ObesityMEMORINGNCT04762849
A Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass
A study testing Laparoscopic one anastomosis gastric bypass and A shape-memory ring for adjustable gastric banding in people with Obesity, run by University Medical Center, Kazakhstan at 1 site in Kazakhstan.
Trial summary
Background and study aims: Currently, the gastric bypass is increasingly performed in the version of the mini gastric bypass (MGB). Another name for the procedure: one anastomosis gastric bypass (OAGB). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Laparoscopic one anastomosis gastric bypass and A shape-memory ring for adjustable gastric banding
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteKazakhstan
- Study dates
- 1 Apr 2021to 1 May 2024
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of Obesity;
- BMI from 30 to 50 kg / m2.
Who cannot join
- Insulin-dependent diabetes;
- BMI less than 30 kg / m2 and more than 50 kg / m2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Clinical Trial of Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass
Background and study aims:
Currently, the gastric bypass is increasingly performed in the version of the mini gastric bypass (MGB). Another name for the procedure: one anastomosis gastric bypass (OAGB). Insufficient weight loss after bariatric surgery or weight gain after surgery is a common big problem in weight loss surgery.
Read more
The use of unregulated and uncontrolled bands and rings is not always effective according to previous studies.
This study compares the loss of weight after the laparoscopic banded one anastomosis gastric bypass with the use of a shape-memory ring and standard laparoscopic one anastomosis gastric bypass.
Methods: Adult participants (n=100) are randomly allocated to one of two groups:
Experimental surgical bariatric procedure in the first (A) group: patients (n=50) will undergo the laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) will undergo the laparoscopic one anastomosis gastric bypass (MGB/OAGB group) without band: standard surgery.
All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index.
Read the detailed description
This study compares the loss of weight after the laparoscopic banded one anastomosis gastric bypass with the use of a shape-memory ring and standard laparoscopic one anastomosis gastric bypass.
Inclusion Criteria:
- BMI from 30 to 50 kg / m2;
- Ages Eligible for Study: 18 Years to 55 Years
Outcome Measures: Change of body mass index [ Time Frame: Baseline, at 12, 24, 36 months after surgery ]
- Conditions
- Obesity
- Being tested
- Laparoscopic one anastomosis gastric bypass, A shape-memory ring for adjustable gastric banding
- Keywords
- Obesity, Bariatric surgery, Ring with shape memory, One anastomosis gastric bypass
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic one anastomosis gastric bypassProcedure or surgery
Laparoscopic one anastomosis gastric bypass include the creation of gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. For the creation of a gastric pouch and gastroenterostomy use a linear stapler.
A shape-memory ring for adjustable gastric bandingDevice
A shape-memory ring (SMR) use for adjustable gastric banding. SMR is placed around the gastric pouch above the gastro-entero-anastomosis.
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) | Experimental | Laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) include the creation of a gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. A ring with shape memory put on the gastric pouch Receives: Procedure: Laparoscopic one anastomosis gastric bypass; Device: A shape-memory ring for adjustable gastric banding |
| laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery | Active comparator | Laparoscopic one anastomosis gastric bypass (MGB/OAGB) include the creation of a gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. Receives: Procedure: Laparoscopic one anastomosis gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body mass index
The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2.
Measured: Baseline, at 12, 24, 36 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2021
- Study start1 Apr 2021
- Primary completion1 Apr 2024 (estimated)
- Study completion1 May 2024 (estimated)
Why it stopped: No Participants Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Model description
- Participants are randomly allocated to one of two groups: Experimental surgical bariatric procedure in the first (A) group: patients will undergo the laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR); Active comparator surgical bariatric procedure in the second (B) group: patients will undergo the laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center, Kazakhstan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oral Ospanov, University Medical Center, Kazakhstan
- Investigators
- Oral Ospanov, Professor, Principal investigator, Corporate Foundation "University Medical Center" (UMC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04762849
- Sponsor's protocol ID
- UMCKazakhstan
- Acronym
- MEMORING
- Status last verified
- May 2023
- First submitted
- 14 Feb 2021
- Last updated
- 15 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial of Banded One Anastomosis Gastric Bypass With Use Shape-memory Ring Versus Non-banded One Anastomosis Gastric Bypass
- ClinicalTrials.gov ID
- NCT04762849
- Acronym / sponsor ID
- MEMORING / UMCKazakhstan
- Conditions
- Obesity
- Keywords
- Obesity, Bariatric surgery, Ring with shape memory, One anastomosis gastric bypass
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Participants Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Medical Center, KazakhstanUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 21 Feb 2021 (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.
