Randomized Controlled Trials: A Systematic Review of Laparoscopic Surgery and Simulation-Based Training

Introduction: This systematic review was conducted to analyze the impact and describe simulation-based training and the acquisition of laparoscopic surgery skills during medical school and residency programs. Methods: This systematic review focused on the published literature that used randomized controlled trials to examine the effectiveness of simulation-based training to develop laparoscopic surgery skills. Searching PubMed from the inception of the databases to May 1, 2014 and specific hand journal searches identified the studies. This current review of the literature addresses the question of whether laparoscopic simulation translates the acquisition of surgical skills to the operating room (OR). Results: This systematic review of simulation-based training and laparoscopic surgery found that specific skills could be translatable to the OR. Twenty-one studies reported learning outcomes measured in five behavioral categories: economy of movement (8 studies); suturing (3 studies); performance time (13 studies); error rates (7 studies), and global rating (7 studies). Conclusion: Simulation-based training can lead to demonstrable benefits of surgical skills in the OR environment. This review suggests that simulation-based training is an effective way to teach laparoscopic surgery skills, increase translation of laparoscopic surgery skills to the OR, and increase patient safety; however, more research should be conducted to determine if and how simulation can become apart of surgical curriculum.


2007).
As the health care community creates and maintains new teaching methods to train competent surgeons, learning opportunities that exist outside the OR are becoming a recommended method for developing laparoscopic surgery skills (Ahlberg et al., 2007;Jordan, Gallagher, McGuigan, McGlade, & McClure, 2000;Verdaasdonk, Dankelman, Lange, & Stassen, 2008). Training outside the OR reduces the risk of adverse surgical events (Hyltander, Liljegren, Rhodin, & Lönroth, 2002;Aggarwal, Ward, Balasundaram, Sains, Athanasiou, & Darzi, 2007;Ahlberg, Heikkinen, Iselius, Leijonmarck, Rutqvist, & Arvidsson, 2002). Simulation-based surgical skills and procedures allows inexperienced surgeons to acquire skills through repetitive practice in a safe, nonthreatening environment, prior to encountering the risk and time pressures inherent in the OR (Andreatta et al., 2006;Miskovic, Wyles, Ni, Darzi, & Hanna, 2010). Those responsible for designing simulation facilities work with limited evidence to resolve complex questions relating to education, translation of skills learned, and patient safety with regard to teaching laparoscopic surgery.
In a systematic review conducted in 2006, researchers found that learners acquire similar clinical results as surgeons in laparoscopic colorectal surgery, if supervised by an expert during training (Sutherland, Middleton, Anthony, Hamdorf, Cregan, Scott, & Maddern, 2006); however, this review was limited only to colorectal surgeries. In a different systematic review, investigators reported that simulation training may not be a better method than patients, cadavers, and animals for teaching surgical skills (Sutherland et al., 2006), but the skills learned by simulation-based training appeared to be transferable to the OR. This review conducted by Strum and researchers (Sturm, Windsor, Cosman, Cregan, Hewett, & Maddern, 2008) was limited to 11 published studies and was conducted in 2008. Gurusamy and colleagues (Gurusamy, Aggarwal, Palanivelu, & Davidson, 2008) found that virtual reality training can supplement laparoscopic surgery training, but variability across research designs and conflicting findings in the published studies prevented the confirmation of clear best practices. More recently, Cook and colleagues (Cook et al., 2001) studied technology-enhanced simulation training and concluded that simulation training is associated with large effects on clinician behaviors and moderate effects on patient care. This current review of the literature addresses the question of whether laparoscopic simulation translates the acquisition of surgical skills to the OR. The conceptual framework for this manuscript is focused on the importance and relevance related to the education of surgical skills, the translation of surgical skills acquired outside of the OR, and improvements focused on safety for patients. A review of published research was completed to describe the impact of simulation-based training on the acquisition of laparoscopic surgery skills and the translation of these skills to the OR. Skills acquisition was assessed for performance time, global rating, suturing, cutting, and cautery skills; errors, and economy of movement.

Methods
This review focused on published literature that examines the effectiveness of simulation-based training to develop laparoscopic surgery skills translation into the OR. The studies reviewed were identified by searching PubMed from the inception of the database to April 1, 2014 and hand searching: Simulation in Health Care, Annals of Surgery, Journal American Surgery, International Journal of Surgery, Surgery, Archives of Surgery, and The British Journal of Surgery from 2000 -May 2014. Multiple combinations of several relevant key words were used to identify articles for review (haptic or simulation or simulation education or simulation medicine or laparoscopic simulation or simulation training or translation AND laparoscopic surgery). Figure 1 demonstrates the elimination of articles that came up during the search process.

