Haptic Devices Impact on Laparoscopic Simulators

NCT05191589 | Completed

• 1 other identifier: CAMES
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Medical Education

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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)

Other Outcomes (1)

• Exploratory outcome: To observe and register mechanical/technical malfunctions during the intervention and retention.

  During trial, up to 1 year

Study Arms (2)

Intervention Group

EXPERIMENTAL

In the intervention group trainees will train in an already validated laparoscopic training program with haptic devices.

Other: Haptic

Control

NO INTERVENTION

In the control group trainees will complete the same validated training program in the conventional non-haptic setting.

Interventions

Haptic OTHER

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

Intervention Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be a junior doctor working in a surgical department

You may not qualify if:

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

Sponsors & Collaborators

• Copenhagen Academy for Medical Education and Simulation: lead

Study Sites (2)

CAMES

Copenhagen, Capital Region, 2100, Denmark

Location

CAMES

Copenhagen, 2100, Denmark

Location

MeSH Terms

Interventions

Haptic Technology

Intervention Hierarchy (Ancestors)

Bioengineering; Engineering; Technology, Industry, and Agriculture; Technology; Man-Machine Systems

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Student and Research Fellow

Model Details: 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.

Study Record Dates

• First Submitted: February 11, 2021
• First Posted: January 13, 2022
• Study Start: October 1, 2020
• Primary Completion: January 15, 2021
• Study Completion: February 1, 2021
• Last Updated: January 13, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)