Seroma as Procedural Complication Clinical Trial
— ELBCEOfficial title:
A Prospective Randomized Study Comparing Surgery Using Electrosurgical Bipolar Sealing Devices and Surgery Using Conventional Electro-cautery
NCT number | NCT03166384 |
Other study ID # | 1-2017-0002 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2017 |
Est. completion date | June 27, 2022 |
Verified date | September 2023 |
Source | Severance Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 82 |
Est. completion date | June 27, 2022 |
Est. primary completion date | March 1, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 20 Years to 100 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Yonsei University College of Medicine | Seoul |
Lead Sponsor | Collaborator |
---|---|
Severance Hospital |
Korea, Republic of,
Cortadellas 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. — View Citation
Manouras 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. — View Citation
Miyagi 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. — View Citation
Nespoli 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. — View Citation
Park 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.20 — View Citation
van 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total drainage volume after surgery: mL | Total amount of drainage until drain tube removal Drain tube removal timing: When drainage volume is under 50mL/day for at least 2 days | Up to 30 weeks after surgery | |
Secondary | Total exact drainage volume | total amount volume of drainage bag and amount of aspiration from seroma after drain tube removal | Up to 30 weeks after surgery | |
Secondary | Drainage volume In hospital: mL | Drainage volume In hospital: mL | Up to 30 weeks after surgery | |
Secondary | Total operation running time | Total operation running time | Up to 30 weeks after surgery | |
Secondary | Complication ratio within a month after surgery | possible pre-defined complications were defined in reference to previous studies | Up to 1 year after surgery | |
Secondary | Frequency of seroma aspiration | examination for frequency and total amount of seroma aspiration within a month after surgery. Under 10mL/day, aspiration is stopped | Up to 30 weeks after surgery |
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