<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03010280</url>
  </required_header>
  <id_info>
    <org_study_id>INMUNOBAR-HURJC-15/01</org_study_id>
    <nct_id>NCT03010280</nct_id>
  </id_info>
  <brief_title>Effect of Immunonutrition on Inflamatory Markers After Bariatric Surgery</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Hospital Universitario Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective randomized clinical trial of all the patients undergoing Roux - en-Y gastric&#xD;
      bypass will be performed. Patients will be randomly assigned into 2 groups: those patients&#xD;
      receiving a preoperative balanced energy high-protein formula (group 1) and those receiving&#xD;
      preoperative Immunonutrition (group 2). Changes between groups in acute inflamatory markers,&#xD;
      pain, postoperative septic complications and lenght of stay, among others will be&#xD;
      investigated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective randomized clinical trial of all the patients undergoing Roux - en-Y gastric&#xD;
      bypass will be performed. Patients will be randomly assigned into 2 groups: those patients&#xD;
      receiving a preoperative balanced energy high-protein formula (group 1) and those receiving&#xD;
      preoperative Immunonutrition (group 2). Changes between groups in acute inflamatory markers&#xD;
      (CRP, fibrinogen, leucocites), pain (VAS scale), postoperative septic complications&#xD;
      .(anastomotic leak and organ/space SSI)and lenght of stay, among others will be investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Decrease in systemic inflamatory response in terms of CRP</measure>
    <time_frame>24h after surgery</time_frame>
    <description>Proportion of patients with at least a 50% decrease in CRP 24 after surgery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease in systemic inflamatory response in terms of other inflamatory biomarkers</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Mean decrease in leukocite count, fibrinogen</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>24h after surgery</time_frame>
    <description>Mean VAS score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Rate of complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital stay</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>In-hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of readmissions</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>Number of readmissions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse Events Ocurrence</measure>
    <time_frame>30 days after surgery</time_frame>
    <description>AE rate</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Postoperative Complications</condition>
  <arm_group>
    <arm_group_label>Immunonutrition</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receiving a preoperative balanced energy high-protein formula, enriched with Omega - 3 fatty acids (Immunonutrition formula)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Balanced high-protein formula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients receiving a preoperative balanced energy high-protein formula, without including Omega - 3 fatty acids</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Immunonutrition</intervention_name>
    <description>Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively</description>
    <arm_group_label>Immunonutrition</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Balanced high-protein formula</intervention_name>
    <description>Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively</description>
    <arm_group_label>Balanced high-protein formula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients undergoing a laparoscopic gastric bypass (BPG) as a bariatric procedure&#xD;
&#xD;
          2. Men and Women older than 18 years.&#xD;
&#xD;
          3. Willing to participate in the study and giving their written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients younger than 18 years.&#xD;
&#xD;
          2. Patients undergoing other bariatric surgery techniques.&#xD;
&#xD;
          3. Patients undergoing any other surgical procedure added to the bariatric technique.&#xD;
&#xD;
          4. Patients with medical or surgical pathologies that at the discretion of the&#xD;
             investigator do not allow their participation in the study.&#xD;
&#xD;
          5. Inability to understand the nature and purpose of the study and / or to accept written&#xD;
             participation in the study.&#xD;
&#xD;
          6. Impossibility to comply with pre-established clinical follow-up.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jaime Ruiz-Tovar</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fundacion Jimenez Diaz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fundacion Jimenez Diaz</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 5, 2017</study_first_posted>
  <last_update_submitted>February 12, 2018</last_update_submitted>
  <last_update_submitted_qc>February 12, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Postoperative Complications</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03010280
org study id: INMUNOBAR-HURJC-15/01
nct id: NCT03010280
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Decrease in systemic inflamatory response in terms of CRP
time frame: 24h after surgery
description: Proportion of patients with at least a 50% decrease in CRP 24 after surgery
measure: Decrease in systemic inflamatory response in terms of other inflamatory biomarkers
time frame: 24 hours after surgery
description: Mean decrease in leukocite count, fibrinogen
measure: Postoperative pain
time frame: 24h after surgery
description: Mean VAS score
measure: Complications
time frame: 30 days after surgery
description: Rate of complications
measure: In-hospital stay
time frame: 30 days after surgery
description: In-hospital stay
measure: Number of readmissions
time frame: 30 days after surgery
description: Number of readmissions
measure: Adverse Events Ocurrence
time frame: 30 days after surgery
description: AE rate
arm group label: Immunonutrition
arm group type: Experimental
description: Patients receiving a preoperative balanced energy high-protein formula, enriched with Omega - 3 fatty acids (Immunonutrition formula)
arm group label: Balanced high-protein formula
arm group type: Active Comparator
description: Patients receiving a preoperative balanced energy high-protein formula, without including Omega - 3 fatty acids
intervention type: Dietary Supplement
intervention name: Immunonutrition
description: Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively
arm group label: Immunonutrition
intervention type: Dietary Supplement
intervention name: Balanced high-protein formula
description: Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively
arm group label: Balanced high-protein formula
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jaime Ruiz-Tovar
role: Principal Investigator
affiliation: Fundacion Jimenez Diaz
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Postoperative Complications