ObesityOAGBvsLLbypassNCT04812132
RCT Comparing OAGB and Long Limb Roux Gastric Bypass
A study testing One-anastomosis gastric bypass and Long biliary limb Roux gastric bypass in people with Obesity, run by Tartu University Hospital at 1 site in Estonia.
Trial summary
A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass. We plan to enroll up to 500 patients from three different clinics in Estonia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- One-anastomosis gastric bypass and Long biliary limb Roux gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteEstonia
- Study dates
- 1 Jan 2021to 31 Dec 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- BMI over 35 and obesity related disease
- BMI over 40
- age between 18-60 years
- agrees to participate in the study
Who cannot join
- age under 18 years or over 60 years
- abundant adhesions discovered during the surgery
- active upper gastrointestinal ulcer disease
- prior bariatric surgery
- active symptomatic reflux disease
- active psychiatric disease (eg psychosis)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Estonia1 site, 1 recruiting
- Recruiting
Tartu University Hospital
Tartu, 50406
Eva-Maria Kikkas, Dr, +37258162720, evamariakikkas@gmail.com
Toomas Sillakivi, Dr, PhD, toomas.sillakivi@kliinikum.ee
About this study
Official title: A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.
A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass.
We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea.
Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life.
There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts.
There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.
- Conditions
- Obesity
- Being tested
- One-anastomosis gastric bypass, Long biliary limb Roux gastric bypass
- Keywords
- OAGB, Long biliary limb Roux gastric bypass, Metabolic surgery, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-anastomosis gastric bypassProcedure or surgery
One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)
Long biliary limb Roux gastric bypassProcedure or surgery
Other group is planned to receive a long biliary limb Roux gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| Women | Active comparator | Not described Receives: Procedure: One-anastomosis gastric bypass; Procedure: Long biliary limb Roux gastric bypass |
| Men | Active comparator | Not described Receives: Procedure: One-anastomosis gastric bypass; Procedure: Long biliary limb Roux gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Excess weight loss %
Calculated loss of the excess weight
Measured: 10 years
Impact on type 2 diabetes mellitus
Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %
Measured: 10 years
Impact on type 2 diabetes mellitus
Outcome of type 2 diabetes mellitus after the surgery, measured in usage of medication (same dosage, decreased dosage, insulin to peroral, ended all medication)
Measured: 10 years
Impact on hypertensive disease
Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)
Measured: 10 years
Impact on total cholesterol
Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).
Measured: 10 years
Impact on hyperlipidemia
Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)
Measured: 10 years
Impact on hyperlipidemia
Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L)
Measured: 10 years
Impact on hyperlipidemia
Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)
Measured: 10 years
Impact on hyperlipidemias
Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides
Measured: 10 years
Secondary outcomes (3)
Nutritional deficiencies: anemia
% of subjects having hemoglobin below sex adjusted reference (g/L) and ferritin below sex adjusted references (ug/L)
Measured: 10 years
Nutritional deficiencies
Occurrence of B12 deficiency, measured in % of subjects with vitamin B12 below reference (measures in pmol/L)
Measured: 10 years
GERD
% of subjects reporting reflux disease symptoms and/or PPI usage after the surgery
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2021
- Study start1 Jan 2021
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2036 (estimated)
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
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tartu University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- North Estonia Medical Centre, Fertilitas (private clinic)
- Responsible party
- Principal investigator, Eva-Maria Kikkas, Tartu University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04812132
- Sponsor's protocol ID
- TartuUH
- Acronym
- OAGBvsLLbypass
- Status last verified
- Mar 2021
- First submitted
- 27 Feb 2021
- Last updated
- 23 Mar 2021
- 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 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Randomized Controlled Trial Comparing Outcome of Laparoscopic One-anastomosis Gastric Bypass and Laparoscopic Long Biliopancreatic Limb Roux Gastric Bypass for Treatment of Morbid Obesity.
- ClinicalTrials.gov ID
- NCT04812132
- Acronym / sponsor ID
- OAGBvsLLbypass / TartuUH
- Conditions
- Obesity
- Keywords
- OAGB, Long biliary limb Roux gastric bypass, Metabolic surgery, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Tartu University HospitalUniversity, hospital or other
- Collaborators
- North Estonia Medical Centre, Fertilitas (private clinic)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2036 (estimated)
- First posted
- 23 Mar 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.
A prospective multicenter randomized controlled trial to compare the outcomes of one-anastomosis gastric bypass to long biliary limb Roux gastric bypass.
We plan to enroll up to 500 patients from three different clinics in Estonia. Outcomes are excess weight loss %, impact on type 2 diabetes, hypertension, hyperlipidemia and obstructive sleep apnea.
Other outcomes are nutritional deficiencies, occurrence of reflux disease and impact on quality of life.
There are planned outpatient visits 1, 5 and 10 years after the surgery to measure the impacts.
There are a lot of studies comparing OAGB to standard Roux gastric bypass but non comparing it to long biliary limb gastric bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women | Active comparator | Procedure: One-anastomosis gastric bypass, Procedure: Long biliary limb Roux gastric bypass |
| Men | Active comparator | Procedure: One-anastomosis gastric bypass, Procedure: Long biliary limb Roux gastric bypass |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI over 35 and obesity related disease
- BMI over 40
- age between 18-60 years
- agrees to participate in the study
Key exclusion criteria (6 listed)
- age under 18 years or over 60 years
- abundant adhesions discovered during the surgery
- active upper gastrointestinal ulcer disease
- prior bariatric surgery
- active symptomatic reflux disease
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 |
|---|---|---|
| One-anastomosis gastric bypassOne group is planned to have one-anastomosis gastric bypass (also known as mini-bypass) | Procedure or surgery | Men, Women |
| Long biliary limb Roux gastric bypassOther group is planned to receive a long biliary limb Roux gastric bypass | Procedure or surgery | Men, Women |
Primary outcome
Excess weight loss %
Time frame: 10 years
Calculated loss of the excess weight
Impact on type 2 diabetes mellitus
Time frame: 10 years
Outcome of type 2 diabetes mellitus after the surgery, measured in change in HbA1c %
Impact on type 2 diabetes mellitus
Time frame: 10 years
Outcome of type 2 diabetes mellitus after the surgery, measured in usage of medication (same dosage, decreased dosage, insulin to peroral, ended all medication)
Impact on hypertensive disease
Time frame: 10 years
Outcome of hypertensive disease after the surgery; measured in antihypertensive drug usage (same, decrease, ended)
Impact on total cholesterol
Time frame: 10 years
Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol (mmol/L).
Impact on hyperlipidemia
Time frame: 10 years
Outcome of hyperlipidemias after the surgery, measured in change in levels of HDL (mmol/L)
Impact on hyperlipidemia
Time frame: 10 years
Outcome of hyperlipidemias after the surgery, measured in change in levels of LDL (mmol/L)
Impact on hyperlipidemia
Time frame: 10 years
Outcome of hyperlipidemias after the surgery, measured in change in levels of triglycerides (mmol/L)
Impact on hyperlipidemias
Time frame: 10 years
Outcome of hyperlipidemias after the surgery, measured in change in levels of total cholesterol, HDL,LDL and triglycerides
3 secondary outcomes
Nutritional deficiencies: anemia
Time frame: 10 years
Nutritional deficiencies
Time frame: 10 years
GERD
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-anastomosis gastric bypass and Long biliary limb Roux gastric bypass in people with Obesity, run by Tartu University Hospital at 1 site in Estonia.
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 4 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Mar 2021. 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 Estonia. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Excess weight loss % (time frame: 10 years). The study lists 9 primary outcomes in all. 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 23 Mar 2021.