Inclusion and Exclusion Criteria
Inclusion criteria required that studies: (a) use a randomized controlled design that includes at least one intervention group and one control group that either received no training or traditional training in the operating room, (b) single-group pretest-posttest, (c) two group nonrandomized, (d) parallel-group (e) crossover designs, (f) use simulation-based training as the educational intervention for teaching laparoscopic surgery skills, and (e) translation of skills was measured into the OR setting. Simulation-based training was defined broadly to include equipment that replicated the task environment with sufficient realism to serve as a training tool. Examples of the simulators included in this systematic review were box trainers, computer software, virtual reality simulators, task trainers, and high fidelity and static mannequins. The exclusion criteria were: (a) studies that did not use simulation as the educational intervention for teaching laparoscopic surgery skills, (b) literature reviews, and (c) translation of skills was not measured into the OR setting. An adopted coding framework based on PRISMA (Liberati et al., 2001) and Cochrane handbook (Higgins, 2012) was used to review the literature. The first author independently coded each of the articles discovered through the literature search. When reviewing the literature some abstracts provided enough detail and information related to the methods to determine if the inclusion criteria were met; if not, the full manuscript was read to determine if the methods met the inclusion criteria. The manuscripts were eliminated because the methods did not meet the inclusion criteria.
Initial Search for Research Articles Search Terms: haptic or simulation or simulation education or simulation medicine or laparoscopic simulation or simulation training or translation = 693,374 Narrowing of Research Articles Search Terms: haptic or simulation or simulation education or simulation medicine or laparoscopic simulation or simulation training or translation AND laparoscopic surgery = 1,118 Research Abstract and Titles Reviewed Search Terms: haptic or simulation or simulation education or simulation medicine or simulation nursing or simulation training or simulation-based-training AND laparoscopic surgery AND Clinical Trials =154 Finalized Research Articles for Review Search Terms: haptic or simulation or simulation education or simulation medicine or laparoscopic simulation or simulation training or translation AND laparoscopic surgery AND Clinical Trials = 21 693,374 research articles were reduced by adding the search term: laparoscopic surgery 1,118 research articles were reduced by adding the search term: clinical trials 154 research articles were reduced by reading abstracts and full reach articles to determine if the inclusion criteria were met

Results
The results reported in this section are based on the 20 articles we determined met our inclusion criteria. Table 1 describes the types of simulators implemented in the 21 studies, manufacturers for the simulators, definitions for the simulators, and performance skills the simulators provide. A total of 21 studies were analyzed; the specific simulators, participants, assessments, and details of the 21 studies are provided in Tables 2 and 3. All post-training assessment were translational to either a porcine model or the OR, 9 (43%) studies conducted the posttest in a Porcine Model, 12 (57%) studies conducted the posttest in the OR with patients.
3.1 Performance Time (n = 13 Studies) (Bennett et al., 2011;Andreatta et al., 2006;Aggarwal et al., 2007;Ahlberg et al., 2007;Gala et al., 2013;Larsen et al., 2009;Grantcharov et al., 2004;Clevin & Grantcharov, 2008;Hiemstra et al., 2011;Ganai et al., 2007;Stefanidis et al., 2008;Stefanidis et al., 2007) Performance time was reported as the amount of time taken to perform the laparoscopic procedure of interest at the posttest evaluation. Of the 13 (62%) studies that assessed whether the training intervention resulted in the improvement of performance time, thirteen studies reported statistically significant improvement. For example, in one study researchers reported that the control group took 58% longer to perform the surgery (Ahlberg et al., 2007) and in another study investigators reported that the control group, on average, performed the surgery twice as long as the intervention group (24 minutes as compared to 12 minutes, P < .001) (Van Sickle et al., 2008). In yet another study the intervention group was 29% faster in dissecting the gallbladder during a cholecystectomy than the control group (Van Sickle et al., 2008). On the other hand, two studies (Bennett et al., 2011;Gala et al., 2013) reported no significant changes in time between the intervention and control groups when performance time was measured.

Task Trainer
A partial component of a simulator or simulation modality, for example, an arm, leg, or torso.

