Training for laparoscopic Nissen fundoplication with a newly designed model: a replacement for animal tissue models?
Identifieur interne : 000890 ( Pmc/Curation ); précédent : 000889; suivant : 000891Training for laparoscopic Nissen fundoplication with a newly designed model: a replacement for animal tissue models?
Auteurs : Sanne M. B. I. Botden [Pays-Bas] ; Lorna Christie [Royaume-Uni] ; Richard Goossens [Pays-Bas] ; Jack J. Jakimowicz [Pays-Bas]Source :
- Surgical Endoscopy [ 0930-2794 ] ; 2010.
Abstract
To bridge the early learning curve for laparoscopic Nissen fundoplication from the clinical setting to a safe environment, training models can be used. This study aimed to develop a reusable, low-cost model to be used for training in laparoscopic Nissen fundoplication procedure as an alternative to the use of animal tissue models.
From artificial organs and tissue, an anatomic model of the human upper abdomen was developed for training in performing laparoscopic Nissen fundoplication. The 20 participants and tutors in the European Association for Endoscopic Surgery (EAES) upper gastrointestinal surgery course completed four complementary tasks of laparoscopic Nissen fundoplication with the artificial model, then compared the realism, haptic feedback, and training properties of the model with those of animal tissue models.
The main difference between the two training models was seen in the properties of the stomach. The wrapping of the stomach in the artificial model was rated significantly lower than that in the animal tissue model (mean, 3.6 vs. 4.2;
The newly developed model is regarded as a good tool for training in laparoscopic Nissen fundoplication procedure. It is cheaper, more durable, and more readily available for training and can therefore be used in every training center. The stomach of this model, however, still needs improvement because it is too rigid for making the wrap.
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DOI: 10.1007/s00464-010-1104-0
PubMed: 20526629
PubMed Central: 2982997
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Training for laparoscopic Nissen fundoplication with a newly designed model: a replacement for animal tissue models?</title><author><name sortKey="Botden, Sanne M B I" sort="Botden, Sanne M B I" uniqKey="Botden S" first="Sanne M. B. I." last="Botden">Sanne M. B. I. Botden</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 ZA Eindhoven, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 ZA Eindhoven</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Faculty of Industrial Design Engineering, Delft University of Technology, Delft, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Faculty of Industrial Design Engineering, Delft University of Technology, Delft</wicri:regionArea></affiliation></author><author><name sortKey="Christie, Lorna" sort="Christie, Lorna" uniqKey="Christie L" first="Lorna" last="Christie">Lorna Christie</name><affiliation wicri:level="1"><nlm:aff id="Aff3">Cuschieri Skills Centre, Dundee, Scotland, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Cuschieri Skills Centre, Dundee, Scotland</wicri:regionArea></affiliation></author><author><name sortKey="Goossens, Richard" sort="Goossens, Richard" uniqKey="Goossens R" first="Richard" last="Goossens">Richard Goossens</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Faculty of Industrial Design Engineering, Delft University of Technology, Delft, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Faculty of Industrial Design Engineering, Delft University of Technology, Delft</wicri:regionArea></affiliation></author><author><name sortKey="Jakimowicz, Jack J" sort="Jakimowicz, Jack J" uniqKey="Jakimowicz J" first="Jack J." last="Jakimowicz">Jack J. Jakimowicz</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 ZA Eindhoven, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 ZA Eindhoven</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Faculty of Industrial Design Engineering, Delft University of Technology, Delft, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Faculty of Industrial Design Engineering, Delft University of Technology, Delft</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">20526629</idno><idno type="pmc">2982997</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2982997</idno><idno type="RBID">PMC:2982997</idno><idno type="doi">10.1007/s00464-010-1104-0</idno><date when="2010">2010</date><idno type="wicri:Area/Pmc/Corpus">000890</idno><idno type="wicri:Area/Pmc/Curation">000890</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">Training for laparoscopic Nissen fundoplication with a newly designed model: a replacement for animal tissue models?