Original Research—Endocrine Surgery

A Prospective, Randomized Study between the Small JawÒ and the Harmonic FocusÒ in Open Thyroidectomy

Otolaryngology– Head and Neck Surgery 2014, Vol. 150(6) 943–948 Ó American Academy of Otolaryngology—Head and Neck Surgery Foundation 2014 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0194599814527730 http://otojournal.org

Seung Ook Hwang, MD, PhD1, Jin Hyang Jung, MD, PhD1, Ho Yong Park, MD, PhD1, and Wan Wook Kim, MD1

No sponsorships or competing interests have been disclosed for this article.

Abstract Objectives. LigaSure Small JawÒ (LSJ) was recently developed and applied to thyroid surgery along with Harmonic FocusÒ (HF). We compared the 2 devices in open total thyroidectomy for papillary thyroid carcinoma (PTC). Study Design. A prospective, randomized study. Setting. Tertiary care center. Methods. This prospective, randomized study included 126 patients enrolled between December 2011 and June 2012. The numbers of patients in the LSJ group and the HF group were 64 and 62, respectively. Operative times, drain output, parathyroid status, complications, laboratory data, hospital stay, and analgesia requirements were analyzed. Results. Operation time, parathyroid status, postoperative complications including hypocalcemia, oral calcium supplement, calcium, parathyroid hormone, usage count of painkiller, and hospital stay were not different among the 2 groups. Ionized calcium on postoperative days 1, 2, and 10 was higher in the LSJ group (P = .04, P = .04, P = .01), and drain output was lower in the LSJ group (106.8 vs 123.6 mL, P = .01). Conclusions. Open thyroidectomy for PTC using the HF or the LSJ was safe and effective and was not associated with any increase in complications. Surgical outcomes and operative morbidity were equivalent between the 2 groups. Keywords comparison, Energy-Based Device, Harmonic Focus, open thyroidectomy, Small Jaw, thyroid carcinoma Received November 26, 2013; revised February 5, 2014; accepted February 21, 2014.

T

he prevalence of thyroid cancer continues to increase, and many new surgical approaches are being introduced to address this threat. The thyroid has a highly developed vascular system, and to prevent

hemorrhage, thyroid surgery requires extensive ligation, which has traditionally been performed by clamp-and-tie maneuvers. Surgeons devote much of their time to vessel ligation during thyroid operations, and failure to control bleeding can lead to catastrophic hemorrhage and hypoxemia-induced brain death due to hematoma in severe cases, as well as other acute conditions. Therefore, meticulous hemostasis is essential in thyroid surgery. Energy-based ligation and cutting tools are common to most, if not all, minimally invasive surgical procedures. The advantages of these tools include (1) permanent sealing, (2) shorter operation times, (3) reduced foreign body inflammatory reaction, (4) minimal thermal effect on surrounding tissues, (5) minimized tissue tangling and carbonization, (6) smaller skin incision in thyroid surgeries because a large surgical space is not required for tie-related work, and (7) assistant-independent surgery, regardless of the assistant’s tying experience. Previous studies comparing the usefulness of energy-based devices versus clamp-and-tie maneuvers in open thyroidectomy procedures have concluded that the energy-based devices allow effective curtailment of surgery time and safe tissue removal with no increase in postsurgical complications.1-4 Many open thyroidectomy procedures now include energy-based devices: harmonic scalpels or bipolar vessel sealing systems. The Harmonic FocusÒ (HF; Ethicon Endo-Surgery, Inc, Seoul, Korea; Figure 1) and LigaSure Small JawÒ (LSJ; Covidien, Energy-Based Devices, Boulder, Colorado; Figure 2) are 2 brands of energy-based devices that are frequently used in thyroid surgery. There are previous studies comparing harmonic scalpels, bipolar vessel sealing systems, and conventional surgical methods,5-7 but since the introduction of the LSJ in 2010, there have been few studies comparing the LSJ with the HF or with conventional surgical methods,4,8 and to our knowledge, there is no 1 Department of Surgery, Kyungpook National University School of Medicine, Daegu, Republic of Korea

Corresponding Author: Wan Wook Kim, MD, Department of Surgery, Kyungpook National University School of Medicine, 130 Hogukno, Buk-gu, Daegu 702-120, Republic of Korea. Email: [email protected]

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Figure 1. Harmonic FocusÒ (Ethicon Endo-Surgery, Inc, Seoul, Korea).

