Efficacy and safety of ultrasonically activated shears in thyroid surgery

BACKGROUND: The purpose of this prospective study is to evaluate the efficacy of ultrasonically activated shears (UAS) in hemostasis as well as its safety in regard to complications in thyroid surgery. METHODS: Three hundred patients who had undergone surgery on the thyroid gland were divided into 2 groups of 150 patients each. Hemostasis as well as division of blood vessels and thyroid tissue were performed with the use of UAS in the first group and by conventional ligations in the second group. RESULTS: The use of UAS resulted in as much as a 39.7% reduction in the operative time of the total thyroidectomy and a 30.8% reduction of the lobectomy (p < .001). However, there was no important difference in the postoperative blood loss in either the temporary hypoparathyroidism or the paresis of recurrent laryngeal nerves. CONCLUSIONS: The use of UAS in thyroid surgery is a safe method for hemostasis, as well as for the division of blood vessels and thyroid tissue. It leads to the reduction of the total operative time without serious complications.     

Hepatectomy using the coagulating shears type of ultrasonically activated scalpel.

Since the ultrasonically activated scalpel (UAS) incorporates multiple functions, we have used it for hepatectomies. The present study discusses the noteworthy points and problems of use, and shows initial results. Intraoperative ultrasonography is an important tool for comprehending the positional relationship between the plane of division and the main blood vessels. It allows initial adjustment of coagulation and cutting effects according to the rigidity of the liver parenchyma by means of variable ultrasound levels and exchangeable blade tips, and offers good visibility of the cut surface in deep sites as long as adequate tension on the tissue and an upper position for the blade are maintained. 30 patients underwent hepatectomies using the UAS. The amount of blood loss for lobectomy was significantly less than that for partial lobectomy in normal livers in addition to a significant difference between normal and damaged livers in each group according to the extent of resection. There were no serious complications seen in all cases during the operation. The incidence of positive bile leakage was high. It is recommended that bile leakage testing be carried out as thoroughly as possible. There were 3 postoperative bile fistulas and 1 postoperative hemorrhage. In conclusion, although a dramatic improvement in blood loss and shortened operating time could not be obtained in all procedures, the safety and usefulness were demonstrated in lobectomy. The UAS can be considered as a surgical device that can contribute to the efficiency of hepatectomy, depending on the indications selected.     

Use of ultrasonically activated shears improves the safety of pancreaticojejunostomy after pancreaticoduodenectomy

OBJECTIVE: To study whether the use of ultrasonically activated shears (UAS) would improve the safety of pancreatojejunal anastomosis after pancreaticoduodenectomy. DESIGN: Retrospective analysis. SETTING: University teaching hospital. PATIENTS: Seventy patients underwent pancreaticoduodenectomy between April 1997 and May 2001. MAIN OUTCOME MEASURES: Leakage of pancreatojejunal anastomosis as judged from the contents of the drain within 7 days after operation, and defined as a high amylase level of discharge that was 3 times higher than that of serum. RESULTS: Leakage of pancreatojejunal anastomosis was observed in 1 (1.4%) of the 70 cases. Other complications were stomal ulcer, bile leakage, renal failure, and intra-abdominal abscess in one case each. CONCLUSIONS: Use of UAS to perform pancreatectomy eliminates bleeding and pancreatic juice leakage from the branches of the pancreatic duct. Therefore, the cut surface of the pancreas is kept dry, simplifying anastomosis. Use of UAS improves the safety of pancreatojejunal anastomosis after pancreaticoduodenectomy.     

New-model ultrasonically activated shears for hemostatic sectioning during video-assisted thoracic surgery

During video-assisted-thoracic surgery (VATS), bleeding limits the field of view and requires frequent exchange of surgical instruments through ports, complicating the surgical procedure. The poor video view also increases the risk of vessel injury. Attention must be paid to hemostasis to achieve safe, smooth VATS. The Harmonic Scalpel (HS) is able to grasp and divide tissues while sealing small vessels, which often cause bleeding during electrocautery, and lymphatic vessels. We obtained experience using a new model of HS, which appears effective for separating membranous or streak adhesions, cutting pulmonary parenchyma, and dividing lymphatic tissues. Compared to previous models, it allows superior handling during VATS. Tissue holding with this HS is greatly improved.     

