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Langenbeck's Archives of Surgery

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01-09-2016 | ORIGINAL ARTICLE

Comparison of the harmonic focus and the thunderbeat for open thyroidectomy

Authors: Sam Van Slycke, Jean-Pierre Gillardin, Klaas Van Den Heede, Joan Minguet, Hubert Vermeersch, Nele Brusselaers

Published in: Langenbeck's Archives of Surgery | Issue 6/2016

Abstract

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.

Touzopoulos P, Karanikas M, Zarogoulidis P, Mitrakas A, Porpodis K, Katsikogiannis N et al (2011) Current surgical status of thyroid diseases. J Multidiscip Healthc 4:441–449PubMedPubMedCentral

Contin P, Goossen K, Grummich K, Jensen K, Schmitz-Winnenthal H, Buchler MW et al (2013) ENERgized vessel sealing systems versus CONventional hemostasis techniques in thyroid surgery—the ENERCON systematic review and network meta-analysis. Langenbecks Arch Surg 398(8):1039–1056CrossRefPubMed

Chang LY, O’Neill C, Suliburk J, Sidhu S, Delbridge L, Sywak M (2011) Sutureless total thyroidectomy: a safe and cost-effective alternative. ANZ J Surg 81(7-8):510–514CrossRefPubMed

Darr EA, Randolph GW (2013) Management of laryngeal nerves and parathyroid glands at thyroidectomy. Oral Oncol 49(7):665–670CrossRefPubMed

Bliss RD, Gauger PG, Delbridge LW (2000) Surgeon’s approach to the thyroid gland: surgical anatomy and the importance of technique. World J Surg 24(8):891–897CrossRefPubMed

Rosato L, Avenia N, Bernante P, De Palma M, Gulino G, Nasi PG et al (2004) Complications of thyroid surgery: analysis of a multicentric study on 14,934 patients operated on in Italy over 5 years. World J Surg 28(3):271–276CrossRefPubMed

Tredici P, Grosso E, Gibelli B, Massaro MA, Arrigoni C, Tradati N (2011) Identification of patients at high risk for hypocalcemia after total thyroidectomy. Acta Otorhinolaryngol Ital 31(3):144–148PubMedPubMedCentral

Lyons SD, Law KS (2013) Laparoscopic vessel sealing technologies. J Minim Invasive Gynecol 20(3):301–307CrossRefPubMed

Dhepnorrarat RC, Witterick IJ (2013) New technologies in thyroid cancer surgery. Oral Oncol 49(7):659–664CrossRefPubMed

10.

Rothmund R, Kraemer B, Neis F, Brucker S, Wallwiener M, Reda A et al (2012) Efficacy and safety of the novel electrosurgical vessel sealing and cutting instrument BiCision(R). Surg Endosc 26(11):3334–3343CrossRefPubMed

11.

Campbell PA, Cresswell AB, Frank TG, Cuschieri A (2003) Real-time thermography during energized vessel sealing and dissection. Surg Endosc 17(10):1640–1645CrossRefPubMed

12.

Emam TA, Cuschieri A (2003) How safe is high-power ultrasonic dissection? Ann Surg 237(2):186–191PubMedPubMedCentral

13.

Hefermehl LJ, Largo RA, Hermanns T, Poyet C, Sulser T, Eberli D (2013) Lateral temperature spread of monopolar, bipolar and ultrasonic instruments for robot-assisted laparoscopic surgery. BJU Int 114(2):245–252CrossRef

14.

Gossot D, Buess G, Cuschieri A, Leporte E, Lirici M, Marvik R et al (1999) Ultrasonic dissection for endoscopic surgery. The E.A.E.S. Technology Group. Surg Endosc 13(4):412–417CrossRefPubMed

15.

Ruggiero R, Gubitosi A, Conzo G, Gili S, Bosco A, Pirozzi R et al (2014) Sutureless thyroidectomy. Int J Surg 12:S189–S193CrossRefPubMed

16.

Duan YF, Xue W, Zhu F, Sun DL (2013) FOCUS harmonic scalpel compared to conventional hemostasis in open total thyroidectomy—a prospective randomized study. J Otolaryngol Head Neck Surg 42:62CrossRefPubMedPubMedCentral

17.

Pons Y, Gauthier J, Ukkola-Pons E, Clement P, Roguet E, Poncet JL et al (2009) Comparison of LigaSure vessel sealing system, harmonic scalpel, and conventional hemostasis in total thyroidectomy. Otolaryngol Head Neck Surg 141(4):496–501CrossRefPubMed

18.

Seehofer D, Mogl M, Boas-Knoop S, Unger J, Schirmeier A, Chopra S et al (2012) Safety and efficacy of new integrated bipolar and ultrasonic scissors compared to conventional laparoscopic 5-mm sealing and cutting instruments. Surg Endosc 26(9):2541–2549CrossRefPubMedPubMedCentral

19.

Milsom J, Trencheva K, Monette S, Pavoor R, Shukla P, Ma J et al (2012) Evaluation of the safety, efficacy, and versatility of a new surgical energy device (THUNDERBEAT) in comparison with Harmonic ACE, LigaSure V, and EnSeal devices in a porcine model. J Laparoendosc Adv Surg Tech A 22(4):378–386CrossRefPubMed

20.

Dionigi G, Boni L, Rausei S, Frattini F, Ferrari CC, Mangano A et al (2012) The safety of energy-based devices in open thyroidectomy: a prospective, randomised study comparing the LigaSure (LF1212) and the Harmonic(R) FOCUS. Langenbecks Arch Surg 397(5):817–823CrossRefPubMed

21.

