One or two trainees per workplace in a structured multimodality training curriculum for laparoscopic surgery? Study protocol for a randomized controlled trial – DRKS00004675
Identifieur interne : 000F81 ( Main/Exploration ); précédent : 000F80; suivant : 000F82One or two trainees per workplace in a structured multimodality training curriculum for laparoscopic surgery? Study protocol for a randomized controlled trial – DRKS00004675
Auteurs : Felix Nickel [Allemagne] ; Felix Jede [Allemagne] ; Andreas Minassian [Allemagne] ; Matthias Gondan [Danemark] ; Jonathan D. Hendrie [Allemagne] ; Tobias Gehrig [Allemagne] ; Georg R. Linke [Allemagne] ; Martina Kadmon [Allemagne] ; Lars Fischer [Allemagne] ; Beat P. Müller-Stich [Allemagne]Source :
- Trials [ 1745-6215 ] ; 2014.
Abstract
Laparoscopy training courses have been established in many centers worldwide to ensure adequate skill learning before performing operations on patients. Different training modalities and their combinations have been compared regarding training effects. Multimodality training combines different approaches for optimal training outcome. However, no standards currently exist for the number of trainees assigned per workplace.
This is a monocentric, open, three-arm randomized controlled trial. The participants are laparoscopically-naive medical students from Heidelberg University. After a standardized introduction to laparoscopic cholecystectomy (LC) with online learning modules, the participants perform a baseline test for basic skills and LC performance on a virtual reality (VR) trainer. A total of 100 students will be randomized into three study arms, in a 2:2:1 ratio. The intervention groups participate individually (Group 1) or in pairs (Group 2) in a standardized and structured multimodality training curriculum. Basic skills are trained on the box and VR trainers. Procedural skills and LC modules are trained on the VR trainer. The control group (Group C) does not receive training between tests. A post-test is performed to reassess basic skills and LC performance on the VR trainer. The performance of a cadaveric porcine LC is then measured as the primary outcome using standardized and validated ratings by blinded experts with the Objective Structured Assessment of Technical Skills. The Global Operative Assessment of Laparoscopic Surgical skills score and the time taken for completion are used as secondary outcome measures as well as the improvement of skills and VR LC performance between baseline and post-test. Cognitive tests and questionnaires are used to identify individual factors that might exert influence on training outcome.
This study aims to assess whether workplaces in laparoscopy training courses for beginners should be used by one trainee or two trainees simultaneously, by measuring the impact on operative performance and learning curves. Possible factors of influence, such as the role of observing the training partner, exchange of thoughts, active reflection, model learning, motivation, pauses, and sympathy will be explored in the data analysis. This study will help optimize the efficiency of laparoscopy training courses.
Url:
DOI: 10.1186/1745-6215-15-137
PubMed: 24754961
PubMed Central: 3999459
Affiliations:
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Linke</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Kadmon, Martina" sort="Kadmon, Martina" uniqKey="Kadmon M" first="Martina" last="Kadmon">Martina Kadmon</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Fischer, Lars" sort="Fischer, Lars" uniqKey="Fischer L" first="Lars" last="Fischer">Lars Fischer</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Muller Stich, Beat P" sort="Muller Stich, Beat P" uniqKey="Muller Stich B" first="Beat P" last="Müller-Stich">Beat P. Müller-Stich</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24754961</idno><idno type="pmc">3999459</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3999459</idno><idno type="RBID">PMC:3999459</idno><idno type="doi">10.1186/1745-6215-15-137</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">001287</idno><idno type="wicri:Area/Pmc/Curation">001287</idno><idno type="wicri:Area/Pmc/Checkpoint">000A62</idno><idno type="wicri:Area/Ncbi/Merge">002F09</idno><idno type="wicri:Area/Ncbi/Curation">002F09</idno><idno type="wicri:Area/Ncbi/Checkpoint">002F09</idno><idno type="wicri:Area/Main/Merge">000F81</idno><idno type="wicri:Area/Main/Curation">000F81</idno><idno type="wicri:Area/Main/Exploration">000F81</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">One or two trainees per workplace in a structured multimodality training curriculum for laparoscopic surgery? Study protocol for a randomized controlled trial – DRKS00004675</title><author><name sortKey="Nickel, Felix" sort="Nickel, Felix" uniqKey="Nickel