Assessment of Educational Effect of Home-made Robotic Surgery Simulator for Novice Robotic Surgeons

To overcome the obstacles of endoscopic surgery, the da vinci surgical robot system was applied to the various surgery area . And the complete understanding and practice of the robotic system is very important condition for successful robotic surgery.

Investigator developed a home made robotic surgery simulator for novice robotic surgeons. And investigator want to study about the ability of home made robotic surgery simulator versus existing robotic simulation system.

Study Overview

• Status: Completed
• Conditions: Healthy Population; Medical School Student
• Intervention / Treatment: Procedure: existed simulation system user; Procedure: home made simulator user

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03722
    • Department of Surgery, Yonsei University College of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. medical student of Yonsei University College of Medicine
2. first time of robotic surgery system
3. voluntary participation of this study

Exclusion Criteria:

1. minors & foreigner
2. involuntary participation of this study
3. refuse to sign a consent form

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
Active Comparator: B	Procedure: home made simulator user; Investigator will divide the subject by the two groups. Each group will take about 15 minutes for exercising drive robotic surgery instrument by each simulation system. After 15 minutes, both group will take an short exam to check the ability to manage the robotic surgery instrument.
Experimental: A	Procedure: existed simulation system user; Investigator will divide the subject by the two groups. Each group will take about 15 minutes for exercising drive robotic surgery instrument by each simulation system. After 15 minutes, both group will take an short exam to check the ability to manage the robotic surgery instrument.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
comparing the understanding and competence level of robotic surgery system	questionnaire : please score the difference after finish this study; understanding about the robotic surgery; upskilling of the robotic system drive; system's advantagesportableanytime possiblepracticality as a real robotic surgeryunderstandable of using clutchcamera management between A and B group system before managing the simulation system and after finishing the simulation system	examination day of study participation

Collaborators and Investigators

• Sponsor: Yonsei University

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2017
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): September 1, 2017

Study Registration Dates

• First Submitted: February 26, 2017
• First Submitted That Met QC Criteria: February 26, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): February 11, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 1-2016-0070

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