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Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Immunonutrition
Balanced high-protein formula
Sponsored by
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Fundacion Jimenez Diaz

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Immunonutrition

Balanced high-protein formula

Arm Description

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

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

Outcomes

Primary Outcome Measures

Decrease in systemic inflamatory response in terms of CRP
Proportion of patients with at least a 50% decrease in CRP 24 after surgery

Secondary Outcome Measures

Decrease in systemic inflamatory response in terms of other inflamatory biomarkers
Mean decrease in leukocite count, fibrinogen
Postoperative pain
Mean VAS score
Complications
Rate of complications
In-hospital stay
In-hospital stay
Number of readmissions
Number of readmissions
Adverse Events Ocurrence
AE rate

Full Information

First Posted
January 3, 2017
Last Updated
February 12, 2018
Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
Hospital Universitario Rey Juan Carlos
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1. Study Identification

Unique Protocol Identification Number
NCT03010280
Brief Title
Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Collaborators
Hospital Universitario Rey Juan Carlos

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Immunonutrition
Arm Type
Experimental
Arm Description
Patients receiving a preoperative balanced energy high-protein formula, enriched with Omega - 3 fatty acids (Immunonutrition formula)
Arm Title
Balanced high-protein formula
Arm Type
Active Comparator
Arm Description
Patients receiving a preoperative balanced energy high-protein formula, without including Omega - 3 fatty acids
Intervention Type
Dietary Supplement
Intervention Name(s)
Immunonutrition
Intervention Description
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
Intervention Name(s)
Balanced high-protein formula
Intervention Description
Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively
Primary Outcome Measure Information:
Title
Decrease in systemic inflamatory response in terms of CRP
Description
Proportion of patients with at least a 50% decrease in CRP 24 after surgery
Time Frame
24h after surgery
Secondary Outcome Measure Information:
Title
Decrease in systemic inflamatory response in terms of other inflamatory biomarkers
Description
Mean decrease in leukocite count, fibrinogen
Time Frame
24 hours after surgery
Title
Postoperative pain
Description
Mean VAS score
Time Frame
24h after surgery
Title
Complications
Description
Rate of complications
Time Frame
30 days after surgery
Title
In-hospital stay
Description
In-hospital stay
Time Frame
30 days after surgery
Title
Number of readmissions
Description
Number of readmissions
Time Frame
30 days after surgery
Title
Adverse Events Ocurrence
Description
AE rate
Time Frame
30 days after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Ruiz-Tovar
Organizational Affiliation
Fundacion Jimenez Diaz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion Jimenez Diaz
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
30097364
Citation
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.
Results Reference
derived

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Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery

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