Comparing electrosurgical bipolar systems to conventional electrocautery in breast cancer surgery
A Prospective Randomized Study Comparing Electrosurgical Bipolar Systems Versus Conventional Electrocautery After Sentinel Lymph Node Biopsy in Obese or Preoperative Chemotherapy Treated Breast Cancer Patients
This study is testing if a new electrosurgical tool can help women with breast cancer have fewer complications after surgery compared to the standard method.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 20 Years to 80 Years |
| Sex | Female |
| Sponsor | SMG-SNU Boramae Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul, Dongjak-gu) |
| Trial ID | NCT06426810 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of electrosurgical bipolar systems in reducing seroma formation in high-risk patients undergoing sentinel lymph node biopsy (SLNB) for breast cancer. It focuses on women aged 20-80 with a BMI over 25 or those who have received preoperative chemotherapy. The study aims to determine if using the LigaSure system can minimize complications associated with seroma, which can lead to prolonged hospital stays and discomfort. By comparing this method to traditional electrocautery, the researchers hope to improve surgical outcomes for patients.
Who should consider this trial
Good fit: Ideal candidates include women aged 20-80 who are undergoing breast-conserving surgery and sentinel lymph node biopsy with a BMI over 25 or those who have received preoperative chemotherapy.
Not a fit: Patients with suspected axillary lymph node metastasis or those planning for mastectomy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of seroma and related complications in breast cancer surgery patients.
How similar studies have performed: Previous studies have shown promising results with electrosurgical bipolar systems in reducing surgical complications, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged 20-80 * Candidates for breast-conserving surgery and axillary sentinel lymph node biopsy * BMI over 25 or those who have received preoperative chemotherapy * Overall performance status of Eastern Cooperative Oncology Group (ECOG) 0-2 * Participants who understand the study contents and can provide written consent * Participants without evidence of distant metastasis Exclusion Criteria: * Those with suspected axillary lymph node enlargement or metastasis on preoperative imaging (breast MRI, chest CT, breast ultrasound) * Among patients who had confirmed lymph node metastasis before neoadjuvant chemotherapy, whose preopreative image showed residual disease at axillary lymph node * Those planning for mastectomy * Those planning for axillary lymph node dissection without SLNBx * Male breast cancer patients * Patients with bilateral breast cancer * Illiterate individuals, foreigners, or others who cannot read or understand the consent form * Individuals who voluntarily decide not to participate in the study or do not sign the consent form * Those judged by the researcher to be inappropriate for participation in this study * Study participants who did not have a drain inserted in the surgical area * If the randomized device is not used due to surgical room conditions (e.g., unavailability due to other emergency surgeries, device malfunction) and another device is substituted
Where this trial is running
Seoul, Dongjak-gu
- SMG-SNU Boramae medical center — Seoul, Dongjak-gu, South Korea (Recruiting)
Study contacts
- Principal investigator: Jong-Ho Cheun, M.S. — SMG-SNU Boramae Medical Center
- Study coordinator: Jong-Ho Cheun, M.S.
- Email: chun89aaa@naver.com
- Phone: +82-10-8754-3054
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.