[Efficacy and budget impact of the Focus harmonic scalpel compared to the ACS-14C device in total thyroidectomy due to multinodular goitre. A prospective randomised study]. / Eficacia e impacto económico del bisturí armónico Focus frente al dispositivo ACS-14C en la tiroidectomía total por bocio multinodular. Estudio prospectivo aleatorizado.

ABSTRACT

OBJECTIVE: To analyse the potential advantages and outcomes of the new Harmonic Focus™ (Focus) device compared to the Harmonic Scalpel™ ACS-14C in benign thyroid surgery. METHODS: A controlled randomised study was conducted in which the Focus was compared to former ACS-14C device in patients undergoing total thyroidectomy for multinodular goitre. The primary endpoint was time of surgery. The secondary endpoints were time of use of the device, number of ligatures, blood loss, hypocalcaemia, laryngeal nerve impairment, postoperative pain and quality of life. RESULTS: Two groups of patients were included, 26 patients in group i (ACS-14C) and 28 in group ii (Focus). There was a 16% reduction in surgical time (78.7 ± 22.01 vs. 66 ± 17.0 min; P<.05) between group i and ii respectively. The Focus was used longer than ACE-14S, both in absolute time (26.0 ± 7.7 vs. 10.0 ± 3.5 minutes; P<.05), as well as in relative time (40.7 ± 11.8% vs. 13.1 ± 4.1%; P<.05), respectively. A significant reduction in number of ligatures in Focus patients was also observed (0,3 ± 0,8 vs. 2.9 ± 3.6; P<.05). Budget impact analysis showed an additional average savings per procedure of 179.74 €. CONCLUSIONS: Focus ergonomics significantly improved the operation time in thyroidectomy causing a positive impact on the budget. Focus also adds further benefits to those previously achieved by Harmonic technology, and it is by itself more cost-effective in total thyroidectomy than ACS-14C.