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Completed

NCT Number: NCT03010280

Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery

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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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fundacion Jimenez Diaz

Madrid, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Immunonutrition

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

Dietary Supplement

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

Primary outcomes

  1. Decrease in systemic inflamatory response in terms of CRP

    Time frame: 24h after surgery

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

Secondary outcomes

  1. Decrease in systemic inflamatory response in terms of other inflamatory biomarkers

    Time frame: 24 hours after surgery

    Mean decrease in leukocite count, fibrinogen

  2. Postoperative pain

    Time frame: 24h after surgery

    Mean VAS score

  3. Complications

    Time frame: 30 days after surgery

    Rate of complications

  4. In-hospital stay

    Time frame: 30 days after surgery

    In-hospital stay

  5. Number of readmissions

    Time frame: 30 days after surgery

    Number of readmissions

  6. Adverse Events Ocurrence

    Time frame: 30 days after surgery

    AE rate

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

Other

Collaborators

  • Hospital Universitario Rey Juan Carlos

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Jan 5, 2017
Registry last updated
Feb 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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