xml: <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/NCT05961930</url>
    </required_header>
    <id_info>
      <org_study_id>2022-64</org_study_id>
      <nct_id>NCT05961930</nct_id>
    </id_info>
    <brief_title>Surgeon's Performance in Predicting Postoperative Infections</brief_title>
    <acronym>SPIRIT</acronym>
    <official_title>Surgeon's Performance in Predicting Postoperative Infections</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Leiden University Medical Center</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Leiden University Medical 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>
        Post-surgical (bacterial) infections are the most frequent post-surgical complications,&#xD;
        including deep or superficial wound infections, urinary tract infections, pneumonia, and even&#xD;
        sepsis. Approximately 6.5-25% of all surgical patients will develop any type of bacterial&#xD;
        infection. To personalize surgical infection management, (Artificial Intelligence) models are&#xD;
        in the making to predict which patients are at high or low risk of developing a post-surgical&#xD;
        infection. In order to benchmark these prediction models to the predictive capabilities of&#xD;
        surgeons, the investigators aim to investigate the performance of surgeons in predicting the&#xD;
        risk of a patient developing (any type) of post-surgical infection within 30 days.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        A prospective non-interventional study is performed to collect surgeons' predictions on the&#xD;
        risk of a patient developing a postoperative infection within 30 days of surgery. Surgeons&#xD;
        are asked to fill in a short questionnaire asking about the estimated infection risk. The&#xD;
        actual outcome (infection &lt; 30 days of surgery) of a patient will be collected&#xD;
        retrospectively after completion of the study. This study will have no effect on standard&#xD;
        care: surgical interventions and postoperative care will be carried out according to standard&#xD;
        clinical practice. Besides a one-time estimate of the surgeon, immediately after the surgical&#xD;
        procedure, no other interventions will be performed and surgical specialists will carry out&#xD;
        their normal post-surgical care, including screening and treating (if necessary) their&#xD;
        patients for postoperative infections.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Other</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The discriminative predictive performance of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery</measure>
      <time_frame>30 days</time_frame>
      <description>The primary outcome measure of discrimination are area under the receiving operating characteristic curve (AUROC). Predictions are compared to the occurrence of a postoperative infection requiring treatment, surgical intervention or registration within 30 days of surgery.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>The calibration properties of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery</measure>
      <time_frame>30 days</time_frame>
      <description>Calibration plots with slope and intercept</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Relationship between the certainty in estimate and the predictive performance of surgeons</measure>
      <time_frame>30 days</time_frame>
      <description>Surgeons are questioned on their certainty in the provided estimate</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationship between patient factors and predicted risk</measure>
      <time_frame>30 days</time_frame>
      <description>Surgeons are questioned to indicate for a list of patient factors whether they were of impact to the decision</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Predictive performance per surgeons and patients subgroups</measure>
      <time_frame>30 days</time_frame>
      <description>Surgeons subgroups are based on specialty, years of experience, level of experience, sex. Patient subgroups include, surgical specialty, age groups, type of surgical procedure, planned or emergency intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Relationship between predicted risk of surgeons and if they perform additional actions</measure>
      <time_frame>30 days</time_frame>
      <description>Surgeons are asked to indicate whether they performed additional actions for this patient in the questionnaire.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">588</enrollment>
    <condition>Postoperative Infection</condition>
    <arm_group>
      <arm_group_label>Surgeons estimate of postoperative infection</arm_group_label>
      <description>All surgeons will be asked to fill in a questionnaire, containing 5 questions, pertaining to the estimated risk of postoperative infection (within 30days). Thus there is a single arm and no comparison.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Questionnaire</intervention_name>
      <description>Surgeons will be asked to fill in a short questionnaire after surgery on risk of postoperative infection</description>
      <arm_group_label>Surgeons estimate of postoperative infection</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult, surgical population of different surgical subspecialties.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Predictions are made for patients with the following inclusion and exclusion criteria:&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult patients (&gt;18 years old)&#xD;
  &#xD;
            -  Acute or elective surgery&#xD;
  &#xD;
            -  Invasive or minimally invasive surgical procedures&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Outpatient procedures or procedures not requiring any form of monitoring/anesthesia&#xD;
  &#xD;
            -  Procedures for which the primary indication is (treatment for) an infection&#xD;
  &#xD;
            -  Radiological procedures&#xD;
  &#xD;