Figure 2. LigaSure Small JawÒ (Covidien, Energy-Based Devices, Boulder, CO).

prospective study comparing the LSJ and the HF in open total thyroidectomy with central lymph node dissection (CLND). To this end, we have conducted a prospective randomized trial comparing surgical results using the LSJ and the HF in open thyroid surgery for papillary thyroid carcinoma (PTC).

Patients and Methods The study was performed from December 2011 to June 2012 after obtaining Institutional Review Board approval (KNUMC 12-1030) and signed informed consent from all study participants. The study enrolled participants from among a group of 250 patients who underwent thyroid surgery at the Department of Surgery of Kyungpook National University Hospital. Patients who had undergone robotic or endoscopic surgery, had been operated due to follicular tumor or a benign mass, had undergone modified radical neck dissection or

Figure 3. Trial profile and number of patients identified between the 2 groups in the randomized controlled study.

selective neck dissection, and whose surgical area was reduced by thyroid lobectomy were excluded. Patients who took calcium supplements to treat osteoporosis prior to surgery; who had a history of hyperparathyroidism or hypoparathyroidism, chronic renal failure, renal stones, thyroid or parathyroid surgery, or radiotherapy of the cervical region; and who took aspirin or another antiplatelet agent or anticoagulant within 7 days prior hospital admission were also excluded. Thus, 126 patients were finally chosen who were scheduled to undergo total thyroidectomy and CLND due to PTC except lobectomy (Figure 3). All surgical procedures were conducted by the same team with a single surgeon (W.W.K.), and the study participants were randomly and prospectively assigned to either of 2 groups, HF or LSJ, by random drawing on operation day. The HF group consisted of 62 patients who underwent thyroidectomy using the Harmonic FocusÒ and the LSJ group consisted of 64 patients who underwent thyroidectomy using the LigaSure Small JawÒ. The great parts of vessels (superior thyroid vein and artery, middle thyroid vein, inferior thyroid vein and artery) were ligated using the HF or the LSJ without clamp-and-tie maneuvers, and arteries .5 mm or veins .7 mm were controlled by conventional ligation. The devices were used in areas .3 mm from the recurrent laryngeal nerve and .2 mm from the parathyroid gland to avoid thermal damage to nearby structures. Conventional ligation techniques were used for the remaining sections. The patients and follow-up physicians remained blinded to the devices used. Clinical data including age, gender, operative time, cumulative total drain output, parathyroid status, length of hospital stay, and analgesia requirements were collected for each patient, and calcium and postoperative ionized calcium levels on days 0, 1, 2, 10, and 60, along with parathyroid hormone (PTH) levels at postoperative days (PODs) 1, 10, and 60, were recorded as laboratory data. Each of 4 parathyroids was scored as salvage = 1.5, salvage with mild discoloration = 0.7, autotransplantation = 0.5, not identified = 0.5, and sacrifice = 21 during operation, and the parathyroid score was defined as the sum of the 4 scores. Hypocalcemia,

