MedPath

Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery

Not Applicable
Completed
Conditions
Postoperative Complications
Registration Number
NCT03010280
Lead Sponsor
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
40
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Decrease in systemic inflamatory response in terms of CRP24h after surgery

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

Secondary Outcome Measures
NameTimeMethod
Postoperative pain24h after surgery

Mean VAS score

Decrease in systemic inflamatory response in terms of other inflamatory biomarkers24 hours after surgery

Mean decrease in leukocite count, fibrinogen

Adverse Events Ocurrence30 days after surgery

AE rate

Complications30 days after surgery

Rate of complications

In-hospital stay30 days after surgery

In-hospital stay

Number of readmissions30 days after surgery

Number of readmissions

Trial Locations

Locations (1)

Fundacion Jimenez Diaz

🇪🇸

Madrid, Spain

Fundacion Jimenez Diaz
🇪🇸Madrid, Spain

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.