            -  Cardiological catheterization procedures&#xD;
  &#xD;
            -  Psychiatric treatment under anaesthesia (i.e. electroconvulsive therapy)&#xD;
  &#xD;
            -  Sole anaesthetic procedures except for implantation of a neurostimulator&#xD;
  &#xD;
            -  Brachytherapy procedures&#xD;
  &#xD;
            -  Endoscopic procedures for diagnostic purposes only&#xD;
  &#xD;
            -  Procedures that only entail the taking of a biopsy for diagnostic purposes&#xD;
  &#xD;
            -  Patients that are pregnant&#xD;
  &#xD;
            -  Procedures out of office hours (before 8.00 am or after 5.00 pm)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Sesmu Arbous</name>
        <address>
          <city>Leiden</city>
          <state>Zuid-holland</state>
          <zip>2333 ZA</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>MS Arbous, MD PhD</last_name>
        <phone>071 526 91 11</phone>
        <email>m.s.arbous@lumc.nl</email>
      </contact>
    </location>
    <location_countries>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>March 3, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 18, 2023</last_update_submitted>
    <last_update_submitted_qc>July 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Leiden University Medical Center</investigator_affiliation>
      <investigator_full_name>Sesmu M. Arbous, MD PhD MSc</investigator_full_name>
      <investigator_title>Principal Investigator, Sesmu M. Arbous, MD PhD MSc</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infections</mesh_term>
      <mesh_term>Communicable Diseases</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05961930
  org study id: 2022-64
  nct id: NCT05961930
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Post-surgical (bacterial) infections are the most frequent post-surgical complications,
        including deep or superficial wound infections, urinary tract infections, pneumonia, and even
        sepsis. Approximately 6.5-25% of all surgical patients will develop any type of bacterial
        infection. To personalize surgical infection management, (Artificial Intelligence) models are
        in the making to predict which patients are at high or low risk of developing a post-surgical
        infection. In order to benchmark these prediction models to the predictive capabilities of
        surgeons, the investigators aim to investigate the performance of surgeons in predicting the
        risk of a patient developing (any type) of post-surgical infection within 30 days.
  A prospective non-interventional study is performed to collect surgeons' predictions on the
        risk of a patient developing a postoperative infection within 30 days of surgery. Surgeons
        are asked to fill in a short questionnaire asking about the estimated infection risk. The
        actual outcome (infection < 30 days of surgery) of a patient will be collected
        retrospectively after completion of the study. This study will have no effect on standard
        care: surgical interventions and postoperative care will be carried out according to standard
        clinical practice. Besides a one-time estimate of the surgeon, immediately after the surgical
        procedure, no other interventions will be performed and surgical specialists will carry out
        their normal post-surgical care, including screening and treating (if necessary) their
        patients for postoperative infections.
  observational model: Other
  time perspective: Prospective
  measure: The discriminative predictive performance of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery
  time frame: 30 days
  description: The primary outcome measure of discrimination are area under the receiving operating characteristic curve (AUROC). Predictions are compared to the occurrence of a postoperative infection requiring treatment, surgical intervention or registration within 30 days of surgery.
  measure: The calibration properties of surgeons with respect to estimating the risk of developing (any type) bacterial post-surgical within 30 days of surgery
  time frame: 30 days
  description: Calibration plots with slope and intercept
  measure: Relationship between the certainty in estimate and the predictive performance of surgeons
  time frame: 30 days
  description: Surgeons are questioned on their certainty in the provided estimate
  measure: Relationship between patient factors and predicted risk
  time frame: 30 days
  description: Surgeons are questioned to indicate for a list of patient factors whether they were of impact to the decision
  measure: Predictive performance per surgeons and patients subgroups
  time frame: 30 days
  description: Surgeons subgroups are based on specialty, years of experience, level of experience, sex. Patient subgroups include, surgical specialty, age groups, type of surgical procedure, planned or emergency intervention.
  measure: Relationship between predicted risk of surgeons and if they perform additional actions
  time frame: 30 days
  description: Surgeons are asked to indicate whether they performed additional actions for this patient in the questionnaire.
  arm group label: Surgeons estimate of postoperative infection
  description: All surgeons will be asked to fill in a questionnaire, containing 5 questions, pertaining to the estimated risk of postoperative infection (within 30days). Thus there is a single arm and no comparison.
  intervention type: Behavioral
  intervention name: Questionnaire
  description: Surgeons will be asked to fill in a short questionnaire after surgery on risk of postoperative infection
  arm group label: Surgeons estimate of postoperative infection
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: Netherlands
  responsible party type: Principal Investigator
  investigator affiliation: Leiden University Medical Center
  investigator full name: Sesmu M. Arbous, MD PhD MSc
  investigator title: Principal Investigator, Sesmu M. Arbous, MD PhD MSc
  mesh term: Infections
  mesh term: Communicable Diseases
  sharing ipd: No