Clinical trial · Interventional
ELectrosurgical Bipolar Devices VS Conventional Electro-cauterization in Breast Surgery
A Prospective Randomized Study Comparing Surgery Using Electrosurgical Bipolar Sealing Devices and Surgery Using Conventional Electro-cautery
NCT03166384CI-TRIAL-00069442ELBCEcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
There was no study about application of electrosurgical bipolar sealing device for mastectomy in Korean population, because Korean national insurance did not cover use of the advanced sealing device until last year. Sample size of the previous studies was too small to draw a solid conclusion. Therefore, this study was designed prospectively to evaluate whether application of bipolar energy device for mastectomy could provide clinical benefit in terms of reducing seroma formation.
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 |
|---|---|---|---|
| Seroma as Procedural Complication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| conventional suture and tie | Procedure | — | UNRESOLVED |
| electrosurgical bipolar sealing devices | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- control group
- description
- For the patients in the control group, surgeon dose not use electrosurgical bipolar sealing device at all and use conventional tie and ligation methods during tissue dissection and vessel ligation. interventions: 'conventional suture and tie'
- interventionNames
- Procedure: conventional suture and tie
- type
- EXPERIMENTAL
- label
- study group
- description
- For the patients in the study group, the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible. interventions: electrosurgical bipolar sealing devices
- interventionNames
- Device: electrosurgical bipolar sealing devices
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * 20 years old and over * Patients planned to undergo total mastectomy and axillary lymph node dissection * Patients planned to undergo total mastectomy and sentinel lymph node biopsy and/or reconstruction * Patients planned to undergo partial mastectomy and axillary lymph node dissection Exclusion Criteria: * Bilateral breast cancer patients * Male breast cancer patients * Patients who underwent ipsilateral axillar surgery or axillar radiation therapy * Recurrent breast cancer patients * Patients who cannot give informed consents such as non-Korean speakers and patients with intellectual disabilities * Vulnerable patients such as pregnant women for enrollment * Patients without drain catheter * Patients with Ductal carcinoma in situ who have not undergone ipsilateral sentinel lymph node biopsy or axillar lymph node dissection
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
- RESULTPark 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