Eur opean Rev iew for Med ical and Pharmacol ogical Sci ences 2016; 20: 3544-3551 Study on the use of focus harmonic scalpel in thyroidectomies: is it useful also in preserving voice function? A. MINNI 1, D. ROSATI 1, C. CAVALIERE 1, A. DE CARLO 1, G. ILLUMINATI 2, V. SCARANO CATANZARO 2, M. BONONI 3 1Department of Sensory Organs, “Sapienza” University of Rome, Azienda Policlinico Umberto I, Rome, Italy 2“F. Durante” Department of Surgical Science, “Sapienza” University of Rome, Azienda Policlinico Umberto I, Rome, Italy 3Department of Surgery “P. Valdoni”, “Sapienza” University of Rome, Azienda Policlinico Umberto I, Rome, Italy Abstract. – OBJECTIVE : The aim of this ran - Key Words: domized study is to evaluate the real benefits of Thyroid surgery, Focus Harmonic Scalpel, Voice the FOCUS Harmonic Scalpel in total thyroidec - function . tomies compared with conventional ligation, re - garding operative time, postoperative blood loss, length of stay and complications. Further - Introduction more, as never seen in other studies, we studied the effects of using the FOCUS during thy - roidectomy analyzing the vocal production of During the past decades, the techniques of thy - patients before and after surgery. roid surgery have undergone small changes only. PATIENTS AND METHODS: We enrolled 361 On the other hand, the last twenty years have patients who underwent total thyroidectomy from 2008 to 2014. It was a randomized clinical trial in seen dynamic development of new instruments which all the surgical procedures were performed that has had a significant impact on this kind of by the same surgeon. Patients were randomized surgery 1-3 . into two groups according to the haemostatic Even if effective vessel haemostasis can be technique: 187 patients were included in a “con - achieved by using the conventional clamp-and- ventional” group (C) in whom dissection and tie technique, newer techniques of vessel haemostasis were performed using conventional haemostasis were performed to be more rapid materials (Vicryl, stitches, V titanium hemostatic 4 clips and monopolar or bipolar electrocautery); while achieving the same effectiveness . 174 patients were included in a group in which Actually, during thyroidectomy , classic manu - the FOCUS was used (F group). al suture ligation and electrocoagulation are the RESULTS: Our data show that the FOCUS al - two main options to have a good haemostasis. lows a one-third time-saving vs. classic haemostasis. Moreover, the use of the FOCUS The first one is a time -consuming procedure and would allow reduced traction and reduced ma - implicates the risk of knot slipping, the second nipulation of the thyroid during surgery. Our da - one is a fast procedure but implicates the poten - ta demonstrate that the rate of complications in tial risk to damage surrounding tissues (i.e. la - the Focus group might not be significantly re - ryngeal nerve) by dispersion of heat 5. duced. In our series, we noticed that the quanti - In the last years, several papers have reported tative acoustic assessment of voice quality the utility of bipolar vessel sealing systems 6 or show important alterations in several parame - 7 ters (Shim, Jitt, sPPQ, sAPQ studied with the the Harmonic Scalpel in shortening the length of Multi Dimensional Voice Program evaluation) thyroid surgery and reducing blood loss, while between the C group and F group. maintaining a good safety and low rate of com - CONCLUSIONS: The FOCUS Harmonic Scalpel plications for patients . reduces the operative time, post-operative blood The FOCUS Harmonic Scalpel has been de - loss and length of hospital stay in thyroidectomy. Besides, important vocal alterations after thy - veloped for precise and simultaneous cutting as roidectomy seem more severe using the conven - well as hemostasis with minimal damage to sur - tional technique instead of FOCUS. rounding tissues; it uses high-frequency mechan - 3544 Corresponding Author: Antonio Minni, MD; e-mail: [email protected] Study on the use of focus harmonic scalpel in thyroidectomies ical energy to cut and coagulate at the same time 2. Coagulation disorders; tissues and vessels without the need for knot-ty - 3. Pregnancy; ing 8. 4. Cervicomediastinal goiters; The aim of this randomized study is to evalu - 5. Total thyroidectomy with need of lymph node ate the real benefits of the FOCUS Harmonic dissection as in patients with invasive malig - Scalpel in total thyroidectomies when compared nant cancer; with conventional ligation, concerning operative 6. Concomitant parathyroid disorders; time, postoperative blood loss, length of stay and 7. History of neck irradiation. complications. Besides, as never seen in other studies, we analyzed the effects of using the FO - In all cases, total thyroidectomy was per - CUS Harmonic Scalpel during thyroidectomy on formed under general anesthesia with endotra - vocal production of patients after surgery. cheal intubation . In both groups, the surgical in - cision was always a 4 