The Use of Harmonic Focus and Thunderbeat Open Fine Jaw in Thyroid Surgery: Experience of a High-Volume Center.

Background: In thyroid surgery, achieving accurate haemostasis is fundamental in order to avoid the occurrence of complications. Energy-based devices are currently extensively utilized in this field of surgery. This study aims to compare Harmonic Focus and Thunderbeat Open Fine Jaw with regard to surgical outcomes and complications. Methods: Patients submitted to total thyroidectomy in our center, between January 2017 and June 2020, were retrospectively analysed. Based on the energy-based device utilized, two groups were identified: Group A (Harmonic Focus) and Group B (Thunderbeat Open Fine Jaw). Results: A total of 527 patients were included: 409 in Group A and 118 in Group B. About surgical outcomes, the mean operative time was significantly shorter in Group B than in Group A (p < 0.001), while as regards complications, the occurrence of transient recurrent laryngeal nerve injury was significantly greater in Group B than in Group A (p = 0.019). Conclusions. Both Harmonic Focus and Thunderbeat Open Fine Jaw have proven to be effective devices. Operative times were significantly shorter in thyroidectomies performed with Thunderbeat Open Fine Jaw; however, the occurrence of transient recurrent laryngeal nerve injury was significantly greater in patients operated on with this device.

Thyroidectomy with energy-based devices: surgical outcomes and complications-comparison between Harmonic Focus, LigaSure Small Jaw and Thunderbeat Open Fine Jaw.

BACKGROUND: Being the thyroid gland a highly vascularized organ, achieving a meticulous hemostasis is essential to avoid serious complications. Currently, energy-based devices are widely used in thyroid surgery. The aim of this study was to compare Harmonic Focus (HF), LigaSure Small Jaw (LSJ) and Thunderbeat Open Fine Jaw (TB) in terms of surgical outcomes and complications. METHODS: Patients undergoing thyroidectomy in our Unit between January 2012 and June 2018 were retrospectively analyzed. According to the type of energy-device used, patients were divided into three groups: Group A (HF), Group B (LSJ) and Group C (TB). RESULTS: A total of 1,165 patients were included in this study: 1,012 in Group A, 96 in Group B and 57 in Group C. Demographic data and histopathological findings were comparable between the three groups. About the postoperative stay and complications, no statistically significant difference was found. The mean operative time was 89.41±20.60 minutes in Group A, 85.57±15.91 minutes in Group B and 78.07±17.67 minutes in Group C (P<0.01). However, the post-hoc test for all pairwise comparisons showed a statistically significant difference only between Group A and Group C. CONCLUSIONS: HF, LSJ and TB have proved to be safe and effective. The postoperative stay and complications were comparable between the three groups. Considering the limits of our investigation, further studies are needed to investigate the effect of TB on operative times.

The impact of the ultrasonic, bipolar and integrated energy devices in the adrenal gland surgery: literature review and our experience.

BACKGROUND: The gold standard approach for surgical treatment of benign and malignant adrenal lesion is considered the laparoscopic one, due to a lot of advantages compared to open approach. The rapid propagation of this surgical technique is due to the diffusion of haemostatic devices in laparoscopic adrenal surgery. The principal aim of this study is to analyze the outcome of LA using each energy modality, evaluating the eventual superiority of an instrument over the others. METHODS: A retrospective study, involving 75 consecutive patients submitted to LA by transperitoneal lateral approach from January 2013 to June 2017, was performed. Age less than 70 years old, adrenal adenomas less than 8 cm in diameter, incidentalomas < 6 cm, myelolipomas < 13 cm, adrenal metastases < 7 cm and ASA score ≤ III were the main surgical inclusion criteria. All involved patients were divided into three group, one for each energy device: group 1 - Harmonic Scalpel, group 2 - Ligasure vessel sealing system and group 3 - Thunderbeat. In each group only one device was applied for dissection and haemostasis during the whole operation. Each group consisted of 25 patients, well matched for histology, tumor size and site, gender and age. The following parameters were collected: age, gender, size of the tumor, side of the affected gland, pathology, operating time, intraoperative blood losses, hospitalization time, complication and conversion rate. RESULTS: There was no significant statistical difference between groups regarding the relationship between male/female, right site/left site, the mean age, hospitalization time and the tumor size (p > 0.05). Significant statistical difference are detectable in operation time and intraoperative blood losses. Thunderbeat, compared respectively with Ligasure and Harmonic Scalpel, is the fastest device (p < 0,001). The second faster device resulted Harmonic Scalpel, which meanly reduced the operation time compared to Ligasure (p = 0.048). intraoperative blood losses are reduced using Thunderbeat (p < 0,001) and HS (p = 0.006) compared to Ligasure, but between Thunderbeat and Harmonic Scalpel there isn't significant statistical difference (p = 0.178). CONCLUSIONS: Analyzing the results, laparoscopic adrenalectomy carried out using Thunderbeat appeared to show a statistically significant decrease in operation time and intraoperative blood losses compared with laparoscopic adrenalectomy performed using Harmonic Scalpel and Ligasure, while hospitalization time was superimposable in all groups. According to our data, a responsible use of advanced energy devices can improve surgical outcomes guarantying a cost savings and patient's satisfaction.

