Efficacy of RUS GA Surgical Navigation for Robot-assisted Distal Gastrectomy in Gastric Cancer Patients

Launched by YONSEI UNIVERSITY · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new tool called RUS GA Surgical Navigation, which is a type of software designed to help doctors perform robot-assisted surgery for patients with gastric cancer. The goal is to see if using this software can make surgeries quicker and safer. Researchers will compare two groups of patients: one group will use the RUS GA software during their surgery, while the other group will have surgery without it. They hope to see that the surgery for the group using the software takes about 8.7% less time.

To participate in this trial, individuals need to be diagnosed with gastric cancer and be at least 20 years old. They must be able to understand the details of the trial and give their consent to participate. Patients who have certain complications or previous surgeries that affect the stomach may not be eligible. The trial will last for about 30 months, and a total of 330 participants are expected to be involved from various locations worldwide. Participants can expect to undergo additional imaging tests and will receive close monitoring during the trial to ensure their safety.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Individuals diagnosed with gastric cancer and scheduled for robot-assisted gastrectomy.
• • 2. Adults aged 20 and above who are capable of independent judgment.
• • 3. Individuals capable of undergoing CT imaging according to the prescribed protocol.
• • 4. Individuals who, before participating in the clinical trial, undergo an interview in a separate place, understand sufficient explanation of the purpose and content of the trial, and voluntarily sign informed consent form (approved by the Institutional Review Board)
• Exclusion Criteria:
• • 1. Vulnerable individuals (those lacking decision-making capacity, illiterate individuals, pregnant women, newborns, minors under the age of 20, etc.).
• • 2. Patients who cannot undergo CT imaging according to the prescribed protocol before gastric cancer surgery (due to contrast agent allergies, creatinine levels exceeding 1.5 times the normal upper limit, claustrophobia, etc.).
• • 3. Individuals whose major gastric or intra-abdominal arterial/venous structures have been altered due to previous gastric or other abdominal surgeries (however, those with a history of intra-abdominal surgery that did not affect the stomach or major blood vessels are eligible).
• • 4. Patients with a history of residual gastric cancer from previous surgery.
• • 5. Patients who do not consent to participate in the study or withdraw their consent.
• • 6. Patients scheduled for simultaneous resection of other organs besides the stomach.