Long-term Follow up After Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Versus One-Anastomosis Gastric Bypass: A Comparative Study of Weight Loss
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 600
- Primary Endpoint
- Weight loss
Study Overview
Brief Summary
A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing SG, those ones undergoing RYGB and those ones undergoing OAGB. BMI, excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.
Detailed Description
A prospective randomized clinical study of all morbidly obese patients undergoing SG, RYGB and OAGB, as primary bariatric procedures, was performed. Patients were randomly assigned into 3 groups: those patients undergoing Sleeve Gastrectomy, those ones undergoing Roux-en-Y Gastric Bypass and those ones undergoing One-Anastomosis Gastric Bypass. Body Mass Index (BMI), excess BMI loss (EBMIL) and remission of type 2 diabetes (T2DM), hypertension (HT) and dyslipidemia (DL) were assessed.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •body mass index (BMI) >40 Kg/m2
- •BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
- •age older than 18 years
- •Patients willing to participate in the study and giving their written consent
Exclusion Criteria
- •patients undergoing other bariatric techniques than SG, RYGB and OAGB
- •Patients undergoing any other surgical procedure added to the bariatric surgery
- •patients with medical or surgical pathologies that at the discretion of the investigators do not allow their participation in the study
- •inability to understand the nature and purpose of the study and / or to accept written participation in the study
- •impossibility to comply with pre-established clinical follow-up.
Outcomes
Primary Outcomes
Weight loss
Time Frame: 1 , 2 and 5 years after surgery
The postoperative weight loss is investigated at 1, 2 and 5 years after surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Jaime Ruiz-Tovar, MD, PhD
Head of Bariatric Surgery Unit. Hospital general Elche
Hospital General Universitario Elche