Development of a Versatile Intra-operative On-screen Audiovisual Mentoring System Using TileproTM Program for Robotic Gastrectomy

January 31, 2012 updated by: Yonsei University
Considering the development of gastric cancer surgery using da Vinci Robotic Surgical System, the development of educational program needs to be achieved in Korea and this institute. Moreover, because of the large number of gastrectomy including robotic surgery for gastric cancer treatment, the investigators can provide high quality of educational program using da Vinci System. Therefore, the investigators wanted to create an innovative real-time training module, which can provide an intraoperative step-by-step guide to robotic surgical procedures. This technological project was named as Advanced Robotic Multi-display Educational System (ARMES).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Considering the development of gastric cancer surgery using da Vinci Robotic Surgical System, the development of educational program needs to be achieved in Korea and this institute. Moreover, because of the large number of gastrectomy including robotic surgery for gastric cancer treatment, the investigators can provide high quality of educational program using da Vinci System. Therefore, the investigators wanted to create an innovative real-time training module, which can provide an intraoperative step-by-step guide to robotic surgical procedures. This technological project was named as Advanced Robotic Multi-display Educational System (ARMES).

The four-stages of ARMES development are as follows:

  1. Standardization of the key steps of the selected procedure;
  2. Preparation of well edited short video clips for each of the previously determined steps using our extensive library of videos of over 350 high quality robotic gastrectomies;
  3. Production of a 3D animation of the key surgical steps;
  4. Integration of the video segments into the da Vinci Robot system using TileproTM.

Through predetermined standardized segments of short operation video clips and 3D animation, the investigators are developing a versatile intra-operative on-screen audiovisual mentoring system using TileproTM program, which will improve surgeons' capabilities to perform complex robotic operations achieving quicker operation specific competency. It will help surgeons at initial state of robotic surgery in technical as well as oncological aspect for cancer surgery in detail and step-by-step. Finally this program can be applied to other robotic surgery and progressed to be a standard education program.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

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, 120-752
        • Recruiting
        • Severance Hospital
        • Contact:
          • Woo-Jin Hyung, MD, Ph.D
          • Phone Number: 82-2-2228-2129
          • Email: wjhyung@yuhs.ac

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Outpatient clinic in severance hospital

Description

Inclusion Criteria:

  • Robotic surgery for primary early gastric cancer
  • Distal gastrectomy with Billroth II anastomosis
  • Age: 20~80 years old

Exclusion Criteria:

  • Other malignancy and inflammatory diseases
  • Disease associated with bleeding tendency
  • Previous major abdominal surgery
  • Pregnancy

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
ARMES group
Surgeons who watch Tilepro program before da Vinci Robotic Surgery.
normal group
Surgeons who do not watch Tilepro program before da Vinci Robotic Surgery.

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2011

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2012

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 21, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 31, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1-2010-0062

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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