Comparison of surgical outcomes and complications between the Harmonic FOCUS and conventional surgery for open thyroidectomy.

The aim of the present study was to evaluate the potential advantages of the ultrasonic scalpel compared with the conventional technique in thyroid surgery. Patients with resectable thyroid cancer and Basedow's disease were assigned to ultrasonic scalpel or conventional technique (knot-tying and electrocoagulation). The present study used the Harmonic FOCUS® (HF) as an ultrasonic scalpel. Between February 2013 and May 2016, 45 patients were enrolled into the study. Duration of the surgery was significantly decreased in the HF group compared with the conventional surgery (CS) group (median 142 vs. 151 min; P=0.0406). Intraoperative blood loss and total volume of drainage fluid were significantly decreased in the HF group compared with the CS group (median 40 vs. 125 ml; P=0.0054, and median 120 vs. 175.5 ml; P=0.0490). Duration of drain placement and length of hospitalization stay were similar in the two groups. Furthermore, the overall incidence of postoperative complications did not differ between the two groups. Overall, the present study suggests that open thyroidectomy using the HF is safe and effective and not associated with any increase in complications.

Is the superior laryngeal nerve really safe when using harmonic focus in total thyroidectomy? A prospective randomized study.

BACKGROUND: Harmonic focus (HF) was introduced in thyroid surgery in an effort to reduce operation time and complications. OBJECTIVE: The present study aimed to compare function of superior laryngeal nerve and incidence of other postoperative complications in total thyroidectomies using HF and conventional ligation (CL). METHODS: The trial is a randomized single-center, single-blinded study. Patients aged ≥ 18 years scheduled for total thyroidectomy were considered for participation. An ultrasonic dissector was used for coagulation and cutting in the HF group, while the standard technique was used in the CL group. Demographic, surgical data, and complications were recorded. Data were analyzed using SPSS for Windows. RESULTS: Of 244 eligible patients, data of 206 patients who completed the study were analyzed. The groups were similar in terms of age, sex, and indication for operation. The mean operative time in the HF group was significantly shorter than that in CL group (p=0.01). Drain necessity, duration of drainage, duration of postoperative hospitalization, and the incidence of postoperative complications was similar in the groups (p>0.05). The external branch of the superior laryngeal nerve and recurrent laryngeal nerve palsy were noted in three and two patients in the HF group and in two and one patients in the CL group at 6 months. CONCLUSION: To the best of our knowledge, this is the first study comparing conventional technique with HF in total thyroidectomy, focusing on the function of the external branch of the superior laryngeal nerve using laryngostroboscopy; results showed that HF is as safe as the conventional technique.

Safety assessment of the use of ultrasonic energy in the proximity of the recurrent laryngeal nerve in a porcine model.

BACKGROUND: Advanced bipolar and ultrasonic energy have demonstrated reduction of operating time and blood loss in thyroidectomy. However, these devices generate heat and thermal dispersion that may damage adjacent structures such as the recurrent laryngeal nerve (RLN). This study was designed to evaluate the safety profile of the Harmonic Focus+® (HF+) device through the evaluation of thermal injury to the RLN using different algorithms of distance and time with state of the art technology. METHODS: 25 Vietnamese pigs underwent activation of HF+ in the proximity of their RLN. They were divided into 4 groups according to activation distance (3 mm, 2 mm, 1 mm and on the RLN). Time of activation, time between tones of the ultrasonic generator, changes in the electromyographic signal using continuous nerve neuromonitoring, vocal fold mobility assessed by direct laryngoscopy and histological thermal damaged were evaluated. RESULTS: None of the pigs had loss of signal in the electromyography during the procedure; only one pig had isolated transient decrease in amplitude and one increase in latency. One pig had transient vocal fold paresis in the group with activation on the nerve. Evaluation of the nerves by histology and immunohistochemistry did not show significant changes attributed to thermal injury. CONCLUSIONS: The use of ultrasonic energy close to the RLN is safe, provided that activation time does not exceed the necessary time to safely transect the tissue.

