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Procedure-to-procedure Transfer Trial

A Randomised Educational Trial of Practicing One Versus Two Laparoscopic Procedural Modules in Simulator Training for Novices on Procedure-to-procedure Transferability

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02069951
Enrollment
96
Registered
2014-02-24
Start date
2014-02-28
Completion date
2014-09-30
Last updated
2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgery

Keywords

Laparoscopy, Training, Simulator

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.

Interventions

OTHERPractice a procedural module on a simulator

Sponsors

Copenhagen University Hospital, Denmark
CollaboratorOTHER
Rigshospitalet, Denmark
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The number of repetitions needed to reach a predefined proficiency level for a procedural module on a simulatorUp to 26 weeksThe number of repetitions needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.

Secondary

MeasureTime frameDescription
The effective training time on the simulator (minutes) needed to reach the predefined proficiency level for a procedural module.Up to 26 weeksThe effective training time on the simulator (minutes) needed to reach a predefined proficiency level for a procedural module (a laparoscopic salpingectomy) on the simulator.

Other

MeasureTime frameDescription
Subjective Mental Effort Question score after the 1st repetitionUp to 26 weeksTo score the level of stress, all the participants will be required to the Subjective Mental Effort Questionnaire after the first repetition of a procedural module. The SMEQ is a cognitive workload questionnaire with a scale of 0 to 150 points
Motor skills performance parametersUp to 26 weeks1. The total path length (cumulative distance tip movement for both the right and left instrument) for the first attempt on procedural module B will be compared for the intervention and the control group. 2. The total angular path (cumulative angular degrees for both the right and left instrument) for the first attempt on procedural module B will be compared for the intervention and the control group. 3. The total procedure time for the first attempt on procedural module B will be compared for the intervention and the control group.

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 19, 2026