Long-term Follow up After SG vs RYGB vs OAGB

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Weight Loss

Treatments: Procedure: One-Anastomosis Gastric Bypass; Procedure: Sleeve Gastrectomy; Procedure: Roux-en-Y gastric bypass

Study type: Interventional

Funder types: Other

Identifiers

NCT03467646

HRJC-CTO18

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 3 patient groups

Sleeve Gastrectomy

Active Comparator group

Description:

Patients undergo a laparoscopic sleeve gastrectomy as bariatric procedure

Treatment:

Procedure: Sleeve Gastrectomy

Roux-en-Y gastric bypass

Active Comparator group

Description:

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

Treatment:

Procedure: Roux-en-Y gastric bypass

One-Anastomosis gastric bypass

Experimental group

Description:

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

Treatment:

Procedure: One-Anastomosis Gastric Bypass