Safety and Cost-Effectiveness in Thyroidectomy Using the HARMONIC Scalpel Compared to Traditional Hemostasis: A Controlled Clinical Assay.

INTRODUCTION: 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.

MATERIALS AND METHODS: 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.

RESULTS: 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.

CONCLUSION: 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.