Exploring the Intervals in Distributed Laparoscopic Skills Training (DPiLS)

April 26, 2023 updated by: Hai-Yen Tang, Copenhagen Academy for Medical Education and Simulation
The objective of this trial is to investigate if short intervals (1-2 days) between training sessions are more efficient than practicing with longer intervals (6-8 days) between sessions during proficiency-based laparoscopic simulator training. Our hypothesis is that just 1-2 days of break between sessions is optimal for the acquisition of laparoscopic skills and that a shorter interval between sessions is optimal for training.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

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
    • Capital Region
      • Copenhagen, Capital Region, Denmark, 2100
        • Copenhagen Academy For Medical Education and Simulation (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

No

Description

Inclusion Criteria:

- Master's degree medical students, enrolled at a Danish University.

Exclusion Criteria:

  • Medical students that have participated in prior studies or similar involving laparoscopic training.
  • Performing laparoscopy surgery between the intervention and the retention test 3-5 weeks after.
  • No informed consent.
  • Does not speak Danish on a conversational level.
  • Any disability or injury regarding eyesight and mobility.

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
No Intervention: Control group
The control group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 6-8 days of break in between training sessions until proficiency level is achieved.
Experimental: Intervention Group
The intervention group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 1-2 days of break in between training sessions until proficiency level is achieved.
Other: Short distributed training (1-2 days)
The intervention group will practice four basic skills and one procedural module on the Laparoscopic "Lapsim" Virtual Reality Simulator. They will practice with 1-2 days of break in between training sessions until proficiency level is achieved.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to proficiency
Time Frame: 6 months
The total effective training time (minutes) to reach the predefined proficiency level for both the four basic skills and the salpingectomy module.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention test
Time Frame: 6 months
The total effective training time (minutes) to reach the predefined proficiency level for both the four basic skills and the salpingectomy module after 3-5 weeks without laparoscopic training from the last training session.
6 months

Collaborators and Investigators

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

Sponsor

Copenhagen Academy for Medical Education and Simulation

Investigators

  • Study Director: Flemming Bjerrum, MD, 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)

August 29, 2022

Primary Completion (Actual)

March 26, 2023

Study Completion (Actual)

March 26, 2023

Study Registration Dates

First Submitted

August 22, 2022

First Submitted That Met QC Criteria

April 26, 2023

First Posted (Actual)

April 28, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2023

Last Update Submitted That Met QC Criteria

April 26, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • DPiLS trial

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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