Gastric Bypass With Different Lengths of the Bilipancreatic Limb

NCT ID: NCT05334173

Last Updated: 2023-10-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2026-09-21

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

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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

150 cm alimentary limb and 70 cm biliopancreatic limb

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

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

70 cm alimentary limb and 150 cm biliopancreatic limb

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Other Intervention Names

Biliopancreatic and alimentary limbs of 150cm / 70cm; Biliopancreatic and alimentary limbs of 70cm / 150cm

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Spanish Association of Surgeons (AEC)

OTHER

Sponsor Role: collaborator

Hospital Universitario de Fuenlabrada

OTHER

Sponsor Role: lead

Responsible Party

Débora Acín

MD, PhD, Bariatric Surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Juan José Arroyo Martín

Denia, Alicante, Spain

Esther Mans Muntwyler

Mataró, Barcelona, Spain

Débora Acín Gándara

Fuenlabrada, Madrid, Spain

Countries

Spain

Other Identifiers

BPG-1

Identifier Type: -

Identifier Source: org_study_id