<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/NCT03040544</url>
  </required_header>
  <id_info>
    <org_study_id>NOVICE trial</org_study_id>
    <nct_id>NCT03040544</nct_id>
  </id_info>
  <brief_title>Goal-directed MIS Simulation Training With the LTB-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE)</brief_title>
  <acronym>NOVICE</acronym>
  <official_title>Efficacy of Goal-directed Minimally Invasive Surgery Simulation Training With the Lübeck Toolbox-Curriculum Prior to First Operations on Patients: Study Protocol for a Multi-centre Randomized Controlled Validation Trial (NOVICE)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Schleswig-Holstein</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Schleswig-Holstein</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Laparoscopic surgical procedures have become increasingly established in&#xD;
      operative medicine. They require special motor, haptic, and spatial-visual skills to perform&#xD;
      the interventions safely and effectively. These minimally invasive surgery (MIS) basic skills&#xD;
      are often learned in the operating room (OR) on the patient. This is economically inefficient&#xD;
      and can be improved with regard to patient safety. Against the background of this problem,&#xD;
      various simulators and video-box trainer have been developed in order to train laparoscopic&#xD;
      basic skills outside the OR. The Lübecker Toolbox (LTB) curriculum is a video-based trainer&#xD;
      including standardized and validated exercises with defined targets, based on the skills of&#xD;
      experts MIS. Conducting MIS training outside the OR prior to performing the first MIS&#xD;
      procedures on patients could be a sensible and valuable contribution to effective surgical&#xD;
      education. An evidence of effectiveness in the practice transfer could have a considerable&#xD;
      relevance with regard to the integration of MIS training programs into surgical education&#xD;
      programs.&#xD;
&#xD;
      Aim of the study: The aim of the study is to investigate whether surgical residents without&#xD;
      previous active experience in MIS are able to improve laparoscopic skills in MIS procedures&#xD;
      in the OR, if they have successfully completed the LTB curriculum.&#xD;
&#xD;
      In the multicentric prospective study, will be conducted with surgical residents (SR) without&#xD;
      prior active experience in MIS (n=14). After the SR have completed their first laparoscopic&#xD;
      cholecystectomy (CHE), they will be randomized into two groups: 1) The intervention group&#xD;
      will perform the LTB-Curriculum, whereas 2) the control group will not undergo any MIS&#xD;
      training. After 6 weeks, both groups will perform the second laparoscopic CHE. Improvements&#xD;
      in operative performance (between CHE I and CHE II) will be evaluated according to the Global&#xD;
      Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 22, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 21, 2020</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>Global Operative Assessment of Laparoscopic Skill (GOALS)-Score</measure>
    <time_frame>end of inclusion of all participants</time_frame>
    <description>The GOALS score is an internationally established score for evaluating the MIS skills of a surgeon</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>operation time</measure>
    <time_frame>8-12 weeks</time_frame>
    <description>operation time of CHE I and CHE 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>percentage of the participants operating time in the total time of the CHE</measure>
    <time_frame>8-12 weeks</time_frame>
    <description>percentage of participants operating time in the total time of the CHE I and CHE II</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of takeovers by the specialist assisting the CHE</measure>
    <time_frame>8-12 weeks</time_frame>
    <description>experienced consultant surgeon will assist the CHE. The specialist can take over the operation at any time and perform surgical steps independently, according to his/her judgement with regard to the individual situation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>potential conversion to laparotomy</measure>
    <time_frame>8-12 weeks</time_frame>
    <description>potential conversion of the MIS CHE to open surgery</description>
  </secondary_outcome>
  <other_outcome>
    <measure>sex of participant</measure>
    <time_frame>8-12 weeks</time_frame>
    <description>sex of participant (male or female)</description>
  </other_outcome>
  <other_outcome>
    <measure>dominant hand of participant</measure>
    <time_frame>8-12 weeks</time_frame>
    <description>dominant hand of participant (right or left)</description>
  </other_outcome>
  <other_outcome>
    <measure>age of participant</measure>
    <time_frame>8-12 weeks</time_frame>
    <description>age of the participants</description>
  </other_outcome>
  <other_outcome>
    <measure>correlation with activities and hobbies</measure>
    <time_frame>8-12 weeks</time_frame>
    <description>in particular playing an instrument, handicrafts and computer games</description>
  </other_outcome>
  <other_outcome>
    <measure>inter-rater reliability</measure>
    <time_frame>8-12 weeks</time_frame>
    <description>possible differences and bias between video ratings by calculation</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">12</enrollment>
