<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/NCT04493905</url>
  </required_header>
  <id_info>
    <org_study_id>ENCORE</org_study_id>
    <nct_id>NCT04493905</nct_id>
  </id_info>
  <brief_title>Effects of Anesthetic Techniques on Time to Start of Adjuvant Chemotherapy, and Early and Late Outcomes Following Surgery for Colorectal Cancer</brief_title>
  <acronym>ENCORE</acronym>
  <official_title>The Effects of Anesthetic Techniques on Time to Start of Adjuvant Chemotherapy, and Early- and Late-outcomes Following Surgery for Colorectal Cancer A Prospective, Multicenter, International, Observational, Pragmatic Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Society of Anaesthesiology</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European Society of Anaesthesiology</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Colorectal cancer (CRC) is the third most common cancer in the world with a high&#xD;
      postoperative mortality (2 - 6%) as well as a low 5-year survival (40%). Despite advances in&#xD;
      surgery and the use of minimally invasive laparoscopic surgery in recent years and adjuvant&#xD;
      chemotherapy after surgery, long-term prognosis has only improved marginally. Epidural&#xD;
      analgesia is commonly used as a part of the perioperative management of patients undergoing&#xD;
      open, colorectal cancer surgery. Not only does it reduce pain and stress, epidurals have been&#xD;
      shown to reduce perioperative inflammation and preserve immunological function, all of which&#xD;
      may be beneficial in perioperative tumorigenesis. In several retrospective studies,&#xD;
      anesthesia and choice of analgesia have shown to improve long-term survival, but no&#xD;
      randomized studies have been published in the literature today. Similarly, the benefits of&#xD;
      propofol anesthesia in comparison to inhalational anesthesia have recently been high-lighted&#xD;
      in relation to cancer surgery, and many patients today request the use of epidurals, total&#xD;
      intravenous anesthesia and loco-regional anesthetic technique during surgery, without clear&#xD;
      evidence from prospective studies in the literature. Therefore, the question as to the real&#xD;
      benefit of anesthesia technique in postoperative outcomes and tumor recurrence remain&#xD;
      unanswered, and skepticism abounds amongst both surgeons and anesthesiologists. It is&#xD;
      therefore important to study short- and long-term outcomes in patients undergoing CRC&#xD;
      surgery, comparing epidural vs. no epidural or inhalational vs. total intravenous anesthesia.&#xD;
      However, prospective, randomized studies are costly, require many patients, and the benefits&#xD;
      of choice of anesthesia and analgesia on outcome remain uncertain from the current&#xD;
      literature. There is a clear diffusion in practice across the world in the choice of&#xD;
      anesthesia for patients undergoing CRC surgery, a lack of evidence in the literature and an&#xD;
      absence of guidelines on best practice anesthesia care. We believe that by performing a&#xD;
      large, prospective, observational, international, pragmatic study, with low costs, it will be&#xD;
      possible to answer some of the important questions pertaining to the choice of anesthesia and&#xD;
      analgesia. The clinical trials network at the European Society of Anesthesiology will play an&#xD;
      important role in the success of this study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 1, 2021</start_date>
  <completion_date type="Anticipated">November 30, 2023</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2023</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>Time in days from onset of surgery for colorectal cancer (Stage I-III) to first initiation of planned adjuvant chemotherapy</measure>
    <time_frame>8 weeks</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>30-day postoperative morbidity assessed by Clavein-Dindo classification</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative mortality for 0-30 days</measure>
    <time_frame>30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cancer recurrence or cancer-related death at 90 days, 1, 3- and 5-years</measure>
    <time_frame>90 days - 1 - 3 - 5 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">10000</enrollment>
  <condition>Colorectal Neoplasms</condition>
  <condition>Anesthesia</condition>
  <condition>Drug Therapy</condition>
  <condition>Surgery</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing surgery for colorectal cancer (stage I-III).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
          -  Scheduled for colorectal cancer surgery for stage I-III&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled renal or liver disease, restrictive&#xD;
&#xD;
          -  (limiting mobility) heart failure or ischemic heart disease&#xD;
&#xD;
          -  Emergency surgery for suspected bowel obstruction from colorectal cancer&#xD;
&#xD;
          -  Speech, language or cognitive difficulties&#xD;
&#xD;
          -  Stage IV colorectal cancer when only palliative surgery is planned&#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_contact>
    <last_name>Max Bell, MD/PhD</last_name>
    <phone>+46 5171000</phone>
    <email>max.bell@sll.se</email>
  </overall_contact>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olof Brattström</last_name>
    </contact>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>July 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 30, 2020</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</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>Colorectal 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/NCT04493905
org study id: ENCORE
nct id: NCT04493905
lead sponsor: 
has dmc: No
Colorectal cancer (CRC) is the third most common cancer in the world with a high
      postoperative mortality (2 - 6%) as well as a low 5-year survival (40%). Despite advances in
      surgery and the use of minimally invasive laparoscopic surgery in recent years and adjuvant
      chemotherapy after surgery, long-term prognosis has only improved marginally. Epidural
      analgesia is commonly used as a part of the perioperative management of patients undergoing
      open, colorectal cancer surgery. Not only does it reduce pain and stress, epidurals have been
      shown to reduce perioperative inflammation and preserve immunological function, all of which
      may be beneficial in perioperative tumorigenesis. In several retrospective studies,
      anesthesia and choice of analgesia have shown to improve long-term survival, but no
      randomized studies have been published in the literature today. Similarly, the benefits of
      propofol anesthesia in comparison to inhalational anesthesia have recently been high-lighted
      in relation to cancer surgery, and many patients today request the use of epidurals, total
      intravenous anesthesia and loco-regional anesthetic technique during surgery, without clear
      evidence from prospective studies in the literature. Therefore, the question as to the real
      benefit of anesthesia technique in postoperative outcomes and tumor recurrence remain
      unanswered, and skepticism abounds amongst both surgeons and anesthesiologists. It is
      therefore important to study short- and long-term outcomes in patients undergoing CRC
      surgery, comparing epidural vs. no epidural or inhalational vs. total intravenous anesthesia.
      However, prospective, randomized studies are costly, require many patients, and the benefits
      of choice of anesthesia and analgesia on outcome remain uncertain from the current
      literature. There is a clear diffusion in practice across the world in the choice of
      anesthesia for patients undergoing CRC surgery, a lack of evidence in the literature and an
      absence of guidelines on best practice anesthesia care. We believe that by performing a
      large, prospective, observational, international, pragmatic study, with low costs, it will be
      possible to answer some of the important questions pertaining to the choice of anesthesia and
      analgesia. The clinical trials network at the European Society of Anesthesiology will play an
      important role in the success of this study.
observational model: Cohort
time perspective: Prospective
measure: Time in days from onset of surgery for colorectal cancer (Stage I-III) to first initiation of planned adjuvant chemotherapy
time frame: 8 weeks
measure: 30-day postoperative morbidity assessed by Clavein-Dindo classification
time frame: 30 days
measure: Postoperative mortality for 0-30 days
time frame: 30 days
measure: Cancer recurrence or cancer-related death at 90 days, 1, 3- and 5-years
time frame: 90 days - 1 - 3 - 5 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Max Bell, MD/PhD
phone: +46 5171000
email: max.bell@sll.se
facility: 
status: Recruiting
contact: 
country: Sweden
responsible party type: Sponsor
mesh term: Colorectal Neoplasms