Purpose: An effective method for controlling haemostasis during open thyroidectomy procedures is crucial because of the high risks of haemorrhage and neck haematoma. This study aimed to demonstrate the efficacy of the integrated ultrasonic/bipolar Thunderbeat™ for this procedure.
Methods: This retrospective non-inferiority study compared the Thunderbeat™ and the ultrasonic Harmonic Focus® devices in 761 consecutive patients receiving a partial or total open thyroidectomy (with or without neck dissection). The main outcomes were duration of surgery, blood loss, and length of hospitalisation. Secondary outcomes were occurrence of hypocalcaemia, recurrent nerve paralysis, or other post-operative complications. A non-inferiority logistic regression approach was used to evaluate primary outcomes, adjusting for age, gender, body mass index, type of surgery, anaesthesiology score, and indication (benign or malign).
Results: The data demonstrated that the Thunderbeat was non-inferior to the Focus in terms of duration of surgery, blood loss, and length of hospital stay. Furthermore, subgroup analyses showed non-inferiority of the Thunderbeat for partial thyroidectomy (all three outcomes), total thyroidectomy (duration of surgery and length of hospitalisation), and total thyroidectomy with neck dissection (length of hospitalisation). In terms of recurrent nerve paralysis and post-operative complications, the Thunderbeat performed at least as well as the Focus; however, no conclusions could be drawn regarding the occurrence of post-operative hypocalcaemia.
Conclusion: In a cohort of patients that underwent partial or total thyroidectomy, the Thunderbeat appeared to be at least as good as the Harmonic Focus.
Keywords: Haemostasis; Harmonic focus; Non-inferiority; Thunderbeat; Thyroidectomy; Ultrasonic.