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

Hospital Universitario de Fuenlabrada

Status: Active, not recruiting

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

Treatments: Procedure: Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb

Study type: Interventional

Funder types: Other

Identifiers

NCT05334173

BPG-1

Details and patient eligibility

About

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

Enrollment: 94 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

RYGB TYPE 1 - LONGER ALIMENTARY LIMB (LAL-GB)

Active Comparator group

Description:

150 cm alimentary limb and 70 cm biliopancreatic limb

Treatment:

Procedure: Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb

RYGB TYPE 2 - LONGER BILIOPANCREATIC LIMB (LBPL-GB)

Active Comparator group

Description:

70 cm alimentary limb and 150 cm biliopancreatic limb

Treatment:

Procedure: Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb