RecruitingNot ApplicableNCT06426810

Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx

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


Sponsor

SMG-SNU Boramae Medical Center

Enrollment

40 participants

Start Date

May 7, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Sex: FEMALEMin Age: 20 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical tools — an electrosurgical bipolar system versus standard electrocautery — used during breast-conserving surgery and sentinel lymph node biopsy for breast cancer. The goal is to see which method causes less fluid buildup (seroma) and fewer complications after surgery. **You may be eligible if...** - You are a woman between 20 and 80 years old - You are scheduled for breast-conserving surgery with a sentinel lymph node biopsy - Your BMI is over 25 or you have received neoadjuvant (pre-surgery) chemotherapy - Your cancer has not spread to distant organs - Your performance status is adequate (ECOG 0–2) **You may NOT be eligible if...** - Imaging suggests lymph node enlargement or cancer spread to the armpit - You are having a full mastectomy - You are a male breast cancer patient - You have cancer in both breasts - You are unable to read or understand the consent form Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEElectrosurgical bipolar system (LigaSure)

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


Locations(1)

SMG-SNU Boramae medical center

Seoul, Dongjak-gu, South Korea

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NCT06426810


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