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NCT05334173 · ClinicalTrials.gov record · last posted 2023-10-17

Gastric Bypass With Different Lengths of the Bilipancreatic Limb

Study acronym: BPG-1
StatusActive, Not Recruiting
PhaseNot applicable
Started2019-01-29
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 17, 2023 (before its estimated October 11, 2024 completion). Its status may not reflect the trial's current state.
from the ClinicalTrials.gov record
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

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Trial Details
NCT Number NCT05334173
Lead Sponsor Hospital Universitario de Fuenlabrada
Collaborators: Spanish Association of Surgeons (AEC)
Conditions Laparoscopic-Roux-en-Y Gastric Bypass, Obesity, Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Sleep Apnea
Enrollment 94 participants
Start Date 2019-01-29
Primary Completion 2024-10-11 (estimated)
Study Completion 2026-09-21 (estimated)
Updated on ClinicalTrials.gov 2023-10-17