</title><author><name sortKey="Botden, Sanne M B I" sort="Botden, Sanne M B I" uniqKey="Botden S" first="Sanne M. B. I." last="Botden">Sanne M. B. I. Botden</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 ZA Eindhoven, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 ZA Eindhoven</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Faculty of Industrial Design Engineering, Delft University of Technology, Delft, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Faculty of Industrial Design Engineering, Delft University of Technology, Delft</wicri:regionArea></affiliation></author><author><name sortKey="Christie, Lorna" sort="Christie, Lorna" uniqKey="Christie L" first="Lorna" last="Christie">Lorna Christie</name><affiliation wicri:level="1"><nlm:aff id="Aff3">Cuschieri Skills Centre, Dundee, Scotland, UK</nlm:aff><country xml:lang="fr">Royaume-Uni</country><wicri:regionArea>Cuschieri Skills Centre, Dundee, Scotland</wicri:regionArea></affiliation></author><author><name sortKey="Goossens, Richard" sort="Goossens, Richard" uniqKey="Goossens R" first="Richard" last="Goossens">Richard Goossens</name><affiliation wicri:level="1"><nlm:aff id="Aff2">Faculty of Industrial Design Engineering, Delft University of Technology, Delft, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Faculty of Industrial Design Engineering, Delft University of Technology, Delft</wicri:regionArea></affiliation></author><author><name sortKey="Jakimowicz, Jack J" sort="Jakimowicz, Jack J" uniqKey="Jakimowicz J" first="Jack J." last="Jakimowicz">Jack J. Jakimowicz</name><affiliation wicri:level="1"><nlm:aff id="Aff1">Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 ZA Eindhoven, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 ZA Eindhoven</wicri:regionArea></affiliation><affiliation wicri:level="1"><nlm:aff id="Aff2">Faculty of Industrial Design Engineering, Delft University of Technology, Delft, The Netherlands</nlm:aff><country xml:lang="fr">Pays-Bas</country><wicri:regionArea>Faculty of Industrial Design Engineering, Delft University of Technology, Delft</wicri:regionArea></affiliation></author></analytic><series><title level="j">Surgical Endoscopy</title><idno type="ISSN">0930-2794</idno><idno type="eISSN">1432-2218</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><sec><title>Background</title><p>To bridge the early learning curve for laparoscopic Nissen fundoplication from the clinical setting to a safe environment, training models can be used. This study aimed to develop a reusable, low-cost model to be used for training in laparoscopic Nissen fundoplication procedure as an alternative to the use of animal tissue models.</p></sec><sec><title>Methods</title><p>From artificial organs and tissue, an anatomic model of the human upper abdomen was developed for training in performing laparoscopic Nissen fundoplication. The 20 participants and tutors in the European Association for Endoscopic Surgery (EAES) upper gastrointestinal surgery course completed four complementary tasks of laparoscopic Nissen fundoplication with the artificial model, then compared the realism, haptic feedback, and training properties of the model with those of animal tissue models.</p></sec><sec><title>Results</title><p>The main difference between the two training models was seen in the properties of the stomach. The wrapping of the stomach in the artificial model was rated significantly lower than that in the animal tissue model (mean, 3.6 vs. 4.2; <italic>p</italic> = 0.010). The main criticism of the stomach of the artificial model was that it was too rigid for making a proper wrap. The suturing of the stomach wall, however, was regarded as fairly realistic (mean, 3.6). The crura on the artificial model were rated better (mean, 4.3) than those on the animal tissue (mean, 4.0), although the difference was not significant. The participants regarded the model as a good to excellent (mean, 4.3) training tool.</p></sec><sec><title>Conclusion</title><p>The newly developed model is regarded as a good tool for training in laparoscopic Nissen fundoplication procedure. It is cheaper, more durable, and more readily available for training and can therefore be used in every training center. The stomach of this model, however, still needs improvement because it is too rigid for making the wrap.</p></sec></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Soot, Sj" uniqKey="Soot S">SJ Soot</name></author><author><name sortKey="Eshraghi, N" uniqKey="Eshraghi N">N Eshraghi</name></author><author><name sortKey="Farahmand, M" uniqKey="Farahmand M">M Farahmand</name></author><author><name sortKey="Sheppard, Bc" uniqKey="Sheppard B">BC Sheppard</name></author><author><name sortKey="Deveney, Cw" uniqKey="Deveney C">CW Deveney</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Watson, Di" uniqKey="Watson D">DI Watson</name></author><author><name sortKey="Baignie, Rj" uniqKey="Baignie R">RJ Baignie</name></author><author><name sortKey="Jamieson, Gg" uniqKey="Jamieson G">GG Jamieson</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Bais, Je" uniqKey="Bais J">JE 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Surg Endosc</journal-id><journal-title-group><journal-title>Surgical Endoscopy</journal-title></journal-title-group><issn pub-type="ppub">0930-2794</issn><issn pub-type="epub">1432-2218</issn><publisher><publisher-name>Springer-Verlag</publisher-name><publisher-loc>New York</publisher-loc></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">20526629</article-id><article-id pub-id-type="pmc">2982997</article-id><article-id pub-id-type="publisher-id">1104</article-id><article-id pub-id-type="doi">10.1007/s00464-010-1104-0</article-id><article-categories><subj-group subj-group-type="heading"><subject>Article</subject></subj-group></article-categories><title-group><article-title>Training for laparoscopic Nissen fundoplication with a newly designed model: a replacement for animal tissue models?</article-title></title-group><contrib-group><contrib contrib-type="author" corresp="yes"><name><surname>Botden</surname><given-names>Sanne M. B. I.