<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/NCT04466696</url>
  </required_header>
  <id_info>
    <org_study_id>3</org_study_id>
    <nct_id>NCT04466696</nct_id>
  </id_info>
  <brief_title>Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients</brief_title>
  <official_title>Feasibility of ERAS Protocol in T4 Colorectal Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Rome Tor Vergata</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Rome Tor Vergata</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>
      Patients diagnosed with T4 colorectal cancer represent a specific subgroup of colorectal&#xD;
      patients, frequently composed of fragile patients whose advanced nature of the disease often&#xD;
      requires a multi organ resection by an open surgery approach and frequently leads to higher&#xD;
      intra/postoperative complication.Those characteristics makes them to be considered less&#xD;
      suitable for ERAS protocol, especially regarding an expected difficult compliance to&#xD;
      postoperative items.&#xD;
&#xD;
      The impact of enhanced recovery program on postoperative outcomes in this subset of patients&#xD;
      has never been addressed in literature, in fact most of studies either excluded T4 patients&#xD;
      due to higher rates of complication or adopted an homogeneous patient sampling analizing all&#xD;
      stage colorectal cancer together.&#xD;
&#xD;
      Our aim is to investigate the feasibility of ERAS protocol in T4 colorectal patient, primary&#xD;
      outcome was to compare postoperative lenght of stay between T4 colorectal patients treated&#xD;
      with ERAS protcol and those treated with standard of care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">July 7, 2020</completion_date>
  <primary_completion_date type="Actual">May 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative length of stay</measure>
    <time_frame>30 days</time_frame>
    <description>number of days from surgery to discharge</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">82</enrollment>
  <condition>T4 Colorectal Cancer</condition>
  <condition>ERAS</condition>
  <condition>Colon Cancer</condition>
  <condition>Fast Track Protocol</condition>
  <arm_group>
    <arm_group_label>t4 colorectal cancer treated with ERAS protocol</arm_group_label>
    <description>prospective from January 2016 to May 2020</description>
  </arm_group>
  <arm_group>
    <arm_group_label>t4 colorectal cancer treated with standards of care</arm_group_label>
    <description>retrospective from January 2010 to December 2015</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>ERAS protocol</intervention_name>
    <description>items of ERAS protocol applied</description>
    <arm_group_label>t4 colorectal cancer treated with ERAS protocol</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with a clinical diagnosis of stage T4 colorectal cancer who underwent surgical&#xD;
        resection between January 2016 to January 2020 at Minimally Invasive Surgery Unit of Tor&#xD;
        Vergata University Hospital were prospectively enrolled in the ERAS group and treated with&#xD;
        fast track protocol. Postoperative short outcomes were compared to a control group treated&#xD;
        with conventional care that underwent surgical resection for T4 colorectal cancer at the&#xD;
        same center from January 2010 to December 2015. Data of the control group were collected&#xD;
        retrospectively from a prospectively mantained database.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  colorectal cacer&#xD;
&#xD;
          -  hystologic diagnosis of adenocarcinoma of the colon/rectum&#xD;
&#xD;
          -  clinically staged T4&#xD;
&#xD;
          -  written informed consent to surgery obtained&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  failure to perform colonic or rectal resection&#xD;
&#xD;
          -  synchronous cancer at time of colorectal cancer diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>December 24, 2020</last_update_submitted>
  <last_update_submitted_qc>December 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Rome Tor Vergata</investigator_affiliation>
    <investigator_full_name>Giuseppe Sigismondo Sica</investigator_full_name>
    <investigator_title>Associate Professor, Head of Department</investigator_title>
  </responsible_party>
  <keyword>colon cancer</keyword>
  <keyword>ERAS</keyword>
  <keyword>fast track</keyword>
  <keyword>t4 colorectal cancer</keyword>
  <keyword>colorectal cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</mesh_term>
    <mesh_term>Colonic Neoplasms</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/NCT04466696
org study id: 3
nct id: NCT04466696
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Patients diagnosed with T4 colorectal cancer represent a specific subgroup of colorectal
      patients, frequently composed of fragile patients whose advanced nature of the disease often
      requires a multi organ resection by an open surgery approach and frequently leads to higher
      intra/postoperative complication.Those characteristics makes them to be considered less
      suitable for ERAS protocol, especially regarding an expected difficult compliance to
      postoperative items.

      The impact of enhanced recovery program on postoperative outcomes in this subset of patients
      has never been addressed in literature, in fact most of studies either excluded T4 patients
      due to higher rates of complication or adopted an homogeneous patient sampling analizing all
      stage colorectal cancer together.

      Our aim is to investigate the feasibility of ERAS protocol in T4 colorectal patient, primary
      outcome was to compare postoperative lenght of stay between T4 colorectal patients treated
      with ERAS protcol and those treated with standard of care.
observational model: Cohort
time perspective: Prospective
measure: Postoperative length of stay
time frame: 30 days
description: number of days from surgery to discharge
arm group label: t4 colorectal cancer treated with ERAS protocol
description: prospective from January 2016 to May 2020
arm group label: t4 colorectal cancer treated with standards of care
description: retrospective from January 2010 to December 2015
intervention type: Behavioral
intervention name: ERAS protocol
description: items of ERAS protocol applied
arm group label: t4 colorectal cancer treated with ERAS protocol
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
responsible party type: Principal Investigator
investigator affiliation: University of Rome Tor Vergata
investigator full name: Giuseppe Sigismondo Sica
investigator title: Associate Professor, Head of Department
mesh term: Colorectal Neoplasms
mesh term: Colonic Neoplasms