Total Thyroidectomy with Central Neck Dissection Using Harmonic Focus: A Randomized Clinical Trial / 대한내분비외과학회지

PURPOSE: The use of sealing devices such as Harmonic scalpel and Ligasure is increasing steadily in thyroid surgery. The Harmonic Focus (HF) is an ultrasonic device that enables simultaneous vessel sealing and tissue coagulation, designed for open surgery such as thyroidectomy. The aim of this study is to assess the efficiency and safety of HF use in thyroid surgery compared to Conventional Tying (CT). METHODS: A prospective study was conducted to compare the efficacy of HF versus CT. We evaluated 50 patients who underwent surgery for thyroid tumor at Korea University Anam Hospital. All patients underwent total thyroidectomy with central neck dissection after being randomly allocated into two groups: HF group and CT group. The differences in surgical outcomes and postoperative complications by device use, i.e. group assignment, were statistically analyzed. RESULTS: There were no differences in number of retrieved lymph nodes (P=0.595), number of resected parathyroid glands (P=0.330), immediate postoperative iPTH (P=0.252), length of hospitalization (P=0.375) between HF group and CT group. However, operative time was shorter in HF group than CT group (106.07±20.92 min vs. 136.54±38.24 min, P=0.046). Postoperative complications of wound infection, seroma, hematoma, chyle leakage, vocal cord palsy, and hypoparathyroidism did not differ between groups. CONCLUSION: HF is a safe, effective, and time-saving technique; outcomes are comparable with CT. Both intraoperative and postoperative variables were similar between groups. Future larger studies are warranted to further investigate the effect on postoperative complications.

Efficacy of harmonic focus scalpel in seroma prevention after axillary clearance.

INTRODUCTION: Seroma formation in breast cancer patients who have undergone axillary lymph node dissection (ALND) is a source of significant discomfort and morbidity. We aimed to ascertain seroma incidence after ALND, when Harmonic Focus (HF) scalpel is used for dissection instead of conventional diathermy (CD). METHODS(AND PATIENTS): This retrospective study was carried out in a single hospital over 6 years. Patients were allocated into HF group (HFG) or CD group (CDG). Seroma volume, hospital stay, and complications were evaluated. RESULTS: Of 94 patients, 42 were in the HFG and 52 in the CDG. Two day median seroma volume was 205 ml (IQR 95-265) for HF, and 227.5 ml (IQR 149-385) for CD. The total median seroma output was 270 ml (IQR 160-478) for HF, and 385 ml (IQR 220-558) for CD. No statistically significant differences between HFG and CDG were identified in these data, as well as patient demographics, operative time, and complication rates. Duration of surgery >2.5 h increased seroma formation (p < 0.001). Mastectomy and ALND increased seroma formation compared to wide local excision (WLE) and ALND (p < 0.05). Nodal involvement, number of lymph nodes resected, and extra nodal spread did not influence seroma formation. DISCUSSION(AND CONCLUSION): In our hands, HF use was not superior to CD in limiting seroma formation in ALND for breast cancer. Increased seroma formation in surgeries >2.5 h in duration is commensurate with surgeries involving mastectomy and ALND (>2.5 h in our study), which entails greater and sustained tissue and lymphovascular trauma.

Preventive effects on seroma formation with use of the harmonic focus shears after breast reconstruction with the latissimus dorsi flap.

BACKGROUND: Postoperative seroma is the most common complication of latissimus dorsi (LD) flap surgery for breast reconstruction. The use of EC for elevation of the flap might cause additional risk for seroma formation by injuring surrounding lymph vessels due to heat dispersion. There is a possibility that seroma formation can be prevented by using alternative devices such as harmonic focus (HF) shears that can dissect the tissue simultaneously with sealing the lymph vessels. METHODS: Forty-eight patients who underwent breast reconstruction with LD flaps since August 2011 up to April 2015 were enrolled. They were retrospectively split into two groups: 24 in group HF, 24 in group EC (conventional electrocautery). The primary outcome measures were rate of seroma formation and total volume of drain discharge and indwelling period of drainage at the anterior chest and donor site. Secondary outcome measures were length of hospital stay and duration of surgery. RESULTS: The incidence of seroma was 45.8% in the EC group and 20.8% in the HF group. The total volumes of the drain discharge and indwelling period of drainage in the back (donor site) were significantly decreased in the HF group. The length of the hospital stay and surgical time was significantly shorter for the HF group. CONCLUSIONS: The use of HF shears on the LD flap donor site is helpful for reducing seroma formation, the length of the drainage period, the surgical time, and the length of the hospital stay.

