One or two trainees per workplace for laparoscopic surgery training courses: results from a randomized controlled trial.

BACKGROUND: There are no standards for optimal utilization of workplaces in laparoscopic training. This study aimed to define whether laparoscopy training should be done alone or in pairs (known as dyad training). METHODS: This was a three-arm randomized controlled trial with laparoscopically naïve medical students (n = 100). Intervention groups participated alone (n = 40) or as dyad (n = 40) in a multimodality training curriculum with e-learning, basic, and procedural skills training using box and VR trainers. The control group (n = 20) had no training. Post-performance of a cadaveric porcine laparoscopic cholecystectomy (LC) was measured as the primary outcome by blinded raters using the objective structured assessment of technical skills (OSATS). Global operative assessment of laparoscopic skills (GOALS), time for LC, and VR performances were secondary outcomes. RESULTS: There were no differences between groups for performance scores [OSATS: alone (40.2 ± 9.8) vs. dyad (39.8 ± 8.6), p = 0.995; alone vs. control (37.1 ± 7.4), p = 0.548; or dyad vs. control, p = 0.590; and GOALS score: alone (10.6 ± 3.0) vs. dyad (10.0 ± 2.7), p = 0.599; alone vs. control (10.1 ± 3.0), p = 0.748; or dyad vs. control, p = 0.998]. Dyad finished LC faster than control [median = 62.5 min (CI 58.0-73.0) vs. 76.5 min (CI 72.0-80+); p = 0.042], while there were no inter-group differences between alone vs. control [median = 69.0 min (CI 62.0-76.0) vs. control; p = 0.099] or alone vs. dyad (p = 0.840). Dyad and alone showed superior performance on the VR trainer vs. control for time, number of movements, and path length, but not for complications and application of cautery. CONCLUSIONS: The curriculum provided trainees with the laparoscopic skills needed to perform LC safely, irrespective of the number of trainees per workplace. Dyad training reduced the operation time needed for LC. Therefore, dyad training seems to be a promising alternative, especially if training time is limited and resources must be used as efficiently as possible. Trial registration German Clinical Trials Register: DRKS00004675.

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

BACKGROUND: 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. METHODS: 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. DISCUSSION: 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. TRIAL REGISTRATION NUMBER: DRKS00004675.