Basurto-Kuba Erich O P, Robles-Estrada Maybelline, Hurtado-López Luis Mauricio, E Oca-Duran Edgar D Montes, Campos-Castillo Carlos, Zaldivar-Ramirez Felipe Rafael, Pulido-Cejudo Abraham
Servicio de Cirugia General, Neck Surgery Clinic Hospital General de México OD, México D.F., México.
Neck Surgery Clinic, Hospital General de México OD, México D.F., México.
Surg Technol Int. 2017 Jul 25;30:141-147.
The aim of this clinical control trial is to analyze the cost-effectiveness and to understand the efficacy of the HARMONIC FOCUS®+ (Ethicon Inc., Somerville, New Jersey) scalpel as the only system to cut and coagulate in thyroidectomy.
One hundered patients of the thyroid clinic of the Mexico City General Hospital were included. All patients underwent surgery and were divided into two randomized groups. In Group 1, the HARMONIC scalpel was the only device used for cut and coagulate (50 patients), and in Group 2 clamp, tie, and electrocautery (50 patients) were used. Surgical bleeding, operative time, complications, diagnosis, thyroid size, and hospital stay were evaluated in both groups. The statistical analysis was done using central trend measurements, Student's t-, chi-squared, and Fisher's exact test, with a significance level of p < 0.05. The cost-effectiveness analysis was completed by determining the total cost of the surgical procedure per hour in US dollars, and the evolution to compare efficacy will be the number of re-interventions due to postoperative bleeding.
The use of the HARMONIC scalpel in thyroid surgery had the same results as the traditional method when comparing complications, reoperation, hospital stay, and hypoparathyroidism. In total thyroidectomy patients, the bleeding in Group 1 was 55.16ml ( ± 32.97) and 85.4ml ( ± 69.41) in Group 2 , p=0.034. Operative time in Group 1 was 74.6 minutes (± 23.39) and 104.09 minutes (± 34.66) in Group 2, p= 0.0001. In both groups, there were no statistical differences in lobectomy. Cost-effectiveness analysis implies an adequate hemostasis if we are using a hemostatic device, and above all, the avoidance of a re-intervention due to hematoma, and the cost-effectiveness with regard to the re-intervention as a result of a hematoma implies that $161 US more is spent for each re-intervention.
The utilization of the HARMONIC scalpel device is similar to the traditional technique of ligature and knots as far as cost-effectiveness is concerned, due to the fact that the greater expense of the device is compensated by the lower expense in time and surgical re-intervention.
本临床对照试验的目的是分析成本效益，并了解HARMONIC FOCUS®+（美国新泽西州萨默维尔市爱惜康公司）手术刀作为甲状腺切除术中唯一的切割和凝血系统的疗效。
纳入墨西哥城综合医院甲状腺门诊的100例患者。所有患者均接受手术，并随机分为两组。第1组仅使用HARMONIC手术刀进行切割和凝血（50例患者），第2组使用止血钳、结扎和电灼（50例患者）。评估两组患者的手术出血情况、手术时间、并发症、诊断结果、甲状腺大小和住院时间。采用集中趋势测量、学生t检验、卡方检验和Fisher精确检验进行统计分析，显著性水平为p<0.05。通过确定每小时手术程序的总成本（以美元计）来完成成本效益分析，而比较疗效的指标将是术后出血导致的再次干预次数。
在比较并发症、再次手术、住院时间和甲状旁腺功能减退时，甲状腺手术中使用HARMONIC手术刀与传统方法的结果相同。在全甲状腺切除患者中，第1组的出血量为55.16ml（±32.97），第2组为85.4ml（±69.41），p=0.034。第1组的手术时间为74.6分钟（±23.39），第2组为104.09分钟（±34.66），p=0.0001。两组在甲状腺叶切除术中无统计学差异。成本效益分析表明，如果使用止血设备，止血效果良好，最重要的是避免因血肿进行再次干预，而因血肿进行再次干预的成本效益意味着每次再次干预要多花费161美元。
就成本效益而言，HARMONIC手术刀的使用与传统的结扎和打结技术相似，因为该设备的较高成本被时间和手术再次干预方面的较低成本所抵消。