超声刀结合保留背膜解剖法在甲状腺切除术中的应用

目的:探讨超声刀结合保留背膜解剖法在甲状腺腺叶全切除手术中的操作技巧,及对喉返神经与甲状旁腺的保护效果。方法:对2009年2月至2012年3月144例甲状腺腺叶切除术均采用保留背膜解剖法,其中超声刀应用组72例与传统组72例的临床资料进行回顾性分析,通过手术时间、术中出血量、术后引流量、术后并发症等临床资料进行统计学分析。结果:应用超声刀结合保留背膜解剖法在甲状腺切除术中最大限度地原位保留了甲状旁腺,实现其功能的保留,喉返神经显露率达99%。同时超声刀的应用对术中出血量、手术时间均优于传统手术组,对术后并发症增加无统计学差异。结论:超声刀结合保留背膜解剖法在甲状腺腺叶全切除术中的应用能最大限度保留甲状旁腺功能,降低喉返神经、甲状旁腺损伤率;同时减少了出血量,缩短了手术时间。     

The role of the ultrasonically activated shears and vascular cutting stapler in hepatic resection

Hemorrhage and liver failure are the two greatest concerns for patients undergoing major liver resection. Inflow occlusion (Pringle maneuver) is often used to minimize blood loss, but hepatic ischemia results in an increased risk of postoperative hepatic dysfunction. We report our experience with the Harmonic Scalpel ultrasonically activated shears (UAS; Ethicon Endo-Surgery, Cincinnati, OH) and a vascular stapler for hepatic resection as technological advances that aid in minimizing blood loss and thereby reduce the need for inflow occlusion. We retrospectively reviewed liver resections performed from September 1997 through July 1998, in which the UAS and articulating vascular endoscopic linear cutting stapler were used. The vascular stapler was used to divide the appropriate portal vein branch and hepatic vein(s) before parenchymal transection. Parenchymal dissection was performed with UAS to a depth of approximately 2 to 3 cm, and the remainder of the liver parenchyma was divided by a clamp crush and clip and suture ligate technique. Patients underwent segmental resection (n = 12), lobectomy (n = 13), or extended lobectomy (n = 11). Resection was performed for metastatic disease, primary liver tumors, or benign disease in 21, 8, and 7 patients, respectively. A Pringle maneuver was performed in 7 of 36 patients (mean clamp time, 8 minutes). The median required intraoperative blood transfusion was 0 units of packed red blood cells. Major and minor complications occurred in 12 and 3 patients, respectively. Two deaths were related to pneumonia and abdominal infection. The vascular stapler safely and securely divides portal vein branches and hepatic veins. The UAS initiates parenchymal transection with minimal blood loss. These two technologies facilitate the surgeon's aim of liver resection without blood transfusion or Pringle maneuver.     

Laparoscopic lymph node dissection using ultrasonically activated shears: comparison with electrosurgery

PURPOSE: To assess and compare perioperative parameters in two groups of patients treated by different laparoscopic techniques of lymph node dissection (LND) for gynecologic cancer. PATIENTS AND METHODS: Between April 1996 and March 2001, 59 consecutive women with microinvasive cervical cancer (N = 5) or clinical stage I endometrial cancer (N = 54) underwent laparoscopic LND during a primary staging procedure using an electrosurgery (ELC) or ultrasonic (US) operative technique. The two groups were compared for perioperative outcomes. Differences between the two groups were determined by the Wilcoxon's rank-sum test. RESULTS: Laparoscopic LND and other staging procedures were completed successfully in 58 women (98.3%). There were no statistically significant differences between the groups with regard to perioperative outcomes (operation time, time for LND, blood loss, hospital stay, complications), but there was a significant difference (P = 0.0008) in the number of lymph nodes harvested: a mean of 13.7 in the ELC group and 17.5 in the US group. The pathologists found that the reading of histology slides was easier after US dissections because of the greater depth of thermal injury in the lymphatic tissue in ELC group. CONCLUSION: The US operative technique ensures efficient coagulation, cutting, dissection, and grasping for laparoscopic LND in patients with cervical and endometrial cancer.     