</given-names></name><address><phone>+31-6-42396621</phone><fax>+31-40-2443370</fax><email>Sanne.Botden@cze.nl</email><email>Sanne_Botden@hotmail.com</email></address><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Christie</surname><given-names>Lorna</given-names></name><address><email>l.s.christie@dundee.ac.uk</email></address><xref ref-type="aff" rid="Aff3">3</xref></contrib><contrib contrib-type="author"><name><surname>Goossens</surname><given-names>Richard</given-names></name><xref ref-type="aff" rid="Aff2">2</xref></contrib><contrib contrib-type="author"><name><surname>Jakimowicz</surname><given-names>Jack J.</given-names></name><xref ref-type="aff" rid="Aff1">1</xref><xref ref-type="aff" rid="Aff2">2</xref></contrib><aff id="Aff1"><label>1</label>Department of Surgery, Catharina Hospital Eindhoven, Michelangelolaan 2, 5623 ZA Eindhoven, The Netherlands</aff><aff id="Aff2"><label>2</label>Faculty of Industrial Design Engineering, Delft University of Technology, Delft, The Netherlands</aff><aff id="Aff3"><label>3</label>Cuschieri Skills Centre, Dundee, Scotland, UK</aff></contrib-group><pub-date pub-type="epub"><day>5</day><month>6</month><year>2010</year></pub-date><pub-date pub-type="pmc-release"><day>5</day><month>6</month><year>2010</year></pub-date><pub-date pub-type="ppub"><month>12</month><year>2010</year></pub-date><volume>24</volume><issue>12</issue><fpage>3134</fpage><lpage>3140</lpage><history><date date-type="received"><day>18</day><month>1</month><year>2009</year></date><date date-type="accepted"><day>14</day><month>8</month><year>2009</year></date></history><permissions><copyright-statement>© The Author(s) 2010</copyright-statement></permissions><abstract><sec><title>Background</title><p>To bridge the early learning curve for laparoscopic Nissen fundoplication from the clinical setting to a safe environment, training models can be used. This study aimed to develop a reusable, low-cost model to be used for training in laparoscopic Nissen fundoplication procedure as an alternative to the use of animal tissue models.</p></sec><sec><title>Methods</title><p>From artificial organs and tissue, an anatomic model of the human upper abdomen was developed for training in performing laparoscopic Nissen fundoplication. The 20 participants and tutors in the European Association for Endoscopic Surgery (EAES) upper gastrointestinal surgery course completed four complementary tasks of laparoscopic Nissen fundoplication with the artificial model, then compared the realism, haptic feedback, and training properties of the model with those of animal tissue models.</p></sec><sec><title>Results</title><p>The main difference between the two training models was seen in the properties of the stomach. The wrapping of the stomach in the artificial model was rated significantly lower than that in the animal tissue model (mean, 3.6 vs. 4.2; <italic>p</italic> = 0.010). The main criticism of the stomach of the artificial model was that it was too rigid for making a proper wrap. The suturing of the stomach wall, however, was regarded as fairly realistic (mean, 3.6). The crura on the artificial model were rated better (mean, 4.3) than those on the animal tissue (mean, 4.0), although the difference was not significant. The participants regarded the model as a good to excellent (mean, 4.3) training tool.</p></sec><sec><title>Conclusion</title><p>The newly developed model is regarded as a good tool for training in laparoscopic Nissen fundoplication procedure. It is cheaper, more durable, and more readily available for training and can therefore be used in every training center. The stomach of this model, however, still needs improvement because it is too rigid for making the wrap.</p></sec></abstract><kwd-group><title>Keywords</title><kwd>Animal tissue model</kwd><kwd>Artificial model</kwd><kwd>Laparoscopic training</kwd><kwd>Procedural training</kwd></kwd-group><custom-meta-group><custom-meta><meta-name>issue-copyright-statement</meta-name><meta-value>© Springer Science+Business Media, LLC 2010</meta-value></custom-meta></custom-meta-group></article-meta></front><body><p>Laparoscopic Nissen fundoplication requires the ability to perform an operation in multiple planes in a three-dimensional environment with two-dimensional visual feedback. The acquisition of these skills and the need to acquire facility using new instruments, suturing techniques, and new technological devices are challenges in performing a safe and effective operation [<xref ref-type="bibr" rid="CR1">1</xref>, <xref ref-type="bibr" rid="CR2">2</xref>].</p><p>Studies have shown laparoscopic Nissen fundoplication to be safe and as effective as open fundoplication [<xref ref-type="bibr" rid="CR1">1</xref>, <xref ref-type="bibr" rid="CR3">3</xref>–<xref ref-type="bibr" rid="CR7">7</xref>], and it has become the preferred surgical option [<xref ref-type="bibr" rid="CR1">1</xref>, <xref ref-type="bibr" rid="CR3">3</xref>]. However, reports have described higher risks for complications with the laparoscopic approach such as esophageal perforation, acute paraesophageal herniation, and stenosis of the esophageal hiatus and pneumothorax [<xref ref-type="bibr" rid="CR2">2</xref>, <xref ref-type="bibr" rid="CR7">7</xref>, <xref ref-type="bibr" rid="CR8">8</xref>]. Also, studies have shown a higher reoperation rate at the early stages of the laparoscopic approach, which decreased with increasing experience [<xref ref-type="bibr" rid="CR2">2</xref>, <xref ref-type="bibr" rid="CR6">6</xref>, <xref ref-type="bibr" rid="CR9">9</xref>].