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AzTrials

Gastric CancerNCT05550974

Articulated Laparoscopic Instruments Clinical Study

An observational study of Gastric Cancer, run by Yonsei University at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Recently, with the development of minimally invasive surgery and the development of instruments, laparoscopic and robotic surgery are increasing, and laparoscopic and robotic surgery are evolving. Read more about this study

Who is it for?
Ages 19 to 90 years
Conditions the study is for
Gastric Cancer
What is being tested?
Minimally Invasive Surgery
Type of treatment
Medical device
How many people
1,155 participants
Where
1 siteSouth Korea
Study dates
Sep 2022to Dec 2024
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 19 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with gastric cancer scheduled to undergo gastrectomy in high volume center

Who may be able to join

  • Patients with gastric cancer shcedulled for gastrectomy

Who cannot join

  • Vulnerable subject (illiterate, pregnant)

Trial locations and contacts

1 site in 1 country.

Hyoung-Il Kim contact

02-2228-2095

cairus@yuhs.ac

South Korea1 site, 1 recruiting

  • Yonsei University Health System, Severance Hospital

    Seoul

    Hyoung-Il Kim, 02-2228-2095, cairus@yuhs.ac

    Recruiting

Other trials in South Korea

About this study

Official title: Articulating Laparoscopic Instrument Assisted Minimally Invasive Upper GastroIntestinal Surgery: AMUGIS Registry

Recently, with the development of minimally invasive surgery and the development of instruments, laparoscopic and robotic surgery are increasing, and laparoscopic and robotic surgery are evolving. The association between the new surgical instruments used in each upper gastrointestinal surgery and the results has been traditionally analyzed through the learning curve, and in addition, the study aims to collect and analyze the utilization of the instrument and surgical results prospectively through surgical video analysis.

Read the detailed description

Prior to surgery, all patients subject to the study are explained and informed of the prior consent form of prior consent is delivered. During surgery, video recording is performed to check the type of surgical instrument, the time of use, and the event that occurred during surgery. After surgery, the morbidity after surgery will be monitored and recorded. Additional morbidity will be recorded one to three months after surgery.

Conditions
Gastric Cancer
Being tested
Minimally Invasive Surgery
Keywords
Articulated laparoscopic instruments, gastrointestinal surgery, complication
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Minimally Invasive SurgeryDevice

    Also called Laparoscopic Surgery

    gynecological, urologic, thoracic, plastic and reconstructive and ENT etc. endoscopic and laparoscopic surgical procedures

Study groups in NCT05550974
Study groupRoleWhat they receive
LClaparoscopic surgery using conventional laparoscopic instruments
Receives: Device: Minimally Invasive Surgery
LWUsing wristed laparoscopic instruments (Artisential Maryland dissector, Artisential Fenestrated gasper)
Receives: Device: Minimally Invasive Surgery
RCConventional robotic surgery
RSSUse of singlesite system for reduced port robotic surgery
RSPUse of da Vinci SP system for reduced port robotic surgery
RRIA new surgical robot Revo-i developed by Meerae company in Korea

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. complication

    One of the most important surgical outcome, complication will be measured at 1 month after surgery

    Measured: 1 month after surgery

Secondary outcomes (12)

  1. Surgical outcome: operative time(min)

    Measured: 1 month after surgery

  2. Surgical outcome: bleeding(ml)

    operative time(min), bleeding(ml), pain score, hospital stay(day), readmission rate(%), serum CRP(mg/L), serum Amylase(U/L), serum Lipase(U/L), Drain Amylase(U/L), Drain Lipase(U/L)

    Measured: 1 month after surgery

  3. Surgical outcome: pain score

    Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be').

    Measured: 1 month after surgery

  4. Surgical outcome: hospital stay(day)

    Measured: 1 month after surgery

  5. Surgical outcome: readmission rate(%)

    Measured: 1 month after surgery

  6. Surgical outcome: serum CRP(mg/L)

    Measured: 1 month after surgery

  7. Surgical outcome: serum Amylase(U/L)

    Measured: 1 month after surgery

  8. Surgical outcome: serum Lipase(U/L)

    Measured: 1 month after surgery

  9. Surgical outcome: Drain Amylase(U/L)

    Measured: 1 month after surgery

  10. Surgical outcome: Drain Lipase(U/L)

    Measured: 1 month after surgery

  11. Duration of use for each surgical instruments

    Duration for each surgical instruments

    Measured: during the operation

  12. number of use for each surgical instruments

    number of use for each surgical instruments

    Measured: during the operation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2022
  2. Study startSep 2022 (estimated)
  3. Primary completionOct 2024 (estimated)
  4. Study completionDec 2024 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
1,155 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05550974
Sponsor's protocol ID
4-2022-0414
Status last verified
Sep 2022
First submitted
7 Sep 2022
Last updated
3 Oct 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric 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 1 inclusion and 1 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 3 Oct 2022. 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?

Contact Hyoung-Il Kim (02-2228-2095, cairus@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

complication (time frame: 1 month after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05550974.

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 3 Oct 2022; AzTrials last refreshed its copy on 28 Oct 2026.

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