Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx

Launched by SMG-SNU BORAMAE MEDICAL CENTER · May 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether using a special surgical tool called an electrosurgical bipolar system can help reduce the formation of fluid buildup, known as seromas, in high-risk women undergoing a specific breast cancer surgery called sentinel lymph node biopsy (SLNB). The focus is on women who may have a higher chance of experiencing fluid buildup after surgery, particularly those who are overweight or have received chemotherapy before the procedure.

To participate, women aged 20 to 80 who are planning to have breast-conserving surgery and SLNB may be eligible if they have a body mass index (BMI) over 25 or have undergone preoperative chemotherapy. Participants will need to understand the study and give their consent. Throughout the trial, participants will receive care that includes the use of the electrosurgical bipolar system or a standard tool, and they will be monitored for any differences in seroma formation. This study aims to find out if the new tool can improve patient outcomes during breast cancer surgery.

Gender

FEMALE

Eligibility 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

Trial Officials