</p><p>A learning curve of 20 procedures per surgeon individually was established previously for laparoscopic fundoplication [<xref ref-type="bibr" rid="CR1">1</xref>, <xref ref-type="bibr" rid="CR2">2</xref>, <xref ref-type="bibr" rid="CR10">10</xref>], although it is recognized that individuals may progress at different rates. Various factors may influence the length of a learning curve and its consequences for patients [<xref ref-type="bibr" rid="CR2">2</xref>]. Important indicators denoting the learning curve for laparoscopic surgery are the conversion rate and operative complications. When individual experiences are examined, it is apparent that problems are most likely to occur during the first five procedures performed by individual surgeons [<xref ref-type="bibr" rid="CR2">2</xref>], with a complication rate of 24% to 55% at the beginning of the learning curve [<xref ref-type="bibr" rid="CR1">1</xref>, <xref ref-type="bibr" rid="CR2">2</xref>, <xref ref-type="bibr" rid="CR5">5</xref>, <xref ref-type="bibr" rid="CR9">9</xref>]. The rate of complications (including reoperations and conversion) declines to approximately 10% during the next 15–25 procedures, with little further improvement beyond this point [<xref ref-type="bibr" rid="CR2">2</xref>].</p><p>Most conversions during the first 20 cases were performed for technical reasons such as adequate dissection of the posterior “window” behind the oesophagus, division of the short gastric vessels and fundal mobilization, closure of the diaphragmatic crura, and suture of the fundoplication [<xref ref-type="bibr" rid="CR1">1</xref>]. Once these steps were learned, conversion rates remained low (2–10%) [<xref ref-type="bibr" rid="CR1">1</xref>, <xref ref-type="bibr" rid="CR2">2</xref>, <xref ref-type="bibr" rid="CR6">6</xref>, <xref ref-type="bibr" rid="CR9">9</xref>, <xref ref-type="bibr" rid="CR10">10</xref>].</p><p>Currently, animal tissue models are used regularly in skills centers to train for laparoscopic procedures such as the Nissen fundoplication outside the clinical setting [<xref ref-type="bibr" rid="CR11">11</xref>, <xref ref-type="bibr" rid="CR12">12</xref>]. The animal organs are prepared and preserved until they are used for practice. However, the animals providing the organs usually are specially bred for these purposes and therefore expensive. In a few selected centers, surgeons still practice their procedural skills on live animals, but because of ethical objections and high costs, these are not used frequently.</p><p>To have an alternative for the animal tissue models, an anatomic model of the upper abdomen was developed to train for laparoscopic Nissen fundoplication. This model can be combined with an instruction video and step-by-step demonstration videos to bridge the early learning curve in the clinical setting to a safe environment. This study aimed to develop a reusable, low-cost model that can be used as a tool to be used in training for laparoscopic Nissen fundoplication.</p><sec id="Sec1" sec-type="materials|methods"><title>Materials and methods</title><sec id="Sec2"><title>Artificial model</title><p>The artificial model was developed by independent researchers from the Technical University of Delft and the Catharina Hospital Eindhoven in The Netherlands. Before development of the organs, the mechanical characteristics of the tissue were examined, and material that most closely resembled these characteristics was used to produce the separate organs. The physical proportions of the organs were derived from three-dimensional imaging of a computed tomography (CT) scan of the human anatomy to resemble the clinical setting closely. The model included the parts important in both the visual and tactile aspects of the training for laparoscopic Nissen fundoplication. Thus, all anatomic structures that could be either seen or touched during execution of the procedure were integrated into the model. If an organ could not be recreated realistically or did not have a significant influence on the training for the procedure, it was excluded from the model.</p><p>The model (Figs. <xref rid="Fig1" ref-type="fig">1</xref>, <xref rid="Fig2" ref-type="fig">2</xref>) included the stomach with the omentum minor and major and the short gastric vessels (vasa brevia) attached to it as well as the esophagus attached to the stomach, which entered the mediastinum through the opening between the crura. The crura were covered with a peritoneal layer, which had to be dissected to free the esophagus. The liver had to be held up by a liver retractor for visualization of the operating field. The model also included the spleen, to which the short gastric vessels were connected.<fig id="Fig1"><label>Fig. 1</label><caption><p>Artificial model for Nissen fundoplication in which the liver is held up to show the operating field</p></caption><graphic xlink:href="464_2010_1104_Fig1_HTML" id="MO1"></graphic></fig><fig id="Fig2"><label>Fig. 2</label><caption><p>Vision of the artificial model shown on the screen during the performance of Nissen fundoplication. The liver is being held up by a liver retractor</p></caption><graphic xlink:href="464_2010_1104_Fig2_HTML" id="MO2"></graphic></fig></p><p>The connections between the different organs were by velcro, pins, or buttons to make it easy and fast to replace the disposable parts (peritoneal layer over crura and omentum with short gastric vessels). The stomach and crura could be used 15–20 times, but the peritoneal layer and omentum had to be replaced after every practice.