<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/NCT04489680</url>
  </required_header>
  <id_info>
    <org_study_id>Cleft Palate 3D Simulator</org_study_id>
    <nct_id>NCT04489680</nct_id>
  </id_info>
  <brief_title>Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.</brief_title>
  <official_title>Educational Impact and Development of a Novel Cleft Palate Surgical Simulator: Improvement in Surgical Trainees' Knowledge and Confidence.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guy's and St Thomas' NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guy's and St Thomas' NHS Foundation Trust</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>
      Trainees' experience in cleft surgery is limited due to the high-risk nature of the surgery&#xD;
      and centralization of cleft care. Simulations allow trainees to learn complex surgical skills&#xD;
      whilst ensuring patient safety. Existing cleft surgical simulators are over-simplified or&#xD;
      prohibitively expensive. We developed and tested a high-fidelity yet cost-effective simulator&#xD;
      for cleft palate repair.&#xD;
&#xD;
      Skeletal elements were obtained through high-resolution scanning of a pathologic specimen, 3D&#xD;
      printed and then molded in plastic. Soft tissue components were formed through molding layers&#xD;
      of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar&#xD;
      veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft&#xD;
      knowledge and surgical confidence were compared for statistical significance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Trainees' experience in cleft surgery is limited due to the high-risk nature of&#xD;
      the surgery and centralization of cleft care. Simulations allow trainees to learn complex&#xD;
      surgical skills whilst ensuring patient safety. Existing cleft surgical simulators are&#xD;
      over-simplified or prohibitively expensive. We developed and tested a high-fidelity yet&#xD;
      cost-effective simulator for cleft palate repair.&#xD;
&#xD;
      Methods: Skeletal elements were obtained through high-resolution scanning of a pathologic&#xD;
      specimen, 3D printed and then molded in plastic. Soft tissue components were formed through&#xD;
      molding layers of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and&#xD;
      intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires&#xD;
      assessing cleft knowledge and surgical confidence were compared for statistical significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">August 31, 2019</completion_date>
  <primary_completion_date type="Actual">April 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cleft lip palate surgical knowledge</measure>
    <time_frame>Day 1</time_frame>
    <description>The knowledge questionnaire was a 10-part questionnaire, developed through consensus between a panel of expert cleft surgeons. Answers were marked by a single assessor according to the agreed marking criteria and participants received a score of 0-10</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Cleft lip palate surgical confidence</measure>
    <time_frame>Day 1</time_frame>
    <description>The confidence questionnaire was a 10-part questionnaire, each scored on a Likert scale of 1-5 that has previously been published and validated for use in cleft palate surgery(Appendix 3).(18) The total score ranged from 10-50, converted by division of 10 to an overall confidence score of 1-5 with 1 being not at all confident to 5 being very confident/at the level of an attending/consultant surgeon</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Cleft Palate Lip</condition>
  <arm_group>
    <arm_group_label>Surgical Trainees undergoing Cleft Palate Training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Educational</intervention_name>
    <description>Teaching session</description>
    <arm_group_label>Surgical Trainees undergoing Cleft Palate Training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Plastic Surgery Training Residents&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kezia Echlin</last_name>
    <role>Principal Investigator</role>
    <affiliation>Birmingham Children's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guys and St Thomas Hospital Plastic Surgery</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>July 25, 2020</last_update_submitted>
  <last_update_submitted_qc>July 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Guy's and St Thomas' NHS Foundation Trust</investigator_affiliation>
    <investigator_full_name>zavira heinze</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cleft Palate</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>On request</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Anonymous data will be available on request to the authors. Data will be kept for 15 years minimum.</ipd_time_frame>
    <ipd_access_criteria>The request needs to be done by a practicing clinician, able to provide registration proof.</ipd_access_criteria>
  </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/NCT04489680
org study id: Cleft Palate 3D Simulator
nct id: NCT04489680
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Trainees' experience in cleft surgery is limited due to the high-risk nature of the surgery
      and centralization of cleft care. Simulations allow trainees to learn complex surgical skills
      whilst ensuring patient safety. Existing cleft surgical simulators are over-simplified or
      prohibitively expensive. We developed and tested a high-fidelity yet cost-effective simulator
      for cleft palate repair.

      Skeletal elements were obtained through high-resolution scanning of a pathologic specimen, 3D
      printed and then molded in plastic. Soft tissue components were formed through molding layers
      of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar
      veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft
      knowledge and surgical confidence were compared for statistical significance.
Background: Trainees' experience in cleft surgery is limited due to the high-risk nature of
      the surgery and centralization of cleft care. Simulations allow trainees to learn complex
      surgical skills whilst ensuring patient safety. Existing cleft surgical simulators are
      over-simplified or prohibitively expensive. We developed and tested a high-fidelity yet
      cost-effective simulator for cleft palate repair.

      Methods: Skeletal elements were obtained through high-resolution scanning of a pathologic
      specimen, 3D printed and then molded in plastic. Soft tissue components were formed through
      molding layers of silicone. 26 UK specialty trainees performed a vomerine mucosal flap and
      intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires
      assessing cleft knowledge and surgical confidence were compared for statistical significance.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Cleft lip palate surgical knowledge
time frame: Day 1
description: The knowledge questionnaire was a 10-part questionnaire, developed through consensus between a panel of expert cleft surgeons. Answers were marked by a single assessor according to the agreed marking criteria and participants received a score of 0-10
measure: Cleft lip palate surgical confidence
time frame: Day 1
description: The confidence questionnaire was a 10-part questionnaire, each scored on a Likert scale of 1-5 that has previously been published and validated for use in cleft palate surgery(Appendix 3).(18) The total score ranged from 10-50, converted by division of 10 to an overall confidence score of 1-5 with 1 being not at all confident to 5 being very confident/at the level of an attending/consultant surgeon
arm group label: Surgical Trainees undergoing Cleft Palate Training
arm group type: Experimental
description: 26 UK specialty trainees performed a vomerine mucosal flap and intra-velar veloplasty in a one-hour workshop. Pre- and post-simulation questionnaires assessing cleft knowledge and surgical confidence were compared for statistical significance.
intervention type: Other
intervention name: Educational
description: Teaching session
arm group label: Surgical Trainees undergoing Cleft Palate Training
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kezia Echlin
role: Principal Investigator
affiliation: Birmingham Children's Hospital
facility: 
country: United Kingdom
responsible party type: Principal Investigator
investigator affiliation: Guy's and St Thomas' NHS Foundation Trust
investigator full name: zavira heinze
investigator title: Principle Investigator
mesh term: Cleft Palate
sharing ipd: Yes
ipd description: On request
ipd info type: Study Protocol
ipd time frame: Anonymous data will be available on request to the authors. Data will be kept for 15 years minimum.
ipd access criteria: The request needs to be done by a practicing clinician, able to provide registration proof.