Laparoscopic Training With Laser Guidance Trial | NCT02407483

Studies
Laparoscopic Training With Laser Guidance Trial

NCT02407483

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Oct 2, 2018Actual

Enrollment

32Actual

Phase

Not Applicable

Conditions

Depth Perception

Interventions

Laser Visual Guidance
2 D vision

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Jul 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Mar 19, 2015

First Submission Date that Met QC Criteria

Apr 2, 2015

First Posted Date

Apr 3, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 1, 2018

Last Update Posted Date

Oct 2, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Background: The loss of depth perception due to working in a three-dimensional space based on two-dimensional images is one of the challenging aspects of laparoscopy compared to conventional open surgery.

Objectives: To examine the effect of laser visual guidance on laparoscopic performance and cognitive load in a simulated setting for novices.

Methods: Randomised Clinical Trial- Laser visual guidance vs. normal 2 D vision.

Outcomes:

Primary outcome: Motor skills performance parameters-movement-time:

Cumulative instrument movement-time for both the right and left instrument for the test session,

Secondary outcome: 2) The overall composite score.

Exploratory outcomes: 3) The NASA Task Load index (NASA-TLX).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

32Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Laser Visual Guidance	Device	Laparoscopic simulator training, tested with laser visual guidance	Laser Visual Guidance group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Motor skills performance parameters (Cumulative Instrument movement-time)	Cumulative Instrument movement-time	3 hours

Secondary Outcomes

Measure	Description	Time Frame
The composite performance score (errors)	points	3 hours

Other Outcomes

Measure	Description	Time Frame
The NASA Task Load index (NASA-TLX).	Work load index	3 hours

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Surgical novices / medical students enrolled at The Faculty of Health Science, University of Copenhagen.
Participants are required to provide informed consent before inclusion.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lars Konge, MD, PhD	Center for Clinical Education, Rigshospitalet,	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre for Clinical Education		Copenhagen	Cooenhagen Ø	2100	Denmark