A novel technique of harmonic tissue dissection reduces seroma formation after modified radical mastectomy compared to conventional electrocautery: a single-blind randomized controlled trial

Abstract

Background: Seroma is the most frequent postoperative complication following breast cancer surgery. Our aim was to evaluate the effect of the harmonic focus scalpel versus electrocautery in reducing seroma formation post-mastectomy and axillary clearance.

Methods: A prospective randomized controlled trial study was conducted at the Department of Surgery of Suez Canal University Hospital from April 26th 2014 to 30th June 2016. Seventy-two women, in whom a mastectomy and axillary clearance for breast cancer were performed, were randomly allocated to either harmonic dissection (n = 36) or electrocautery (n = 36).

Results: The mean operative time was significantly longer for harmonic dissection compared with electrocautery (2.63 ± 0.41 vs. 1.75 ± 0.26 h; p < 0.0001). In addition, a significantly smaller amount of intraoperative blood loss (69.4 ± 25.1 vs. 255.5 ± 41.6 ml; p = 0.002) and total drainage volume (1277.8 ± 172.5 ml vs. 3300 ± 167.5 ml; p = 0.002) were found in the harmonic group. Moreover, there was a significant reduction in the time of drain removal (10.9 ± 1.12 vs. 15.9 ± 1.44; p = 0.001) and the incidence of seroma formation after drain removal [8.3% vs 33.3%; p = 0.003] in the harmonic group compared with those in the electrocautery group.

Conclusion: Harmonic dissection technique leads to significant decreases in intraoperative blood loss, total drainage volume and postoperative seroma in terms of shorter drain duration with a minimal increase in the operative time and better quality of life. Here, we recommend the use of the harmonic dissection technique in mastectomy and axillary clearance.

Conflict of interest statement

The study was approved by the Hospital Ethics Committee and written informed patient consent was obtained after providing an explanation of the purpose, methods, effects and complications of the intervention.We have consent to publish case reports through our institutional consent form.The authors declare that no competing interests exist. None of the authors had any commercial bias related to the product analyzed in this study, including consulting fees, reimbursement for travel and lodging costs, speaking fees, stocks, grants, and any other financial interest with the company and the product.Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1

Flow diagram of participants

Fig. 2

Showing bloodless field in raising skin flaps in MRM using harmonic focus scalpel

Fig. 3

Showing axillary lymph node dissection using harmonic focus