The safety of the Harmonic® FOCUS in open thyroidectomy: a prospective, randomized study comparing the Harmonic® FOCUS and traditional suture ligation (knot and tie) technique

Since Kocher and Billroth refined an acceptable technique, the thyroidectomy has become one of the most frequent procedures in endocrine surgery and bilateral total thyroidectomy is performed in the majority of thyroid diseases. This work evaluated the use of the Harmonic(®) FOCUS and traditional suture ligation (knot and tie) technique in a prospective, randomized study of open thyroidectomy. Eighty two patients were randomized and divided into two similarly sized groups: the Harmonic(®) FOCUS group (F group) and traditional group (T group). The use of the harmonic FOCUS shows some statistically significant advantages limited to a few intraoperative parameters: surgical time and volume of blood loss. The surgical time was significantly shorter in F group than in the T group (105 ± 27 min vs 143 ± 32 respectively; p < 0.05). Intraoperative volume blood loss was significantly more in the T group than in the F group (36 ± 23 ml vs. 24 ± 18; p < 0.05). The postoperative parameters (volume of drainage fluid, serum calcium at 12 and 48 h, hypocalcemia, wound complication, RLN palsy, postoperative pain and length of hospital stay) showed no statistical difference. The Harmonic Focus may provide a cost-effective option only in high volume centers where reducing operative time may balance the number of daily procedures.