Diabetes Mellitus, Type 2, Dyslipidemias, Hypertension, Laparoscopic-Roux-en-Y Gastric Bypass, Obesity, Sleep Apnea
Conditions
Keywords
Diabetes Mellitus, Type 2, Hypertension, Dyslipidemia, Obstructive Sleep Apnea Syndrome, Quality of life, Nutritional deficit, Laparoscopic-Roux-en-Y-Gastric-Bypass, Biliopancreatic limb, Alimentary limb, Common limb
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
Interventions
PROCEDURERoux-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
Spanish Association of Surgeons (AEC)
Hospital Universitario de Fuenlabrada
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Blinded for the patient and to the surgeon up to the time of intervention
Intervention model description
Randomized trial in blocks (1:1). Type 1 laparoscopic Gastric Bypass (150cm alimentary limb and 70cm biliopancreatic limb) or type 2 laparoscopic Gastric Bypass (70cm alimentary limb and 150cm biliopancreatic limb)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Outcome results
None listed