Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-09-30

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.

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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.

Conditions

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Postoperative Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immunonutrition

Patients receiving a preoperative balanced energy high-protein formula, enriched with Omega - 3 fatty acids (Immunonutrition formula)

Group Type EXPERIMENTAL

Immunonutrition

Intervention Type DIETARY_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 formula

Patients receiving a preoperative balanced energy high-protein formula, without including Omega - 3 fatty acids

Group Type ACTIVE_COMPARATOR

Balanced high-protein formula

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Immunonutrition

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

Intervention Type DIETARY_SUPPLEMENT

Balanced high-protein formula

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No