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Gastric Bypass With Different Lengths of the Bilipancreatic Limb

NCT05334173 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2023-10-17

No results posted yet for this study

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

Interventions

PROCEDURE

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.

Sponsors & Collaborators

  • Spanish Association of Surgeons (AEC)

    collaborator OTHER

  • Hospital Universitario de Fuenlabrada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-29
Primary Completion
2024-10-11
Completion
2026-09-21

Countries

  • Spain

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05334173 on ClinicalTrials.gov