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Haptic Devices Impact on Laparoscopic Simulators

Haptic Devices vs Non Haptic Devices - Results of a Randomized Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05191589
Enrollment
40
Registered
2022-01-13
Start date
2020-10-01
Completion date
2021-02-01
Last updated
2022-01-13

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

Conditions

Medical Education

Brief summary

The study investigates the impact haptic devices have on reaching proficiency on a laparoscopic simulator as well as investigation if there is a difference in retention of the acquired skills.

Interventions

OTHERHaptic

Trainees are randomized in this group to use the haptic device.

Sponsors

Copenhagen Academy for Medical Education and Simulation
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Intervention model description

Trainees/participants are randomized to either control or interventional group. After reaching proficiency participants must come back after 3-6 weeks to perform a retention test.

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

Inclusion criteria

* Must be a junior doctor working in a surgical department

Exclusion criteria

* Having performed any laparoscopic surgeries as primary surgeon * Lack of Basic Danish on a conversational basis

Design outcomes

Primary

MeasureTime frameDescription
Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedureFrom randomization till participants have passed all modules on the simulator (approx 3-4 weeks)Measured in minutes

Secondary

MeasureTime frameDescription
Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure after 3-6 weeks without laparoscopic training on the non-haptic devices (retention test).From randomization till participants passes all modules on the virtual reality simulator in the trial (approx. 3-4 weeks)Measured in minutes

Other

MeasureTime frameDescription
Exploratory outcome: To observe and register mechanical/technical malfunctions during the intervention and retention.During trial, up to 1 yearAll mechanical malfunction will be registered and classified afterwards

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026