Gastric Bypass With Different Lengths of the Bilipancreatic Limb

Not Applicable

Active, not recruiting

• Conditions: Obesity; Sleep Apnea; Dyslipidemias; Laparoscopic-Roux-en-Y Gastric Bypass; Diabetes Mellitus, Type 2; Hypertension
• Interventions: Procedure: Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb

• Registration Number: NCT05334173
• Lead Sponsor: Hospital Universitario de Fuenlabrada

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-29
• Study First Submitted: 2022-03-19
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-16
• Last Update Posted: 2023-10-17
• Primary Completion: 2024-10-11
• Study Completion: 2026-09-21

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 94

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RYGB TYPE 1 - LONGER ALIMENTARY LIMB (LAL-GB)	Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb	150 cm alimentary limb and 70 cm biliopancreatic limb
RYGB TYPE 2 - LONGER BILIOPANCREATIC LIMB (LBPL-GB)	Roux-en-Y Gastric Bypass (RYGB) measuring the lengh of the common limb	70 cm alimentary limb and 150 cm biliopancreatic limb

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Remission or improvement of Type 2 Diabetes Mellitus	From baseline to five years after surgery	Remission or improvement of Type 2 Diabetes Mellitus after surgery, according to the Criteria of American Diabetes Association, Spanish Obesity Surgery Society and Spanish Surgeon Association.; Complete remission: HbA1c \< 6% and normalization of fasting blood glucose (100 mg/dl) without medication during one year minimum. Partial remission: HbA1c 6-6.5% and fasting blood glucose between 100 and 125 mg/dl) without medication.; Prolonged remission: at least 5 years of remission. Improvement HbA1c \< 7%, with pharmacological treatment. ADA criteria (American Diabetes Association)
Remission or improvement of Obstructive Sleep Apnea Syndrome	From baseline to five years after surgery	Remission or improvement of Obstructive Sleep Apnea Syndrome after surgery, according to the Criteria of the Spanish Obesity Surgery Society and Spanish Surgeon Association.; Number of apneic-hypopneic episodes/hour, recorded by polysomnography.
Remission of improvement of Dyslipidemia	From baseline to five years after surgery	Remission or improvement of Dyslipidemia after surgery, according to the Criteria of the Spanish Obesity Surgery Society and Spanish Surgeon Association.; Low-density lipoprotein cholesterol (LDLc) \< 100 mg/dl, Triglycerides (TG) \< 150 mg/dl, total cholesterol \< 200 mg/dl, High-density lipoprotein cholesterol (HDLc) \> 60 mg/dl.
Remission or improvement of Hypertension	From baseline to five years after surgery	Remission or improvement of Hypertension after surgery, according to the Criteria of the Spanish Obesity Surgery Society and Spanish Surgeon Association.; Complete remission: blood pressure (BP) \<120/80 without medication Partial remission: systolic BP 120-140 mmHg and diastolic BP 80-89 mmHg without medication.

Trial Locations

Locations (3)

Juan José Arroyo Martín; 🇪🇸 Denia, Alicante, Spain

Esther Mans Muntwyler; 🇪🇸 Mataró, Barcelona, Spain

Débora Acín Gándara; 🇪🇸 Fuenlabrada, Madrid, Spain