Weight LossPhase 3NCT03467646
Long-term Follow up After SG vs RYGB vs OAGB
A Phase 3 study testing Sleeve Gastrectomy, Roux-en-Y gastric bypass and One-Anastomosis Gastric Bypass in people with Weight Loss, run by Hospital General Universitario Elche.
Trial summary
A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones undergoing OAGB. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Weight Loss
- What is being tested?
- Sleeve Gastrectomy, Roux-en-Y gastric bypass and One-Anastomosis Gastric Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- Jun 2010to Dec 2017
- Phase
- Phase 3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- body mass index (BMI) >40 Kg/m2
- BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
- age older than 18 years
- Patients willing to participate in the study and giving their written consent
Who cannot join
- patients undergoing other bariatric techniques than SG, RYGB and OAGB
- Patients undergoing any other surgical procedure added to the bariatric surgery
- patients with medical or surgical pathologies that at the discretion of the investigators do not allow their participation in the study
- inability to understand the nature and purpose of the study and / or to accept written participation in the study
- impossibility to comply with pre-established clinical follow-up.
About this study
Official title: Long-term Follow up After Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Versus One-Anastomosis Gastric Bypass: A Comparative Study of Weight Loss
A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.
Read the detailed description
A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing Sleeve Gastrectomy, those ones undergoing Roux-en-Y Gastric Bypass and those ones undergoing One-Anastomosis Gastric Bypass. Body Mass Index (BMI), excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.
- Conditions
- Weight Loss
- Being tested
- Sleeve Gastrectomy, Roux-en-Y gastric bypass, One-Anastomosis Gastric Bypass
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve GastrectomyProcedure or surgery
The patients undergo a Sleeve Gastrectomy as bariatric procedure
Roux-en-Y gastric bypassProcedure or surgery
The patients undergo a Roux-en-Y gastric bypass as bariatric procedure
One-Anastomosis Gastric BypassProcedure or surgery
The patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure
| Study group | Role | What they receive |
|---|---|---|
| Sleeve Gastrectomy | Active comparator | Patients undergo a laparoscopic sleeve gastrectomy as bariatric procedure Receives: Procedure: Sleeve Gastrectomy |
| Roux-en-Y gastric bypass | Active comparator | Patients undergo a laparoscopic Roux-en-Y gastric bypass as bariatric procedure Receives: Procedure: Roux-en-Y gastric bypass |
| One-Anastomosis gastric bypass | Experimental | Patients undergo a laparoscopic One-Anastomosis gastric bypass as bariatric procedure Receives: Procedure: One-Anastomosis Gastric Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
The postoperative weight loss is investigated at 1, 2 and 5 years after surgery
Measured: 1 , 2 and 5 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study startJun 2010
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Miguel Angel Carbajo, Study director, Centro de Tratamiento de la Obesidad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467646
- Sponsor's protocol ID
- HRJC-CTO18
- Status last verified
- Mar 2018
- First submitted
- 10 Mar 2018
- Last updated
- 16 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruiz-Tovar J, Carbajo MA, Jimenez JM, Castro MJ, Gonzalez G, Ortiz-de-Solorzano J, Zubiaga L. Long-term follow-up after sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass: a prospective randomized comparative study of weight loss and remission of comorbidities. Surg Endosc. 2019 Feb;33(2):401-410. doi: 10.1007/s00464-018-6307-9. Epub 2018 Jun 25.
PubMed 29943058
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Follow up After Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Versus One-Anastomosis Gastric Bypass: A Comparative Study of Weight Loss
- ClinicalTrials.gov ID
- NCT03467646
- Acronym / sponsor ID
- HRJC-CTO18
- Conditions
- Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 600 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 16 Mar 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.
A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.
Detailed description
A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing Sleeve Gastrectomy, those ones undergoing Roux-en-Y Gastric Bypass and those ones undergoing One-Anastomosis Gastric Bypass. Body Mass Index (BMI), excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sleeve Gastrectomy | Active comparator | Procedure: Sleeve GastrectomyPatients undergo a laparoscopic sleeve gastrectomy as bariatric procedure |
| Roux-en-Y gastric bypass | Active comparator | Procedure: Roux-en-Y gastric bypassPatients undergo a laparoscopic Roux-en-Y gastric bypass as bariatric procedure |
| One-Anastomosis gastric bypass | Experimental | Procedure: One-Anastomosis Gastric BypassPatients undergo a laparoscopic One-Anastomosis gastric bypass as bariatric procedure |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- body mass index (BMI) >40 Kg/m2
- BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
- age older than 18 years
- Patients willing to participate in the study and giving their written consent
Key exclusion criteria (5 listed)
- patients undergoing other bariatric techniques than SG, RYGB and OAGB
- Patients undergoing any other surgical procedure added to the bariatric surgery
- patients with medical or surgical pathologies that at the discretion of the investigators do not allow their participation in the study
- inability to understand the nature and purpose of the study and / or to accept written participation in the study
- impossibility to comply with pre-established clinical follow-up.
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 |
|---|---|---|
| Sleeve GastrectomyThe patients undergo a Sleeve Gastrectomy as bariatric procedure | Procedure or surgery | Sleeve Gastrectomy |
| Roux-en-Y gastric bypassThe patients undergo a Roux-en-Y gastric bypass as bariatric procedure | Procedure or surgery | Roux-en-Y gastric bypass |
| One-Anastomosis Gastric BypassThe patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure | Procedure or surgery | One-Anastomosis gastric bypass |
Primary outcome
Weight loss
Time frame: 1 , 2 and 5 years after surgery
The postoperative weight loss is investigated at 1, 2 and 5 years after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2018.
- Derived from this study: PubMed 29943058Ruiz-Tovar J, Carbajo MA, Jimenez JM, Castro MJ, Gonzalez G, Ortiz-de-Solorzano J, Zubiaga L. Long-term follow-up after sleeve gastrectomy versus Roux-en-Y gastric bypass versus one-anastomosis gastric bypass: a prospective randomized comparative study of weight loss and remission of comorbidities. Surg Endosc. 2019 Feb;33(2):401-410. doi: 10.1007/s00464-018-6307-9. Epub 2018 Jun 25.
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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.
Miguel Angel Carbajo study director
Centro de Tratamiento de la Obesidad
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Sleeve Gastrectomy, Roux-en-Y gastric bypass and One-Anastomosis Gastric Bypass in people with Weight Loss, run by Hospital General Universitario Elche.
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 5 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: finished, as of the sponsor's last update on 16 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Weight loss (time frame: 1 , 2 and 5 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03467646, which also lists 1 linked publication.
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 16 Mar 2018.