NCT05834504

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

August 29, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 28, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

August 22, 2022

Last Update Submit

April 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to proficiency

    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 Outcomes (1)

  • Retention test

    6 months

Study Arms (2)

Control group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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)

Interventions

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.

Intervention Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen Academy For Medical Education and Simulation (Cames)

Copenhagen, Capital Region, 2100, Denmark

Location

Study Officials

  • Flemming Bjerrum, MD

    Copenhagen Academy for Medical Education and Simulation

    STUDY DIRECTOR

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
Principal Investigator

Study Record Dates

First Submitted

August 22, 2022

First Posted

April 28, 2023

Study Start

August 29, 2022

Primary Completion

March 26, 2023

Study Completion

March 26, 2023

Last Updated

April 28, 2023

Record last verified: 2023-04

Locations