Long-term Follow up After SG vs RYGB vs OAGB

Study Overview
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Brief Summary
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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
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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.

Official Title
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Long-term Follow up After Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass Versus One-Anastomosis Gastric Bypass: A Comparative Study of Weight Loss

Conditions
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Weight Loss

Intervention / Treatment
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* Procedure: Sleeve Gastrectomy
* Procedure: Roux-en-Y gastric bypass
* Procedure: One-Anastomosis Gastric Bypass


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleeve Gastrectomy<br>Patients undergo a laparoscopic sleeve gastrectomy as bariatric procedure | Procedure: Sleeve Gastrectomy<br>* The patients undergo a Sleeve Gastrectomy as bariatric procedure<br>|
| Active Comparator: Roux-en-Y gastric bypass<br>Patients undergo a laparoscopic Roux-en-Y gastric bypass as bariatric procedure | Procedure: Roux-en-Y gastric bypass<br>* The patients undergo a Roux-en-Y gastric bypass as bariatric procedure<br>|
| Experimental: One-Anastomosis gastric bypass<br>Patients undergo a laparoscopic One-Anastomosis gastric bypass as bariatric procedure | Procedure: One-Anastomosis Gastric Bypass<br>* The patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | The postoperative weight loss is investigated at 1, 2 and 5 years after surgery | 1 , 2 and 5 years after surgery |