Gastric Bypass With Different Lengths of the Bilipancreatic Limb

Study acronym: BPG-1
StatusUnknown
PhaseNot applicable
Started

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.

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Oct 2023); last known: Active, Not Recruiting
  2. Notable Primary completion date: Mar 11, 2023 to Oct 11, 2024v2
  3. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
5,101 trials monitored
See 233 trials at risk
3,888 trials monitored
See 157 trials at risk
2,236 trials monitored
See 113 trials at risk
and 1 more disease
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 Details
NCT Number NCT05334173
Lead Sponsor Hospital Universitario de Fuenlabrada
Collaborators: Spanish Association of Surgeons (AEC)
Conditions
(from sponsor)
Laparoscopic-Roux-en-Y Gastric Bypass, Obesity, Diabetes Mellitus, Type 2, Hypertension, Dyslipidemias, Sleep Apnea
Related terms Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension, Obesity, Sleep Apnea Syndromes, Sleep Apnea, Obstructive
Enrollment 94 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov