<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/NCT03257384</url>
  </required_header>
  <id_info>
    <org_study_id>17-029</org_study_id>
    <nct_id>NCT03257384</nct_id>
  </id_info>
  <brief_title>Minimizing Peri-operative Time Delays, Maximizing Operating Room Efficiency: A Pilot Study</brief_title>
  <official_title>Minimizing Peri-operative Time Delays, Maximizing Operating Room Efficiency: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</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 primary objective is to prospectively identify Operating Room (OR) time delays from the&#xD;
      time the patient who is undergoing total laparoscopic hysterectomy enters the OR to exiting&#xD;
      the OR. This analysis will be used to identify root cause(s) leading to OR delays and define&#xD;
      areas for improvement. The secondary objective is to identify any improvements in OR time&#xD;
      delays and OR utilization following implementation of a standardized framework developed to&#xD;
      increase OR efficiency.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Time delays in the operating room play a role in increasing wait time length, number of&#xD;
      cancelled cases, health care expenditure and resources. Furthermore, it inconveniences&#xD;
      patients and families, and delays care. Minimally invasive surgery (laparoscopy) affords&#xD;
      same-day discharge, faster recovery, and decreased morbidity. However, performing laparoscopy&#xD;
      requires special equipment and multiple steps during set-up that can lead to time delays if&#xD;
      not performed efficiently. Multiple factors have been identified to contribute to inefficient&#xD;
      care delivery including: communication error, equipment failure, lack of teamwork among&#xD;
      nursing, surgical or anesthesia teams, and duplication of tasks.&#xD;
&#xD;
      OR delays due to inefficiency can result from a chain of intraoperative events including&#xD;
      technical factors (ie. equipment failure or case complexity) and from non-technical human&#xD;
      factors (ie. communication errors or lack of coordinated teamwork within and between OR&#xD;
      teams). &quot;The intraoperative period is the period in which the surgical team may have the most&#xD;
      influence&quot; on efficiency. Objective measures of intraoperative OR delays and identification&#xD;
      of their causes can lead to the development of a standardized framework that could be&#xD;
      generalized to any surgical discipline to improve OR efficiency.&#xD;
&#xD;
      The primary objective of this study is to prospectively identify OR time delays from the time&#xD;
      the patient enters the OR who are undergoing total laparoscopic hysterectomy (laparoscopic&#xD;
      gynecologic procedure that involves several potential areas for inefficiency) to case&#xD;
      completion and exiting the OR. This analysis will be used to identify root cause(s) leading&#xD;
      to OR delays and define areas for improvement. The causes of delays can be reported back to&#xD;
      the team members through formative performance-based feedback. The secondary objective is to&#xD;
      identify any improvements in OR time delays and OR utilization following implementation of a&#xD;
      standardized framework developed to increase OR efficiency.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 10, 2017</start_date>
  <completion_date type="Anticipated">August 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">August 10, 2022</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>Operative room time delays</measure>
    <time_frame>Recording starts when patient enters operating room and ends when they exit the room</time_frame>
    <description>Time delays during a total laparoscopic hysterectomy procedure will be recorded</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-technical skills and performance of operative team</measure>
    <time_frame>From time when patient enters operating room to time when they exit the room</time_frame>
    <description>Skills and team performance will be rated using the Oxford NOTECHS Rating Scale</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Operating Room Efficiency</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Black box recording of surgery</intervention_name>
    <description>Time delays will be recorded from the moment the patient is draped and enters the operating room to the moment they exit the operating room.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The study population will include: patients undergoing total laparoscopic hysterectomy, as&#xD;
        well as the surgeons, anesthesiologists, and nurses involved in conducting the surgery.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total laparoscopic hysterectomy cases performed by Minimally Invasive Surgery&#xD;
             gynecologist at St. Michael's Hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Procedure converted to laparotomy&#xD;
&#xD;
          -  Patients who desire future child bearing potential&#xD;
&#xD;
          -  Procedures performed by hysteroscopy or laparotomy&#xD;
&#xD;
          -  General gynecologist surgeon (i.e. non-Minimally Invasive Surgical specialist)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eliane Shore, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5C 2T2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>October 18, 2020</last_update_submitted>
  <last_update_submitted_qc>October 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03257384
org study id: 17-029
nct id: NCT03257384
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective is to prospectively identify Operating Room (OR) time delays from the
      time the patient who is undergoing total laparoscopic hysterectomy enters the OR to exiting
      the OR. This analysis will be used to identify root cause(s) leading to OR delays and define
      areas for improvement. The secondary objective is to identify any improvements in OR time
      delays and OR utilization following implementation of a standardized framework developed to
      increase OR efficiency.
Time delays in the operating room play a role in increasing wait time length, number of
      cancelled cases, health care expenditure and resources. Furthermore, it inconveniences
      patients and families, and delays care. Minimally invasive surgery (laparoscopy) affords
      same-day discharge, faster recovery, and decreased morbidity. However, performing laparoscopy
      requires special equipment and multiple steps during set-up that can lead to time delays if
      not performed efficiently. Multiple factors have been identified to contribute to inefficient
      care delivery including: communication error, equipment failure, lack of teamwork among
      nursing, surgical or anesthesia teams, and duplication of tasks.

      OR delays due to inefficiency can result from a chain of intraoperative events including
      technical factors (ie. equipment failure or case complexity) and from non-technical human
      factors (ie. communication errors or lack of coordinated teamwork within and between OR
      teams). "The intraoperative period is the period in which the surgical team may have the most
      influence" on efficiency. Objective measures of intraoperative OR delays and identification
      of their causes can lead to the development of a standardized framework that could be
      generalized to any surgical discipline to improve OR efficiency.

      The primary objective of this study is to prospectively identify OR time delays from the time
      the patient enters the OR who are undergoing total laparoscopic hysterectomy (laparoscopic
      gynecologic procedure that involves several potential areas for inefficiency) to case
      completion and exiting the OR. This analysis will be used to identify root cause(s) leading
      to OR delays and define areas for improvement. The causes of delays can be reported back to
      the team members through formative performance-based feedback. The secondary objective is to
      identify any improvements in OR time delays and OR utilization following implementation of a
      standardized framework developed to increase OR efficiency.
observational model: Cohort
time perspective: Prospective
measure: Operative room time delays
time frame: Recording starts when patient enters operating room and ends when they exit the room
description: Time delays during a total laparoscopic hysterectomy procedure will be recorded
measure: Non-technical skills and performance of operative team
time frame: From time when patient enters operating room to time when they exit the room
description: Skills and team performance will be rated using the Oxford NOTECHS Rating Scale
intervention type: Other
intervention name: Black box recording of surgery
description: Time delays will be recorded from the moment the patient is draped and enters the operating room to the moment they exit the operating room.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eliane Shore, MD
role: Principal Investigator
affiliation: Unity Health Toronto
facility: 
country: Canada
responsible party type: Sponsor
sharing ipd: No