Simulating Laparoscopy With an Eye Patch

NCT ID: NCT03407235

Last Updated: 2018-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-11

Study Completion Date

2018-08-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Laparoscopic Training

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Laparoscopic Novices

Four laparoscopic task will be undertaken on a computerized laparoscopic trainer and box trainer with eye patch.

Time to completion is recorded.

Group Type OTHER

Computerized Laparoscopic Trainer

Intervention Type DEVICE

Gold standard laparoscopic trainer using simulated computerized equipment.

Box trainer with eye patch

Intervention Type DEVICE

Simple, cost effective box trainer, with loss of dept perception achieved with use of eye patch

Interventions

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Computerized Laparoscopic Trainer

Gold standard laparoscopic trainer using simulated computerized equipment.

Intervention Type DEVICE

Box trainer with eye patch

Simple, cost effective box trainer, with loss of dept perception achieved with use of eye patch

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Laparoscopic Novices
* 20-40 years
* All genders

Exclusion Criteria

* Previous laparoscopic surgical experience
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Nottingham

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University Of Nottingham

Derby, , United Kingdom

Site Status

The Medical School, University of Nottingham, Royal Derby Hospital.

Derby, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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LTf15082013 ammend. 2

Identifier Type: -

Identifier Source: org_study_id

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