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NCT Number: NCT05334173

Gastric Bypass With Different Lengths of the Bilipancreatic 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.

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Laparoscopic-Roux-en-Y Gastric Bypass Apnea Body Weight Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Dyssomnias Endocrine System Diseases Glucose Metabolism Disorders Hypertension Lipid Metabolism Disorders Metabolic Diseases Nervous System Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Sleep Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Sleep Disorders, Intrinsic Sleep Wake Disorders Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Juan José Arroyo Martín, Denia, Alicante, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

  • 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

Treatment and study plan

Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb

Procedure

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.

Other names: Biliopancreatic and alimentary limbs of 150cm / 70cm, Biliopancreatic and alimentary limbs of 70cm / 150cm

Primary outcomes

  1. Excess Weight Loss (%EWL)

    Time frame: From baseline to five years after surgery

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

Secondary outcomes

  1. Remission or improvement of Type 2 Diabetes Mellitus

    Time frame: From baseline to five years after surgery

    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)

  2. Remission or improvement of Hypertension

    Time frame: From baseline to five years after surgery

    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.

  3. Remission of improvement of Dyslipidemia

    Time frame: From baseline to five years after surgery

    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.

  4. Remission or improvement of Obstructive Sleep Apnea Syndrome

    Time frame: From baseline to five years after surgery

    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.

Other outcomes

  1. Quality of life after surgery

    Time frame: From baseline to five years after surgery

    Quality of life with the Bariatric Analysis and Reporting Outcome System (B.A.R.O.S) Scale.

    The score range is from 0 to 6 if the patient doesn´t have comorbidities. The result varies depending on the score. Failed=0, regular=0-1.5, good=1.5-3, very good=3-4.5, excellent=4.5-6.

    The score range is from 0 to 9 if the patient has some comorbidities. The result varies depending on the score. Failed=0-1, regular=1-3, good=3-5, very good=5-7, excellent=7-9.

    We will measure it a year and 5 years after surgery.

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Fuenlabrada

Other

Collaborators

  • Spanish Association of Surgeons (AEC)

Registry information

Official study 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

Acronym: BPG-1

Important dates

Study start
2019
Primary completion
2024
Study completion
2026
First posted
Apr 19, 2022
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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