Actively Recruiting
Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx
Led by SMG-SNU Boramae Medical Center · Updated on 2024-05-23
40
Participants Needed
1
Research Sites
152 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
Electrosurgical Bipolar Systems Versus Conventional Electrocautery After SLNBx
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 20 to 80 years
- Candidates for breast-conserving surgery and axillary sentinel lymph node biopsy
- BMI over 25 or have received preoperative chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Able to understand the study and provide written consent
- No evidence of distant metastasis
You will not qualify if you...
- Suspected axillary lymph node enlargement or metastasis on preoperative imaging (breast MRI, chest CT, breast ultrasound)
- Confirmed lymph node metastasis before neoadjuvant chemotherapy with residual disease seen in preoperative axillary node imaging
- Planning for mastectomy
- Planning for axillary lymph node dissection without sentinel lymph node biopsy
- Male breast cancer patients
- Patients with bilateral breast cancer
- Unable to read or understand the consent form (illiterate, foreigners, others)
- Decline participation or do not sign consent form
- Judged inappropriate for study participation by researcher
- No drain inserted in the surgical area
- Randomized device not used due to surgical room conditions or device malfunction, with substitution of another device
AI-Screening
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Trial Site Locations
Total: 1 location
1
SMG-SNU Boramae medical center
Seoul, Dongjak-gu, South Korea, 07061
Actively Recruiting
Research Team
J
Jong-Ho Cheun, M.S.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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