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Laparoscopic-Roux-en-Y Gastric BypassBPG-1NCT05334173

Gastric Bypass With Different Lengths of the Bilipancreatic Limb

A study testing Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb in people with Laparoscopic-Roux-en-Y Gastric Bypass and Obesity, run by Hospital Universitario de Fuenlabrada at 3 sites in Spain.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) has been the most performed bariatric surgical intervention until a few years ago, due to its good results in terms of weight loss and remission of comorbidities such as hypertension, type 2 diabetes mellitus, dyslipidemia and obstructive sleep apnea syndrome. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
3 sitesSpain
Study dates
29 Jan 2019to 21 Sep 2026
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with BMI 35-40 kg/m2 with associated medical problems (Diabetes Mellitus, Hipertension, Dyslipidemia, Obstructive Sleep Apnea Syndrome) or 40-50 kg/m2 with or without associated medical problems, who comply with the regulatory rules for bariatric surgery in Spain (SECO and AEC)

Who cannot join

  • General contraindications to kind of surgery
  • BMI > 50 kg/m2
  • Known drug or alcohol abuse
  • ASA (American Society of Anesthesiology) physical status classification > III
  • Inability to follow the procedures of the study

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Juan José Arroyo Martín

    Denia, Alicante, 03700

  • Débora Acín Gándara

    Fuenlabrada, Madrid, 28942

  • Esther Mans Muntwyler

    Mataró, Barcelona, 08301

Other trials in Spain

About this study

Official title: Randomized Clinical Trial on the Outcome of Gastric Bypass With Biliopancreatic and Alimentary Limbs of 150 Centimeters (cm)/70 cm Versus(vs) 70/150 cm, Measuring the Length of the Common Limb

Laparoscopic Roux-en-Y Gastric Bypass (LRYGB) has been the most performed bariatric surgical intervention until a few years ago, due to its good results in terms of weight loss and remission of comorbidities such as hypertension, type 2 diabetes mellitus, dyslipidemia and obstructive sleep apnea syndrome. However, more than 25% of patients do not obtain the expected result.

There is no uniform technique to perform a LRYGB, but traditionally it was constructed using a long alimentary limb (AL) and a short biliopancreatic limb (BPL). There is no current consensus on the ideal length of the LRYGB limbs.

Read more

The distal gastric bypass at the expense of a longer biliopancreatic limb (LBPL-GB) could induce more excess of weight loss (EWL%), but with possible protein malnutrition depending on the length of the remaining common limb.

The aim of this study is compare a LBPL-GB (BPL 150cm, AL 70cm) with LAL-GB (BPL 70cm, AL 150cm).

PRIMARY OUTCOME: to evaluate if there are differences in weight loss. SECONDARY OUTCOME: to assess whether there are differences in both groups in remission of the most common comorbidities and in quality of life.

DESIGN: multicenter, prospective, randomized study in blocks (1:1), blinded for the patient and to the surgeon up to the time of intervention, in patients with indication of RYGB for obesity (BMI>35 with associated comorbidity or BMI>40 with or without comorbidity, excluding those of BMI>50). Intervention: LRYGB type 1 (LAL-GB: 150cm ALand 70cm BPL) or type 2 (LBPL-GB: 70cm AL and 150cm BPL).

The expected result is that the patients with LBPL-GB present better EWL%, and higher remission of their comorbidities than the comparison group

Being tested
Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb
Keywords
Diabetes Mellitus, Type 2, Hypertension, Dyslipidemia, Obstructive Sleep Apnea Syndrome, Quality of life, Nutritional deficit, Laparoscopic-Roux-en-Y-Gastric-Bypass, Biliopancreatic limb, Alimentary limb, Common limb
Medical subject headings
Obesity, Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Sleep Apnea Syndromes, Sleep Apnea, Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limbProcedure or surgery

    Also called Biliopancreatic and alimentary limbs of 150cm / 70cm, Biliopancreatic and alimentary limbs of 70cm / 150cm

    The patients are randomized to Type 1 laparoscopic RYGB (150cm alimentary limb and 70cm biliopancreatic limb) or type 2 laparoscopic RYGB (70cm alimentary limb and 150cm biliopancreatic limb). In both groups, the total intestinal length is measured to determine the size of the common limb. We introduce a 10 cm ruler into the abdominal cavity to measure the bowel and then extract it. LRYGB is made with linear stapler anastomosis.

