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

Healthy Population Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03067532
• Other study ID #: 1-2016-0070
• Status: Completed
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: September 1, 2017

Study information

• Verified date: February 2019
• Source: Yonsei University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: September 1, 2017
• Est. primary completion date: September 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Population
• Medical School Student

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Department of Surgery, Yonsei University College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 advantages; portable; anytime possible; practicality as a real robotic surgery; understandable of using clutch; camera management; between A and B group system before managing the simulation system and after finishing the simulation system	examination day of study participation