Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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 (CRP, fibrinogen, leucocites), pain (VAS scale), postoperative septic complications .(anastomotic leak and organ/space SSI)and lenght of stay, among others will be investigated.

Official Title
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A Controlled, Randomized, Open Clinical Trial to Compare the Effect of Preoperatory Treatment With Immunonutrition vs Hyperproteic Nutritional Supplements on Postoperative Inflammation Markers in Patients Going Through Bariatric Surgery

Conditions
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Postoperative Complications

Intervention / Treatment
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* Dietary Supplement: Immunonutrition
* Dietary Supplement: Balanced high-protein formula


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing a laparoscopic gastric bypass (BPG) as a bariatric procedure Men and Women older than 18 years. Willing to participate in the study and giving their written consent Exclusion Criteria: Patients younger than 18 years. Patients undergoing other bariatric surgery techniques. Patients undergoing any other surgical procedure added to the bariatric technique. Patients with medical or surgical pathologies that at the discretion of the investigator 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immunonutrition<br>Patients receiving a preoperative balanced energy high-protein formula, enriched with Omega - 3 fatty acids (Immunonutrition formula) | Dietary Supplement: Immunonutrition<br>* Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively<br>|
| Active Comparator: Balanced high-protein formula<br>Patients receiving a preoperative balanced energy high-protein formula, without including Omega - 3 fatty acids | Dietary Supplement: Balanced high-protein formula<br>* Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |