Randomized clinical trial on Harmonic Focus™ shears versus clamp-and-tie technique for total thyroidectomy

BACKGROUND: The Harmonic Focus is the last ultrasonic device designed for thyroid surgery. The aim is to assess its efficacy and safety compared with traditional dissection in a prospective randomized trial of total thyroidectomy procedures. METHODS: Total thyroidectomy was performed in 34 patients using the Harmonic Focus, and in 34 patients using the clamp-and-tie technique. RESULTS: In the Harmonic Focus group, relative reductions of 29% and 46% were observed in surgical time and blood loss, respectively. The number of intraoperative instrument exchanges also decreased by 70%, and use of specific materials required to achieve hemostasis decreased significantly. Safety was found to be similar in both patient groups. CONCLUSIONS: Our study showed beneficial effects of Harmonic Focus use in thyroid surgery. Further studies therefore are needed to evaluate cost in the light of savings made in surgical time, materials needed for hemostasis, and human resources.