</p></sec><sec id="Sec3"><title>Training module</title><p>The laparoscopic Nissen fundoplication procedure [<xref ref-type="bibr" rid="CR1">1</xref>, <xref ref-type="bibr" rid="CR6">6</xref>, <xref ref-type="bibr" rid="CR13">13</xref>, <xref ref-type="bibr" rid="CR14">14</xref>] was divided into multiple steps, and the importance of each step to be trained preclinically was determined. The ability to perform these steps of the procedure on the model and the importance of each step, together with the limitations of the model itself, concluded in four component tasks.</p><p>Figure <xref rid="Fig3" ref-type="fig">3</xref> shows the four complementary tasks that could be practiced on the model by the participants. In the first task, the lesser omentum had to be opened, after which the phrenoesophageal ligament had to be divided to free both the left and right crura. The esophagus had to be totally free, and the participant had to be able to pull it into the abdomen. In the second task, the short gastric vessels (vasa brevia) had to be dissected to ensure that the fundus would be mobile enough to make the wrap. Therefore, the gastrophrenic attachment also had to be dissected. In the third task, the crura had to be sutured with two thumble knots. Then the wrap could be made. It had to be closed with three sutures to make a proper wrap around the esophagus. The end points of the procedure were proper closure of the crura with two sutures and the wrap, not too tight, closed with three sutures over a length of 1.5 to 2 cm.<fig id="Fig3"><label>Fig. 3</label><caption><p>The four complementary tasks of Nissen fundoplication that could be performed with the artificial model</p></caption><graphic xlink:href="464_2010_1104_Fig3_HTML" id="MO4"></graphic></fig></p></sec><sec id="Sec4"><title>Protocol</title><p>After the model was developed and the procedure divided into the component tasks, the participants were asked to complete the selected tasks on the model placed in a box trainer. Before the start of the training, the participants were shown an introduction video, and before each task, they viewed a step-by-step demonstration video showing the corresponding part of the procedure to be performed.</p><p>After performing the procedure on the model, the participants filled out a questionnaire to evaluate the realism and haptic sensations of the artificial organs and the anatomic model as a training environment for laparoscopic Nissen fundoplication. The target group also practiced laparoscopic Nissen fundoplication on a validated animal tissue model [<xref ref-type="bibr" rid="CR15">15</xref>] as part of an upper gastrointestinal surgery course at the Cuschieri skills center, Dundee, Scotland (Fig. <xref rid="Fig4" ref-type="fig">4</xref>). The experienced surgeons all had previous experience with training on animal tissue models. Next, the participants gave their preference for the training of this procedure using either the described model or the still often-used animal tissue models.<fig id="Fig4"><label>Fig. 4</label><caption><p>Animal tissue model used in the upper gastrointestinal surgery course [<xref ref-type="bibr" rid="CR15">15</xref>]</p></caption><graphic xlink:href="464_2010_1104_Fig4_HTML" id="MO3"></graphic></fig></p></sec><sec id="Sec5"><title>Subjects</title><p>Both the participants and tutors (<italic>n</italic> = 20) of the European Association of Endoscopic Surgery (EAES) upper gastrointestinal surgery course at the Cuschieri skills center, Dundee, Scotland, from 23 to 26 September 2008 completed this study. All the participants in this study were unbiased in relation to the model because it was developed at an independent research center. To have a reference point, the participants in the course first received their initial training on animal tissue models, then practiced on the artificial model. The tutors all were experienced with laparoscopic suturing, the Nissen fundoplication procedure, and the use of animal tissue models.</p></sec><sec id="Sec6"><title>Questionnaire</title><p>The questionnaire used to evaluate the model was divided in four parts. The first part dealt with demographics and laparoscopic experience. The second part contained questions about the realism and haptic feedback with both the artificial model and animal tissue models, with ratings on a 5-point Likert scale. The third part focused on the training properties of the model and whether it would serve as proper training for Nissen fundoplication. The fourth part asked for an opinion on the separate organs with regard to visual aspects and haptic feedback. The questionnaire concluded with an open-ended question for remarks and improvements on the model and tasks.</p></sec><sec id="Sec7"><title>Statistical analysis</title><p>All data were processed and analyzed using the Statistical Package for the Social Sciences (SPSS) 13.0. A statistically significant difference in opinion (alpha = 0.05) between the artificial model and the animal tissue model was determined to be at least 0.7 points in the rating on the 5-point Likert scale, with a maximum standard deviation of 0.90 and a power of 80%. This calculated to a sample size of 20 subjects.</p><p>The results for the properties of the artificial model were compared with the null hypothesis of a neutral opinion on the model (mean 3.0) rather than with the animal tissue model. A <italic>p</italic> value less than 0.05 showed a significantly better or worse opinion than a neutral opinion on the artificial model.