  <condition>Minimally Invasive Surgery Basic Skills</condition>
  <arm_group>
    <arm_group_label>LTB-Curriculum</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First group/arm undergo MIS training according to the LTB curriculum after the first own laparoscopic cholecystectomy in the OR as a baseline. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using the Global Operational Assessment of Laparoscopic Skill (GOALS) score.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no LTB-Curriculums</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Second group/arm will not undergo any MIS trains after their first laparoscopic CHE in the OR. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using GOALS score.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LTB-Curriculum</intervention_name>
    <description>The Lübeck Toolbox (LTB) curriculum has a structured training program, in which the laparoscopic basic skills are to be learned in six consecutive exercises. In doing so, the curriculum has precise targets for each of the six exercises based on the abilities of 15 MIS experts as a benchmark. The LTB curriculum is thus a structured training program with clear objectives that enable the technical learning of MIS basic skills comparable to the expert level.</description>
    <arm_group_label>LTB-Curriculum</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic cholecystectomy</intervention_name>
    <description>Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS</description>
    <arm_group_label>LTB-Curriculum</arm_group_label>
    <arm_group_label>no LTB-Curriculums</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  no motor or sensory restrictions when using surgical instruments surgical instruments.&#xD;
&#xD;
          -  no previous performed MIS simulation training&#xD;
&#xD;
          -  no previous performed MIS procedure ( any previous assisted MIS procedures are not an&#xD;
             exclusion criterion)&#xD;
&#xD;
          -  residents in surgical education for general or visceral surgery in Germany&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The participant are not allowed to perform any other MIS training programs during the&#xD;
             study period&#xD;
&#xD;
          -  Before the start of the study, participants are not allowed to have performed any&#xD;
             prior MIS simulation training or any MIS procedure&#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>Claudia Benecke, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical University Center Schleswig-Holstein Campus Lübeck</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tilman Laubert, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical University Center Schleswig-Holstein Campus Lübeck</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Michael Thomaschewski, MD</last_name>
    <phone>+491784007135</phone>
    <email>Michael.Thomaschewski@uksh.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Medical University Center Schleswig-Holstein Campus Lübeck, Department of surgery</name>
      <address>
        <city>Lubeck</city>
        <state>Schleswig-Holstein</state>
        <zip>23538</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Michael Thomaschewski, MD</last_name>
      <phone>+491784007135</phone>
      <email>Michael.Thomaschewski@uksh.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>January 29, 2017</study_first_submitted>
  <study_first_submitted_qc>January 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 2, 2017</study_first_posted>
  <last_update_submitted>May 12, 2020</last_update_submitted>
  <last_update_submitted_qc>May 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Schleswig-Holstein</investigator_affiliation>
    <investigator_full_name>Michael Thomschewski</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>minimally invasive surgery</keyword>
  <keyword>video-based trainer</keyword>
  <keyword>laparoscopic</keyword>
  <keyword>simulation training</keyword>
  <keyword>surgical education</keyword>
  <!-- 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/NCT03040544
org study id: NOVICE trial
nct id: NCT03040544
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Background: Laparoscopic surgical procedures have become increasingly established in
      operative medicine. They require special motor, haptic, and spatial-visual skills to perform
      the interventions safely and effectively. These minimally invasive surgery (MIS) basic skills
      are often learned in the operating room (OR) on the patient. This is economically inefficient
      and can be improved with regard to patient safety. Against the background of this problem,
      various simulators and video-box trainer have been developed in order to train laparoscopic
      basic skills outside the OR. The Lübecker Toolbox (LTB) curriculum is a video-based trainer
      including standardized and validated exercises with defined targets, based on the skills of
      experts MIS. Conducting MIS training outside the OR prior to performing the first MIS
      procedures on patients could be a sensible and valuable contribution to effective surgical
      education. An evidence of effectiveness in the practice transfer could have a considerable
      relevance with regard to the integration of MIS training programs into surgical education
      programs.

