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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sleeve Gastrectomy | Active Comparator | Patients undergoing the sleeve gastrectomy surgery |
|
| Gastric Bypass | Active Comparator | Patients undergoing the gastric bypass surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transient hepatic elastography | Device |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Prevalence of advanced fibrosis in assyntomatic obese patients | Tha aim is identified patients with advanced disease | Fibrosis will be assessed by transient hepatic elastography in the pre-operative period |
Inclusion Criteria:
The eligibility criteria was:
Exclusion Criteria:
The exclusion criteria were:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fluminense Federal University | Niterói | Rio de Janeiro | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26803754 | Derived | de Barros F, Setubal S, Martinho JM, Leite NC, Guarana T, Monteiro ABS, Villela-Nogueira CA. The Correlation Between Obesity-Related Diseases and Non-alcoholic Fatty Liver Disease in Women in the Pre-operative Evaluation for Bariatric Surgery Assessed by Transient Hepatic Elastography. Obes Surg. 2016 Sep;26(9):2089-2097. doi: 10.1007/s11695-016-2054-y. | |
| 25919069 |
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| de Barros F, Setubal S, Martinho JM, Monteiro AB. Early Endocrine and Metabolic Changes After Bariatric Surgery in Grade III Morbidly Obese Patients: A Randomized Clinical Trial Comparing Sleeve Gastrectomy and Gastric Bypass. Metab Syndr Relat Disord. 2015 Aug;13(6):264-71. doi: 10.1089/met.2014.0152. Epub 2015 Apr 28. |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D005234 | Fatty Liver |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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