</p></sec></sec><sec id="Sec8"><title>Results</title><p>All the participants had experience with laparoscopic procedures, and 17 participants also had experience with general upper gastrointestinal procedures. All had previous experience with laparoscopic suturing, either in the clinical setting or with box trainers. Of the 20 participants, 12 had previous experience with laparoscopic Nissen fundoplication and 8 did not. However, no significant differences in the ratings of the model between these two groups were found.</p><p>Table <xref rid="Tab1" ref-type="table">1</xref> shows the participants’ difference of opinion between the artificial model and animal tissue model. The main difference in opinion between the two training models is seen in the properties of the stomach. The stomach of the artificial model was rated significantly lower than that of the animal tissue model. The main criticism concerning the stomach of the artificial model was that it was too rigid and that the fundus was not sufficiently flexible to make a proper wrap. The suturing of the stomach wall, however, was regarded as fairly realistic (mean, 3.6; Table <xref rid="Tab2" ref-type="table">2</xref>).<table-wrap id="Tab1"><label>Table 1</label><caption><p>Ratings for the complementary tasks of Nissen fundoplication</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left" rowspan="2"></th><th align="left">Artificial model</th><th align="left">Animal tissue models</th><th align="left" rowspan="2"><italic>p</italic> Value</th></tr><tr><th align="left" colspan="2">Mean</th></tr></thead><tbody><tr><td align="left" colspan="4">Task 1</td></tr><tr><td align="left"> Dissecting the lesser omentum</td><td char="±" align="char">3.3 ± 0.79</td><td char="±" align="char">3.2 ± 1.04</td><td char="." align="char">0.649</td></tr><tr><td align="left"> Dissecting the phrenoesophageal ligament</td><td char="±" align="char">3.4 ± 0.75</td><td char="±" align="char">3.5 ± 1.00</td><td char="." align="char">0.606</td></tr><tr><td align="left"> Creating the retroesophageal window</td><td char="±" align="char">3.2 ± 0.83</td><td char="±" align="char">3.7 ± 0.92</td><td char="." align="char">0.014</td></tr><tr><td align="left" colspan="4">Task 2</td></tr><tr><td align="left"> Dissecting the vasa brevia</td><td char="±" align="char">3.2 ± 0.82</td><td char="±" align="char">3.4 ± 1.09</td><td char="." align="char">0.834</td></tr><tr><td align="left"> Freeing the gastrophrenic ligament</td><td char="±" align="char">3.3 ± 0.81</td><td char="±" align="char">3.3 ± 0.95</td><td char="." align="char">0.806</td></tr><tr><td align="left" colspan="4">Task 3</td></tr><tr><td align="left"> Suturing the crura</td><td char="±" align="char">4.3 ± 0.55</td><td char="±" align="char">4.0 ± 0.86</td><td char="." align="char">0.234</td></tr><tr><td align="left"> Bringing the crura together</td><td char="±" align="char">4.3 ± 0.57</td><td char="±" align="char">4.1 ± 0.64</td><td char="." align="char">0.104</td></tr><tr><td align="left" colspan="4">Task 4</td></tr><tr><td align="left"> Pulling the fundus through retroesophageal window</td><td char="±" align="char">3.2 ± 1.23</td><td char="±" align="char">4.1 ± 0.61</td><td char="." align="char">0.004</td></tr><tr><td align="left"> Creating the wrap</td><td char="±" align="char">3.6 ± 0.89</td><td char="±" align="char">4.2 ± 0.75</td><td char="." align="char">0.010</td></tr></tbody></table><table-wrap-foot><p>Ratings of the artificial model and the animal tissue model for laparoscopic Nissen fundoplication given by the 20 participants. They were rated on a 5-point Likert scale on which 1 is really unrealistic, 3 is neutral, and 5 is very realistic. The <italic>p</italic> value was calculated with the paired <italic>t</italic>-test, and a <italic>p</italic> value less than 0.05 was considered to indicate a statistically significant difference</p></table-wrap-foot></table-wrap><table-wrap id="Tab2"><label>Table 2</label><caption><p>Properties of organs in the artificial model</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left"></th><th align="left">Rating mean</th><th align="left"><italic>p</italic> Value</th></tr></thead><tbody><tr><td align="left" colspan="3">Stomach</td></tr><tr><td align="left"> Shape</td><td char="±" align="char">3.8 ± 0.61</td><td char="." align="char"><0.001</td></tr><tr><td align="left"> Size</td><td char="±" align="char">3.8 ± 0.70</td><td char="." align="char"><0.001</td></tr><tr><td align="left"> Flexibility of the stomach wall</td><td char="±" align="char">2.3 ± 0.87</td><td char="." align="char">0.002</td></tr><tr><td align="left"> Haptic feedback of the stomach wall in the grasper</td><td char="±" align="char">2.7 ± 0.98</td><td char="." align="char">0.186</td></tr><tr><td align="left"> Haptic feedback during suturing</td><td char="±" align="char">3.6 ± 0.83</td><td char="." align="char">0.008</td></tr><tr><td align="left" colspan="3">Crura</td></tr><tr><td align="left"> Shape</td><td char="±" align="char">3.9 ± 0.64</td><td char="." align="char"><0.001</td></tr><tr><td align="left"> Size</td><td char="±" align="char">4.0 ± 0.46</td><td char="." align="char"><0.001</td></tr><tr><td align="left"> Haptic feedback during suturing</td><td char="±" align="char">3.8 ± 0.72</td><td char="." align="char"><0.001</td></tr></tbody></table><table-wrap-foot><p>Rating for the several properties of the organs of the artificial model given by the 20 participants. They were