Eficacia e impacto económico del bisturí armónico Focus frente al dispositivo ACS-14C en la tiroidectomía total por bocio multinodular. Estudio prospectivo aleatorizado / 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

OBJETIVO: El bisturí armónico ha mejorado la cirugía tiroidea, cuando se compara con cirugía convencional, en términos de reducción del tiempo quirúrgico, número de ligaduras, dolor postoperatorio y uso de drenajes. Analizamos las posibles ventajas en reducción de tiempo quirúrgico y ahorro de recursos del terminal Focus en comparación con el terminal ACS-14C en la cirugía tiroidea benigna. MÉTODOS: Estudio ciego, prospectivo y aleatorizado realizado desde 2009 hasta 2010.Se compararon los resultados del ACS-14C (grupo I ) con Focus (grupo II ) en pacientes con bocio multinodular operados de tiroidectomía total. Se incluyó a pacientes entre 18 y 80 años que aceptaron participar en el estudio sin cirugía cervical previa, lesión del nervio recurrente laríngeo, tratamiento analgésico crónico, coagulopatía o problemas cognitivos. La variable principal fue el tiempo quirúrgico. Otras variables secundarias fueron: tiempo de uso del dispositivo durante el procedimiento, número de ligaduras, pérdida hemática, hipocalcemia, lesión del nervio recurrente faríngeo, dolor postoperatorio y análisis de calidad de vida. RESULTADOS: Se incluyó a 54 pacientes, 26 en el grupo I y 28 en el grupo II . En el grupo de Focus hubo una reducción del tiempo quirúrgico de 16% (78,7 ± 22,01 vs. 66 ± 17,0 min; p < 0,05), del número de ligaduras (0,3 ± 0,8 vs. 2,9 ± 3,6; p < 0,05) y un ahorro adicional de 179,74 € por procedimiento. Focus se utilizó más tiempo que ACE-14S tanto en valor absoluto (26,0+-7,7 vs. 10,0+-3,5 min; p < 0.05) como en valor relativo (40,7+-11,8 vs. 13,1+-4,1%; p < 0,05). CONCLUSIONES: Focus mejora el tiempo operatorio en la tiroidectomía, causando impacto positivo sobre el presupuesto. Su mayor utilización hace que sea una herramienta más coste-eficaz que el terminal ACS-14C

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

[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.

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.