Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx
Recruiting · NCT06426810 · Interventional (participants receive a specific treatment) · Lead sponsor: SMG-SNU Boramae Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
Electrosurgical bipolar system (LigaSure)
What this trial is about
The efficacy of electrosurgical bipolar systems in axillary lymph node dissection for breast cancer surgery is well known. In this study, the investigators aim to determine whether using electrosurgical bipolar systems helps reduce seroma formation in high-risk patients undergoing sentinel lymph node biopsy (SLNB) for breast cancer surgery. The investigators will focus on patients who are expected to experience high drainage output after SLNB, especially those who are obese (BMI\>25) or have undergone preoperative chemotherapy.
Who can take part
Age range
20 Years to 80 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- SMG-SNU Boramae medical center - Seoul, Dongjak-gu, South Korea