Abstract
Abstract Background: Seroma and lymphorrhea are the most common complication following mastectomy and/or axillary lymph node dissection (ALND). The manifestation of seroma accelerates complications such as post-operative bleeding, wound infection, prolonged recovery period. Sealing blood vessels and lymph drainages adequately during mastectomy and/or ALND may play a main role in reducing complication. Therefore, adequate sealing vessels and lymphatics during the surgery is important to reduce seroma and lymphorrhea related complications in patients with breast cancer. Objective: This study aims to show that electrosurgical bipolar sealing device for mastectomy could provide clinical benefit in reducing seroma formation. Design: ELBCE (ELectrosurgical Bipolar Devices VS Convention Electronicautery, NCT03166384)is a prospective, randomized, two-arm assignment controlled trial of application of electrosurgical bipolar sealing device for mastectomy in patients with breast cancer. Patients is randomized in 1:1 ratio to conventional suture and tie group or electrosurgical bipolar sealing devices group. Randomization is performed using opening sealed envelope before enrollment. The primary end point is to compare the total drainage volume until drain tube removal. The time to drain removal is also measured. The secondary end points is the total amount of aspiration from seroma after drain tube removal, and the frequency of seroma aspiration. Statistical consideration: A sample size 44 subjects per each arm was planned to provide a 90% power to detect a 25% decrease of the total amount of drainage fluid after surgery by using an electrosurgical bipolar sealing device when compared to a conventional suture and tie technique. In our experience, the average total volume of fluid after conventional suture and tie technique is 220 mL, with a standard deviation of 80. Eligibility criteria:Inclusion criteria are patients older than 20 years and those who planned to undergo total mastectomy and/or ALND. Exclusion criteria are bilateral breast cancer patients, male patients, patients who underwent ipsilateral axillar surgery or radiation therapy, recurrent breast cancer patients, patients without drain catheter, and patients with ductal carcinoma in situ who have not undergone ipsilateral sentinel lymph node biopsy or ALND.Present accrual and target accrual:ELSEBA study has an accrual target of 88 patients. To date, 8 patients have been randomized. Contact information:Dr. Hyung Seek Park, E-mail: hyungseokpark.md@gmail.com; imgenius@yuhs.ac, Telephone: +82-2-2228-2100 Citation Format: Yoon KH, Park HS, Kim JH, Kim JY, Lim SM, Kim SI, Cho YU. A prospective randomized study comparing surgery using electrosurgical bipolar sealing devices and surgery using conventional electro-cautery [abstract]. In: Proceedings of the 2017 San Antonio Breast Cancer Symposium; 2017 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2018;78(4 Suppl):Abstract nr OT2-01-03.
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