Limbs and Things
X X X

MIST-VR
A virtual reality simulator with six different tasks to simulate maneuvers performed during laparoscopic cholecystectomy in a computerized environment.
Mentice AB X X X X

LapMentor/ LapMentor II
A virtual reality simulator consisting of a camera and two calibrated working instruments for which the motion of the instruments is translated to a two-dimensional computer screen for student practices.
Simbionix Ltd. X X X X X

LapSim
A computer-based simulator creating a virtual laparoscopic setting through a computer operating system, a video monitor, a laparoscopic interface containing two pistol-grip instruments, and a diathermy pedal without haptic feedback Surgical Science X X X X X

EndoTower
EndoTower software consists of an angled telescope simulator composed of rotating camera and telescopic components.
X X

MISTELS/ FLS trainer
McGill Inanimate System for Training and Evaluation of Laparoscopic Skillsthis inexpensive, portable, and flexible system allows students to practice in a virtual Endotrainer box.
SAGES X X X

SIMENDO VR
Computer software used to train eye-hand coordination skills by camera navigation and basic drills.
Delta Tech X X X

URO Mentor
A hybrid simulator, consisting of a personal computer based system linked to a mannequin with real endoscopes. Cytoscopic and ureterosciopic procedures are performed using either flexible or semi rigid endoscopes Simbionix Ltd. X X X X

Da Vinci Skills Simulator
A portable simulator containing a variety of exercises and scenarios specifically designed to give users the opportunity to improve their proficiency with surgical controls.
Intuitive Surgical X X X X X Note: * Indicates articles that are unclear or do not supply an explanation of information.  Experimental group dropped the needle fewer times and made less frequent unnecessary contact with the tip of the needle against the tissue tan the control group (p<.05).
 No significant differences in the scores assigned to the groups by the two experts (economy of movement p=.114; error assessment p=.148).

Zendejas et al., 2011
OR (pre and post) Observers and medical records  Operative performance by using a global rating using:

1) GOALS
2) operating time 3) proportion of procedure performed by the trainee 4) need for overnight stay 5) recurrence of inguinal hernia and chronic groin pain and complications.


The trained group were on average 6.5 minutes faster than the control group (p<.0001).


Resident participation was also different between the groups with the trained group performing more of the procedure than the control group (88% vs. 73%).


After correcting time to account for varying participation rates, the trained group performed the procedure 13.1 minutes faster.


The trained group had higher performance scores than the trained group (p=.001).
 Intraoperative and postoperative complicates and overnight stay were less likely in the trained group than the control group p<.05.


When follow ups with patients were conducted the number of patients who experienced a hernia recurrence or were evaluated for groin pain at least 3 month post repair there was no difference between the groups.
Note: * Indicates articles that are unclear or do not supply an explanation of information.
3.2 Global Ratings (n =7 studies) (Aggarwal et al., 2007;Verdaasdonk et al., 2008;Hogle et al., 2009;Sroka et al., 2010;Seymour et al., 2002;Zendejas et al., 2011;Grantcharov et al., 2004) Global assessments were conducted using the Objective Structured Assessment of Technical Skill (Lucas, Tuncel, Bensalah, Zeltser, Jenkins, Pearle, & Cadeddu, 2008) (OSATS) rating scale, The OSATS evaluation tool evaluates participants on respect for tissue handling, time and motion, instrument handling, knowledge of instruments, flow of operation, use of assistant, and knowledge of procedure. GOALS rating scale (Watterson, Beiko, Kuan, & Denstedt, 2002) measures performance in 5 domains; three of the domains are specific to laparoscopic surgery (e.g., depth perception, bimanual dexterity and tissue handling) and 2 of the domains are generic (e.g., efficiency and autonomy). The standard Fundamentals of Laparoscopic Surgery (FLS) metrics (Larsen et al., 2009). FLS are the basic psychomotor skills necessary prior to learning how to perform and develop a laparoscopic surgical case. A different study reported that global assessment scores increased and their standard deviation decreased in the intervention group as compared to the non-trained group (P =.004) (Hogle, www.ccsenet.org/gjhs Global Journal of Health Science Vol. 7, No. 2; Chang, Strong, Welcome, Sinaan, Bailey, & Fowler, 2009). Moreover, in the same study 100% of intervention participants reached the passing score level where as only 37.5% of the control group. Investigators did not find any statistical significance between the two groups; however, the participants with low baseline performance increased their scores significantly after simulation training (Hung et al., 2012). (Andreatta et al., 2006;Ahlberg et al., 2002;Van Sickle et al., 2008) Three (14%) of the 21 studies reported significant improvement on suturing, cutting, and cautery skills in the trained group as compared to the control group. Investigators reported that the trained participants outperformed the control participants in the performance of safe electrocautery (P < .01) (Andreatta et al., 2006).

