The use of energy devices for thyroid surgical procedures. Harmonic Focus versus Biclamp 150

Abstract

BACKGROUND: Thyroidectomy is the most frequently performed endocrine surgery, and in recent years, the surgical instruments and techniques used in this surgery have greatly evolved. New devices are created to facilitate dissection, haemostasis increasing the intraoperative cost.

MATERIAL AND METHOD: We prospectively examined patients undergoing to traditional thyroidectomy using reusable vs disposable devices (BiClamp 150, ERBE ® - group A vs. Harmonic Focus, ETHICON® - group B). The patients were treated for benign and malignant diseases from two experienced surgeons. The two groups were separated based on age, sex, skin-to-skin operative time, the number of parathyroid glands identified by the surgeon during the operation, preand post-operative serum calcium levels evaluated with PTH until 24 hours after surgery, the mean hospital stay, the evaluation of the content of the drainages at 6 hours and 24 hours, and the thyroid gland volume calculated via ultrasound preoperatively. The patients were asked to complete a form at 24 hours post-op to self-evaluate dysphagia to liquids and pain on a scale from 0 to 10.

RESULTS: The patients analysed were 80 pts. Analysis of the data showed no significant differences between the groups with respect to age, (p = 0:48), or gender, 9 males and 31 females in group A and 8 males and 32 females in group B.The thyroid volume (in ml), calculated on the basis of preoperative ultrasonography, was 43.89 ± 37.10 in group A vs. 54.54 ± 51.92 in group B (p = 0.35). The skin-to-skin operative time was equal to 50.16 ± 10.43 min.vs. 52.39 ± 11:54 min.(p = 0.36) in groups A and B, respectively. No statistically significant differences in pre e postoperative calcium levels. The amount of drainage at 6 hours after surgery was 16.63 ± 15.24ml. in group A and 23.72 ± 21.93ml. in group B (p = 0.07). At 24 hours after surgery, the amount was 57.84 ± 32.56ml. in group A and 66.79 ± 39.94ml. in group B (p = 0.28). For group A and group B, we analysed dysphagia for liquids on a scale from 0 to 10 (4.5 ± 2.35 vs. 4.18 ± 2.4, p = 0.48, respectively), alterations in patients’ tone of voice (1.97 ± 2.51 vs. 1.43 ± 0:48, p = 0.29, respectively), and postoperative pain at 24 hours after surgery (2.76 ± 1.99 vs. 2.68 ± 2.12, p = 0.87, respectively). The average cost for group A was equal to € 25 × 40 = 1000 vs. € 450 × 40 = 18000 for Group B. The hospital stay in days was equal to 1.70 ± 0.46 (Group A) vs. 1.66 ± 0.53 (Group B) (p = 0.69).

CONCLUSIONS: One limitation of the current study is its small sample size. Both devices are effective and safe for total thyroidectomy because they have similar effects on the operative time, postoperative bleeding and patient outcomes in endocrine experienced surgical team. On the other hand, in a time of the spending review and the standardisation of surgical techniques to ensure the highest quality of services offered, the BiClamp is a viable alternative tool with a high security standard and low cost that offers significant savings to the health care system.