One or two trainees per workplace in a structured multimodality training curriculum for laparoscopic surgery? Study protocol for a randomized controlled trial – DRKS00004675

Minimally invasive surgery (MIS) has been established as a standard for many operations in abdominal surgery. However, in comparison to open surgery, laparoscopic surgeons face technical challenges and increased psychomotor demands resulting in an additional learning curve and prolonged operative times [1‐4]. Different training modalities enable prospective surgeons to acquire the psychomotor abilities and surgical skills necessary before applying them to patients [5‐9]. Current training modalities include box and pelvi trainers with real surgical instruments, organ models, cadavers, cadaveric organs, live animal models, and computer simulators. Cadavers and animal models provide the most realistic training for operations but are of limited availability [10, 11]. Box and pelvi trainers enable the acquisition of basic skills with real instruments and are essential for the training of knot tying and suturing. Virtual reality (VR) trainers enable repetitive training of both basic skills and operations in a virtual environment. In addition, trainees receive automated instructions and feedback, and their performance can be recorded in order to monitor training progress [12, 13]. However, at their current level of performance, VR trainers still lack realism in terms of tissue interaction and haptic feedback, and performance feedback is often limited to metric parameters such as the instrument path length [11].

Positive learning effects of both box and VR trainers have been shown for practical laparoscopic skills without clear superiority of one over the other. Other studies have proven positive effects on the duration of operations and on the clinical outcome of both training modalities [5‐7, 14, 15]. When box trainers are augmented with cadaveric organs, surgical interventions can be realistically simulated, e.g., laparoscopic cholecystectomy (LC) [16‐18]. Online learning platforms provide videos of operations, explanations, and teaching of surgical techniques, the relevant anatomy, and perioperative management [19, 20]. The efficacy of online learning modules has been studied with positive results for online learning both alone and in combination with other training modalities [21]. Multimodality training combines the available training modalities for optimal outcome [11, 22, 23].

The present study is primarily directed at identifying how many trainees should be assigned per workplace in laparoscopy training courses. One may surmise that the option of having one trainee per workplace would be the optimal training environment and lead to the best training outcome. However, there is currently no evidence available for surgical training [24]. Different factors might exert influence on the outcome of training in pairs or alone. Pairs have many potential advantages, such as the exchange of knowledge, technical discussions between training partners, more pauses with active reflection, analysis of errors, and model learning when the partner trains [25‐27]. Evidence from training psychology suggests higher efficiency with pauses and feedback between repetitions of exercises, thus supporting the concept “train less and learn more” [28]. For example, positive effects of intraoperative breaks during long operations have been shown to result in lower stress levels while preserving operation time [29]. Observing peers during learning of practical skills in medical education has been shown to accelerate the learning process, e.g., for physical examination skills [30]. On the other hand, the available literature suggests a learning curve with a certain number of repetitions required for reaching proficiency levels of given tasks and procedures in laparoscopic surgery, thereby suggesting that trainees with a workplace to themselves would benefit [24, 31‐34]. The secondary objective of this study is to analyze individual and general factors that influence laparoscopic learning curves and test results. The factors assessed include sex, cognitive measures, gaming experience, and personal characteristics [35, 36].

This study aims to assess the differences in laparoscopy training courses for laparoscopic beginners by using a single workplace to train one or two trainees simultaneously. Since the study participants of Group 2 work in pairs, they repeat each individual exercise less and essentially work for only half of the total training time. Intuitively, this seems disadvantageous, but there is no evidence to support this conjecture. Educating prospective surgeons on common laparoscopic training programs as groups of two might even lead to more successful performances in comparison to solo training. Additionally, this would lead to an effective optimization of resources, as twice the number of trainees could participate in courses.

Despite the careful avoidance of bias, some possible factors of influence still remain, e.g., the contradiction of the high vigilance and motivation of each study participant and the implicated individual difference. Furthermore, it is not ensured that active pauses during exercises always have the same quality for each participant, even though the staff is encouraged to keep making pauses periodically in standardized intervals. We measure if cooperative learning and other exchange effects between the trainees occurs, but not how or why they occur. The expected clinical performance of the study participants will be assessed by the best available simulation, a cadaveric perfused animal organ. Comparison of the two intervention groups will show whether there is a difference in surgical performance based on training alone or in pairs. Comparison of the intervention groups with the control group will show if there exists any training effect at all. The results of the baseline and post-test of the VR trainer should demonstrate the differences in learning success between the trained groups 1 and 2 versus group C without training. The continuous data recording of the VR trainer and the tests will help understand if there is a difference in learning curves between both training groups and between the partners in group 2, as the same training partner always starts the exercises. The assessment of general and individual parameters of the study participants will help understand the possible factors of influence for successful surgical education. As the study is limited to laparoscopically-naive medical students and the performance of basic skills and LC, the results cannot be directly transferred to more experienced surgeons and other interventions. However, the results of this study will increase knowledge about the optimal training conditions for laparoscopic surgery, i.e., if workplaces in surgical training centers should be used by one or two trainees simultaneously in order to achieve the optimal training outcome.

Recruitment started in October 2012 and is planned to be finished in June 2014.