<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/NCT03770897</url>
  </required_header>
  <id_info>
    <org_study_id>NVettoretto</org_study_id>
    <nct_id>NCT03770897</nct_id>
  </id_info>
  <brief_title>Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome</brief_title>
  <acronym>LAPSUS</acronym>
  <official_title>Laparoscopic Appendectomy Performed by Junior SUrgeonS: Impact of 3D Visualization on Surgical Outcome. Randomized Multicenter Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</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>
      Laparoscopy has revolutionized the approach to a number of surgical problems causing a&#xD;
      re-evaluation of several clinical strategies. Now it has become the standard treatment for&#xD;
      majority of ailments including symptomatic gall stone disease, appendicitis, GERD&#xD;
      (gastroesophageal reflux disease), morbid obesity and colorectal disease. All these&#xD;
      developments aim at minimizing perioperative morbidities, providing rapid postoperative&#xD;
      recovery and enhancing patient's safety profile. One of the major limitations of conventional&#xD;
      laparoscopy is lack of depth perception. Introduction of 3D imaging, has removed many of&#xD;
      these technical obstacles. In 1993, Becker et al., reported that a 3D display might improve&#xD;
      laparoscopic skills. Since then, many researchers have demonstrated benefit of 3D imaging .&#xD;
      Starting from this, we can theorize an impact of 3D technologies on surgeon's learning&#xD;
      curves. This concern is recently being demonstrated in experimental and clinical setting with&#xD;
      improvement of hand-eye coordination, better laparoscopic skills and less time to learn&#xD;
      surgical procedure. Usually junior surgeons (JS) start their activities with cholecystectomy&#xD;
      and appendectomy but, despite an amount of literature regarding the first procedure, there is&#xD;
      a 'black hole' regarding the use of 3D imaging in laparoscopic appendectomy (LA).&#xD;
&#xD;
      The investigators decided to investigate the impact of 3D visualization on surgeons' and&#xD;
      surgical outcome during laparoscopic appendectomy (LA) performed by junior surgeons (JS).&#xD;
      Operative details and clinical aspect are both take in account in order to looking for any&#xD;
      advantages or concerns conferred on JS in performing LA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2018</start_date>
  <completion_date type="Actual">May 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>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Operative time.</measure>
    <time_frame>1 minute after surgery</time_frame>
    <description>Time taken for the completion of the procedure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Conversion to open appendectomy.</measure>
    <time_frame>1 minute after surgery</time_frame>
    <description>Compare the rate of conversion between each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative complication</measure>
    <time_frame>1 minute after surgery</time_frame>
    <description>Accidental bowel or bladder perforation, uncontrolled bleeding.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-operative complication. morbidity, readmission at 30th days, mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Post-operative complication. morbidity, readmission at 30th days, mortality</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Surgeon's comfort</measure>
    <time_frame>1 hour after surgery</time_frame>
    <description>based on questionnaire following the operation: LIKERT scale: from 1 to 5 points for 8 items divided in 2 evaluation: surgical outcome and surgical strain.&#xD;
Surgical outcome:&#xD;
item 1: surgical skill perception item 2: definition of surgical field item 3: deep perception&#xD;
Surgical strain:&#xD;
item1: hand and wrist strain item 2: neck strain item 3: back strain item 4: eye strain item 5: performance anxiety</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">128</enrollment>
  <condition>Appendicolith</condition>
  <condition>Appendicitis</condition>
  <condition>Appendicitis With Perforation</condition>
  <condition>Appendicitis Peritonitis</condition>
  <condition>Appendiceal Abscess</condition>
  <condition>Appendicitis Acute</condition>
  <arm_group>
    <arm_group_label>3D laparoscopic appendectomy.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Laparoscopic appendectomy will be performed with 3d technology device by young surgeons, tutored by an expert assistant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2D laparoscopic appendectomy.</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laparoscopic appendectomy will be performed by young surgeons (tutored by an expert assistant) with the standard 2D viewing method.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>3D Laparoscopic Appendectomy</intervention_name>
    <description>surgical removal of inflamed cecal appendix by 3D laparoscopic procedure</description>
    <arm_group_label>3D laparoscopic appendectomy.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>2D Laparoscopic Appendectomy</intervention_name>
    <description>surgical removal of inflamed cecal appendix by 2D laparoscopic procedure</description>
    <arm_group_label>2D laparoscopic appendectomy.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All adult patients scheduled to undergo laparoscopic appendectomy. Ages eligible for&#xD;
