Long-term Follow up After SG vs RYGB vs OAGB

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2017-12-31

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.

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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.

Conditions

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Weight Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Sleeve Gastrectomy

Patients undergo a laparoscopic sleeve gastrectomy as bariatric procedure

Group Type ACTIVE_COMPARATOR

Sleeve Gastrectomy

Intervention Type PROCEDURE

The patients undergo a Sleeve Gastrectomy as bariatric procedure

Roux-en-Y gastric bypass

Patients undergo a laparoscopic Roux-en-Y gastric bypass as bariatric procedure

Group Type ACTIVE_COMPARATOR

Roux-en-Y gastric bypass

Intervention Type PROCEDURE

The patients undergo a Roux-en-Y gastric bypass as bariatric procedure

One-Anastomosis gastric bypass

Patients undergo a laparoscopic One-Anastomosis gastric bypass as bariatric procedure

Group Type EXPERIMENTAL

One-Anastomosis Gastric Bypass

Intervention Type PROCEDURE

The patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure

Interventions

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Sleeve Gastrectomy

The patients undergo a Sleeve Gastrectomy as bariatric procedure

Intervention Type PROCEDURE

Roux-en-Y gastric bypass

The patients undergo a Roux-en-Y gastric bypass as bariatric procedure

Intervention Type PROCEDURE

One-Anastomosis Gastric Bypass

The patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure

Intervention Type PROCEDURE

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No