Bariatric SurgeryNCT04609449
A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass
A study testing Long biliopancreatic limb Roux-en-Y gastric bypass. and Standard Roux-en-Y gastric bypass in people with Bariatric Surgery and Metabolic Surgery, run by CARLOS ZERRWECK LOPEZ at 1 site in Mexico.
Trial summary
Prospective study including patients submitted to RYGB (n=94) and L-RYGB (n=94) at a single institution. The aim was to compare the effect on comorbidities and weight loss of a long biliopancreatic limb Roux-en-Y gastric bypass (L-RYGB), compared with a standard RYGB. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Bariatric Surgery, Metabolic Surgery, Roux-en-Y Gastric Bypass
- What is being tested?
- Long biliopancreatic limb Roux-en-Y gastric bypass. and Standard Roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2016to Dec 2018
- 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
- Patient submitted to bariatric surgery
- All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity
Who cannot join
- •Patients with incomplete surgery data sheet and those submitted to other type of bariatric surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass: Early Outcomes of a Prospective Study
Prospective study including patients submitted to RYGB (n=94) and L-RYGB (n=94) at a single institution. The aim was to compare the effect on comorbidities and weight loss of a long biliopancreatic limb Roux-en-Y gastric bypass (L-RYGB), compared with a standard RYGB. Procedure selection was randomly assigned (1:1), and surgeries were performed, during 24 months (2016-2017). Weight loss, comorbidities control and nutritional status were assessed at baseline and 12 months.
- Being tested
- Long biliopancreatic limb Roux-en-Y gastric bypass., Standard Roux-en-Y gastric bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long biliopancreatic limb Roux-en-Y gastric bypass.Procedure or surgery
Long biliopancreatic limb Roux-en-Y gastric bypass.
Standard Roux-en-Y gastric bypassProcedure or surgery
Standard Roux-en-Y gastric bypass
| Study group | Role | What they receive |
|---|---|---|
| Long biliopancreatic limb | Experimental | Patients submitted to long biliopancreatic limb Roux-en-Y gastric bypass. Receives: Procedure: Long biliopancreatic limb Roux-en-Y gastric bypass. |
| Standard biliopancreatic limb | Active comparator | Patients submitted to standard Roux-en-Y gastric bypass. Receives: Procedure: Standard Roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss
Measures: Weight in kilograms
Measured: 12 months
Weight loss
Measures: Body Mass Index
Measured: 12 months
Weight loss
Measures: Percent of excess weight loss
Measured: 12 months
Weight loss
Measures: Percent of total weight loss
Measured: 12 months
Secondary outcomes (6)
Complete Diabetes Remission Rate
Measures: No need for anti-diabetics while on glucose <100 mg/dl and HbA1c% <6
Measured: 12 months
Major early complications
Measure: Rate of re-operations and re-admissions
Measured: First 30 days
Major late complications
Measure: Rate of re-operations and re-admisions
Measured: 2-12 months
Nutritional status
Measure: serum albumin (gr/dL)
Measured: 12 months
Nutritional status
Measure: serum total proteins (gr/dL)
Measured: 12 months
Nutritional status
Measure: hemoglobin (g/dL)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2020
- Study startJan 2016
- Primary completionDec 2017
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- CARLOS ZERRWECK LOPEZ
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, CARLOS ZERRWECK LOPEZ, Hospital General Tlahuac
- Investigators
- Carlos Zerrweck, MD, Study director, Head of Department. The Obesity Clinic at Hospital General TlahuacAntonio Herrera, MD, Principal investigator, The Obesity Clinic at Hospital General Tlahuac
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04609449
- Sponsor's protocol ID
- CZL-030619
- Status last verified
- Nov 2020
- First submitted
- 15 Jun 2020
- Last updated
- 5 Nov 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Short vs. Long Biliopancreatic Limb Gastric Bypass: Early Outcomes of a Prospective Study
- ClinicalTrials.gov ID
- NCT04609449
- Acronym / sponsor ID
- CZL-030619
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- CARLOS ZERRWECK LOPEZOther government
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 30 Oct 2020 (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.
Prospective study including patients submitted to RYGB (n=94) and L-RYGB (n=94) at a single institution. The aim was to compare the effect on comorbidities and weight loss of a long biliopancreatic limb Roux-en-Y gastric bypass (L-RYGB), compared with a standard RYGB. Procedure selection was randomly assigned (1:1), and surgeries were performed, during 24 months (2016-2017). Weight loss, comorbidities control and nutritional status were assessed at baseline and 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Long biliopancreatic limb | Experimental | Procedure: Long biliopancreatic limb Roux-en-Y gastric bypass.Patients submitted to long biliopancreatic limb Roux-en-Y gastric bypass. |
| Standard biliopancreatic limb | Active comparator | Procedure: Standard Roux-en-Y gastric bypassPatients submitted to standard Roux-en-Y gastric bypass. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patient submitted to bariatric surgery
- All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity
Key exclusion criteria (1 listed)
- •Patients with incomplete surgery data sheet and those submitted to other type of bariatric surgery
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 |
|---|---|---|
| Long biliopancreatic limb Roux-en-Y gastric bypass.Long biliopancreatic limb Roux-en-Y gastric bypass. | Procedure or surgery | Long biliopancreatic limb |
| Standard Roux-en-Y gastric bypassStandard Roux-en-Y gastric bypass | Procedure or surgery | Standard biliopancreatic limb |
Primary outcome
Weight loss
Time frame: 12 months
Measures: Weight in kilograms
Weight loss
Time frame: 12 months
Measures: Body Mass Index
Weight loss
Time frame: 12 months
Measures: Percent of excess weight loss
Weight loss
Time frame: 12 months
Measures: Percent of total weight loss
6 secondary outcomes
Complete Diabetes Remission Rate
Time frame: 12 months
Major early complications
Time frame: First 30 days
Major late complications
Time frame: 2-12 months
Nutritional status
Time frame: 12 months
Nutritional status
Time frame: 12 months
Nutritional status
Time frame: 12 months
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 5 Nov 2020.
- 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.
Carlos Zerrweck, MD study director
Head of Department. The Obesity Clinic at Hospital General Tlahuac
Antonio Herrera, MD principal investigator
The Obesity Clinic at Hospital General Tlahuac
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Long biliopancreatic limb Roux-en-Y gastric bypass. and Standard Roux-en-Y gastric bypass in people with Bariatric Surgery and Metabolic Surgery, run by CARLOS ZERRWECK LOPEZ at 1 site in Mexico.
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 1 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 5 Nov 2020. 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 Mexico. 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 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: 12 months). The study lists 4 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 5 Nov 2020.