F" first="Felix" last="Nickel">Felix Nickel</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Jede, Felix" sort="Jede, Felix" uniqKey="Jede F" first="Felix" last="Jede">Felix Jede</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Minassian, Andreas" sort="Minassian, Andreas" uniqKey="Minassian A" first="Andreas" last="Minassian">Andreas Minassian</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Gondan, Matthias" sort="Gondan, Matthias" uniqKey="Gondan M" first="Matthias" last="Gondan">Matthias Gondan</name><affiliation wicri:level="1"><nlm:aff id="I2">Department of Psychology, University of Copenhagen, Oster Farimagsgade 2A, 1353 Copenhagen, Denmark</nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea>Department of Psychology, University of Copenhagen, Oster Farimagsgade 2A, 1353 Copenhagen</wicri:regionArea><placeName><settlement type="city">Copenhague</settlement><region type="région" nuts="2">Hovedstaden</region></placeName></affiliation></author><author><name sortKey="Hendrie, Jonathan D" sort="Hendrie, Jonathan D" uniqKey="Hendrie J" first="Jonathan D" last="Hendrie">Jonathan D. Hendrie</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Gehrig, Tobias" sort="Gehrig, Tobias" uniqKey="Gehrig T" first="Tobias" last="Gehrig">Tobias Gehrig</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Linke, Georg R" sort="Linke, Georg R" uniqKey="Linke G" first="Georg R" last="Linke">Georg R. Linke</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Kadmon, Martina" sort="Kadmon, Martina" uniqKey="Kadmon M" first="Martina" last="Kadmon">Martina Kadmon</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Fischer, Lars" sort="Fischer, Lars" uniqKey="Fischer L" first="Lars" last="Fischer">Lars Fischer</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author><author><name sortKey="Muller Stich, Beat P" sort="Muller Stich, Beat P" uniqKey="Muller Stich B" first="Beat P" last="Müller-Stich">Beat P. Müller-Stich</name><affiliation wicri:level="3"><nlm:aff id="I1">Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany</nlm:aff><country xml:lang="fr">Allemagne</country><wicri:regionArea>Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg</wicri:regionArea><placeName><region type="land" nuts="1">Bade-Wurtemberg</region><region type="district" nuts="2">District de Karlsruhe</region><settlement type="city">Heidelberg</settlement></placeName></affiliation></author></analytic><series><title level="j">Trials</title><idno type="eISSN">1745-6215</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>Laparoscopy training courses have been established in many centers worldwide to ensure adequate skill learning before performing operations on patients. Different training modalities and their combinations have been compared regarding training effects. Multimodality training combines different approaches for optimal training outcome. However, no standards currently exist for the number of trainees assigned per workplace.</p></sec><sec><title>Methods</title><p>This is a monocentric, open, three-arm randomized controlled trial. The participants are laparoscopically-naive medical students from Heidelberg University. After a standardized introduction to laparoscopic cholecystectomy (LC) with online learning modules, the participants perform a baseline test for basic skills and LC performance on a virtual reality (VR) trainer. A total of 100 students will be randomized into three study arms, in a 2:2:1 ratio. The intervention groups participate individually (Group 1) or in pairs (Group 2) in a standardized and structured multimodality training curriculum. Basic skills are trained on the box and VR trainers. Procedural skills and LC modules are trained on the VR trainer. The control group (Group C) does not receive training between tests. A post-test is performed to reassess basic skills and LC performance on the VR trainer. The performance of a cadaveric porcine LC is then measured as the primary outcome using standardized and validated ratings by blinded experts with the Objective Structured Assessment of Technical Skills. The Global Operative Assessment of Laparoscopic Surgical skills score and the time taken for completion are used as secondary outcome measures as well as the improvement of skills and VR LC performance between baseline and post-test. Cognitive tests and questionnaires are used to identify individual factors that might exert influence on training outcome.</p></sec><sec><title>Discussion</title><p>This study aims to assess whether workplaces in laparoscopy training courses for beginners should be used by one trainee or two trainees simultaneously, by measuring the impact on operative performance and learning curves. Possible factors of influence, such as the role of observing the training partner, exchange of thoughts, active reflection, model learning, motivation, pauses, and sympathy will be explored in the data analysis. This study will help optimize the efficiency of laparoscopy training courses.