Study groups in NCT05334173
Study groupRoleWhat they receive
RYGB TYPE 1 - LONGER ALIMENTARY LIMB (LAL-GB)Active comparator150 cm alimentary limb and 70 cm biliopancreatic limb
Receives: Procedure: Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb
RYGB TYPE 2 - LONGER BILIOPANCREATIC LIMB (LBPL-GB)Active comparator70 cm alimentary limb and 150 cm biliopancreatic limb
Receives: Procedure: Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Excess Weight Loss (%EWL)

    The Excess Weight Loss (%EWL) after surgery. (Preoperatory weight in kilograms - current weight in kilograms) / (preoperatory weight in kilograms) x 100

    Measured: From baseline to five years after surgery

Secondary outcomes (4)

  1. Remission or improvement of Type 2 Diabetes Mellitus

    Remission or improvement of Type 2 Diabetes Mellitus after surgery, according to the Criteria of American Diabetes Association, Spanish Obesity Surgery Society and Spanish Surgeon Association.

    Complete remission: HbA1c < 6% and normalization of fasting blood glucose (100 mg/dl) without medication during one year minimum. Partial remission: HbA1c 6-6.5% and fasting blood glucose between 100 and 125 mg/dl) without medication.

    Prolonged remission: at least 5 years of remission. Improvement HbA1c < 7%, with pharmacological treatment. ADA criteria (American Diabetes Association)

    Measured: From baseline to five years after surgery

  2. Remission or improvement of Hypertension

    Remission or improvement of Hypertension after surgery, according to the Criteria of the Spanish Obesity Surgery Society and Spanish Surgeon Association.

    Complete remission: blood pressure (BP) <120/80 without medication Partial remission: systolic BP 120-140 mmHg and diastolic BP 80-89 mmHg without medication.

    Measured: From baseline to five years after surgery

  3. Remission of improvement of Dyslipidemia

    Remission or improvement of Dyslipidemia after surgery, according to the Criteria of the Spanish Obesity Surgery Society and Spanish Surgeon Association.

    Low-density lipoprotein cholesterol (LDLc) < 100 mg/dl, Triglycerides (TG) < 150 mg/dl, total cholesterol < 200 mg/dl, High-density lipoprotein cholesterol (HDLc) > 60 mg/dl.

    Measured: From baseline to five years after surgery

  4. Remission or improvement of Obstructive Sleep Apnea Syndrome

    Remission or improvement of Obstructive Sleep Apnea Syndrome after surgery, according to the Criteria of the Spanish Obesity Surgery Society and Spanish Surgeon Association.

    Number of apneic-hypopneic episodes/hour, recorded by polysomnography.

    Measured: From baseline to five years after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2022
  2. Study start29 Jan 2019
  3. Primary completion11 Oct 2024 (estimated)
  4. Study completion21 Sep 2026 (estimated)

Resources

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
Randomized trial in blocks (1:1). Type 1 laparoscopic Gastric Bypass (150cm alimentary limb and 70cm biliopancreatic limb) or type 2 laparoscopic Gastric Bypass (70cm alimentary limb and 150cm biliopancreatic limb)
Masking
Single blind
Who is masked
Participant
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05334173
Sponsor's protocol ID
BPG-1
Acronym
BPG-1
Status last verified
Oct 2023
First submitted
19 Mar 2022
Last updated
17 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb in people with Laparoscopic-Roux-en-Y Gastric Bypass and Obesity, run by Hospital Universitario de Fuenlabrada at 3 sites in Spain.

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 1 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: status not confirmed, as of the sponsor's last update on 17 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. 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?

Results are not available in the source record.

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?

Excess Weight Loss (%EWL) (time frame: From baseline to five 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 NCT05334173.

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 17 Oct 2023.

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