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

Comparison of 3D Versus 2D Training of Basic Laparoscopic Skills in Terms of Training Effectiveness

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopy
• Intervention / Treatment: Other: 3D training; Other: 2D training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Medical University Vienna

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 3D training; Basic laparoscopic skills (FLS tasks) training using 3D visualization	Other: 3D training; Skills (FLS tasks) training using 3D visualization
Other: 2D training; Basic laparoscopic skills (FLS tasks) training using 2D visualization	Other: 2D training; Skills (FLS tasks) training using 2D visualization

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in total Fundamentals of Laparoscopic Surgery (FLS) manual skills scores using 2D versus 3D training of basic laparoscopic skills (using four different FLS tasks)	Performance of four different Fundamentals of Laparoscopic Surgery (FLS) tasks will be assessed according to the time needed to complete the task as well as the accuracy of task performance using the FLS scoring system as previously described [Derossis AM, Fried GM, Abrahamowicz M, et al. Development of a model for training and evaluation of laparoscopic skills. Am J Surg 1998;175:482-7.]. The improvement of performance for the total score as well as for each FLS task will be calculated by subtracting the baseline test scores from the posttraining test scores. The primary outcome measure will be the improvement in total test scores.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progress in basic laparoscopic skills improvement according to the time required for completion of the different FLS tasks during the training period in the 3D and the 2D visualization group	Analysis of the progress in basic laparoscopic skills improvement according to the time required for FLS task completion during the training period for each of the two visualization modalities	5 weeks

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Heinrich Husslein, MD, PLL.M., Department of Obstetrics and Gynecology, Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2018
• Primary Completion (Actual): December 14, 2018
• Study Completion (Actual): December 14, 2018

Study Registration Dates

• First Submitted: November 28, 2018
• First Submitted That Met QC Criteria: December 2, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 1, 2019
• Last Update Submitted That Met QC Criteria: March 29, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: laparoscopic surgery; skills training
• Other Study ID Numbers: 2018_123

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