             study: &gt;18 Sexes eligible for study: All&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who decline to join the study&#xD;
&#xD;
          -  Patients under 18 years old&#xD;
&#xD;
          -  Patients with contraindication to undergo laparoscopic surgery.&#xD;
&#xD;
          -  Patients without appendicular disease found at laparoscopy (such as complicated&#xD;
             inflammatory bowel disease, tumor, complicated diverticula, gynecological disorder)&#xD;
&#xD;
          -  Patients undergoing open appendectomy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Presidio Ospedaliero di Montichiari, ASST degli Spedali Civili di Brescia</name>
      <address>
        <city>Montichiari</city>
        <state>Brescia</state>
        <zip>25018</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>August 28, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 10, 2018</study_first_posted>
  <last_update_submitted>May 31, 2019</last_update_submitted>
  <last_update_submitted_qc>May 31, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia</investigator_affiliation>
    <investigator_full_name>Nereo Vettoretto</investigator_full_name>
    <investigator_title>Head of Surgery, Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>3d Laparoscopy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Appendicitis</mesh_term>
    <mesh_term>Peritonitis</mesh_term>
  </condition_browse>
  <!-- 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/NCT03770897
org study id: NVettoretto
nct id: NCT03770897
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Laparoscopy has revolutionized the approach to a number of surgical problems causing a
      re-evaluation of several clinical strategies. Now it has become the standard treatment for
      majority of ailments including symptomatic gall stone disease, appendicitis, GERD
      (gastroesophageal reflux disease), morbid obesity and colorectal disease. All these
      developments aim at minimizing perioperative morbidities, providing rapid postoperative
      recovery and enhancing patient's safety profile. One of the major limitations of conventional
      laparoscopy is lack of depth perception. Introduction of 3D imaging, has removed many of
      these technical obstacles. In 1993, Becker et al., reported that a 3D display might improve
      laparoscopic skills. Since then, many researchers have demonstrated benefit of 3D imaging .
      Starting from this, we can theorize an impact of 3D technologies on surgeon's learning
      curves. This concern is recently being demonstrated in experimental and clinical setting with
      improvement of hand-eye coordination, better laparoscopic skills and less time to learn
      surgical procedure. Usually junior surgeons (JS) start their activities with cholecystectomy
      and appendectomy but, despite an amount of literature regarding the first procedure, there is
      a 'black hole' regarding the use of 3D imaging in laparoscopic appendectomy (LA).

      The investigators decided to investigate the impact of 3D visualization on surgeons' and
      surgical outcome during laparoscopic appendectomy (LA) performed by junior surgeons (JS).
      Operative details and clinical aspect are both take in account in order to looking for any
      advantages or concerns conferred on JS in performing LA.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Operative time.
time frame: 1 minute after surgery
description: Time taken for the completion of the procedure
measure: Conversion to open appendectomy.
time frame: 1 minute after surgery
description: Compare the rate of conversion between each arm.
measure: Intraoperative complication
time frame: 1 minute after surgery
description: Accidental bowel or bladder perforation, uncontrolled bleeding.
measure: Post-operative complication. morbidity, readmission at 30th days, mortality
time frame: 30 days
description: Post-operative complication. morbidity, readmission at 30th days, mortality
measure: Surgeon's comfort
time frame: 1 hour after surgery
description: based on questionnaire following the operation: LIKERT scale: from 1 to 5 points for 8 items divided in 2 evaluation: surgical outcome and surgical strain.
Surgical outcome:
item 1: surgical skill perception item 2: definition of surgical field item 3: deep perception
Surgical strain:
item1: hand and wrist strain item 2: neck strain item 3: back strain item 4: eye strain item 5: performance anxiety
arm group label: 3D laparoscopic appendectomy.
arm group type: Experimental
description: Laparoscopic appendectomy will be performed with 3d technology device by young surgeons, tutored by an expert assistant.
arm group label: 2D laparoscopic appendectomy.
arm group type: Active Comparator
description: Laparoscopic appendectomy will be performed by young surgeons (tutored by an expert assistant) with the standard 2D viewing method.
intervention type: Procedure
intervention name: 3D Laparoscopic Appendectomy
description: surgical removal of inflamed cecal appendix by 3D laparoscopic procedure
arm group label: 3D laparoscopic appendectomy.
intervention type: Procedure
intervention name: 2D Laparoscopic Appendectomy
description: surgical removal of inflamed cecal appendix by 2D laparoscopic procedure
arm group label: 2D laparoscopic appendectomy.
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia
investigator full name: Nereo Vettoretto
investigator title: Head of Surgery, Principal Investigator
mesh term: Appendicitis
mesh term: Peritonitis