title: [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].
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.
authors.affiliation: Unidad de Cirugía Endocrina, Departamento de Cirugía General y Digestiva, Hospital Universitari de Bellvitge, Universitat de Barcelona (UB), Instituto de Investigación Biomédica de Bellvitge, Barcelona, España. Electronic address: 25108pml@gmail.com.
authors.forename: Pablo
authors.initials: P
authors.lastname: Moreno
authors.forename: José Manuel
authors.initials: JM
authors.lastname: Francos
authors.forename: Arantxa
authors.initials: A
authors.lastname: García-Barrasa
authors.forename: Enrique
authors.initials: E
authors.lastname: Fernández-Alsina
authors.forename: Eugenia
authors.initials: E
authors.lastname: de Lama
authors.forename: Rosario
authors.initials: R
authors.lastname: Martínez
authors.forename: María
authors.initials: M
authors.lastname: Carral
authors.forename: Josefina
authors.initials: J
authors.lastname: Martín-Lobato
mesh_terms: D002017:Budgets; D005260:Female; D006044:Goiter, Nodular / Q000601:surgery*; D006801:Humans; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D016037:Single-Blind Method; D013525:Surgical Instruments; D013965:Thyroidectomy / Q000295:instrumentation / Q000379:methods
keywords: Bisturí armónico; Bocio multinodular; Budget impact; Harmonic scalpel; Impacto económico; Multinodular goitre; Thyroidectomy; Tiroidectomía