Clinical trial

Gastric Bypass With Different Lengths of the Bilipancreatic Limb

Active, not recruiting · Not applicable · 1 countries · Registry ID NCT05334173

Active, not recruitingNot applicableInterventional

What this study is 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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

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

Full registry 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

Treatments and study arms

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

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.

Primary outcomes

Excess Weight Loss (%EWL)From baseline to five years after surgery

The Excess Weight Loss (%EWL) after surgery. (Preoperatory weight in kilograms - current weight in kilograms) / (preoperatory weight in kilograms) x 100

Study locations

3 locations were listed when this page was built. The first 40 are shown.

Juan José Arroyo Martín🇪🇸 Denia, Alicante, Spain

Open map

Débora Acín Gándara🇪🇸 Fuenlabrada, Madrid, Spain

Open map

Esther Mans Muntwyler🇪🇸 Mataró, Barcelona, Spain

Open map