Haptic Devices Impact on Laparoscopic Simulators

Medical Education Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05191589
• Other study ID #: CAMES
• Status: Completed
• Phase: N/A
• Start date: October 1, 2020
• Est. completion date: February 1, 2021

Study information

• Verified date: January 2022
• Source: Copenhagen Academy for Medical Education and Simulation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: February 1, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Medical Education

Intervention

Other:
• Haptic
Trainees are randomized in this group to use the haptic device.

Locations

Country	Name	City	State
Denmark	CAMES	Copenhagen	Region Hovedstaden
Denmark	CAMES	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Copenhagen Academy for Medical Education and Simulation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory outcome: To observe and register mechanical/technical malfunctions during the intervention and retention.	All mechanical malfunction will be registered and classified afterwards	During trial, up to 1 year
Primary	Time (minutes) to reach the predefined proficiency level for the basic skills and salpingectomy procedure	Measured in minutes	From randomization till participants have passed all modules on the simulator (approx 3-4 weeks)
Secondary	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).	Measured in minutes	From randomization till participants passes all modules on the virtual reality simulator in the trial (approx. 3-4 weeks)