Impact of Bariatric Surgery on the Evolution of Nonalcoholic Fatty Liver Disease: a Comparative Clinical Trial Between Sleeve Gastrectomy and Gastric Bypass

Phase 1

Completed

• Conditions: Obesity; Fatty Liver
• Interventions: Device: Transient hepatic elastography

• Registration Number: NCT02394353
• Lead Sponsor: Ministry of Health, Brazil

Brief Summary

Aim: To compare prospectively two bariatric surgery techniques: sleeve gastrectomy (SG) vs gastric bypass (GB) in the evolution of nonalcoholic fatty liver disease (NAFLD) measured by the transient elastography in the first year. Methods: This is a randomized clinical trial with morbidly obese patients, between 18-60 years old from a Federal Hospital, Ministry of Health, Brazil. Patients were divided into 2 groups: group 1 - SG (n = 30) and group 2 - GB (n = 30). The randomization was made by lots. In the GB the investigators created 30 ml pouch, with a pancreatic and an alimentary limb of 1 meter, and a calibrated gastroenterostomy (1.5 cm diameter). In SG the investigators calibrated the gastric tube with a bougie number 32 (70 ml). The variables were compared one week before surgery and in the postoperative time (1, 3, 6 and 12 months). The variables were: patient anthropometry, laboratory tests and the transient liver elastography.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01
• Study First Submitted: 2015-03-04
• Study First Submitted QC: 2015-03-16
• Study First Posted: 2015-03-20
• Primary Completion: 2015-05
• Study Completion: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-03
• Last Update Posted: 2016-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

The eligibility criteria was:

• morbid obesity patient grade II or grade III (BMI > 35) in prepare to bariatric surgery.

Exclusion Criteria

The exclusion criteria were:

• age under 18 years or greater than 65 years old,
• chronic diseases (heart failure, chronic liver disease), and
• alcohol abuse (abuse was considered in those who consume more than 14 drinks per week).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleeve Gastrectomy	Transient hepatic elastography	Patients undergoing the sleeve gastrectomy surgery
Gastric Bypass	Transient hepatic elastography	Patients undergoing the gastric bypass surgery

Primary Outcome Measures

Name	Time	Method
Measure of fatty liver disease by transient hepatic elastography	Participants will be followed an average of 3 months	Tha aim is to compare the evolution of the fatty liver disease between the sleeve gastrectomy and gastric bypass

Secondary Outcome Measures

Name	Time	Method
Transversal study comparing comorbidities and transient hepatic elastography	Participants will be submitted a correlation with comorbidities	Tha aim is to find some relationship

Trial Locations

Locations (1)

Fluminense Federal University; 🇧🇷 Niteroi, Rio de Janeiro, Brazil