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

February 8, 2019 updated by: Yonsei University

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: examination day of study participation

questionnaire : please score the difference after finish this study

  • understanding about the robotic surgery
  • upskilling of the robotic system drive

  • system's advantages

    1. portable
    2. anytime possible
    3. practicality as a real robotic surgery
    4. understandable of using clutch
    5. camera 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

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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