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| Name | Class |
|---|---|
| Hospital Universitario Rey Juan Carlos | OTHER |
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A prospective randomized clinical trial of all the patients undergoing Roux - en-Y gastric bypass will be performed. Patients will be randomly assigned into 2 groups: those patients receiving a preoperative balanced energy high-protein formula (group 1) and those receiving preoperative Immunonutrition (group 2). Changes between groups in acute inflamatory markers, pain, postoperative septic complications and lenght of stay, among others will be investigated.
A prospective randomized clinical trial of all the patients undergoing Roux - en-Y gastric bypass will be performed. Patients will be randomly assigned into 2 groups: those patients receiving a preoperative balanced energy high-protein formula (group 1) and those receiving preoperative Immunonutrition (group 2). Changes between groups in acute inflamatory markers (CRP, fibrinogen, leucocites), pain (VAS scale), postoperative septic complications .(anastomotic leak and organ/space SSI)and lenght of stay, among others will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunonutrition | Experimental | Patients receiving a preoperative balanced energy high-protein formula, enriched with Omega - 3 fatty acids (Immunonutrition formula) |
|
| Balanced high-protein formula | Active Comparator | Patients receiving a preoperative balanced energy high-protein formula, without including Omega - 3 fatty acids |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunonutrition | Dietary Supplement | Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in systemic inflamatory response in terms of CRP | Proportion of patients with at least a 50% decrease in CRP 24 after surgery | 24h after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Decrease in systemic inflamatory response in terms of other inflamatory biomarkers | Mean decrease in leukocite count, fibrinogen | 24 hours after surgery |
| Postoperative pain | Mean VAS score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaime Ruiz-Tovar | Fundacion Jimenez Diaz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fundacion Jimenez Diaz | Madrid | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30097364 | Derived | Ruiz-Tovar J, Blanca M, Garcia A, Gonzalez J, Gutierrez S, Paniagua A, Prieto MJ, Ramallo L, Llanos L, Duran M. Preoperative administration of Omega-3 fatty acids on postoperative pain and acute-phase reactants in patients undergoing Roux-en-Y gastric bypass: A randomized clinical trial. Clin Nutr. 2019 Aug;38(4):1588-1593. doi: 10.1016/j.clnu.2018.07.026. Epub 2018 Jul 29. |
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| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000093702 | Immunonutrition Diet |
| ID | Term |
|---|---|
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Balanced high-protein formula | Dietary Supplement | Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively |
|
| 24h after surgery |
| Complications | Rate of complications | 30 days after surgery |
| In-hospital stay | In-hospital stay | 30 days after surgery |
| Number of readmissions | Number of readmissions | 30 days after surgery |
| Adverse Events Ocurrence | AE rate | 30 days after surgery |