Comparison of the Effectiveness of 2D Versus 3D Basic Laparoscopic Skills Training

NCT ID: NCT03763903

Last Updated: 2019-04-01

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

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-11-13

Study Completion Date

2018-12-14

Brief Summary

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The aim of this study is to find out whether basic laparoscopic skills training (FLS tasks) on a standard pelvic trainer using conventional 2D visualization is at least equally effective in terms of skills improvement compared to practicing with 3D visualization. Furthermore, the progress in basic laparoscopic skills improvement for each visualization modality will be analyzed.

Detailed Description

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An increasing number of operations are done minimal invasively. For example, appendectomy, cholecystectomy, bariatric procedures, colorectal resections as well as hysterectomy and many other gynecologic procedures, are routinely performed laparoscopically.

Laparoscopy requires psychomotor skills that may be difficult to learn and result in prolonged learning curves. In order to become familiar with the 2-dimensional visualization and to learn and improve laparoscopic skills, training is needed. As traditional training in the operating room is expensive and comprises an increased operating risk for the patient, various training alternatives outside the operating room have been developed and shown to be effective in translating the thereby acquired skills to the operating room. Besides training on live animals or cadavers, there are virtual reality simulators, augmented reality simulators and different box trainers. Each of these training devices has specific advantages and limitations. However, some types could be superior to others in terms of training effectiveness. For instance, with implementation of 3D visualization during laparoscopic interventions which facilitates spatial perception, the question arises as to whether training of basic laparoscopic skills using conventional 2D visualization is at least equally effective compared to training with 3D visualization.

The aim of this study is to find out whether basic laparoscopic skills (FLS tasks) training on a standard pelvic trainer using conventional 2D visualization is at least equally effective in terms of skills improvement compared to practicing with 3D visualization. Furthermore, the progress in basic laparoscopic skills improvement for each visualization modality will be analyzed.

Conditions

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Laparoscopy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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3D training

Basic laparoscopic skills (FLS tasks) training using 3D visualization

Group Type OTHER

3D training

Intervention Type OTHER

Skills (FLS tasks) training using 3D visualization

2D training

Basic laparoscopic skills (FLS tasks) training using 2D visualization

Group Type OTHER

2D training

Intervention Type OTHER

Skills (FLS tasks) training using 2D visualization

Interventions

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3D training

Skills (FLS tasks) training using 3D visualization

Intervention Type OTHER

2D training

Skills (FLS tasks) training using 2D visualization

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* medical students with limited experience in laparoscopic surgery

Exclusion Criteria

* any laparoscopic operation performed as the primary surgeon
* regular (e.g., once per month) practice on a box trainer for the last 12 months
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medical University of Vienna

OTHER

Sponsor Role lead

Responsible Party

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Heinrich Husslein

Assoc.-Prof. Priv.-Doz. Dr., PLL.M.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heinrich Husslein, MD, PLL.M.

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynecology, Medical University of Vienna

Locations

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Medical University Vienna

Vienna, , Austria

Site Status

Countries

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Austria

Other Identifiers

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2018_123

Identifier Type: -

Identifier Source: org_study_id

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