Clinical trial NCT02069951: Procedure-to-procedure Transfer Trial
Official title: A Randomised Educational Trial of Practicing One Versus Two Laparoscopic Procedural Modules in Simulator Training for Novices on Procedure-to-procedure Transferability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Keywords: Laparoscopy
Training
Simulator
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Copenhagen University Hospital, Denmark
First posted: 2014-02-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Surgical training programs using virtual reality simulators often only use basic skills training and the use of procedural training is very limited. Procedural training differs from basic skills training by requiring integration of isolated skills and decision making and planning components. However, it is unknown if it is necessary to practice all procedures before operating on actual patients or whether it is simply a matter of learning psychomotor skills and if these skills are transferable between different tasks.

The main hypothesis is that practicing a laparoscopic procedure on a simulator makes it easier to reach proficiency on a different laparoscopic procedure on the simulator because participants have already practiced the integration of isolated skills.


Eligibility criteria: Inclusion Criteria:

* Medical students enrolled at The Faculty of Health Science, University of Copenhagen.
* Obtained the bachelor degree in medicine.
* Signed informed consent.

Exclusion Criteria:

* Previous participation in trials involving laparoscopic training.
* Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
* No informed consent.
* Does not speak Danish on a conversational level.

Primary outcomes:
measure: The number of repetitions needed to reach a predefined proficiency level for a procedural module on a simulator
timeFrame: Up to 26 weeks
Secondary outcomes:
measure: The effective training time on the simulator (minutes) needed to reach the predefined proficiency level for a procedural module.
timeFrame: Up to 26 weeks
Other outcomes:
measure: Subjective Mental Effort Question score after the 1st repetition
timeFrame: Up to 26 weeks
measure: Motor skills performance parameters
timeFrame: Up to 26 weeks
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Flemming Bjerrum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjerrum F, Sorensen JL, Konge L, Rosthoj S, Lindschou J, Ottesen B, Strandbygaard J. Randomized trial to examine procedure-to-procedure transfer in laparoscopic simulator training. Br J Surg. 2016 Jan;103(1):44-50. doi: 10.1002/bjs.9966. Epub 2015 Oct 29.
citation: Bjerrum F, Sorensen JL, Konge L, Lindschou J, Rosthoj S, Ottesen B, Strandbygaard J. Procedural specificity in laparoscopic simulator training: protocol for a randomised educational superiority trial. BMC Med Educ. 2014 Oct 10;14:215. doi: 10.1186/1472-6920-14-215.