NCT06426810Recruiting
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
Source: ClinicalTrials.gov · Last updated 23 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 7 May 2024
- Start date
- 7 May 2024
- Primary completion date
- 7 Apr 2027
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Diseases
- Obesity
- NCT number
- NCT06426810
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 7 May 2024 to the primary completion date, 7 Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Study participants who did not have a drain inserted in the surgical area
Other illness
- Among patients who had confirmed lymph node metastasis before neoadjuvant chemotherapy, whose preopreative image showed residual disease at axillary lymph node
- Male breast cancer patients
- Patients with bilateral breast cancer
- 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
Other
- Those with suspected axillary lymph node enlargement or metastasis on preoperative imaging (breast MRI, chest CT, breast ultrasound)
- Those planning for mastectomy
- Those planning for axillary lymph node dissection without SLNBx
- 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
Who the study is looking for
- 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
Age in the registry: 20 years to 80 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| SMG-SNU Boramae Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.