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Open Access Study protocol

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

Felix Nickel1, Felix Jede1, Andreas Minassian1, Matthias Gondan2, Jonathan D Hendrie1, Tobias Gehrig1, Georg R Linke1, Martina Kadmon1, Lars Fischer1 and Beat P Müller-Stich1*

Author Affiliations

1 Department of General, Visceral, and Transplantation Surgery, University Hospital of Heidelberg, Im Neuenheimer Feld 110, 69120 Heidelberg, Germany

2 Department of Psychology, University of Copenhagen, Oster Farimagsgade 2A, 1353 Copenhagen, Denmark

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Trials 2014, 15:137  doi:10.1186/1745-6215-15-137

Published: 23 April 2014

Abstract

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

Keywords:
Cholecystectomy; Education; Laparoscopy; Minimally invasive surgery; Training