Suturing, Cutting and Cautery Skills (n = 3 Studies)
Errors (n = 7 Studies) (Ahlberg et al., 2007;Verdaasdonk et al., 2008;Clevin & Grantcharov, 2008;Hiemstra et al., 2011;Korndorffer Jr et al., 2005;Stefanidis, Acker,& Heniford, 2008;Stefanidis et al., 2007) Seven (33%) of the studies assessed whether simulation-based training resulted in a decrease in errors. Errors were reported as clipping errors, dissection errors, tissue damage, incorrect plane for dissection, lack of progress, and instrument out of view. All seven-research articles reported statistical findings that the intervention decreased the amount of errors that occurred. For example, investigators that the intervention group made significantly fewer errors related to tissue division (P=.008) and dissection (P=.03) with the control group producing three times as many errors (Ahlberg et al., 2007).
3.4 Economy of Movement (n = 8 Studies) (Bennett et al., 2011;Andreatta et al., 2006;Aggarwal et al., 2007;Ahlberg et al., 2002;Gala et al., 2013;Hogle et al., 2009;Zendejas et al., 2011;Torkington et al., 2001) Eight of the studies assessed if simulation-based training resulted in an increase in the economy of movement. Economy of movement was reported as camera navigation, efficiency of instrument, total path length, number of movements, navigation, and bimanual dexterity. The eight studies (38%) reported statistical findings that the intervention increased the economy of movement. More specifically, training was significantly related to path length (P<.001) and total number of movements (P =.009) (Aggarwal et al., 2007). In contrast, investigators found no difference in economy of movement between the control and intervention groups (P =.40) (Bennett et al., 2011). In two different studies, researchers found that the control groups did not show significant differences compared to the intervention group as related to economy of movement (Bennett et al., 2011;Hogle et al., 2009).

Discussion
This review of laparoscopic literature and translation of skills summarizes the evidence for the simulation-based training studies and supports skill transfer in a safe and effective way for novice surgeons to learn to perform procedures on patients in the OR (Table 3). Those responsible for teaching and assessing surgical performance should consider implications of these findings in three major areas: (1) education for competence or improved skills practiced in a controlled setting, (2) translation of new knowledge into performance outside the simulated setting, and (3) safety for patients.

Education
Laparoscopic surgery curricula may be modified or supplemented with the implementation of simulation-based training. Simulation can lead to improved assessment, improved training, error reduction, and the development of technical skills in laparoscopic surgery necessary to operate on real patients (Van Sickle et al., 2008). Residents in the intervention group made fewer errors and were less likely to injure the gallbladder or to burn non-target tissue on real patients (Van Sickle et al., 2008). Simulation-based training allows for repeated practice of standardized tasks under reproducible conditions and enables the use of objective measures for assessment purposes (Sroka, Feldman, Vassiliou, Kaneva, Fayez, & Fried, 2010) and student feedback. A simulation-based training curriculum has the potential to shorten the learning time for laparoscopic procedures compared to traditional teaching methods in laparoscopic surgery (Seymour et al., 2002).
Surgical residents who received simulation-based training curriculum significantly outperformed surgical residents who received the standard curriculum on knot tying (Zendejas et al., 2011). Additionally, surgical residents who received simulation-based training performed the suturing task faster, made fewer errors, and were more efficient in handling the suture (Zendejas et al., 2011). Overall, participants who received simulation based skills training demonstrated faster attainment of those skills than their peers from the control group in a high stakes environment (Grantcharov et al., 2004). Training curriculum related to laparoscopic surgery skills allows for more learning opportunities for novice surgeons to practice with simulation-based training prior to entering OR environment; thus, allowing for the potential of skills translating into the OR.
Finally, the studies in this review show that simulation-based training should be incorporated into surgical curricula specifically targeting novice learners. Presently, simulation-based training programs are generally offered as a supplement to traditional surgical training and are voluntary (Graber, Wyatt, Kasparek, & Xu, 2005). Currently, there is not a standard or universal specific surgical curriculum in place in surgical educational programs; however, there has been a recent change, FES (Fundamentals of Endoscopic Surgery) was approved in March, 2014 as an additional requirement for residents graduating in 2018 and after this is a simulation-based training program.
Further research is needed to determine the best longitudinal curriculum for basic and advanced skills acquisition and transfer to the OR environment. Simulation-based training will allow for the novice to learn the psychomotor skills and spatial judgments necessary for laparoscopic surgical skills allowing them to focus more on learning operative strategies and handling intraoperative complications while in the OR (Torkington, Smith, Rees, & Darzi, 2001). Training in proficiency-based skills should be incorporated into a comprehensive surgical training and assessment curriculum for residents prior to operating on real patients (Banks, Chudnoff, Karmin, Wang, & Pardanani, 2007). The pressure to make surgical training more efficient and safer for patients is substantial, and simulation-based training has the potential to improve surgical curricula (Clevin & Grantcharov, 2008).

