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NCT03467646 Clinical Trial

Long-term Follow up After SG vs RYGB vs OAGB

Weight Loss Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03467646
Other study ID # HRJC-CTO18
Secondary ID
Status Completed
Phase Phase 3
First received March 10, 2018
Last updated March 10, 2018
Start date June 2010
Est. completion date December 2017

Study information
Verified date March 2018
Source Hospital General Universitario Elche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 600
Est. completion date December 2017
Est. primary completion date December 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Procedure:
• Sleeve Gastrectomy
The patients undergo a Sleeve Gastrectomy as bariatric procedure
• Roux-en-Y gastric bypass
The patients undergo a Roux-en-Y gastric bypass as bariatric procedure
• One-Anastomosis Gastric Bypass
The patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital General Universitario Elche

Outcome
Type Measure Description Time frame Safety issue
Primary Weight loss The postoperative weight loss is investigated at 1, 2 and 5 years after surgery 1 , 2 and 5 years after surgery
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