Simulating Laparoscopy With an Eye Patch (LapACQ)

Laparoscopic Skill Acquisition; Can the Loss of Depth Perception Associated With Laparoscopic Surgery be Adequately Simulated by an Eye Patch?

Comparison of laparoscopic training simulator v use of eye patch (to simulate loss of dept perception) to investigate acquisition of laparoscopic skills.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Training
• Intervention / Treatment: Device: Computerized Laparoscopic Trainer; Device: Box trainer with eye patch

Detailed Description

Healthy volunteers who are laparoscopic novices will perform four validated laparoscopic training exercises on both the laparoscopic computerized trainer and on a simple box trainer with an eye patch.

Novices will be allowed to familiarize themselves with the laparoscopic instruments and will be shown short video clips to demonstrate tasks.

They then will have five minutes to complete each of the four tasks. They will return 1-2 weeks later to complete the same process on the alternative training method.

All participants will complete the tasks on both the computerized lap simulator and the box trainer.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Derby, United Kingdom, DE22 3NE
    • University of Nottingham
  • Derby, United Kingdom, DE22
    • The Medical School, University of Nottingham, Royal Derby Hospital.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Laparoscopic Novices
• 20-40 years
• All genders

Exclusion Criteria:

• Previous laparoscopic surgical experience

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Laparoscopic Novices; Four laparoscopic task will be undertaken on a computerized laparoscopic trainer and box trainer with eye patch. Time to completion is recorded.	Device: Computerized Laparoscopic Trainer; Gold standard laparoscopic trainer using simulated computerized equipment.; Device: Box trainer with eye patch; Simple, cost effective box trainer, with loss of dept perception achieved with use of eye patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to completion of laparoscopic tasks.	5 minutes

Collaborators and Investigators

• Sponsor: University of Nottingham

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): August 1, 2018

Study Registration Dates

• First Submitted: January 16, 2018
• First Submitted That Met QC Criteria: January 22, 2018
• First Posted (Actual): January 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 15, 2018
• Last Update Submitted That Met QC Criteria: October 10, 2018
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: LTf15082013 ammend. 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No