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. 2022 Aug;25(4):307-317.
doi: 10.4048/jbc.2022.25.e29. Epub 2022 Jun 27.

A Prospective Randomized Study to Compare Postoperative Drainage After Mastectomy Using Electrosurgical Bipolar Systems and Conventional Electro-Cautery

Hyung Seok Park #  1 , Jeea Lee #  2 , Jee Ye Kim  3 , Jung Mi Park  4 , Yonghan Kwon  4
Affiliations

A Prospective Randomized Study to Compare Postoperative Drainage After Mastectomy Using Electrosurgical Bipolar Systems and Conventional Electro-Cautery

Hyung Seok Park et al. J Breast Cancer. 2022 Aug.

Abstract

Purpose: Advanced energy devices, including electrosurgical bipolar systems or ultrasonic shears, are widely used in various surgeries. An electrosurgical bipolar device allows surgeons to grasp and dissect tissues, as well as simultaneously ligate and cut vessels and lymphatics during surgery. This study aimed to evaluate the effects of advanced bipolar energy devices on the reduction in seroma formation during mastectomy, axillary staging, and/or reconstruction.

Methods: This prospective randomized clinical trial with a 1:1 ratio compared the use of an electrosurgical bipolar device, LigaSureTM (LGS), against conventional cut-and-ligate techniques in mastectomy with axillary procedures for patients with breast cancer. A total of 82 patients with breast cancer who underwent definitive surgery were enrolled in this study. The primary endpoint was the total drainage volume after surgery.

Results: The clinicopathological characteristics of the two groups were not significantly different. The total postoperative drainage volume was significantly lower in the LGS group than in the control group (756.26 mL vs. 1,167.74 mL, p = 0.009). The actual postoperative drainage volume and duration also decreased significantly in the LGS group compared with those in the control group (all p < 0.05). The rate of postoperative complications was lower in the LGS group than in the control group (9.8% vs. 27.5%, p = 0.05).

Conclusion: Electrosurgical bipolar devices showed better performance in terms of decreasing postoperative drainage during mastectomy and axillary staging and/or reconstruction.

Keywords: Breast Neoplasms; Postoperative Complications; Seroma; Surgical Procedures, Operative.

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Conflict of interest statement

This study was supported by Medtronic. The funding source was not involved in the study design, data collection, analyses, and manuscript writing. The funding was distributed: salary, support of authors, study coordinator, resident, fellow, statistician, secretary, or other; laboratory analyses/equipment; devices, medications or materials; and administration duties.

Figures

Figure 1
Figure 1. Study diagram according to the CONSORT statement.
Figure 2
Figure 2. Forest plot of clinical outcomes between the LigaSure and control groups.
SD = standard deviation; CI = confidence interval. *One patient in the control group who did not attend follow-up after drain removal within 30 postoperative days was excluded (n = 40).
Figure 3
Figure 3. The curves of cumulative drainage removal in the LigaSure and control groups.
Figure 4
Figure 4. Forest plot of multivariate analyses for associated factors in drainage removal by logistic regression analysis.
HR = hazard ratio; CI = confidence interval; HER = human epidermal growth factor receptor; PM = partial mastectomy; ALND = axillary lymph node dissection; MRM = modified radical mastectomy; TM = total mastectomy.
See this image and copyright information in PMC

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