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recurrent laryngeal nerve (RLN) palsy, bleeding, chylous fistula, seroma, and wound infection were evaluated as complications. Tumor size, papillary thyroid microcarcinoma (PTMC), multiplicity, thyroiditis, extrathyroidal extension, number of retrieved and metastatic lymph nodes (LNs), and TNM stage were recorded as pathologic data. Operative times were measured from the point of skin incision by the surgeon to the point of placement of the last suture. Length of hospital stay was defined as the period from the point of returning to the hospital room from the recovery room to the point of discharge, which was permitted when the patient had no signs of bleeding and no other complications, had a total drain amount output of less than 30 mL/d, did not exhibit hypocalcemic symptoms, and had maintained a total calcium level of .8.0 mg/dL or an ionized calcium level .1.0 mmol/L for 2 consecutive days following surgery. If the patient had a hoarse voice, was unable to produce high-pitched sounds, or experienced laryngeal aspiration, in particular, laryngoscopy was recommended to check for paralysis of the vocal cords. The determination of hypocalcemia was based on the presence and extent of numbness in the hands or other symptoms, total serum calcium and ionized calcium levels, and administration of oral calcium supplement or intravenous calcium. Patients were considered hypocalcemic when they showed relevant symptoms or when their total calcium level and ionized calcium level dropped below 8.0 mg/dL and 1.0 mmol/L, respectively, even once during the postsurgical examinations or if they received a calcium supplement. Calcium supplements were given to patients who were deemed hypocalcemic by the above criteria or those whose PTH levels were \5 on POD 1, because in our experience, despite calcium and ionized calcium levels being normal and there being no other symptoms observed, PTH \5 at this point has been associated with a drop in the calcium levels by POD 2 or 3 and has given rise to preventable hypocalcemia symptoms, possibly prolonging the length of hospital stay. Patients who did not exhibit symptoms of hypocalcemia and those whose total calcium and ionized calcium levels were 8.0 mg/dL and 1.0 mmol/L, respectively, were kept under observation without administration of oral calcium supplements. Hypocalcemic patients who required medical treatment received calcium carbonate 500 mg 3T (Carnit, Jinyang Pharm Co, Seoul, Korea) 3 times daily with calcitriol 0.25 mg 1C (Bonky, Yu Yu Pharmaceutical Co, Seoul, Korea) twice daily. Hypocalcemia was categorized as mild (mild tingling sensation or numbness in hands or feet), moderate (severe tingling sensation or numbness in hands or feet, insensitivity around the mouth, positive Chvostek’s sign), or severe (positive Trousseau’s sign, tetany, carpopedal spasm). Patients exhibiting symptoms of severe hypocalcemia and those who did not respond well to oral calcium supplements received intravenous calcium formulations. Statistical analyses were conducted using SPSS 17.0 K for Windows (SPSS Inc, Chicago, Illinois), with x2 test or Fisher exact test applied for categorical variables and

independent t test or Mann-Whitney test for continuous variables, and a P value of \.05 was considered statistically significant.

Results Table 1 lists the clinical characteristics of the study participants. There were no significant differences in terms of gender, age, length of hospitalization, or analgesia requirement. Operative time was 106.6 6 2.1 min for the HF group and 104.3 6 3.0 min for the LSJ group, and the difference was not statistically significant. Total drain output was 123.6 6 5.9 mL for the HF group and 106.8 6 4.7 mL for the LSJ group, and this difference, indicating a lower drain output for the LSJ group, was statistically significant (P = .01). Parathyroid score and number of parathyroids autotransplantated were 3.0 6 0.1 and 0.40 6 0.07 for the HF group and 2.9 6 0.1 and 0.35 6 0.06 for the LSJ group, respectively, and the difference was not statistically significant. In terms of pathologic data, no statistically significant differences were observed in size, PTMC, multiplicity, extent of thyroiditis, extrathyroidal extension, or stage. Retrieved LN count and metastatic LN count were also similar at 10.4 6 0.7 and 1.1 6 0.2 for the HF group and 9.5 6 0.7 and 1.5 6 0.3 for the LSJ group, respectively (Table 2). Postoperative laboratory data indicated no difference between the groups in terms of calcium levels on PODs 0, 1, 2, 10, or 60 or in PTH levels on PODs 1, 10, and 60. The ionized calcium levels were similar between the groups on POD 0 and 60, but the ionized calcium level was significantly higher in the LSJ group on PODs 1 (1.07 6 0.01 mmol/L vs 1.04 6 0.01 mmol/L for the HF group, P = .04), PODs 2 (1.07 6 0.01 mmol/L vs 1.04 6 0.01 mmol/L, P = .04), and PODs 10 (1.13 6 0.01 mmol/L vs 1.09 6 0.01 mmol/L, P = .01; Table 3; Figure 4). Postoperative hypocalcemia was a complication in 25 patients in the HF group (40.3%) and 22 in the LSJ group (34.4%), and while the LSJ group had fewer patients who developed hypocalcemia, the difference was not significant. Table 1. Clinical Characteristics.