Background and study aims:
Currently, the gastric bypass is increasingly performed in the version of the mini gastric bypass (MGB). Another name for the procedure: one anastomosis gastric bypass (OAGB). Insufficient weight loss after bariatric surgery or weight gain after surgery is a common big problem in weight loss surgery.
The use of unregulated and uncontrolled bands and rings is not always effective according to previous studies.
This study compares the loss of weight after the laparoscopic banded one anastomosis gastric bypass with the use of a shape-memory ring and standard laparoscopic one anastomosis gastric bypass.
Methods: Adult participants (n=100) are randomly allocated to one of two groups:
Experimental surgical bariatric procedure in the first (A) group: patients (n=50) will undergo the laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR group); Active comparator surgical bariatric procedure in the second (B) group: patients (n=50) will undergo the laparoscopic one anastomosis gastric bypass (MGB/OAGB group) without band: standard surgery.
All patients are then followed up 12, 24, 36 months after surgery where record the changing body mass index.
Detailed description
This study compares the loss of weight after the laparoscopic banded one anastomosis gastric bypass with the use of a shape-memory ring and standard laparoscopic one anastomosis gastric bypass.
Inclusion Criteria:
- BMI from 30 to 50 kg / m2;
- Ages Eligible for Study: 18 Years to 55 Years
Outcome Measures: Change of body mass index [ Time Frame: Baseline, at 12, 24, 36 months after surgery ]
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are randomly allocated to one of two groups: Experimental surgical bariatric procedure in the first (A) group: patients will undergo the laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR); Active comparator surgical bariatric procedure in the second (B) group: patients will undergo the laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery.
| Arm | Type | Receives |
|---|---|---|
| laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) | Experimental | Procedure: Laparoscopic one anastomosis gastric bypass, Device: A shape-memory ring for adjustable gastric bandingLaparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) include the creation of a gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. A ring with shape memory put on the gastric pouch |
| laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery | Active comparator | Procedure: Laparoscopic one anastomosis gastric bypassLaparoscopic one anastomosis gastric bypass (MGB/OAGB) include the creation of a gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Obesity;
- BMI from 30 to 50 kg / m2.
Key exclusion criteria (2 listed)
- Insulin-dependent diabetes;
- BMI less than 30 kg / m2 and more than 50 kg / m2.
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 |
|---|---|---|
| Laparoscopic one anastomosis gastric bypassLaparoscopic one anastomosis gastric bypass include the creation of gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. For the creation of a gastric pouch and gastroenterostomy use a linear stapler. | Procedure or surgery | laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR), laparoscopic one anastomosis gastric bypass (MGB/OAGB) without band: standard surgery |
| A shape-memory ring for adjustable gastric bandingA shape-memory ring (SMR) use for adjustable gastric banding. SMR is placed around the gastric pouch above the gastro-entero-anastomosis. | Device | laparoscopic banded one anastomosis gastric bypass with use of a shape-memory ring (MGB/OAGB+SMR) |
Primary outcome
Change of body mass index
Time frame: Baseline, at 12, 24, 36 months after surgery
The measure is assessing a change of body mass index. Weight (kg) and height (cm) will be combined with the report of measurement by body mass index (BMI) kg/m2.
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 15 May 2023.
- Individual participant dataSharing planned: No
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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.
Oral Ospanov, Professor principal investigator
Corporate Foundation "University Medical Center" (UMC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic one anastomosis gastric bypass and A shape-memory ring for adjustable gastric banding in people with Obesity, run by University Medical Center, Kazakhstan at 1 site in Kazakhstan.
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 2 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 15 May 2023. 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 Kazakhstan. 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?
Change of body mass index (time frame: Baseline, at 12, 24, 36 months after 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 15 May 2023.