A clinical study on the efficacy of ultrasonic Energy Devices for Surgical Applications developed with Domestic technology in laparoscopic colorectal surgery.
- Conditions
- Neoplasms
- Registration Number
- KCT0007445
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 20
over 20 years old
A patient who was diagnosed with colorectal cancer as a result of a biopsy performed with a colonoscopy and is scheduled to undergo laparoscopic colorectal resection
Patients with ECOG (Estern Cooperative Oncology Group Performance Status) performance of 0 or 1
Patients who have not received chemotherapy or radiation therapy prior to surgery
Patients who did not take an anticoagulation agent/antiplatelet agent before surgery
Patients with diseases that are eligible for laparoscopic surgery
Patients who explained the study outline and, in principle, obtained informed consent (regulation form) from the patient himself/herself.
However, if it is necessary for patients over 70 years of age, ? the research subject understands information related to the research (eg, the nature of the research and expected research results), ? can logically handle the information about the research, and ? After confirming that they have the ability to clearly express their choice regarding whether or not they want to participate, if the subject's understanding and willingness to participate in the study are repeatedly confirmed, they should participate in the study. If necessary, also have appropriate safeguards, such as obtaining your consent with a family member or legal representative.
If the patient or guardian does not consent to this study
open surgery
In case of accompanying cancer other than colorectal cancer
When there are two or more cancerous lesions
If patient have received chemotherapy or radiation therapy before surgery
If distant metastasis is confirmed in preoperative examination
In case of metastatic colorectal cancer
If patient do not have the ability making decision
If patient is pregnant
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cutting and sealing time of major vessels;Stickiness of jaw in energy device;Degree of disturbance of vision due to smoke generation during use;Wrist fatigue assessment
- Secondary Outcome Measures
Name Time Method Intraoperative bleeding;Postoperative bleeding;Pain assessment;Length of hospital stay