Translation
Translational impact was achieved in the OR with live patients when simulation-based training was used for the educational intervention. Researchers found that training in a simulated environment led to improved surgical performance on either animals or humans (Ahlberg et al., 2007;Verdaasdonk et al., 2008;Ahlberg et al., 2002;Van Sickle et al., 2008;Seymour et al., 2002;Zendejas et al., 2011;Banks et al., 2007;Clevin & Grantcharov, 2008;Crochet et al., 2011). Simulation-based training, influences the translation of laparoscopic surgery skills to the OR. As a result of these findings, simulation-based training has the potential to provide the foundational skills necessary for future surgeons to learn in a controlled environment and translate those acquired skills to the OR. With increases in technology and the need for a standard surgical curricula there is potential with simulation as an educational tool to further the translation of laparoscopic surgical skills into the OR. More specifically, typical skills that translate into the OR are suturing, camera navigation, and the manipulation of equipment.

Patient Safety
Simulation-based training has the potential to lead to an increase in patient safety. Residents who trained with simulation had fewer errors than control groups (Van Sickle et al., 2008;Hiemstra et al., 2011) while in the OR. Participants in the intervention group had fewer incidents of the supervising surgeon taking over the procedure. These types of events can significantly affect clinical outcomes because they represent potential errors in technique compromising patient safety (Ahlberg et al., 2002).
Using simulation for training surgical skills can benefit the larger goal of improved patient safety in several ways. With simulation, learners can repeat a procedure or even a specific element of a procedure until competency is demonstrated. Novice surgeons enter the OR more apt to produce favorable patient outcomes and are better prepared to participate in surgical cases with live patients in the OR if they previously trained on a simulator. Simulation can also provide more opportunities for remedial training to reduce skill decay (Sroka et al., 2010). Laparoscopic surgical simulators provide opportunities to train other concepts central to patient safety. For example, teamwork skills can be trained through surgeons interacting with camera navigators or nurses in a simulated OR. Simulating laparoscopic surgical equipment and interfaces can even be used to introduce, test, and train new equipment or protocols before they are implemented in the OR, leading to identification of potential latent threats to safety and avoidance of medical errors due to poor human systems integrations.

Limitations
As with any literature review, our review and results are limited by the data provided in the original studies. Our findings are limited by the lack of descriptions of the data collection process and interventions of the included studies. In particular, it was difficult to discern many of the potential covariates that were used in the data analyses as well as the timing between pre-and post-tests once the interventions were implemented. Moreover, a majority of the studies that reported statistical results reported the results using p-values. The lack of effect size reporting contributes to the difficulty in truly understanding the magnitude of the effect of these interventions on the acquisition of surgical skills.
Another limitation to this study is this was only one database was used to identify all literature, data, or studies related to a specific topic. Therefore, potentially, excluding conference presentations, other online search engines, and contacting colleagues within the field to identify any potential missing studies that may not have been www.ccsenet.org/gjhs Global Journal of Health Science Vol. 7, No. 2; included. Furthermore, not all surgical journals were hand searched, just those identified by one author as to be key surgery journals within the field.
The scope of our review is both a strength and limitation. Restricting our scope to only randomized control trials increased the stability of the findings reported in the original studies. However, it is not possible to draw firm conclusions about the effectiveness of the different types of simulation based on our findings as many of the RCTs did not conduct comparative analyses between varying types of simulations. Nonetheless, we argue that our review does provide useful insight into the literature that examines the effectiveness of simulation based laparoscopic training interventions. The need for more robust comparisons of these training interventions is needed to be able to provide an unequivocal conclusion to the impact on surgical skills.

Conclusion
Simulation-based training can lead to demonstrable benefits of surgical skills in the OR. These benefits include decreased procedural errors as well as other effects on overall patient safety. This review suggests that simulation-based training is an effective way to teach laparoscopic surgery skills, increase translation of laparoscopic surgical skills to the OR and increase patient safety. However, more research should be conducted to determine if and how simulation can become apart of the surgical curriculum.

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