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

Laparoscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03763903
• Other study ID #: 2018_123
• Status: Completed
• Phase: N/A
• Start date: November 13, 2018
• Est. completion date: December 14, 2018

Study information

• Verified date: March 2019
• Source: Medical University of Vienna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: December 14, 2018
• Est. primary completion date: December 14, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Laparoscopy

Intervention

Other:
• 3D training
Skills (FLS tasks) training using 3D visualization
• 2D training
Skills (FLS tasks) training using 2D visualization

Locations

Country	Name	City	State
Austria	Medical University Vienna	Vienna

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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