rated on a 5-point Likert scale on which 1 is really unrealistic, 3 is neutral, and 5 is very realistic. The <italic>p</italic> values were calculated with the one-sample <italic>t</italic>-test comparing the rating with the neutral opinion of 3.0. A <italic>p</italic> value less than 0.05 was considered to indicate a statistically significant difference</p></table-wrap-foot></table-wrap></p><p>The creation of the retroesophageal window also was regarded as significantly less realistic with the artificial model than with the animal tissue model (Table <xref rid="Tab1" ref-type="table">1</xref>). The crura on the artificial model were rated better than those on the animal tissue model, but the difference was not statistically significant (Table <xref rid="Tab1" ref-type="table">1</xref>). The properties of the crura were rated as realistic (mean, 3.8–4.0), which is a significantly better result than a neutral opinion.</p><p>The other organs in the model also were rated by the participants. The omentum was rated at 2.6 in visual appearances and flexibility (<italic>p</italic> = 0.042 and 0.025, respectively) and at 2.5 in haptic feedback (<italic>p</italic> = 0.014). The main remark was that it did not look realistic and should be more transparent but that it was not essential for the model and served its purpose. The liver was rated at a mean of 3.25 (<italic>p</italic> = 0.287), the spleen at 3.5 (<italic>p</italic> = 0.009), and the esophagus at 3.6 (<italic>p</italic> = 0.012) (Table <xref rid="Tab2" ref-type="table">2</xref>).</p><p>The general remarks given at the end of the questionnaire were “(very) good” (<italic>n</italic> = 10), “effective model” (<italic>n</italic> = 2), “excellent for training” (<italic>n</italic> = 1), “very nice” (<italic>n</italic> = 1), and “anatomy is superior to animal tissue models” (<italic>n</italic> = 1).</p><p>In answer to the question about the potential of the artificial model as a training tool for surgical residents learning to perform Nissen fundoplication, the model was rated good to excellent (mean, 4.3). As a replacement for the animal tissue model, it was rated at a mean of 3.5 (Table <xref rid="Tab3" ref-type="table">3</xref>). In answer to the question whether this model was a proper trainer for laparoscopic Nissen fundoplication, 15 participants said it was a proper training instrument.<table-wrap id="Tab3"><label>Table 3</label><caption><p>Training properties of the artificial model</p></caption><table frame="hsides" rules="groups"><thead><tr><th align="left"></th><th align="left">Rating mean</th><th align="left"><italic>p</italic> Value</th></tr></thead><tbody><tr><td align="left">Training tool for surgical residents</td><td char="±" align="char">4.3 ± 0.57</td><td char="." align="char"><0.001</td></tr><tr><td align="left">Training tool for surgeons</td><td char="±" align="char">3.6 ± 1.00</td><td char="." align="char">0.014</td></tr><tr><td align="left">Replacing the porcine model</td><td char="±" align="char">3.5 ± 0.76</td><td char="." align="char">0.016</td></tr><tr><td align="left">Replacing pigs under anesthesia</td><td char="±" align="char">2.9 ± 1.15</td><td char="." align="char">0.695</td></tr></tbody></table><table-wrap-foot><p>Rating for the training properties of the artificial model for laparoscopic Nissen fundoplication given by the 20 participants. They were rated on the 5-point Likert scale. The <italic>p</italic> values were calculated with the one-sample <italic>t</italic>-test comparing the rating with the neutral opinion of 3.0. A <italic>p</italic> value less than 0.05 was considered to indicate a statistically significant difference</p></table-wrap-foot></table-wrap></p></sec><sec id="Sec9"><title>Discussion</title><p>A Nissen fundoplication prevents transient lower esophageal sphincter relaxation [<xref ref-type="bibr" rid="CR6">6</xref>, <xref ref-type="bibr" rid="CR14">14</xref>]. It even increases the pressure of the distal esophageal spincter to three times the preoperative levels. This new 360° high-pressure zone restores the competence of the esophagogastric junction, thus eliminating both acid and nonacid gastroesophageal reflux [<xref ref-type="bibr" rid="CR14">14</xref>]. With regard to reflux control, no difference exists between the laparoscopic and open procedures. However, the complication of persistent severe dysphagia is reported to be greater with the laparoscopic procedure than with the open procedure [<xref ref-type="bibr" rid="CR3">3</xref>, <xref ref-type="bibr" rid="CR7">7</xref>, <xref ref-type="bibr" rid="CR14">14</xref>]. Both the length and tightness of the fundoplication [<xref ref-type="bibr" rid="CR3">3</xref>, <xref ref-type="bibr" rid="CR7">7</xref>, <xref ref-type="bibr" rid="CR16">16</xref>] play a part in this complication. However, the role of the division of the short gastric vessels has not been proved in this matter [<xref ref-type="bibr" rid="CR4">4</xref>]. The artificial model allows training and objective assessment of the essential technical skills for crural closure and creation of a wrap around the esophagus to minimize these types of complications in the clinical setting.</p><p>Animal tissue models and live animals are used quite regularly to train procedures before they are performed on patients [<xref ref-type="bibr" rid="CR11">11</xref>, <xref ref-type="bibr" rid="CR12">12</xref>]. However, as articulated in the statements of the American College of Surgeons, only as many animals as necessary should be used. Any pain or distress that animals may experience should be minimized or alleviated, and wherever feasible, alternatives to the use of live animals should be developed and used [<xref ref-type="bibr" rid="CR17">17</xref>].