Sex, F:M Age, y Operation time, min Hospitalization, d Pain killer supplement, n Total drain amount, mL Parathyroid scoreb Autotransplantation, n

HFa (n = 62)

LSJa (n = 64)

P Value

54:8 47.4 106.6 3.1 5.3 123.6 3.0 0.040

58:6 49.1 6 1.5 104.4 6 1.5 3.3 6 0.1 5.1 6 0.2 106.8 6 4.7 2.9 6 0.1 0.35 6 0.06

.58 .39 .52 .50 .56 .01 .61 .65

6 1.3 6 2.1 6 0.1 6 0.2 6 5.9 6 0.1 6 0.07

Abbreviations: HF, Harmonic FocusÒ; LSJ, LigaSure Small JawÒ. a Value of HF and LSJ represents mean 6 SD or n. b Each of 4 parathyroids was scored as salvage = 1.5, salvage with mild discoloration = 0.7, autotransplantation = 0.5, not identified = 0.5, and sacrifice = 21 during operation, and the parathyroid score was defined as the sum of the 4 scores.

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Table 2. Pathologic Data. HFa (n = 62) Size, cm 0.9 6 0.1 PTMC, n (%) 47 (75.8) Multiplicity, n (%) 25 (40.3) Thyroiditis, n (%) 23 (37.1) Extrathyroidal 35 (56.5) extension, n (%) Lymph node (retrieved), n 10.4 6 0.7 Lymph node (metastatic), n 1.1 6 0.2 TNM stage (I:II:III:IV) 34 : 2 : 26 : 0

LSJa (n = 64) P Value 1.1 6 0.1 40 (62.5) 26 (40.6) 18 (28.1) 38 (59.4)

.15 .10 .97 .15 .74

9.5 6 0.3 1.5 6 0.3 38 : 2 : 24 : 0

.40 .36 .87

Abbreviations: HF, Harmonic FocusÒ; LSJ, LigaSure Small JawÒ; PTMC, papillary thyroid microcarcinoma. a Value of HF and LSJ represents mean 6 SD or n.

Figure 4. Changing patterns of serum calcium and ionized calcium between the Harmonic FocusÒ and the LigaSure Small JawÒ. Table 3. Postoperative Laboratory Data. HFa (n = 62) Calcium, mg/dL POD 0 POD 1 POD 2 POD 10 POD 60 Ionized calcium, mmol/L POD 0 POD 1 POD 2 POD 10 POD 60 PTH, pg/mL POD 1 POD 10 POD 60

LSJa (n = 64)

P Value Table 4. Postoperative Complications.

8.7 8.1 8.0 9.1 9.6

6 0.1 6 0.1 6 0.1 6 0.1 6 0.1

8.6 6 8.1 6 8.1 6 9.2 6 9.6 6

0.1 0.1 0.1 0.1 0.1

.73 .84 .43 .17 .14

1.09 1.04 1.04 1.09 1.13

6 0.01 6 0.01 6 0.01 6 0.01 6 0.01

1.10 6 1.07 6 1.07 6 1.13 6 1.15 6

0.01 0.01 0.01 0.01 0.01

.35 .04 .04 .01 .39

18.5 6 2.6 24.9 6 2.7 35.2 6 4.0

16.5 6 1.8 24.2 6 2.5 32.5 6 4.8

.54 .86 .69

Abbreviations: HF, Harmonic FocusÒ; LSJ, LigaSure Small JawÒ; POD, postoperative day; PTH, parathyroid hormone level. a Value of HF and LSJ represents mean 6 SD.

