Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Postoperative Complications

Interventions

ImmunonutritionDIETARY_SUPPLEMENT

Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively

Balanced high-protein formulaDIETARY_SUPPLEMENT

Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients undergoing a laparoscopic gastric bypass (BPG) as a bariatric procedure 2. Men and Women older than 18 years. 3. Willing to participate in the study and giving their written consent Exclusion Criteria: 1. Patients younger than 18 years. 2. Patients undergoing other bariatric surgery techniques. 3. Patients undergoing any other surgical procedure added to the bariatric technique. 4. Patients with medical or surgical pathologies that at the discretion of the investigator do not allow their participation in the study. 5. Inability to understand the nature and purpose of the study and / or to accept written participation in the study. 6. Impossibility to comply with pre-established clinical follow-up.

Locations (1)

Fundacion Jimenez Diaz

Madrid, Spain

Outcomes

Primary Outcomes

Decrease in systemic inflamatory response in terms of CRP

Proportion of patients with at least a 50% decrease in CRP 24 after surgery

Time frame: 24h after surgery

Secondary Outcomes

Decrease in systemic inflamatory response in terms of other inflamatory biomarkers

Mean decrease in leukocite count, fibrinogen

Time frame: 24 hours after surgery

Postoperative pain

Mean VAS score

Time frame: 24h after surgery

Complications

Rate of complications

Time frame: 30 days after surgery

In-hospital stay

Time frame: 30 days after surgery

Number of readmissions

Time frame: 30 days after surgery

Adverse Events Ocurrence

AE rate

Time frame: 30 days after surgery

Data from ClinicalTrials.gov

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