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

NCT03763903 | Completed

• 1 other identifier: 2018_123
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Laparoscopy

Keywords

skills training; laparoscopic surgery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  5 weeks

Study Arms (2)

3D training

OTHER

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

Other: 3D training

2D training

OTHER

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

Other: 2D training

Interventions

3D training OTHER

Skills (FLS tasks) training using 3D visualization

3D training

2D training OTHER

Skills (FLS tasks) training using 2D visualization

2D training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• medical students with limited experience in laparoscopic surgery

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University Vienna

Vienna, Austria

Location

Study Officials

• Heinrich Husslein, MD, PLL.M.

  Department of Obstetrics and Gynecology, Medical University of Vienna

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc.-Prof. Priv.-Doz. Dr., PLL.M.

Study Record Dates

• First Submitted: November 28, 2018
• First Posted: December 4, 2018
• Study Start: November 13, 2018
• Primary Completion: December 14, 2018
• Study Completion: December 14, 2018
• Last Updated: April 1, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)