Rahbari R, Mathur A, Kitano M, Guerrero M, Shen WT, Duh QY et al (2011) Prospective randomized trial of ligasure versus harmonic hemostasis technique in thyroidectomy. Ann Surg Oncol 18(4):1023–1027CrossRefPubMed

22.

Lang BH, Yih PC, Hung GK (2013) Does using an energized device in open thyroidectomy reduce complications? J Surg Res 181(1):e23–e29CrossRefPubMed

23.

Lang BH, Ng SH, Lau LL, Cowling BJ, Wong KP (2013) A systematic review and meta-analysis comparing the efficacy and surgical outcomes of total thyroidectomy between harmonic scalpel versus ligasure. Ann Surg Oncol 20(6):1918–1926CrossRefPubMed

24.

Olympus Medical Systems Corp. 510(k) SUMMARY - Surgical Tissue Management System Ultrasonic surgical system 2012 [cited 2015 February 27]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf11/K111202.pdf.

25.

Fagotti A, Vizzielli G, Fanfani F, Gallotta V, Rossitto C, Costantini B et al (2013) A randomized study comparing the use of Thunderbeat technology vs. standard electrosurgery during laparoscopic radical hysterectomy and pelvic lymphadenectomy for gynecological cancer. J Minim Invasive Gynecol 21(3):447–453CrossRefPubMed

26.

Lin HZ, Ng YW, Agarwal A, Fong YF (2013) Application of a new integrated bipolar and ultrasonic energy device in laparoscopic hysterectomies. ISRN Minimally Invasive Surg 2013:4CrossRef

27.

Ng YW, Lim LM, Fong YF (2014) Minilaparoscopic hysterectomy made easy: first report on alternative instrumentation and new integrated energy platform. J Obstet Gynaecol Res 40(5):1436–1440CrossRefPubMed

28.

Ethicon-Endo-Surgery. Traditional 510(k) Premarket Notification Harmonic FOCUS shears 2010 [updated April 07]. Available from: http://www.accessdata.fda.gov/cdrh_docs/pdf10/K100597.pdf.

29.

Randolph GW, Dralle H, with the International Intraoperative Monitoring Study G, Abdullah H, Barczynski M, Bellantone R et al (2011) Electrophysiologic recurrent laryngeal nerve monitoring during thyroid and parathyroid surgery: International standards guideline statement. Laryngoscope 121(S1):S1–S16CrossRefPubMed

30.

Van Slycke S, Gillardin J-P, Brusselaers N, Vermeersch H (2013) Initial experience with S-shaped electrode for continuous vagal nerve stimulation in thyroid surgery. Langenbeck’s Arch Surg 398(5):717–722CrossRef

31.

Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240(2):205–213CrossRefPubMedPubMedCentral

32.

Owens WD, Felts JA, Spitznagel EL Jr (1978) ASA physical status classifications: a study of consistency of ratings. Anesthesiology 49(4):239–243CrossRefPubMed

33.

Cates C, Karner C (2015) Clinical importance cannot be ruled out using mean difference alone. BMJ 351:h5496CrossRefPubMed

34.

Mascha EJ, Sessler DI (2011) Equivalence and noninferiority testing in regression models and repeated-measures designs. Anesth Analg 112(3):678–687CrossRefPubMed

35.

Tamayo-Sarver JH, Albert JM, Tamayo-Sarver M, Cydulka RK (2005) Advanced statistics: how to determine whether your intervention is different, at least as effective as, or equivalent: a basic introduction. Acad Emerg Med 12(6):536–542CrossRefPubMed

36.

Kwak HY, Dionigi G, Kim D, Lee HY, Son GS, Lee JB et al (2016) Thermal injury of the recurrent laryngeal nerve by THUNDERBEAT during thyroid surgery: findings from continuous intraoperative neuromonitoring in a porcine model. J Surg Res 200(1):177–182CrossRefPubMed

37.

Wu CW, Chai YJ, Dionigi G, Chiang FY, Liu X, Sun H et al (2015) Recurrent laryngeal nerve safety parameters of the Harmonic Focus during thyroid surgery: Porcine model using continuous monitoring. Laryngoscope 125(12):2838–2845CrossRefPubMed

38.

Nair CG, Babu MJ, Menon R, Jacob P (2013) Hypocalcaemia following total thyroidectomy: an analysis of 806 patients. Indian J Endocrinol Metab 17(2):298–303CrossRefPubMedPubMedCentral

39.

Zanghi A, Cavallaro A, Di Vita M, Cardi F, Di Mattia P, Piccolo G et al (2014) The safety of the Harmonic FOCUS in open thyroidectomy: a prospective, randomized study comparing the Harmonic FOCUS and traditional suture ligation (knot and tie) technique. Int J Surg 12:S132–S135CrossRefPubMed

Title: Comparison of the harmonic focus and the thunderbeat for open thyroidectomy
Authors: Sam Van Slycke
Jean-Pierre Gillardin
Klaas Van Den Heede
Joan Minguet
Hubert Vermeersch
Nele Brusselaers
Publication date: 01-09-2016
Publisher: Springer Berlin Heidelberg
Published in: Langenbeck's Archives of Surgery / Issue 6/2016
Print ISSN: 1435-2443
Electronic ISSN: 1435-2451
DOI: https://doi.org/10.1007/s00423-016-1448-6

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Comparison of the harmonic focus and the thunderbeat for open thyroidectomy

Abstract

Purpose

Methods

Results

Conclusion

Keynote webinar | Spotlight on medication adherence

Springer Medicine

Abstract

Purpose

Methods

Results

Conclusion

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