Bariatric Surgery, Metabolic Surgery, Roux-en-Y Gastric Bypass
Conditions
Brief summary
Prospective study including patients submitted to RYGB (n=94) and L-RYGB (n=94) at a single institution. The aim was to compare the effect on comorbidities and weight loss of a long biliopancreatic limb Roux-en-Y gastric bypass (L-RYGB), compared with a standard RYGB. Procedure selection was randomly assigned (1:1), and surgeries were performed, during 24 months (2016-2017). Weight loss, comorbidities control and nutritional status were assessed at baseline and 12 months.
Interventions
PROCEDURELong biliopancreatic limb Roux-en-Y gastric bypass.
Long biliopancreatic limb Roux-en-Y gastric bypass.
PROCEDUREStandard Roux-en-Y gastric bypass
Standard Roux-en-Y gastric bypass
Sponsors
CARLOS ZERRWECK LOPEZ
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Patient submitted to bariatric surgery * All patients met the guidelines defined by the National Institutes of Health (NIH) consensus: BMI equal or greater to 40kg/m2 or BMI 35 - 40 kg/m2 with some comorbidity
Exclusion criteria
•Patients with incomplete surgery data sheet and those submitted to other type of bariatric surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Weight loss | 12 months | Measures: Weight in kilograms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Diabetes Remission Rate | 12 months | Measures: No need for anti-diabetics while on glucose \<100 mg/dl and HbA1c% \<6 |
| Major early complications | First 30 days | Measure: Rate of re-operations and re-admissions |
| Major late complications | 2-12 months | Measure: Rate of re-operations and re-admisions |
| Nutritional status | 12 months | Measure: serum albumin (gr/dL) |
Countries
Mexico
Outcome results
None listed