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A clinical study on the efficacy of ultrasonic Energy Devices for Surgical Applications developed with Domestic technology in laparoscopic colorectal surgery.

A clinical study on the efficacy of ultrasonic Energy Devices for Surgical Applications developed with Domestic technology in laparoscopic colorectal surgery.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CRIS
Registry ID
KCT0007445
Enrollment
20
Registered
2022-06-28
Start date
2022-06-15
Completion date
Unknown
Last updated
2022-09-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Group A: Using Medisonic DU series (generator: Meditom DUB-100) during laparscopic colorectal surgery Group B: Using Harmonic HD 1000i during laparscopic colorectal surgery The surgi

Sponsors

Samsung Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Intraoperative bleeding;Postoperative bleeding;Pain assessment;Length of hospital stay

Countries

Korea, Republic of

Contacts

Public ContactSeijong Kim

Samsung Medical Center

steamwash7@naver.com+82-2-3410-0926

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026