There were 23 patients in the HF group (37.1%) and 20 in the LSJ group (31.3%) who required oral calcium supplements and 2 from each group (3.2%) who received intravenous calcium formulations, a nonsignificant difference. Most patients who experienced hypocalcemia recovered within 2 to 3 months after surgery, and no case of permanent hypocalcemia has been reported in either group. Two patients from each group (3.2%) developed RLN palsy, and 1 patient from each group experienced transient palsy and recovered within 2 months. In each group, there was 1 patient who had 1 RLN branch unintentionally cut during the surgery. These patients remain under outpatient observation and will be scheduled to undergo injection laryngoplasty if their vocal capabilities do not improve within the next 6 months. Other postoperative complications included

HFa (n = 62) Hypocalcemiab Oral calcium supplement IV calcium supplement RLN palsy Miscellaneous Bleeding Chylous fistula Seroma

25 23 2 2 1 1 0 0

(40.3) (37.1) (3.2) (3.2) (1.6) (1.6)

LSJa (n = 64)

P Value

22 (34.4) 20 (31.3) 2 (3.2) 2 (3.2) 1 (1.6) 0 0 1 (1.6)

.49 .48 1.00 1.00 1.00

Abbreviations: HF, Harmonic FocusÒ; LSJ, LigaSure Small JawÒ; IV, intravenous; RLN, recurrent laryngeal nerve. a Value of HF and LSJ represents n (%). b Hypocalcemia: calcium \8.0, i-calcium \1.0, or symptom (1) or calcium supplement (1).

bleeding, chylous fistula, seroma, and wound infection (1 per group, 1.6%). All of the minor complications were resolved through conservative treatment options (Table 4). Postoperative thyroid hormone off thyroglobulin (off-Tg) was 2.41 6 0.85 ng/mL for the HF group (n = 26) and 1.06 6 0.35 ng/mL for the LSJ group (n = 27), a nonsignificant difference, with P = .14.

Discussion The thyroid gland has a highly developed vascular system, and detailed identification of vessels, nerves, and other anatomical structures, along with careful ligation of the vessels, is essential during thyroid surgery to minimize hemorrhaging and related complications. The traditionally accepted mode of ligation has been via the clamp-and-tie maneuver, but more recently, energy-based devices have come into wide use for open thyroid surgeries as well as for endoscopic

