Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electrosurgical bipolar system (LigaSure) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Electrosurgical bipolar systems group
- description
- Study participants using a electrosurgical bipolar energy system will undergo sentinel lymph node biopsy using only LigaSure during the surgery.
- interventionNames
- Device: Electrosurgical bipolar system (LigaSure)
- type
- NO_INTERVENTION
- label
- Conventional electrocautery group
- description
- Study participants using a conventional electrocautery will undergo sentinel lymph node biopsy using conventional bovie electrocautery during the surgery.
Primary outcomes (1)
- measure
- Drainage amount
- timeFrame
- Up to four weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDvan Bemmel AJ, van de Velde CJ, Schmitz RF, Liefers GJ. Prevention of seroma formation after axillary dissection in breast cancer: a systematic review. Eur J Surg Oncol. 2011 Oct;37(10):829-35. doi: 10.1016/j.ejso.2011.04.012. Epub 2011 Aug 17. PMID 21849243
- BACKGROUNDManouras A, Markogiannakis H, Genetzakis M, Filippakis GM, Lagoudianakis EE, Kafiri G, Filis K, Zografos GC. Modified radical mastectomy with axillary dissection using the electrothermal bipolar vessel sealing system. Arch Surg. 2008 Jun;143(6):575-80; discussion 581. doi: 10.1001/archsurg.143.6.575. PMID 18559751
- BACKGROUNDNespoli L, Antolini L, Stucchi C, Nespoli A, Valsecchi MG, Gianotti L. Axillary lymphadenectomy for breast cancer. A randomized controlled trial comparing a bipolar vessel sealing system to the conventional technique. Breast. 2012 Dec;21(6):739-45. doi: 10.1016/j.breast.2012.08.003. Epub 2012 Sep 7. PMID 22959311
- BACKGROUNDCortadellas T, Cordoba O, Espinosa-Bravo M, Mendoza-Santin C, Rodriguez-Fernandez J, Esgueva A, Alvarez-Vinuesa M, Rubio IT, Xercavins J. Electrothermal bipolar vessel sealing system in axillary dissection: a prospective randomized clinical study. Int J Surg. 2011;9(8):636-40. doi: 10.1016/j.ijsu.2011.08.002. Epub 2011 Sep 10. PMID 21925293
- BACKGROUNDMiyagi K, Rossi SH, Malata CM, Forouhi P. Novel use of LigaSure Impact electrosurgical bipolar vessel sealing system in skin-sparing mastectomy. J Plast Reconstr Aesthet Surg. 2015 Jun;68(6):e126-8. doi: 10.1016/j.bjps.2015.01.005. Epub 2015 Jan 26. No abstract available. PMID 25682592
- BACKGROUNDPark HS, Lee J, Kim JY, Park JM, Kwon Y. A Prospective Randomized Study to Compare Postoperative Drainage After Mastectomy Using Electrosurgical Bipolar Systems and Conventional Electro-Cautery. J Breast Cancer. 2022 Aug;25(4):307-317. doi: 10.4048/jbc.2022.25.e29. Epub 2022 Jun 27. PMID 35914746