Comparison of the harmonic focus and the thunderbeat for open thyroidectomy.

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.

A Prospective Study Comparing the Efficacy and Surgical Outcomes of Harmonic Focus Scalpel Versus LigaSure Small Jaw in Thyroid and Parathyroid Surgery.

Background The use of sealing devices has been established in thyroid surgeries. Recently, LigaSure Small Jaw (LS), a new device that utilizes bipolar energy, was approved by the Food and Drug Administration for use in different head and neck procedures. The purpose of this study is to assess the efficiency and safety of LS use in thyroid surgery compared to Harmonic Focus Scalpel (HS), a well-established device. Methods A prospective study was conducted to compare the efficacy of LS versus the HS. We evaluated 301 patients who underwent surgery at a North American academic institution. Patients were allocated into two groups according to LS or HS use. All patients underwent vocal cord assessment using direct laryngoscopy preoperatively and postoperatively. Analyses were performed to examine the difference in perioperative outcomes resulting from the utilization of either device. Results No difference was seen in operative time between both groups (124.20 ± 68.44 minutes in HS vs 125.20 ± 72.13 minutes in LS, P = .99). Overall complications were similar between both groups (22.86% in HS vs 13.84% in LS, P = .05). However, LS use was also associated with a lower incidence of postoperative transient hypocalcemia as compared to the HS (P = .025). No significant difference was found between both groups regarding the incidence of recurrent laryngeal nerve injury (P = .52). Conclusion The use of the LS is safe, feasible, and is associated with comparable outcomes to HS. Both intraoperative and postoperative variables were similar between both devices. Future larger studies are warranted to further investigate the effect on postoperative transient hypocalcemia.

Complications in thyroid surgery. Harmonic Scalpel, Harmonic Focus versus Conventional Hemostasis: A meta-analysis.

BACKGROUND: To evaluate the incidence of postoperative complications, hemostatic effects and safety of Total Thyroidectomy (TT) performed using the Harmonic Scalpel (HS), the Harmonic Focus (HF) or Conventional Hemostasis (CH). METHODS: The meta-analysis was performed according to PRISMA guidelines. A literature search was conducted from 2003 to 2014 and stringent criteria were required for inclusion. Thirteen studies concerning an overall population of 1458 compared HS versus CH, whilst 8 studies with 1667 patients compared HF versus CH. RESULTS: There was a significant reduction of operative time (Mean Difference [MD] = -25.49 min.; 95% CI -32.43 to -18.55), intraoperative blood loss (MD = -30.49 mL; 95% CI -53.01 to -7.97), postoperative drainage volume (MD = -12.90 mL; 95% CI -22.83 to -2.98) and postoperative pain (MD = -0.87; 95% CI -1.27 to -0.46) in patients underwent TT with HS. Regarding HF group, a significant reduction of operative time (MD = -25.99 min., 95% CI -34.56 to -17.41), length of hospital stay (MD = -0.57; 95% CI -0.97 to -0.17), transient hypocalcemia (OR = 0.56; 95% CI 0.39 to 0.81) and postoperative pain (MD = -1.33 days; 95% CI -2.49 to -0.17) resulted. CONCLUSIONS: HS TT can be a safe, useful and fast alternative to conventional TT. The newer HF can reduce the rate of hypocalcemia. Future RCTs of larger patient cohorts with more detailed data of postoperative complications, cost-effectiveness and cosmetic results, randomization procedures, intention-to-treat analyses and blinding of outcome assessors are needed to draw more meaningful conclusions.