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dissections and robotic thyroidectomies. With the traditional clamp-and-tie maneuver, the operative time is largely dependent on the capabilities of the assistants. With energybased devices, surgeons rely less on assistants and can therefore reduce operative times. There are 2 main types of energy-based devices, based on mechanism of action. The harmonic scalpel emits 55,000 Hz of ultrasonic energy for cutting and sealing tissue, and the bipolar vessel sealing system uses electrothermal energy to denature collagen and seal tissues. Energy-based devices have been progressively improved with clinical feedback and advances in technology, and the HF (2007) and LSJ (2010) are now frequently used in open thyroid surgery. In several previous studies that have compared harmonic scalpels and bipolar vessel sealing systems in thyroid surgery, the 2 devices had similar efficiency and safety profiles. Recent meta-analyses have noted shorter operative times and smaller amounts of blood loss with the harmonic scalpel, although these results are clinically less important.5,6 Furthermore, most bipolar vessel sealing systems examined in these studies were earlier models of the LSJ, which did not have cutting capability, meaning that the cutting procedure during surgery with the bipolar vessel sealing system required an instrument change that may have prolonged surgeries compared with the harmonic scalpel. There are few studies comparing the LSJ with the HF or with conventional surgical methods. PTC commonly has associated central LN metastases, and CLND often accompanies thyroidectomy.9,10 Therefore, the appropriate choice of energybased device is particularly important in surgery for PTC, because thyroidectomy with CLND requires more delicate surgical skills to conduct a successful procedure. To our knowledge, the present study is the first prospective randomized trial comparing surgical results using the LSJ and the HF in open total thyroidectomy with CLND for PTC. The LSJ generally takes 3.5 seconds to cut a 7-mm vessel, while the HF should take between 4 and 6 seconds, and both instruments are capable of cutting and sealing vessels up to 7 mm in diameter and can withstand similar levels of pressure (400 to 500 mm Hg for HF and 385 6 76 mm Hg for LSJ). Based on experience, the authors of the present study believe that while the LSJ is slightly faster for cutting connective tissue, there is little difference between the 2 devices in terms of operative times. Dionigi et al8 have also reported similar results. In terms of usability, the LSJ requires an additional step to make a cut (2 steps versus 1), and it has short, blunt blades that can cause a little difficulty when operating in confined spaces such as in the area around the thyroid. The LSJ can be used with a general electrosurgical generator, and there is no requirement for an additional transducer. The HF, on the other hand, has long, sharp, and curved blades, which often may be easier to use. The activation button can be manipulated from a 270° angle, the blade does not stick to the tissues, and it does not produce electrical stimuli that cause muscular twitching. The costs of both devices are comparable (LSJ $733 and HF $835 at our institution).

The thermal effects of the HF and the LSJ differ in that the HF completes transection within 4 to 6 seconds and the blade temperatures do not exceed 100°C, although with longer activation times, the blade temperature of the HF can rise as high as 280°C and may cause thermal injury to nearby tissues. Thermal spread from the front tip can cause thermal injury to cricoid cartilage, muscles, and nerves. Blade temperatures with an LSJ are never to exceed 80°C, even after multiple activations. Furthermore, the blade cools to \60°C very rapidly, within approximately 1 s, which should translate to minimal risk of thermal injury to nearby tissues. The radius of potential thermal damage from a harmonic scalpel has been reported to be within 2 mm to 3 mm from the blades.11-13 Accordingly, in our study, the superior thyroid vessel was sealed as close to the thyroid border as possible, and the shears were used no closer than 3 mm from the RLN and the parathyroid gland in order to minimize the risk of thermal damage. By adhering to these guidelines, surgeons should be able to operate safely and without damaging the RLN, the external branch of the superior laryngeal nerve, or the parathyroids, and there should be no increase in related complications. However, the rate of vocal cord paralysis may have been underestimated because not all patients underwent laryngoscopy because of discomfort with the procedure or deferral by asymptomatic patients. There were no differences in complication rates between the 2 groups in a previous study that compared the HF and the LSJ.8 However, although perhaps of lesser clinical importance, the patients in the LSJ group required smaller surgical incisions, experienced a lower incidence of swallowing difficulty, and had higher rates of intact postoperative PTH levels with lower requirements for oral calcium replacement for hypocalcemia. Similarly, we observed equivalent clinical results between the 2 groups in the present study, with only minimal differences. The total drain output was lower in the LSJ group than in the HF group, but this did not have clinical significance because there were no differences in duration of hospital stay. In addition, the ionized calcium level was significantly higher in the LSJ group on PODs 1, 2, and 10. However, these were small differences within normal ranges and so did not affect the rates of hypocalcemia. The number of hypocalcemia cases in the present study was somewhat higher than in other comparable studies. This is likely due to variance in the criteria for diagnosing hypocalcemia. In other studies, a patient was deemed hypocalcemic if the total blood calcium level was \8.0 mg/dL in 2 or more consecutive measurements or if the total blood calcium level was \8.0 mg/dL and the ionized calcium level was \1.0 mmol/L on PODs 1, 3, and 7, regardless of presence of symptoms.12 Conversely, a patient in the present study was classified as hypocalcemic in the presence of relevant symptoms or when any one of the blood tests performed on POD 0, 1, 2, 10, or 60 showed a total calcium level \8.0 mg/dL or an ionized calcium level \1.0 mmol/ L, or when calcium was supplemented due to a PTH level

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of \5 on POD 1 even with normal calcium levels and in the absence of hypocalcemic symptoms.

