Long-term Follow up After SG vs RYGB vs OAGB

March 10, 2018 updated by: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

600

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 , 2 and 5 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital General Universitario Elche

Investigators

  • Study Director: Miguel Angel Carbajo, Centro de Tratamiento de la Obesidad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2010

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

December 1, 2017

Study Registration Dates

First Submitted

March 10, 2018

First Submitted That Met QC Criteria

March 10, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

March 16, 2018

Last Update Submitted That Met QC Criteria

March 10, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRJC-CTO18

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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