Haptic Devices Impact on Laparoscopic Simulators

January 2, 2022 updated by: Anishan Vamadevan, Copenhagen Academy for Medical Education and Simulation

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: From randomization till participants have passed all modules on the simulator (approx 3-4 weeks)
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).
Time Frame: From randomization till participants passes all modules on the virtual reality simulator in the trial (approx. 3-4 weeks)
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.
Time Frame: During trial, up to 1 year
All mechanical malfunction will be registered and classified afterwards
During trial, up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Copenhagen Academy for Medical Education and Simulation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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