The safety of energy-based devices in open thyroidectomy: a prospective, randomised study comparing the LigaSure™ (LF1212) and the Harmonic® FOCUS.
OBJECTIVE
The options for haemostasis and dissection during modern thyroid surgery include the use of a bipolar vessel sealing system and ultrasonic technology. The aim of this study was to compare these energy-based devices (EBDs) with respect to their use in open thyroidectomy.


METHODS
The FOCUS Shear (F) and LigaSure LF1212 (L) were evaluated. A total of 182 consecutive patients scheduled for open thyroidectomy were prospectively randomised into two similarly sized groups. The parameters of operative time, morbidity, incision length, postoperative pain and hospital stay were analysed.


RESULTS
The main clinically primary endpoints of the two devices were identical in the study as the rate of nerve lesions, bleeding, drainage, operative time and postoperative calcium concentration with no significant differences with respect to the instrument utilised. The mean length of the incision was greater in the F group (p < 0.05). Patients in the F group were more likely to complain of pain while swallowing (p < 0.001). Early postoperative measurements of intact parathyroid hormone plasma levels revealed that although the levels were within the reference range, they were significantly lower in the F group (p < 0.001). Oral calcium supplementation was significantly higher and more prolonged in the F group.


CONCLUSIONS
The present study demonstrated no significant difference in the rates of postoperative morbidity associated with these two different EBDs used. Differences in clinically less significant were founded and focused on.
Department of Surgical Sciences, University of Insubria, Varese-Como, Italy. gianlorenzo.dionigi@uninsubria.it
Gianlorenzo
G
Dionigi
Luigi
L
Boni
Stefano
S
Rausei
Francesco
F
Frattini
Cesare Carlo
CC
Ferrari
Alberto
A
Mangano
Andrea
A
Leotta
Marco
M
Franchin
D000328:Adult; D000368:Aged; D016063:Blood Loss, Surgical / Q000517:prevention & control*; D004867:Equipment Design; D004869:Equipment Safety; D005260:Female; D005500:Follow-Up Studies; D006488:Hemostasis, Surgical / Q000295:instrumentation*; D006801:Humans; D008026:Ligation / Q000379:methods; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D013525:Surgical Instruments; D013964:Thyroid Neoplasms / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D013965:Thyroidectomy / Q000295:instrumentation* / Q000379:methods; D016896:Treatment Outcome; D055815:Young Adult