Comparative research of the Harmonic Focus? and Ligasure Small Jaw? in open thyroid surgery / 中国癌症杂志

Background and purpose:In recent years, energy-based instruments have been widely used in today’s open surgeries. Harmonic Focus? (HF) and Ligasure Small Jaw? (LSJ) are both custom-made for thyroid open surgery. This study aimed to explore the effcacy and safety of HF and LSJ in open thyroidectomy.Methods:The data from patients who undertook total thyroidectomy with central neck dissection by the same surgeon during last year in this hospital were reviewed. HF was used in 100 patients, and LSJ was used in 104 patients. The effectiveness was appraised by comparing operation time and postoperative volume of drainage on the ifrst postoperative day. The safety was appraised by comparing the incidence of postoperative complications.Results:The results of the effectiveness:the average duration of operation was (95.8±18.0) min for HF group, and (97.8±19.1) min for LSJ group, there was no statistical signiifcance (P=0.363). Postoperative volume of drainage on the ifrst postoperative day was (35.2±20.3) mL for HF group, and (36.3±23.8) mL for LSJ group, there was no statistical signiifcance (P=0.977). One patient (1.0%) had temporary vocal cord paralysis in HF and one had postoperative hematoma (1.0%) in LSJ group. Temporary hypo-parathyroidism was detected in 18 patients (18.0%) of HF group, and 16 patients (15.4%) of LSJ group. The decline of parathyroid hormone during the ifrst postoperative day was (12.3±12.8) pg/mL in HF group, and (13.9±13.4) pg/mL in LSJ group. The decline of serum calcium was (0.20±0.13) mg/dL in HF group, and (0.20±0.16) mg/dL in LSJ group. There were all no statistical signiifcances (P>0.05).Conclusion:Both HF and LSJ are safe and effective in open thy-roidectomy without similar operative complications.

A systematic review and meta-analysis of Harmonic Focus in thyroidectomy compared to conventional techniques.

INTRODUCTION: Several meta-analyses have been performed comparing the use of a variety of ultrasonic devices in thyroidectomy to conventional procedures. These studies have shown the superiority of ultrasonic devices for most outcomes studied including faster operative time and less blood loss, and equivalent or better safety for recurrent laryngeal nerve paresis and hypocalcemia. The current work is the first to examine a single ultrasonic device specifically designed for thyroid surgery, the Harmonic Focus, in order to confirm its efficacy and safety in thyroidectomy. METHODS: A comprehensive literature search without language restrictions was performed for randomized clinical trials comparing Harmonic Focus and conventional clamp, cut and tie in thyroidectomy. Outcome measures included operating time, blood loss, post-operative pain, length of hospital stay, hypocalcemia and recurrent laryngeal nerve paresis. Risk of bias was analyzed for all studies. Meta-analysis was performed using random effects models with the inverse-variance method for mean differences of continuous variables and the Mantel-Haenszel method for risk ratios of dichotomous variables. RESULTS: A total of 14 studies met the inclusion criteria. Harmonic Focus reduced operative time by 29 min, a 31 % decrease (p < 0.001), intra-operative blood loss by 45 ml (p < 0.001), post-operative pain (p < 0.001), length of hospital stay by 0.68 days (p = 0.005), drainage volume by 29 ml (p = 0.01), and occurrence of transient hypocalcemia by 40 % (p = 0.001). There were no significant differences between Harmonic Focus and conventional procedures in rate of persistent hypocalcemia, or rates of transient and persistent recurrent laryngeal nerve paresis. CONCLUSION: This is the first meta-analysis of Harmonic Focus in thyroid surgery. In agreement with meta-analyses previously performed on ultrasonic devices, use of the Harmonic Focus has been shown to be a more effective surgical procedure compared to conventional methods in thyroidectomy. The low occurrence of hypocalcemia and recurrent laryngeal nerve paresis confirms that Harmonic Focus can improve thyroidectomy efficiency without increasing the risk of complications.

Recurrent laryngeal nerve safety parameters of the Harmonic Focus during thyroid surgery: Porcine model using continuous monitoring.

OBJECTIVES/HYPOTHESIS: The Harmonic Focus (HF) is one of the most popular energy-based devices. The aim of this study was to provide recurrent laryngeal nerve (RLN) functional data that define the safety parameters of the HF during thyroidectomy. STUDY DESIGN: Prospective porcine model using continuous electrophysiologic monitoring. METHODS: Ten piglets were used. At varying distances from the RLN, the HF was activated (activation study). The HF was also applied directly on the RLN after activation on sternocleidomastoid muscle for 10 seconds with different cooling times (cooling study). RESULTS: In the activation study, there was no adverse electromyography (EMG) event at more than 1 mm distance. In the cooling study, there was no adverse EMG event after a 10-second cooling period. When the HF was cooled on the sternocleidomastoid muscle, there was no adverse EMG event after 2 seconds cooling time. CONCLUSIONS: The safe distance of the HF was 1 mm, and it should be cooled for more than 10 seconds or 2 seconds after cooling on muscle. The HF should be used in a standardized manner to avoid RLN injury. LEVEL OF EVIDENCE: NA.

