Laparoscopic Proficiency Clinical Trial
Official title:
Impact of Instructor Feedback on Performance in a Virtual Reality Simulator: A Randomized, Controlled Trial
With a worldwide proliferation of simulation centers, it is essential to explore the optimal
setting for laparoscopic training and investigate different learning approaches, e.g. a
self-directed approach. Therefore, the researchers investigated the following in a
randomized controlled trial: the impact of instructor feedback vs. an independent,
self-directed approach when training a complex operational task on a laparoscopic virtual
reality simulator.
The study hypothesis is that instructor feedback has a pivotal effect on surgical skills
when training on a virtual reality simulator.
For virtual reality (VR) simulation the benefits are clear; the drawbacks are less clear.
Throughout the last decade several studies have found a positive effect on the learning
curve as well as improvement of basic psychomotor skills in the operating room after VR
training. VR simulators offer standardized and reproducible laparoscopic tasks, ranging from
simple basic skills training to full procedures such as a cholecystectomy or salpingectomy.
Despite the now well-established advantages of VR simulators, the majority of surgical and
gynecological departments encounter hurdles when implementing this form of training in the
surgical education. This is mainly due to lack of knowledge concerning the time and human
resources/cost needed to train novice surgeons to an adequate level.
This randomized trial investigates whether instructor feedback is pivotal for the trainee
when training operational tasks (a laparoscopic salpingectomy) on a VR simulator. The VR
simulator used in this trial is the LapSim from Surgical Science, Sweden. Instructor
feedback consists of standardized feedback for ten minutes and with a maximum of three
optional feedback sessions; the trainees (in the intervention group) decides them selves
when they want a feedback session. The trainees in both the control group and the
intervention group have to reach a predefined proficiency level on the VR simulator within 8
weeks with 3-hour training sessions each time. Furthermore, the trial focuses on different
learning approaches, e.g. a self-directed approach and an independent approach.
The randomization process will take place at a central unit; Copenhagen Trial Unit, Denmark.
Stratification variables are: 1)Gender 2)Computer game experience (less that 20 hours
annually)
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label