A Clinical Study on Ultrasonic Energy Devices for Surgical Applications Developed with Domestic Technology

Not Applicable

Completed

• Conditions: Neoplasms

• Registration Number: KCT0006314
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

1. patient clinicopathologic characteristics - no significance 2. operative details - significance(total VAS average) 3. early postoperative complications within 30 days - no significance 4. comparison of specific variables of each device - significance(cutting speed - LGA(sec))

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-04-30
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1) Patients aged between 20 and 75 years of age;
2) Patients diagnosed with gastroscopic biopsy with gastric cancer (adenocarcinoma)
3) Patients with an ECOG performance status of 0 or 1
4) Patients who have not received chemotherapy or radiation treatment prior to surgery
5) Patients who have not taken anticoagulation agent prior to surgery
6) Patients with no previous abdominal surgery
7) Patients capable of laparoscopic and robotic surgery
8) Patients who outline the research and receive an informed consent form (Regulation Form) from the patient themselves in principle;
However, if necessary in patients older than 70 years of age, study subjects can understand research-related information (e.g., study nature and expected findings), handle information about the study logically, and clearly express their choices about whether or not they want to participate. If necessary, they are also equipped with appropriate protection, such as obtaining their consent with their family members or legal representatives.

Exclusion Criteria

1) If the patient or guardian does not agree with this study
2) Patients subject to open surgery
3) If you have been treated for another organ cancer before being diagnosed with stomach cancer or currently accompanied by another cancer
4) More than one lesion site
5) Where chemotherapy or radiation treatment has been received in the past;
6) Preoperative examination confirms remote metastasis
7) For residual cancer
8) Metastatic gastric cancer
9) A person who lacks medical ability, is pregnant or is planning to become pregnant;

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigate advantages and disadvantages of using domestic energy devices

Secondary Outcome Measures

Name	Time	Method
Check the non-feriority of domestic devices compared to foreign devices