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

Study Overview
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Brief Summary
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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.

Conditions
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Obesity, Fatty Liver

Intervention / Treatment
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* Device: Transient hepatic elastography


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sleeve Gastrectomy<br>Patients undergoing the sleeve gastrectomy surgery | Device: Transient hepatic elastography<br> <br> |
| Active Comparator: Gastric Bypass<br>Patients undergoing the gastric bypass surgery | Device: Transient hepatic elastography<br> <br> |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transversal study comparing comorbidities and transient hepatic elastography | Tha aim is to find some relationship | Participants will be submitted a correlation with comorbidities | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatrics, transient elastography