</p><p>Other drawbacks of animal tissue models are the costs, the short preservation period, and the fact that they can be used only once. Besides this, the haptic feedback of dead tissue is different from that of living tissue [<xref ref-type="bibr" rid="CR18">18</xref>]. Another important aspect of animal models is the infection rate. Therefore, they cannot be used in hospital settings, but only in specialized animal labs. An artificial model with reusable organs and replaceable tissue that can be used over and over again is more cost effective.</p><p>With the artificial model, only the peritoneal layer over the crura and the omentum with the short gastric vessels must be replaced after each practice. The stomach and crura can last for approximately 15–20 procedures. A modular model, as presented in this study, allows the exchange of organs or tissue on demand, which is not the case with animal tissue models. Thus, the costs per training can remain low, making such training accessible for all training centers and hospitals. This model also is easier to preserve, has a better scent than animal tissue models, is portable, and can be used in any skills center that has at least one box trainer.</p></sec><sec id="Sec10"><title>Study limitations</title><p>The most important aspect in the development of this model was the material used for the production. To realize a product that can compete with the use of animal tissue, it is of great importance that the material be perceived as realistic. Realism is perceived when the properties of the material closely approach the properties of real human tissue. However, human and animal tissue is very complicated material consisting of several layers. Its properties therefore depend on the number of layers, the layer thickness, the orientation of the muscular layers, the moisture level, the temperature, and the like. Information about the mechanical characteristics of human abdominal tissue is limited, which made it challenging to develop the organs for the artificial model that resemble realistic characteristics.</p><p>The participants in this study regarded the artificial stomach as less realistic for making a proper wrap than the stomach in the animal tissue model because the artificial stomach was too rigid and the stomach wall was slightly too thick. This aspect should be improved to make the model more suitable for laparoscopic Nissen fundoplication training. Also the color could be more realistic. The artificial stomach appeared to be a bit too orange, which made it less realistic. On the screen, however, it looked less bright (Figs. <xref rid="Fig1" ref-type="fig">1</xref>, <xref rid="Fig2" ref-type="fig">2</xref>).</p><p>The haptic feedback during the suturing was regarded as realistic, and this property of the stomach should therefore not be changed. The crura were regarded as realistic, and most participants preferred to train for this task on this Nissen model rather than on an animal tissue model. The human anatomy is quite different from the porcine anatomy, which means that the surgical resident trains for a different type of procedure when using the animal tissue model. For practicing the dissection of tissue (e.g., tissue connected to the esophagus), an animal tissue model is regarded as superior because it was not possible to simulate such dissection realistically with the artificial model. The step of dissecting is implemented in the tasks (Fig. <xref rid="Fig3" ref-type="fig">3</xref>), but in a simplistic form, so that the trainee learns the sequence of the procedure. This step is important for the prevention of esophageal perforations and pneumothorax, but it cannot be trained using the artificial model in its current form.
</p><p>In Middle Eastern countries, animal tissue models cannot be used for training for ethical reasons. Therefore, a model with the proper anatomy could be a good way to train these types of advanced procedures.</p></sec><sec id="Sec11"><title>Conclusion</title><p>The newly developed artificial model was regarded as a good training tool for the laparoscopic Nissen fundoplication procedure by the participants in this study. It is cheaper, more durable, and readily available for training and can therefore be used in every training center. Further improvements on the stomach are necessary because in the current form, the artificial stomach is too rigid for making a proper wrap around the esophagus. We recommend the development of such models for more laparoscopic procedures to replace the animal models (e.g., porcine cadaver models and pigs under anesthesia) that are still used in skills centers.</p></sec></body><back><ack><p>We thank Kim Rutten for development of the model and production of the prototypes. We also thank the Cuschieri Skills center, Dundee, Scotland, for facilitating the validation process during the course. This study was partly funded by The Scientific Foundation of the Catharina Hospital Eindhoven, The Netherlands. It was carried out by objective researchers who have no attachments to the industry.</p><p><bold>Disclosures</bold> Sanne M. B. I. Botden, Lorna Christie, Richard Goossens, and Jack J. 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