Langenbeck's Archives of Surgery

, Volume 397, Issue 5, pp 817–823 | Cite as

The safety of energy-based devices in open thyroidectomy: a prospective, randomised study comparing the LigaSure™ (LF1212) and the Harmonic® FOCUS

  • Gianlorenzo DionigiEmail author
  • Luigi Boni
  • Stefano Rausei
  • Francesco Frattini
  • Cesare Carlo Ferrari
  • Alberto Mangano
  • Andrea Leotta
  • Marco Franchin
Rapid Communication



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.


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.


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.


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.


Thyroidectomy Energy-based devices Morbidity Recurrent laryngeal nerve Hypocalcaemia 



The authors are grateful to Kimberly Krugman for general support, technical assistance and helpful discussions.

Conflicts of interest

Authors and institutions mentioned in this study do not have any competing interest. This specific report does not endorse any specific company. Johnson and Johnson which manufactures the FOCUS device provided the instrument. Covidien which manufactures the LigaSure provided the instruments. Medtronic provided the monitoring device. The protocol was formally approved by an independent local institutional review board of the Department of Surgical Sciences, University of Insubria (Varese–Como), Italy.


  1. 1.
    Dionigi G, Bacuzzi A, Boni L, Rovera F, Piantanida E, Tanda ML, Diurni M, Carcano G, Luigi B, Cuffari S, Dionigi R (2005) Influence of new technologies on thyroid surgery: state of the art. Expert Rev Med Devices 2(5):547–557PubMedCrossRefGoogle Scholar
  2. 2.
    Dralle H (2006) Impact of modern technologies on quality of thyroid surgery. Langenbecks Arch Surg 391(1):1–3PubMedCrossRefGoogle Scholar
  3. 3.
    Dionigi G, Boni L, Rovera F, Dionigi R (2006) Thyroid surgery: new approach to dissection and hemostasis. Surg Technol Int 15:75–80PubMedGoogle Scholar
  4. 4.
    Dionigi G (2009) Energy based devices and recurrent laryngeal nerve injury: the need for safer instruments. Langenbecks Arch Surg 94(3):579–580CrossRefGoogle Scholar
  5. 5.
    Miccoli P, Materazzi G, Miccoli M, Frustaci G, Fosso A, Berti P (2010) Evaluation of a new ultrasonic device in thyroid surgery: comparative randomized study. Am J Surg 199(6):736–740PubMedCrossRefGoogle Scholar
  6. 6.
    Barbaros U, Erbil Y, Bozbora A, Deveci U, Aksakal N, Dinccag A, Ozarmagan S (2006) The use of LigaSure in patients with hyperthyroidism. Langenbecks Arch Surg 391(6):575–579PubMedCrossRefGoogle Scholar
  7. 7.
    Franko J, Kish KJ, Pezzi CM, Pak H, Kukora JS (2006) Safely increasing the efficiency of thyroidectomy using a new bipolar electrosealing device (LigaSure) versus conventional clamp-and-tie technique. Am Surg 72(2):132–136PubMedGoogle Scholar
  8. 8.
    Kirdak T, Korun N, Ozguc H (2005) Use of ligasure in thyroidectomy procedures: results of a prospective comparative study. World J Surg 29(6):771–774PubMedCrossRefGoogle Scholar
  9. 9.
    Musunuru S, Schaefer S, Chen H (2008) The use of the Ligasure for hemostasis during thyroid lobectomy. Am J Surg 195(3):382–384, discussion 4-5PubMedCrossRefGoogle Scholar
  10. 10.
    Lachanas VA, Prokopakis EP, Mpenakis AA, Karatzanis AD, Velegrakis GA (2005) The use of Ligasure Vessel Sealing System in thyroid surgery. Otolaryngol Head Neck Surg 132(3):487–489PubMedCrossRefGoogle Scholar
  11. 11.
    Miccoli P, Berti P, Dionigi G, D'Agostino J, Orlandini C, Donatini G (2006) Randomized controlled trial of harmonic scalpel use during thyroidectomy. Arch Otolaryngol Head Neck Surg 132(10):1069–1073PubMedCrossRefGoogle Scholar
  12. 12.
    Campbell PA, Cresswell AB, Frank TG, Cuschieri A (2003) Real-time thermography during energized vessel sealing and dissection. Surg Endosc 17(10):1640–1645PubMedCrossRefGoogle Scholar
  13. 13.
    Emam TA, Cuschieri A (2003) How safe is high-power ultrasonic dissection? Ann Surg 237(2):186–191PubMedGoogle Scholar
  14. 14.
    Smith CT, Zarebczan B, Alhefdhi A, Chen H (2011) Infrared thermographic profiles of vessel sealing devices on thyroid parenchyma. J Surg Res 170(1):64–68PubMedCrossRefGoogle Scholar
  15. 15.
    Dionigi G, Boni L, Rovera F, Rausei S, Castelnuovo P, Dionigi R (2010) Postoperative laryngoscopy in thyroid surgery: proper timing to detect recurrent laryngeal nerve injury. Langenbecks Arch Surg 395(4):327–331PubMedCrossRefGoogle Scholar
  16. 16.
    Barczyński M, Cichoń S, Konturek A, Cichoń W (2008) Applicability of intraoperative parathyroid hormone assay during total thyroidectomy as a guide for the surgeon to selective parathyroid tissue autotransplantation. World J Surg 32(5):822–828PubMedCrossRefGoogle Scholar
  17. 17.
    Barczyński M, Cichoń S, Konturek A (2007) Which criterion of intraoperative iPTH assay is the most accurate in prediction of true serum calcium levels after thyroid surgery? Langenbecks Arch Surg 392(6):693–698PubMedCrossRefGoogle Scholar
  18. 18.
    Dionigi G, Barczynski M, Chiang FY, Dralle H, Duran-Poveda M, Iacobone M, Lombardi CP, Materazzi G, Mihai R, Randolph GW, Sitges-Serra A (2010) Why monitor the recurrent laryngeal nerve in thyroid surgery? J Endocrinol Invest 33(11):819–822PubMedGoogle Scholar
  19. 19.
    Curfman GD, Redberg RF (2011) Medical devices—balancing regulation and innovation. N Engl J Med 365(11):975–977PubMedCrossRefGoogle Scholar
  20. 20.

Copyright information

© Springer-Verlag 2012

Authors and Affiliations

  • Gianlorenzo Dionigi
    • 1
    Email author
  • Luigi Boni
    • 1
  • Stefano Rausei
    • 1
  • Francesco Frattini
    • 1
  • Cesare Carlo Ferrari
    • 1
  • Alberto Mangano
    • 1
  • Andrea Leotta
    • 1
  • Marco Franchin
    • 1
  1. 1.Department of Surgical SciencesUniversity of InsubriaVarese–ComoItaly

Personalised recommendations