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
1 other identifier
interventional
94
1 country
3
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 29, 2019
CompletedFirst Submitted
Initial submission to the registry
March 19, 2022
CompletedFirst Posted
Study publicly available on registry
April 19, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 11, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
September 21, 2026
ExpectedOctober 17, 2023
October 1, 2023
5.7 years
March 19, 2022
October 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (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
From baseline to five years after surgery
Secondary Outcomes (4)
Remission or improvement of Type 2 Diabetes Mellitus
From baseline to five years after surgery
Remission or improvement of Hypertension
From baseline to five years after surgery
Remission of improvement of Dyslipidemia
From baseline to five years after surgery
Remission or improvement of Obstructive Sleep Apnea Syndrome
From baseline to five years after surgery
Other Outcomes (1)
Quality of life after surgery
From baseline to five years after surgery
Study Arms (2)
RYGB TYPE 1 - LONGER ALIMENTARY LIMB (LAL-GB)
ACTIVE COMPARATOR150 cm alimentary limb and 70 cm biliopancreatic limb
RYGB TYPE 2 - LONGER BILIOPANCREATIC LIMB (LBPL-GB)
ACTIVE COMPARATOR70 cm alimentary limb and 150 cm biliopancreatic limb
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Juan José Arroyo Martín
Denia, Alicante, 03700, Spain
Esther Mans Muntwyler
Mataró, Barcelona, 08301, Spain
Débora Acín Gándara
Fuenlabrada, Madrid, 28942, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Blinded for the patient and to the surgeon up to the time of intervention
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, PhD, Bariatric Surgeon
Study Record Dates
First Submitted
March 19, 2022
First Posted
April 19, 2022
Study Start
January 29, 2019
Primary Completion
October 11, 2024
Study Completion (Estimated)
September 21, 2026
Last Updated
October 17, 2023
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share