NCT02407483

Brief Summary

"Laparoscopic simulation training with or without laser visual guidance -A randomised study" which investigates if the use of laser visual guidance can help the novices to learn the laparoscopic skills.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

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

Study Start

First participant enrolled

March 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

March 19, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

April 3, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

October 2, 2018

Status Verified

October 1, 2018

Enrollment Period

4 months

First QC Date

March 19, 2015

Last Update Submit

October 1, 2018

Conditions

Depth Perception

Keywords

LaparoscopyTraining Programs

Outcome Measures

Primary Outcomes (1)

  • Motor skills performance parameters (Cumulative Instrument movement-time)

    Cumulative Instrument movement-time

    3 hours

Secondary Outcomes (1)

  • The composite performance score (errors)

    3 hours

Other Outcomes (1)

  • The NASA Task Load index (NASA-TLX).

    3 hours

Study Arms (2)

Laser Visual Guidance group

EXPERIMENTAL

Will be tested using simulated laparoscopic tasks with the use of laser visual guidance

Device: Laser Visual Guidance

Normal 2D vision group

ACTIVE COMPARATOR

Will be tested using simulated laparoscopic tasks without the use of laser visual guidance

Device: 2 D vision

Interventions

Laser Visual GuidanceDEVICE

Laparoscopic simulator training, tested with laser visual guidance

Laser Visual Guidance group
2 D visionDEVICE

Laparoscopic simulator training, tested without laser visual guidance

Normal 2D vision group

Eligibility Criteria

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

You may qualify if:

  • Surgical novices / medical students enrolled at The Faculty of Health Science, University of Copenhagen.

You may not qualify if:

  • Participation in prior studies involving laparoscopic training.
  • Experience with laparoscopy surgery (having performed minimum one laparoscopic procedure as primary surgeon, including supervised procedures).
  • No informed consent.
  • Does not speak Danish on a conversational level.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre for Clinical Education

Copenhagen, Cooenhagen Ø, 2100, Denmark

Location

Study Officials

  • Lars Konge, MD, PhD

    Center for Clinical Education, Rigshospitalet,

    PRINCIPAL INVESTIGATOR

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
Medical Student

Study Record Dates

First Submitted

March 19, 2015

First Posted

April 3, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

August 1, 2015

Last Updated

October 2, 2018

Record last verified: 2018-10

Locations

DK(1)