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

• ClinicalTrials.gov Identifier: NCT05334173
• Recruitment Status: Active, not recruiting
• First Posted: April 19, 2022
• Last Update Posted: October 17, 2023
• Sponsor: Hospital Universitario de Fuenlabrada
• Collaborator: Spanish Association of Surgeons (AEC)
• Information provided by (Responsible Party): Débora Acín, Hospital Universitario de Fuenlabrada

Tracking Information

• First Submitted Date: March 19, 2022
• First Posted Date: April 19, 2022
• Last Update Posted Date: October 17, 2023
• Actual Study Start Date: January 29, 2019
• Estimated Primary Completion Date: October 11, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 18, 2022)

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 18, 2022)

• 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)
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: April 18, 2022)

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.

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: Gastric Bypass With Different Lengths of the Bilipancreatic Limb
• 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

Brief 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. 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

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Masking Description:

Blinded for the patient and to the surgeon up to the time of intervention

Primary Purpose: Treatment

Condition

• Laparoscopic-Roux-en-Y Gastric Bypass
• Obesity
• Diabetes Mellitus, Type 2
• Hypertension
• Dyslipidemias
• Sleep Apnea

Intervention

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

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: April 18, 2022): 94
• Original Actual Enrollment: Same as current
• Estimated Study Completion Date: September 21, 2026
• Estimated Primary Completion Date: October 11, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Spain

Administrative Information

• NCT Number: NCT05334173
• Other Study ID Numbers: BPG-1
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Débora Acín, Hospital Universitario de Fuenlabrada
• Original Responsible Party: Same as current
• Current Study Sponsor: Hospital Universitario de Fuenlabrada
• Original Study Sponsor: Same as current
• Collaborators: Spanish Association of Surgeons (AEC)
• Investigators: Not Provided
• PRS Account: Hospital Universitario de Fuenlabrada
• Verification Date: October 2023