BPG-1: Gastric Bypass With Different Lengths of the Bilipancreatic Limb
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: RYGB TYPE 1 - LONGER ALIMENTARY LIMB (LAL-GB) 150 cm alimentary limb and 70 cm biliopancreatic limb |
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.
Other Names:
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| Active Comparator: RYGB TYPE 2 - LONGER BILIOPANCREATIC LIMB (LBPL-GB) 70 cm alimentary limb and 150 cm biliopancreatic limb |
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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- 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
- 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 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.
- 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 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.
Other Outcome Measures
- Quality of life after surgery [From baseline to five years after surgery]
Quality of life with the Bariatric Analysis and Reporting Outcome System (B.A.R.O.S) Scale. The score range is from 0 to 6 if the patient doesn´t have comorbidities. The result varies depending on the score. Failed=0, regular=0-1.5, good=1.5-3, very good=3-4.5, excellent=4.5-6. The score range is from 0 to 9 if the patient has some comorbidities. The result varies depending on the score. Failed=0-1, regular=1-3, good=3-5, very good=5-7, excellent=7-9. We will measure it a year and 5 years after surgery.
Eligibility Criteria
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:
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General contraindications to kind of surgery
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BMI > 50 kg/m2
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Known drug or alcohol abuse
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ASA (American Society of Anesthesiology) physical status classification > III
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Inability to follow the procedures of the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Juan José Arroyo Martín | Denia | Alicante | Spain | 03700 |
| 2 | Esther Mans Muntwyler | Mataró | Barcelona | Spain | 08301 |
| 3 | Débora Acín Gándara | Fuenlabrada | Madrid | Spain | 28942 |
Sponsors and Collaborators
- Hospital Universitario de Fuenlabrada
- Spanish Association of Surgeons (AEC)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BPG-1