Gastric Bypass With Different Lengths of the Bilipancreatic Limb (BPG-1)

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.

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Obesity; Diabetes Mellitus, Type 2; Dyslipidemias; Sleep Apnea; Laparoscopic-Roux-en-Y Gastric Bypass
• Intervention / Treatment: Procedure: Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Alicante
    • Denia, Alicante, Spain, 03700
      • Juan José Arroyo Martín
  • Barcelona
    • Mataró, Barcelona, Spain, 08301
      • Esther Mans Muntwyler
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Débora Acín Gándara

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: RYGB TYPE 1 - LONGER ALIMENTARY LIMB (LAL-GB); 150 cm alimentary limb and 70 cm biliopancreatic limb	Procedure: Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb; 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
Active Comparator: RYGB TYPE 2 - LONGER BILIOPANCREATIC LIMB (LBPL-GB); 70 cm alimentary limb and 150 cm biliopancreatic limb	Procedure: Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From baseline to five years after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From baseline to five years after surgery
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.	From baseline to five years after surgery
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.	From baseline to five years after surgery
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.	From baseline to five years after surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life 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.	From baseline to five years after surgery

Collaborators and Investigators

• Sponsor: Hospital Universitario de Fuenlabrada
• Collaborators: Spanish Association of Surgeons (AEC)

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2019
• Primary Completion (Estimated): October 11, 2024
• Study Completion (Estimated): September 21, 2026

Study Registration Dates

• First Submitted: March 19, 2022
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (Actual): April 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 17, 2023
• Last Update Submitted That Met QC Criteria: October 16, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Dyslipidemia; Hypertension; Quality of life; Diabetes Mellitus, Type 2; Obstructive Sleep Apnea Syndrome; Biliopancreatic limb; Nutritional deficit; Laparoscopic-Roux-en-Y-Gastric-Bypass; Alimentary limb; Common limb
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Respiratory Tract Diseases; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Endocrine System Diseases; Lipid Metabolism Disorders; Sleep Apnea Syndromes; Hypertension; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dyslipidemias
• Other Study ID Numbers: BPG-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No