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OpenTrials
Completed

NCT Number: NCT05191589

Haptic Devices Impact on Laparoscopic Simulators

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.

Completed

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Key information

Conditions

Medical Education

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CAMES, Copenhagen, Capital Region, Denmark

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Haptic

Other

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

Primary outcomes

  1. 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

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).

    Time frame: From randomization till participants passes all modules on the virtual reality simulator in the trial (approx. 3-4 weeks)

    Measured in minutes

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Copenhagen Academy for Medical Education and Simulation

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jan 13, 2022
Registry last updated
Jan 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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