DPiLS: Exploring the Intervals in Distributed Laparoscopic Skills Training

Sponsor

Copenhagen Academy for Medical Education and Simulation (Other)

Overall Status

Completed

CT.gov ID

NCT05834504

Collaborator

(none)

Enrollment

Location

Arms

6.9

Actual Duration (Months)

5.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Skills Acquisition Simulation Laparoscopy	Other: Short distributed training (1-2 days)	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

39 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Exploring the Intervals in Distributed Laparoscopic Skills Training

Actual Study Start Date :

Aug 29, 2022

Actual Primary Completion Date :

Mar 26, 2023

Actual Study Completion Date :

Mar 26, 2023

Arms and Interventions

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.

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)

Outcome Measures

Primary Outcome Measures

Time to proficiency [6 months]
The total effective training time (minutes) to reach the predefined proficiency level for both the four basic skills and the salpingectomy module.

Secondary Outcome Measures

Retention test [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Copenhagen Academy For Medical Education and Simulation (Cames)	Copenhagen	Capital Region	Denmark	2100

Sponsors and Collaborators

Copenhagen Academy for Medical Education and Simulation

Investigators

Study Director: Flemming Bjerrum, MD, Copenhagen Academy for Medical Education and Simulation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hai-Yen Tang, Principal Investigator, Copenhagen Academy for Medical Education and Simulation

ClinicalTrials.gov Identifier:

NCT05834504

Other Study ID Numbers:

DPiLS trial

First Posted:

Apr 28, 2023

Last Update Posted:

Apr 28, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Apr 28, 2023