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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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 20
Maximum Age: 80
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
SMG-SNU Boramae medical center
RECRUITING
Seoul
Contact Information
Primary
Jong-Ho Cheun, M.S.
chun89aaa@naver.com
+82-10-8754-3054
Time Frame
Start Date: 2024-05-07
Estimated Completion Date: 2027-04-07
Participants
Target number of participants: 40
Treatments
Experimental: Electrosurgical bipolar systems group
Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery.
No_intervention: Conventional electrocautery group
Study participants using a conventional electrocautery will undergo sentinel lymph node biopsy using conventional bovie electrocautery during the surgery.
Related Therapeutic Areas
Sponsors
Leads: SMG-SNU Boramae Medical Center

This content was sourced from clinicaltrials.gov