Stomach CancerNCT01319084
Development of a Versatile Intra-operative On-screen Audiovisual Mentoring System Using TileproTM Program for Robotic Gastrectomy
An observational study of Stomach Cancer, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Stomach Cancer
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2011to Feb 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Outpatient clinic in severance hospital
Who may be able to join
- Robotic surgery for primary early gastric cancer
- Distal gastrectomy with Billroth II anastomosis
- Age: 20~80 years old
Who cannot join
- Other malignancy and inflammatory diseases
- Disease associated with bleeding tendency
- Previous major abdominal surgery
- Pregnancy
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 120-752
Woo-Jin Hyung, MD, Ph.D, 82-2-2228-2129, wjhyung@yuhs.ac
About this study
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).
Read the 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:
- Standardization of the key steps of the selected procedure;
- 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;
- Production of a 3D animation of the key surgical steps;
- 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.
- Conditions
- Stomach Cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stomach CancerStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01319084
- Sponsor's protocol ID
- 1-2010-0062
- Status last verified
- Jan 2012
- First submitted
- 18 Mar 2011
- Last updated
- 2 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Versatile Intra-operative On-screen Audiovisual Mentoring System Using TileproTM Program for Robotic Gastrectomy
- ClinicalTrials.gov ID
- NCT01319084
- Acronym / sponsor ID
- 1-2010-0062
- Conditions
- Stomach Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 21 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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:
- Standardization of the key steps of the selected procedure;
- 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;
- Production of a 3D animation of the key surgical steps;
- 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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Outpatient clinic in severance hospital
Key inclusion criteria (3 listed)
- Robotic surgery for primary early gastric cancer
- Distal gastrectomy with Billroth II anastomosis
- Age: 20~80 years old
Key exclusion criteria (4 listed)
- Other malignancy and inflammatory diseases
- Disease associated with bleeding tendency
- Previous major abdominal surgery
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stomach Cancer, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2012.