<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/NCT02235636</url>
  </required_header>
  <id_info>
    <org_study_id>098-12</org_study_id>
    <nct_id>NCT02235636</nct_id>
  </id_info>
  <brief_title>A Randomized Cross-over Trial of Comparison Between Robotic and Laparoscopic Suturing for Gastric Defect by Novices</brief_title>
  <official_title>Da Vinci Robot Compared to Laparoscopic Suturing for Closure of Gastric Incision Among Novice: a Randomized Cross Over Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and&#xD;
      conventional Laparoscopic surgical suturing among novice&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background Da Vinci® Robotic Surgical System (DVRSS) has been widely applied to perform&#xD;
      complex minimally invasive surgical procedures across different specialties. This study aimed&#xD;
      to investigate the impact of DVRSS on surgical proficiencies among inexperience novice&#xD;
      surgeons and compared to conventional laparoscopic surgery.&#xD;
&#xD;
      Methods Twenty medical students (n=20) without surgical experience were enrolled. After a&#xD;
      constructive training for basic surgical techniques, participants were randomly allocated&#xD;
      into DVR or laparoscopy group. Participants were asked to close five cases (also named five&#xD;
      tasks) of a 2cm long incision on pig stomach by using DVR or laparoscopy. Surgical time,&#xD;
      successful closure rate and pneumatic bursting pressure of gastric incision withstanding were&#xD;
      recorded. In addition, participant performance and workload were quantified by using&#xD;
      performance score, scales of Global Rating Scale Assessment (GSA) and NASA-Task Load Index&#xD;
      (NASATLI).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">August 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Task performance</measure>
    <time_frame>1 day</time_frame>
    <description>The performance of participants for each task would be assessed by objective scoring scale basing on the task completion time, plus well-defined errors during suturing and tying knot.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of success in closure of gastrotomy</measure>
    <time_frame>1 day</time_frame>
    <description>The success in closure of the standardized gastrotomy was defined as followings: (1) The gastrotomy must be closed with 20 minutes using a 10 cm-long suture with intracorporeal knots tying; (2) Sutures should not be broken during the experiment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pneumatic bursting pressure for gastric incision</measure>
    <time_frame>1 day</time_frame>
    <description>The efficiency of the two groups in using DVRSS and laparoscopic suturing for closure of gastrotomy was assessed by the maximal pneumatic bursting pressure that the suture line could withstand.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of participant workload</measure>
    <time_frame>1 day</time_frame>
    <description>Participant workload was assessed by using National Aeronautics and Space Administration-task load index scale (NASATLX) after completion of each task. The scale focused on six domains, including mental, physical and temporal demand, as well as performance, effort and frustration.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">20</enrollment>
  <condition>Surgical Suturing for Closure of Gastrotomy</condition>
  <condition>Laparoscopic Suturing</condition>
  <condition>Robotic Surgical Suturing</condition>
  <arm_group>
    <arm_group_label>Laparoscopic group</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Robotic group</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Medical students with no prior experience in surgery&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Medical Students with no prior surgical experience&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Surgeons&#xD;
&#xD;
          -  Age &lt; 16 or &gt; 60&#xD;
&#xD;
          -  Disability and not able to control the Da Vinci Robot through the console&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philip W Chiu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Surgery, The Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CUHK Jockey Club Minimally Invasive Surgical Skills Center</name>
      <address>
        <city>Hong Kong SAR</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 4, 2014</study_first_submitted>
  <study_first_submitted_qc>September 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2014</study_first_posted>
  <last_update_submitted>September 8, 2014</last_update_submitted>
  <last_update_submitted_qc>September 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 10, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Philip Wai Yan Chiu</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT02235636
org study id: 098-12
nct id: NCT02235636
lead sponsor: 
has dmc: No
To compare the performance of surgical suturing using Da Vinci Robotic Surgical System and
      conventional Laparoscopic surgical suturing among novice
Background Da Vinci® Robotic Surgical System (DVRSS) has been widely applied to perform
      complex minimally invasive surgical procedures across different specialties. This study aimed
      to investigate the impact of DVRSS on surgical proficiencies among inexperience novice
      surgeons and compared to conventional laparoscopic surgery.

      Methods Twenty medical students (n=20) without surgical experience were enrolled. After a
      constructive training for basic surgical techniques, participants were randomly allocated
      into DVR or laparoscopy group. Participants were asked to close five cases (also named five
      tasks) of a 2cm long incision on pig stomach by using DVR or laparoscopy. Surgical time,
      successful closure rate and pneumatic bursting pressure of gastric incision withstanding were
      recorded. In addition, participant performance and workload were quantified by using
      performance score, scales of Global Rating Scale Assessment (GSA) and NASA-Task Load Index
      (NASATLI).
observational model: Case-Crossover
time perspective: Prospective
measure: Task performance
time frame: 1 day
description: The performance of participants for each task would be assessed by objective scoring scale basing on the task completion time, plus well-defined errors during suturing and tying knot.
measure: Rate of success in closure of gastrotomy
time frame: 1 day
description: The success in closure of the standardized gastrotomy was defined as followings: (1) The gastrotomy must be closed with 20 minutes using a 10 cm-long suture with intracorporeal knots tying; (2) Sutures should not be broken during the experiment.
measure: Pneumatic bursting pressure for gastric incision
time frame: 1 day
description: The efficiency of the two groups in using DVRSS and laparoscopic suturing for closure of gastrotomy was assessed by the maximal pneumatic bursting pressure that the suture line could withstand.
measure: Assessment of participant workload
time frame: 1 day
description: Participant workload was assessed by using National Aeronautics and Space Administration-task load index scale (NASATLX) after completion of each task. The scale focused on six domains, including mental, physical and temporal demand, as well as performance, effort and frustration.
arm group label: Laparoscopic group
arm group label: Robotic group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Philip W Chiu, MD
role: Principal Investigator
affiliation: Department of Surgery, The Chinese University of Hong Kong
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Philip Wai Yan Chiu
investigator title: Professor