Long-term Follow up After SG vs RYGB vs OAGB

Phase 3

Completed

• Conditions: Weight Loss
• Interventions: Procedure: Sleeve Gastrectomy; Procedure: Roux-en-Y gastric bypass; Procedure: One-Anastomosis Gastric Bypass

• Registration Number: NCT03467646
• Lead Sponsor: Hospital General Universitario Elche

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 Timeline

• Study Start: 2010-06
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Status Verified: 2018-03
• Study First Submitted: 2018-03-10
• Study First Submitted QC: 2018-03-10
• Last Update Submitted: 2018-03-10
• Study First Posted: 2018-03-16
• Last Update Posted: 2018-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 600

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleeve Gastrectomy	Sleeve Gastrectomy	Patients undergo a laparoscopic sleeve gastrectomy as bariatric procedure
Roux-en-Y gastric bypass	Roux-en-Y gastric bypass	Patients undergo a laparoscopic Roux-en-Y gastric bypass as bariatric procedure
One-Anastomosis gastric bypass	One-Anastomosis Gastric Bypass	Patients undergo a laparoscopic One-Anastomosis gastric bypass as bariatric procedure

Primary Outcome Measures

Name	Time	Method
Weight loss	1 , 2 and 5 years after surgery	The postoperative weight loss is investigated at 1, 2 and 5 years after surgery