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OpenTrials
Completed

NCT Number: NCT03467646

Long-term Follow up After SG vs RYGB vs OAGB

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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Key information

Conditions

Weight Loss Body Weight Body Weight Changes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sleeve gastrectomy

Procedure

The patients undergo a Sleeve Gastrectomy as bariatric procedure

Roux-en-Y gastric bypass

Procedure

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

One-Anastomosis Gastric Bypass

Procedure

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Hospital General Universitario Elche

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2017
Study completion
2017
First posted
Mar 16, 2018
Registry last updated
Mar 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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