Weight LossPhase 3NCT03607305
Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric Bypass
A Phase 3 study testing BP limb 70cm and BP limb 120cm in people with Weight Loss, run by Hospital General Universitario Elche.
Trial summary
Patients were randomly assigned into 2 groups: those patients undergoing RYGB with a BPL of 70cm and those ones undergoing RYGB with a BPL of 120 cm. Excess BMI loss 5 years after surgery was investigated Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weight Loss
- What is being tested?
- BP limb 70cm and BP limb 120cm
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 506 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Dec 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >40 Kg/m2
- BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
- Age older than 18 years
Who cannot join
- Patients undergoing other bariatric techniques than RYGB
- Patients undergoing RYGB with different BPL or AL lengths than that reported for this study
- Any other surgical procedure added to the bariatric surgery
- Impossibility to comply with pre-established clinical follow-up.
About this study
Official title: Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric
Patients were randomly assigned into 2 groups: those patients undergoing RYGB with a BPL of 70cm and those ones undergoing RYGB with a BPL of 120 cm.
Excess BMI loss 5 years after surgery was investigated
Read the detailed description
Patients were randomly assigned into 2 groups: those patients undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 70cm and those ones undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 120 cm. Alimentary limb was constant in both groups (150cm).
Excess BMI loss 5 years after surgery was investigated
- Conditions
- Weight Loss
- Being tested
- BP limb 70cm, BP limb 120cm
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BP limb 70cmProcedure or surgery
Performance of RYGB with a BP limb of 70cm
BP limb 120cmProcedure or surgery
Performance of RYGB with a BP limb of 120cm
| Study group | Role | What they receive |
|---|---|---|
| BP limb 70cm | Active comparator | Patients underwent a RYGB with a biliopancreatic limb of 70cm Receives: Procedure: BP limb 70cm |
| BP limb 120cm | Experimental | Patients underwent a RYGB with a biliopancreatic limb of 120cm Receives: Procedure: BP limb 120cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Weight loss was evaluated
Measured: 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 posted31 Jul 2018
- Study startJan 2011
- Primary completionDec 2012
- Study completionDec 2012
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
- 506 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
- Jaime Ruiz-Tovar, Principal investigator, HOSPITAL REY JUAN CARLOS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03607305
- Sponsor's protocol ID
- HGUE 2012-12
- Status last verified
- Jul 2018
- First submitted
- 23 Jul 2018
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruiz-Tovar J, Vorwald P, Gonzalez-Ramirez G, Posada M, Salcedo G, Llavero C, Garcia-Olmo D. Impact of Biliopancreatic Limb Length (70 cm vs 120 cm), with Constant 150 cm Alimentary Limb, on Long-Term Weight Loss, Remission of Comorbidities and Supplementation Needs After Roux-En-Y Gastric Bypass: a Prospective Randomized Clinical Trial. Obes Surg. 2019 Aug;29(8):2367-2372. doi: 10.1007/s11695-019-03717-7.
PubMed 31104282
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Biliopancreatic Limb Lenght on Long-term Weight Loss After Roux-en-Y Gastric
- ClinicalTrials.gov ID
- NCT03607305
- Acronym / sponsor ID
- HGUE 2012-12
- Conditions
- Weight Loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 506 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 31 Jul 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.
Patients were randomly assigned into 2 groups: those patients undergoing RYGB with a BPL of 70cm and those ones undergoing RYGB with a BPL of 120 cm.
Excess BMI loss 5 years after surgery was investigated
Detailed description
Patients were randomly assigned into 2 groups: those patients undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 70cm and those ones undergoing Roux-en-Y gastric bypass with a biliopancreatic limb of 120 cm. Alimentary limb was constant in both groups (150cm).
Excess BMI loss 5 years after surgery was investigated
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BP limb 70cm | Active comparator | Procedure: BP limb 70cmPatients underwent a RYGB with a biliopancreatic limb of 70cm |
| BP limb 120cm | Experimental | Procedure: BP limb 120cmPatients underwent a RYGB with a biliopancreatic limb of 120cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI >40 Kg/m2
- BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
- Age older than 18 years
Key exclusion criteria (4 listed)
- Patients undergoing other bariatric techniques than RYGB
- Patients undergoing RYGB with different BPL or AL lengths than that reported for this study
- Any other surgical procedure added to the bariatric surgery
- 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 |
|---|---|---|
| BP limb 70cmPerformance of RYGB with a BP limb of 70cm | Procedure or surgery | BP limb 70cm |
| BP limb 120cmPerformance of RYGB with a BP limb of 120cm | Procedure or surgery | BP limb 120cm |
Primary outcome
Weight loss
Time frame: 5 years after surgery
Weight loss was evaluated
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 31 Jul 2018.
- Derived from this study: PubMed 31104282Ruiz-Tovar J, Vorwald P, Gonzalez-Ramirez G, Posada M, Salcedo G, Llavero C, Garcia-Olmo D. Impact of Biliopancreatic Limb Length (70 cm vs 120 cm), with Constant 150 cm Alimentary Limb, on Long-Term Weight Loss, Remission of Comorbidities and Supplementation Needs After Roux-En-Y Gastric Bypass: a Prospective Randomized Clinical Trial. Obes Surg. 2019 Aug;29(8):2367-2372. doi: 10.1007/s11695-019-03717-7.
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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.
Jaime Ruiz-Tovar principal investigator
HOSPITAL REY JUAN CARLOS
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BP limb 70cm and BP limb 120cm 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 3 inclusion and 4 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 31 Jul 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: 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 NCT03607305, 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 31 Jul 2018.