Conclusions Open thyroidectomy for PTC using the HF or the LSJ was safe and effective and was not associated with any increase in complications. Surgical outcomes and operative morbidity were equivalent between the 2 groups. Author Contributions Seung Ook Hwang, acquisition, analysis, and interpretation of data, drafting and revising the work, final approval of last version, agreement to be accountable for all aspects of the work; Jin Hyang Jung, acquisition of data, revising the work, final approval of last version, agreement to be accountable for all aspects of the work; Ho Yong, acquisition of data, revising the work, final approval of last version, agreement to be accountable for all aspects of the work; Wan Wook Kim, conception of the work and the acquisition of data, revising the work, final approval of last version, agreement to be accountable for all aspects of the work.

Disclosures Competing interests: None. Sponsorships: None. Funding source: None.

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4. Kuboki A, Nakayama T, Konno W, et al. New technique using an energy-based device versus conventional technique in open thyroidectomy. Auris Nasus Larynx. 2013;40:558-562. 5. Lang BH, Ng SH, Lau LL, Cowling BJ, Wong KP. A systematic review and meta-analysis comparing the efficacy and surgical outcomes of total thyroidectomy between harmonic scalpel versus ligasure. Ann Surg Oncol. 2013;20:1918-1926. 6. Garas G, Okabayashi K, Ashrafian H, et al. Which hemostatic device in thyroid surgery? A network meta-analysis of surgical technologies. Thyroid. 2013;23:1138-1150. 7. Ecker T, Carvalho AL, Choe JH, Walosek G, Preuss KJ. Hemostasis in thyroid surgery: harmonic scalpel versus other techniques—a meta-analysis. Otolaryngol Head Neck Surg. 2010;143:17-25. 8. Dionigi G, Boni L, Rausei S, et al. 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. 2012;397:817-823. 9. Wada N, Duh QY, Sugino K, et al. Lymph node metastasis from 259 papillary thyroid microcarcinomas: frequency, pattern of occurrence and recurrence, and optimal strategy for neck dissection. Ann Surg. 2003;237:399-407. 10. Roh JL, Kim JM, Park CI. Central cervical nodal metastasis from papillary thyroid microcarcinoma: pattern and factors predictive of nodal metastasis. Ann Surg Oncol. 2008;15:2482-2486. 11. Landman J, Kerbl K, Rehman J, et al. Evaluation of a vessel sealing system, bipolar electrosurgery, harmonic scalpel, titanium clips, endoscopic gastrointestinal anastomosis vascular staples and sutures for arterial and venous ligation in a porcine model. J Urol. 2003;169:697-700. 12. Harold KL, Pollinger H, Matthews BD, et al. Comparison of ultrasonic energy, bipolar thermal energy, and vascular clips for the hemostasis of small-, medium-, and large-sized arteries. Surg Endosc. 2003;17:1228-1230. 13. Goldstein SL, Harold KL, Lentzner A, et al. Comparison of thermal spread after ureteral ligation with the Laparo-Sonic ultrasonic shears and the Ligasure system. J Laparoendosc Adv Surg Tech A. 2002;12:61-63.

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A Prospective, Randomized Study between the Small Jaw® and the Harmonic Focus® in Open Thyroidectomy.

LigaSure Small Jaw(®) (LSJ) was recently developed and applied to thyroid surgery along with Harmonic Focus(®) (HF). We compared the 2 devices in open...
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