<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/NCT03765827</url>
  </required_header>
  <id_info>
    <org_study_id>HRJC 18-11</org_study_id>
    <nct_id>NCT03765827</nct_id>
  </id_info>
  <brief_title>Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass</brief_title>
  <official_title>Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital General Universitario Elche</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital General Universitario Elche</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Patients will be randomized into 2 groups:&#xD;
&#xD;
        -  Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses&#xD;
&#xD;
        -  Control group: Vitamin E will not be applied&#xD;
&#xD;
      Postoperative pain will be assessed 24 hours after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients will be randomized into 2 groups:&#xD;
&#xD;
        -  Vit E group: Vitamin E acetate ointment will be applied over staple lines and&#xD;
           anastomoses in Roux-en-Y gastric bypass.&#xD;
&#xD;
        -  Control group: Vitamin E will not be applied&#xD;
&#xD;
      Postoperative pain will be assessed 24 hours after surgery, by means of visuala analogic&#xD;
      scale (ranging from 0 to 100mm).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 5, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>Phase 3</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>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>The patient and the epidemiology nurse will not know the treatgment assigned.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">140</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Vitamin E acetate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>No ointment will be applied</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vitamine E Acetate</intervention_name>
    <description>Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass</description>
    <arm_group_label>Vitamin E acetate</arm_group_label>
    <other_name>Vitamin E acetate ointment</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>No application of vitamin E acetate</intervention_name>
    <description>Vitamin E acetate ointment will not be applied in this group</description>
    <arm_group_label>Control group</arm_group_label>
    <other_name>No application of vitamin E acetate oinment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  BMI &gt;40 Kg/m2 or &gt;35 Kg/m2 associated to obesity-related comorbidities&#xD;
&#xD;
          -  Patients undergoing Roux-en-Y gastric bypass as bariatric procedure&#xD;
&#xD;
          -  Patients accepting to participate in the study and signing and Informed Consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients undergoing other bariatric techniques&#xD;
&#xD;
          -  Patients undergoing Roux-en-Y gastric bypass as revisional procedure&#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>Damian Garcia, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Hospital Rey Juan Carlos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>General Hospital Elche</name>
      <address>
        <city>Elche</city>
        <state>Alicante</state>
        <zip>03203</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>December 4, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>February 13, 2020</last_update_submitted>
  <last_update_submitted_qc>February 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 17, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hospital General Universitario Elche</investigator_affiliation>
    <investigator_full_name>Jaime Ruiz-Tovar, MD, PhD</investigator_full_name>
    <investigator_title>Department of Surgery</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamins</mesh_term>
    <mesh_term>Vitamin E</mesh_term>
    <mesh_term>Tocopherols</mesh_term>
    <mesh_term>Tocotrienols</mesh_term>
    <mesh_term>alpha-Tocopherol</mesh_term>
  </intervention_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/NCT03765827
org study id: HRJC 18-11
nct id: NCT03765827
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Patients will be randomized into 2 groups:

        -  Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses

        -  Control group: Vitamin E will not be applied

      Postoperative pain will be assessed 24 hours after surgery.
Patients will be randomized into 2 groups:

        -  Vit E group: Vitamin E acetate ointment will be applied over staple lines and
           anastomoses in Roux-en-Y gastric bypass.

        -  Control group: Vitamin E will not be applied

      Postoperative pain will be assessed 24 hours after surgery, by means of visuala analogic
      scale (ranging from 0 to 100mm).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
masking description: The patient and the epidemiology nurse will not know the treatgment assigned.
measure: Postoperative pain
time frame: 24 hours after surgery
description: Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)
arm group label: Vitamin E acetate
arm group type: Experimental
description: Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
arm group label: Control group
arm group type: Sham Comparator
description: No ointment will be applied
intervention type: Drug
intervention name: Vitamine E Acetate
description: Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
arm group label: Vitamin E acetate
other name: Vitamin E acetate ointment
intervention type: Drug
intervention name: No application of vitamin E acetate
description: Vitamin E acetate ointment will not be applied in this group
arm group label: Control group
other name: No application of vitamin E acetate oinment
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Damian Garcia, MD, PhD
role: Study Director
affiliation: Hospital Rey Juan Carlos
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Hospital General Universitario Elche
investigator full name: Jaime Ruiz-Tovar, MD, PhD
investigator title: Department of Surgery
mesh term: Pain, Postoperative
mesh term: Vitamins
mesh term: Vitamin E
mesh term: Tocopherols
mesh term: Tocotrienols
mesh term: alpha-Tocopherol