Clinical trial

Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx

Recruiting now · Not applicable · 1 countries · Registry ID NCT06426810

Recruiting nowNot applicableInterventional

What this study 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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age20 Years to 80 Years

SexFemale

Healthy volunteersNot accepted

ConditionBreast Cancer

Full registry 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

Treatments and study arms

Electrosurgical bipolar system (LigaSure)

Device

Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery.

Primary outcomes

Drainage amountUp to four weeks

Total drainage amount from axilla after surgery (ml)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

SMG-SNU Boramae medical center🇰🇷 Seoul, Dongjak-gu, South Korea

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Jong-Ho Cheun, M.S.Contact

Email · Call +82-10-8754-3054