Haptic Devices Impact on Laparoscopic Simulators

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

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.

Study Overview

• Status: Completed
• Conditions: Medical Education
• Intervention / Treatment: Other: Haptic

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2100
    • CAMES
  • Region Hovedstaden
    • Copenhagen, Region Hovedstaden, Denmark, 2100
      • CAMES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; In the intervention group trainees will train in an already validated laparoscopic training program with haptic devices.	Other: Haptic; Trainees are randomized in this group to use the haptic device.
No Intervention: Control; In the control group trainees will complete the same validated training program in the conventional non-haptic setting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Copenhagen Academy for Medical Education and Simulation

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2020
• Primary Completion (Actual): January 15, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: February 11, 2021
• First Submitted That Met QC Criteria: January 2, 2022
• First Posted (Actual): January 13, 2022

Study Record Updates

• Last Update Posted (Actual): January 13, 2022
• Last Update Submitted That Met QC Criteria: January 2, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CAMES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No