</p></sec><sec><title>Trial registration number</title><p><ext-link ext-link-type="uri" xlink:href="http://www.germanctr.de/">DRKS00004675</ext-link></p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct></biblStruct><biblStruct></biblStruct><biblStruct><analytic><author><name sortKey="Hamad, Gg" uniqKey="Hamad G">GG Hamad</name></author><author><name sortKey="Curet, M" uniqKey="Curet M">M Curet</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Harrell, Ag" uniqKey="Harrell A">AG Harrell</name></author><author><name sortKey="Heniford, Bt" uniqKey="Heniford B">BT Heniford</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Aggarwal, R" uniqKey="Aggarwal R">R Aggarwal</name></author><author><name sortKey="Balasundaram, I" uniqKey="Balasundaram I">I Balasundaram</name></author><author><name sortKey="Darzi, A" uniqKey="Darzi 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Maan</name></author><author><name sortKey="Darzi, Aw" uniqKey="Darzi A">AW Darzi</name></author><author><name sortKey="Aggarwal, R" uniqKey="Aggarwal R">R Aggarwal</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Wong, G" uniqKey="Wong G">G Wong</name></author><author><name sortKey="Greenhalgh, T" uniqKey="Greenhalgh T">T Greenhalgh</name></author><author><name sortKey="Pawson, R" uniqKey="Pawson R">R Pawson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Grantcharov, Tp" uniqKey="Grantcharov T">TP Grantcharov</name></author><author><name sortKey="Bardram, L" uniqKey="Bardram L">L Bardram</name></author><author><name sortKey="Funch Jensen, P" uniqKey="Funch Jensen P">P Funch-Jensen</name></author><author><name sortKey="Rosenberg, J" uniqKey="Rosenberg J">J Rosenberg</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Madan, Ak" uniqKey="Madan A">AK Madan</name></author><author><name sortKey="Harper, Jl" uniqKey="Harper J">JL Harper</name></author><author><name sortKey="Frantzides, Ct" uniqKey="Frantzides C">CT Frantzides</name></author><author><name sortKey="Tichansky, Ds" uniqKey="Tichansky D">DS Tichansky</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Sarker, Sk" uniqKey="Sarker S">SK Sarker</name></author><author><name sortKey="Chang, A" uniqKey="Chang A">A Chang</name></author><author><name sortKey="Vincent, C" uniqKey="Vincent C">C Vincent</name></author><author><name sortKey="Darzi, Sa" uniqKey="Darzi S">SA Darzi</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Buckley, Ce" uniqKey="Buckley C">CE Buckley</name></author><author><name sortKey="Kavanagh, Do" uniqKey="Kavanagh D">DO Kavanagh</name></author><author><name sortKey="Gallagher, Tk" uniqKey="Gallagher T">TK Gallagher</name></author><author><name sortKey="Conroy, Rm" uniqKey="Conroy R">RM Conroy</name></author><author><name sortKey="Traynor, Oj" uniqKey="Traynor O">OJ Traynor</name></author><author><name sortKey="Neary, Pc" uniqKey="Neary P">PC Neary</name></author></analytic></biblStruct></listBibl></div1></back></TEI><affiliations><list><country><li>Allemagne</li><li>Danemark</li></country><region><li>Bade-Wurtemberg</li><li>District de Karlsruhe</li><li>Hovedstaden</li></region><settlement><li>Copenhague</li><li>Heidelberg</li></settlement></list><tree><country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Nickel, Felix" sort="Nickel, Felix" uniqKey="Nickel F" first="Felix" last="Nickel">Felix Nickel</name></region><name sortKey="Fischer, Lars" sort="Fischer, Lars" uniqKey="Fischer L" first="Lars" last="Fischer">Lars Fischer</name><name sortKey="Gehrig, Tobias" sort="Gehrig, Tobias" uniqKey="Gehrig T" first="Tobias" last="Gehrig">Tobias Gehrig</name><name sortKey="Hendrie, Jonathan D" sort="Hendrie, Jonathan D" uniqKey="Hendrie J" first="Jonathan D" last="Hendrie">Jonathan D. Hendrie</name><name sortKey="Jede, Felix" sort="Jede, Felix" uniqKey="Jede F" first="Felix" last="Jede">Felix Jede</name><name sortKey="Kadmon, Martina" sort="Kadmon, Martina" uniqKey="Kadmon M" first="Martina" last="Kadmon">Martina Kadmon</name><name sortKey="Linke, Georg R" sort="Linke, Georg R" uniqKey="Linke G" first="Georg R" last="Linke">Georg R. Linke</name><name sortKey="Minassian, Andreas" sort="Minassian, Andreas" uniqKey="Minassian A" first="Andreas" last="Minassian">Andreas Minassian</name><name sortKey="Muller Stich, Beat P" sort="Muller Stich, Beat P" uniqKey="Muller Stich B" first="Beat P" last="Müller-Stich">Beat P. Müller-Stich</name></country><country name="Danemark"><region name="Hovedstaden"><name sortKey="Gondan, Matthias" sort="Gondan, Matthias" uniqKey="Gondan M" first="Matthias" last="Gondan">Matthias Gondan</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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