remission
Measured: 6 months, 2 years, 5 years and 10 years
Morbidity
Morbidity
Measured: 6 months, 2 years, 5 years and 10 years
Mortality
Mortality
Measured: 6 months, 2 years, 5 years and 10 years
Operative time
Operative time
Measured: 6 months, 2 years, 5 years and 10 years
Length of stay
Length of stay
Measured: 6 months, 2 years, 5 years and 10 years
Readmission rate
Readmission rate
Measured: 6 months, 2 years, 5 years and 10 years
Lipid profile
Lipid profile
Measured: 6 months, 2 years, 5 years and 10 years
Malnutrition
Malnutrition
Measured: 6 months, 2 years, 5 years and 10 years
Liver failure
Liver failure
Measured: 6 months, 2 years, 5 years and 10 years
Gastro-oesophageal reflux
Gastro-oesophageal reflux
Measured: 6 months, 2 years, 5 years and 10 years
Upper GI cancer
Upper GI cancer
Measured: 6 months, 2 years, 5 years and 10 years
Diarrhoea
Diarrhoea
Measured: 6 months, 2 years, 5 years and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start1 Feb 2019 (estimated)
- Primary completion24 Jul 2019
- Study completion24 Jul 2019
Why it stopped: Lack of funding to progress the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric BypassStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Doncaster And Bassetlaw Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03673969
- Sponsor's protocol ID
- 0945 2018 NCTS
- Acronym
- MGB vs RYGB
- Status last verified
- Jul 2019
- First submitted
- 13 Sep 2018
- Last updated
- 26 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Final report and findings will be appropriately disseminated following completion of the study
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini Gastric Bypass vs Roux enY Gastric Bypass
- ClinicalTrials.gov ID
- NCT03673969
- Acronym / sponsor ID
- MGB vs RYGB / 0945 2018 NCTS
- Conditions
- Gastric Bypass
- Keywords
- Mini Gastric Bypass, Roux En-Y Gastric Bypass, Bariatric surgery, Type 2 diabetes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding to progress the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Doncaster And Bassetlaw Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Feb 2019 (estimated)
- Primary completion
- 24 Jul 2019 (actual)
- Study completion
- 24 Jul 2019 (actual)
- First posted
- 17 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MGB | Active comparator | Procedure: Gastric bypassMini gastric bypass |
| Roux enY gastric bypass | Active comparator | Procedure: Gastric bypassRoux enY gastric bypass |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Not meeting the eligibility criteria
- Under 18s
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gastric bypassSurgical method of gastric bypass | Procedure or surgery | MGB, Roux enY gastric bypass |
Primary outcome
Excess weight loss
Time frame: 2 years post surgery
Amount of weight lost
12 secondary outcomes
Type 2 diabetes remission
Time frame: 6 months, 2 years, 5 years and 10 years
Morbidity
Time frame: 6 months, 2 years, 5 years and 10 years
Mortality
Time frame: 6 months, 2 years, 5 years and 10 years
Operative time
Time frame: 6 months, 2 years, 5 years and 10 years
Length of stay
Time frame: 6 months, 2 years, 5 years and 10 years
Readmission rate
Time frame: 6 months, 2 years, 5 years and 10 years
Lipid profile
Time frame: 6 months, 2 years, 5 years and 10 years
Malnutrition
Time frame: 6 months, 2 years, 5 years and 10 years
Liver failure
Time frame: 6 months, 2 years, 5 years and 10 years
Gastro-oesophageal reflux
Time frame: 6 months, 2 years, 5 years and 10 years
Upper GI cancer
Time frame: 6 months, 2 years, 5 years and 10 years
Diarrhoea
Time frame: 6 months, 2 years, 5 years and 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
- Individual participant dataSharing planned: No. Final report and findings will be appropriately disseminated following completion of the study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric bypass in people with Gastric Bypass, run by Doncaster And Bassetlaw Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess weight loss (time frame: 2 years post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.