<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/NCT03793933</url>
  </required_header>
  <id_info>
    <org_study_id>ACS-NSQIP</org_study_id>
    <nct_id>NCT03793933</nct_id>
  </id_info>
  <brief_title>ACS-NSQIP Calculator for Liver Surgery</brief_title>
  <official_title>Performance of the American College of Surgeons Surgical Risk Calculator in Patients Undergoing Hepatectomy for Liver Tumors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Humanitas Clinical and Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Humanitas Clinical and Research Center</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>
      The American College of Surgeons National Surgical Quality Improvement Program's (ACS-NSQIP)&#xD;
      calculator has been endorsed by the surgeons' community to counsel patients and relatives&#xD;
      regarding estimated postoperative complications. However, it does not include organ-specific&#xD;
      risks. The aim of this study was to assess the ACS-NSQIP calculator's ability to predict&#xD;
      complications, mortality and length of stay (LOS) in patients undergoing hepatectomy for&#xD;
      liver tumors&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is an observational retrospective study conducted in a tertiary-referral university&#xD;
      hospital. An established classification of complications, including post-hepatectomy&#xD;
      insufficiency and bile leak, was adopted. The endpoint was the rate of complications,&#xD;
      mortality and LOS as expected by the ACS-NSQIP calculator and as observed within 90-day after&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 1, 2015</start_date>
  <completion_date type="Actual">January 1, 2019</completion_date>
  <primary_completion_date type="Actual">July 1, 2018</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ACS-NSQIP calculator's ability</measure>
    <time_frame>From the date of surgery up to three months from the date of surgery</time_frame>
    <description>The primary study endpoint was to assess the ACS-NSQIP calculator's ability to predict complications, mortality and length of stay in patients undergoing hepatectomy for liver tumors</description>
  </primary_outcome>
  <enrollment type="Actual">450</enrollment>
  <condition>Liver Surgery</condition>
  <condition>Hepatectomy</condition>
  <condition>Outcome After Hepatectomy</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Liver resection</intervention_name>
    <description>Surgery for the liver</description>
    <other_name>Hepatectomy</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study examined a cohort of consecutive patients that underwent hepatectomy at our&#xD;
        institution between November 2015 and July 2018.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient who underwent surgery for a liver tumor at our Institution between the&#xD;
             defined period of time&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any patient with missing data&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 3, 2019</study_first_submitted>
  <study_first_submitted_qc>January 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 4, 2019</study_first_posted>
  <last_update_submitted>January 3, 2019</last_update_submitted>
  <last_update_submitted_qc>January 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Humanitas Clinical and Research Center</investigator_affiliation>
    <investigator_full_name>Matteo Donadon</investigator_full_name>
    <investigator_title>Assistant Professor of Surgery</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03793933
org study id: ACS-NSQIP
nct id: NCT03793933
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The American College of Surgeons National Surgical Quality Improvement Program's (ACS-NSQIP)
      calculator has been endorsed by the surgeons' community to counsel patients and relatives
      regarding estimated postoperative complications. However, it does not include organ-specific
      risks. The aim of this study was to assess the ACS-NSQIP calculator's ability to predict
      complications, mortality and length of stay (LOS) in patients undergoing hepatectomy for
      liver tumors
This is an observational retrospective study conducted in a tertiary-referral university
      hospital. An established classification of complications, including post-hepatectomy
      insufficiency and bile leak, was adopted. The endpoint was the rate of complications,
      mortality and LOS as expected by the ACS-NSQIP calculator and as observed within 90-day after
      surgery.
observational model: Cohort
time perspective: Retrospective
measure: ACS-NSQIP calculator's ability
time frame: From the date of surgery up to three months from the date of surgery
description: The primary study endpoint was to assess the ACS-NSQIP calculator's ability to predict complications, mortality and length of stay in patients undergoing hepatectomy for liver tumors
intervention type: Procedure
intervention name: Liver resection
description: Surgery for the liver
other name: Hepatectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Humanitas Clinical and Research Center
investigator full name: Matteo Donadon
investigator title: Assistant Professor of Surgery
sharing ipd: No