to 6 cm low collar inci - sion; after performing subplatysmal flap with Patients and Methods high frequency electric knife, the superficial muscles were isolated at the midline. As the We enrolled 361 patients (152 men and 209 gland was exposed, we separated the two groups women) who underwent total thyroidectomy performing haemostasis of thyroid vessels in one from January 2008 to May 2014. It was a ran - of the following ways: (1) in the conventional domized clinical trial in which all the surgical group: main thyroid vessels (inferior , middle and procedures were performed under general anes - superior) were ligated using 3/0 silk sutures thesia by the same surgeon (to eliminate every while in all other vessels we used absorbable 4/0 kind of surgical technique bias) . sutures and/or electrocauterization ; (2) in the FO - Patients were randomized into two groups ac - CUS group : the haemostasis of all thyroid ves - cording to the haemostatic technique: 187 pa - sels was performed with the FOCUS Harmonic tients (79 men and 108 women) were included in Scalpel. For a better patient safety, we used a the first group (Conventional group or C group), double ligation technique on superior and inferi - in whom haemostasis and other surgical passages or thyroid vessels. Synthetically, the device was were performed using only conventional materi - used two times in 2 succeeding areas of the same als (Vicryl , stitches, haemostatic clips made of ti - vessel: just to coagulate the vessel in the distal tanium and monopolar or bipolar electrocoagula - part, and cutting the tissue after coagulation in tion ); 174 patients (73 men and 101 women) the proximal part. In this way , no suture ligation were included in FOCUS Harmonic scalpel was used. group (Focus group or F group), in which the Other surgical steps were the same for C FOCUS was used: the application of ultrasound group and F group . We identified and isolated re - to tissues was performed during the entire proce - current laryngeal nerves and parathyroid glands dure, to obtain three purposes synergistically: co - every time and a closed suction drain was always agulation, cutting, and cavitation . positioned below the superficial muscles. The patients were divided according to age, The parameters considered in this study were: preoperative diagnosis, and thyroid size to gener - total operating time (since initiation of the inci - ate homogeneous groups. sion until conclusion of skin closure), amount of drainage, time of positioning of drainage bal - The inclusion criteria were loons (the drains were removed if drainage vol - 1. Age > 18 years; ume was less than 10 ml in 24 hours) , post-oper - 2. Acceptance to participate in the study (signed ative hospitalization and occurrence of complica - informed consent form); tions (Table I). Serum parathyroid hormone, 3. Scheduled total thyroidectomy for multinodu - serum Ca and P levels were obtained in all pa - lar goiters or low risk differentiated carcinoma tients during the first post -operative day. We (T1N0M0). considered post-operative biochemical hy - poparathyroidism when serum parathyroid hor - The exclusion criteria were: mone level resulted below 15 ng/L (normal, 15- 1. Preoperative medication including analgesics, 65 ng/L ) and we handed out oral calcium carbon - corticosteroids or nonsteroidal antiinflamma - ate and calcitriol supplementation to patients tory drugs; with transient biochemical hypoparathyroidism, 3545 A. Minni, D. Rosati, C. Cavaliere, A. De Carlo, G. Illuminati, V. Scarano Catanzaro, M. Bononi Table I. Operative and postoperative parameters between 2 groups. Focus group Conventional group Variable (No. = 174) (No. = 187) p-value Mean thyroid weight (g) 46.8 ± 18.5 50.6 ± 14.2 > 0.05 Total operating time (min) 78.8 ± 16.1 133.6 ± 33.4 < 0.05 Amount of drainage (ml) 36.9 ± 2.3 57.2 ± 4.4 < 0.05 Time of drainage (h) 36 ± 12 84 ± 12 < 0.05 Serum PTH (ng/L): Preoperative 46.90 ± 18.58 43.87 ± 17.21 > 0.05 Postoperative 20.6 ± 14.3 19.06 ± 16.88 > 0.05 Serum Ca (mmol/L): Preoperative 2.32 ± 0.13 2.28 ± 0.21 > 0.05 Postoperative 2.12 ± 0.17 2.05 ± 0.23 > 0.05 Serum P (mmol/L): Preoperative 1.36 ± 0.31 1.39 ± 0.33 > 0.05 Postoperative 1.45 ± 0.24 1.48 ± 0.27 > 0.05 Hypoparathyroidism 9 10 > 0.05. Postoperative hospitalization (d) 4.8 ± 1.28 6.9 ± 1.74 < 0.05 Parathyroid gland autotransplantation(n) 14 16 > 0.05. RLN paralysis: Temporary (n) 12> 0.05 Permanent (n) 00 Superior laryngeal nerve injury 00 Lymphatic ducts injured chyle leakage (n) 11> 0.05 Abbreviations: PTH, parathyroid hormone; RLN, recurrent laryngeal nerve. even if they didn’t show any clinical symptoms morphology and motility of the larynx , to as - of hypocalcemia. We defined recurrent laryngeal sess vocal fold vibratory pattern (mucosal nerve palsy as temporary when it resolved be - wave) and to appreciate symmetry and regu - tween 6 months after surgery and as permanent larity of the vocal fold vibration as well as when it persisted more than 6 months .