      Aim of the study: The aim of the study is to investigate whether surgical residents without
      previous active experience in MIS are able to improve laparoscopic skills in MIS procedures
      in the OR, if they have successfully completed the LTB curriculum.

      In the multicentric prospective study, will be conducted with surgical residents (SR) without
      prior active experience in MIS (n=14). After the SR have completed their first laparoscopic
      cholecystectomy (CHE), they will be randomized into two groups: 1) The intervention group
      will perform the LTB-Curriculum, whereas 2) the control group will not undergo any MIS
      training. After 6 weeks, both groups will perform the second laparoscopic CHE. Improvements
      in operative performance (between CHE I and CHE II) will be evaluated according to the Global
      Operative Assessment of Laparoscopic Skill (GOALS) Score (primary endpoint).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Global Operative Assessment of Laparoscopic Skill (GOALS)-Score
time frame: end of inclusion of all participants
description: The GOALS score is an internationally established score for evaluating the MIS skills of a surgeon
measure: operation time
time frame: 8-12 weeks
description: operation time of CHE I and CHE 2
measure: percentage of the participants operating time in the total time of the CHE
time frame: 8-12 weeks
description: percentage of participants operating time in the total time of the CHE I and CHE II
measure: number of takeovers by the specialist assisting the CHE
time frame: 8-12 weeks
description: experienced consultant surgeon will assist the CHE. The specialist can take over the operation at any time and perform surgical steps independently, according to his/her judgement with regard to the individual situation
measure: potential conversion to laparotomy
time frame: 8-12 weeks
description: potential conversion of the MIS CHE to open surgery
measure: sex of participant
time frame: 8-12 weeks
description: sex of participant (male or female)
measure: dominant hand of participant
time frame: 8-12 weeks
description: dominant hand of participant (right or left)
measure: age of participant
time frame: 8-12 weeks
description: age of the participants
measure: correlation with activities and hobbies
time frame: 8-12 weeks
description: in particular playing an instrument, handicrafts and computer games
measure: inter-rater reliability
time frame: 8-12 weeks
description: possible differences and bias between video ratings by calculation
arm group label: LTB-Curriculum
arm group type: Experimental
description: First group/arm undergo MIS training according to the LTB curriculum after the first own laparoscopic cholecystectomy in the OR as a baseline. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using the Global Operational Assessment of Laparoscopic Skill (GOALS) score.
arm group label: no LTB-Curriculums
arm group type: Active Comparator
description: Second group/arm will not undergo any MIS trains after their first laparoscopic CHE in the OR. After 6 weeks, the participants in this group/arm will perform their second CHE. The video recordings of the MIS procedures will be analysed and compared using GOALS score.
intervention type: Procedure
intervention name: LTB-Curriculum
description: The Lübeck Toolbox (LTB) curriculum has a structured training program, in which the laparoscopic basic skills are to be learned in six consecutive exercises. In doing so, the curriculum has precise targets for each of the six exercises based on the abilities of 15 MIS experts as a benchmark. The LTB curriculum is thus a structured training program with clear objectives that enable the technical learning of MIS basic skills comparable to the expert level.
arm group label: LTB-Curriculum
intervention type: Procedure
intervention name: Laparoscopic cholecystectomy
description: Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS
arm group label: LTB-Curriculum
arm group label: no LTB-Curriculums
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Claudia Benecke, MD
role: Study Director
affiliation: Medical University Center Schleswig-Holstein Campus Lübeck
last name: Tilman Laubert, MD
role: Study Director
affiliation: Medical University Center Schleswig-Holstein Campus Lübeck
last name: Michael Thomaschewski, MD
phone: +491784007135
email: Michael.Thomaschewski@uksh.de
facility: 
status: Recruiting
contact: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Schleswig-Holstein
investigator full name: Michael Thomschewski
investigator title: Dr.