The comparison of the harmonic focus shears device with conventional clamp binding in total thyroidectomy.

AIM: Harmonic Focus (HF) is an ultrasonic device developed most recently for thyroid surgery. The aim of this study was to compare the surgical completeness and outcome of total thyroidectomy in two patient groups. One group was treated by HF and one by Conventional Dissection (CD). METHODS: Total thyroidectomy was performed in 38 patients with CD, and in 38 patients with HF. RESULTS: When compared to conventional haemostasis, a reduction was observed in the duration of surgery in the HF group, and the amount of blood loss was reduced by 29%, and 46%, respectively. The number of intraoperative device changes was decreased by 70%. The utilisation of special materials to obtain haemostasis was also significantly decreased. HF was found to be as safe as the conventional haemostasis technique. CONCLUSIONS: Our study has demonstrated the beneficial effects and relative safety of HF in thyroid surgery. Further studies are needed about the financial benefits provided by reductions in human resources, and in materials employed for haemostasis.

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

OBJECTIVES: LigaSure Small Jaw(®) (LSJ) was recently developed and applied to thyroid surgery along with Harmonic Focus(®) (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.

Lessons learned from the first 50 thyroidectomies with Harmonic Focus Curved Shears - technical note.

Precise and safe hemostasis is necessary for successful thyroid surgery. In this respect, the advent of the ultrasonic surgical device Harmonic Focus Curved Shears (HFCS) from Ethicon Endo-Surgery constituted a major progress in the domain by its multiple capabilities of dissection, grasping, vessel sealing and transecting. The paper presents the initial experience of 50 cases with this device of a surgical team with special interest in endocrine surgery, mostly thyroid and parathyroid. The thyroid conditions for which surgery was indicated were: diffuse toxic goiter in 8 patients; multinodular toxic and nontoxic goiter in 30 patients; autonomous nodule in 2 patients; 2 patients with benign nodules at fine needle aspiration biopsy (FNAB); 4 patients with nodules positive for carcinoma at FNAB, among them 2 with unilateral cervical lymph nodes enlargement; 4 patients with highly suspect nodule on FNAB. The types of surgery performed were 4 hemithyroidectomies and 46 total thyroidectomies, 2 in association with unilateral functional neck dissections. We had 4 intraoperative hemorrhagic incidents, all in the first 15 cases and imputable to lack of expertise and improper usage of the device. We registered the following noticeable postoperative complications: 1 cervical hematoma from an arteriolar source in sternothyroid muscle demanding prompt reintervention; 8 hypocalcemias and 2 vocal cord paresis, none of which permanent. We remarked several advantages with HFCS: no necessity of changing instruments, fluentness of the intervention and more comfort for the operating team, reduced operating time, safe hemostasis. Some important tips and tricks with the usage of the instrument are presented.

Total thyroidectomy for non-toxic multinodular goiter with versus without the use of harmonic FOCUS dissecting shears - a prospective randomized study.

INTRODUCTION: Thyroidectomy is among the most commonly performed procedures involving the endocrine glands and the development of advanced surgical methods combined with a strife for performing the operation in a manner that is minimally invasive for the patient has considerably increased the need for instruments that would limit surgical trauma. AIM: To compare of the outcomes of total thyroidectomy operations with and without the use of ultrasonic harmonic FOCUS dissecting shears. MATERIAL AND METHODS: Eighty-two patients with a bilateral, non-toxic multinodular goiter were randomized to two groups of 41 patients each. Total thyroidectomy was performed in each patient. In the clip-ligation group (CL-G), during thyroidectomy, the superior thyroid vessels were clipped and bipolar coagulation was used to secure smaller vessels, whereas in the harmonic FOCUS group (HF-G), a harmonic device was used to dissect and divide all the thyroid vessels. The statistical analysis included the mean operative time, blood loss, postoperative morbidity and cost-effectiveness. RESULTS: HF-G vs. CL-G operations were shorter (45.4 ±8.7 min vs. 64.5 ±14.2 min; p < 0.001), characterized by a lower mean blood loss (29.9 ±9.8 ml vs. 56.8 ±11.0 ml; p < 0.001) and appeared to be more cost-effective (666.2 ±37.5 EUR vs. 718.0 ±69.2 EUR; p < 0.01). No major complications were observed in both groups. CONCLUSIONS: In total thyroidectomy operations, the harmonic FOCUS is safe and facilitates dissection, allowing for a significant decrease in operative time. Other benefits include lower blood loss and a slightly decreased cost of the procedure.