Usefulness of ultrasonically activated scalpel for pulmonary resection in video-assisted thoracoscopic surgery

We evaluated the reliability and efficacy of the ultrasonically activated scalpel (Harmonic Scalpel) for pulmonary resection in video-assisted thoracoscopic surgery (VATS). Fifty-six cases of primary or metastatic lung cancer with history of lobectomy or segmentectomy from July 2003 to June 2006 were investigated. The ultrasonically activated scalpel was used to separate aborted lobulation and segment in the surgery. The outcome of the operation using the ultrasonically activated scalpel revealed the mean operation time of 224.5 minutes and mean blood loss volume of 116.7 ml. The chest drainage catheter was removed at the postoperative day 3.4 and hospitalization lasted 10.4 days on average. By means of statistical analysis, no significant differences were noted when compared with the cases using surgical stapler to separate the lobules or segments of the lungs. Histopathological results showed destruction of alveolar structures and denaturation of cells at the cut surface of the resected lung through the use of the ultrasonically activated scalpel. This method resulted in good lung expansion and preservation of the residual lung volume. Furthermore, it prevented postoperative air leakage by appropriate treatment to the cut surfaces of the residual lung. Indeed, the method appears to be useful in the separation of lung tissues in severe aborted lobulation and segmentectomy by VATS.     

Randomized clinical trial on Harmonic Focus shears versus clamp-and-tie technique for total thyroidectomy

Background

The Harmonic Focus is the last ultrasonic device designed for thyroid surgery. The aim is to assess its efficacy and safety compared with traditional dissection in a prospective randomized trial of total thyroidectomy procedures.

Methods

Total thyroidectomy was performed in 34 patients using the Harmonic Focus, and in 34 patients using the clamp-and-tie technique.

Results

In the Harmonic Focus group, relative reductions of 29% and 46% were observed in surgical time and blood loss, respectively. The number of intraoperative instrument exchanges also decreased by 70%, and use of specific materials required to achieve hemostasis decreased significantly. Safety was found to be similar in both patient groups.

Conclusions

Our study showed beneficial effects of Harmonic Focus use in thyroid surgery. Further studies therefore are needed to evaluate cost in the light of savings made in surgical time, materials needed for hemostasis, and human resources.     

Hemostasis with the ultrasonically activated scalpel

In patients with implanted pacemaker/cardioverter defibrillator (ICD), the use of electrocautery can lead to serious pacemaker dysfunction. The ultrasonically activated scalpel, however, which has been introduced mainly for the use in laparoscopic surgery, could potentially avoid the outlined problem, since no electrical current flows while in use. This hypothesis was tested in a pacemaker patient undergoing laparoscopic cholecystectomy. During the procedure, no abnormal rhythms or ECG interferences were detected while working in close vicinity to the device. Thus, the ultrasonically activated scalpel provides adequate hemostasis and does not bear the risk of pacemaker dysfunction. Received: 12 January 1999/Accepted: 20 January 1999     

应用高频超声刀实施小切口无气腔室内镜下甲状腺手术

目的探讨小切口无气腔室内镜下甲状腺手术的血管离断和出、渗血控制的新方法。方法以Miccoli术式为基本框架,选择高频超声刀作为基本器械,辅以少数其他器械,双械配合操作,对170例初诊为结节性甲状腺肿,甲状腺瘤和Graves病患者行此种内镜下手术。术中按自行设计的顺序式游离-凝闭一切断方法直接离断各较粗动、静脉分、属支;按预凝闭和切一吸-凝一分交替配合方法综合控制腺体分离过程中内断面出血。对这2种方法的安全性和有效性进行观察。结果170例患者除2例因术中冰冻报告为癌中转开放手术外,其余手术均顺利完成,无一例因术中出血失控或术后创口内出血再改为开放手术。按顺序式游离-凝闭-切断方法操作,可以用高频超声刀直接离断较粗大的甲状腺动、静脉血管分、属支,而不必结扎或用血管夹处理血管断端。切开前先用超声刀对切口附近血管及局部被膜血管网做适当的凝闭处理,可以显著减少切开分离时的出血量。结论高频超声刀是一种适用于内镜下甲状腺手术的新型外科工具,不仅能显著提高手术安全性,而且可以大幅降低操作难度。     

超声刀在乳腺癌全乳切除和腋窝淋巴结解剖术中的应用

目的研究超声刀在乳腺癌全乳切除和腋窝淋巴结解剖术中的应用效果。方法回顾性分析177例乳腺癌全乳切除和腋窝淋巴结解剖术患者的临床资料,其中91例联合使用超声刀与电刀,86例单用电刀,比较两组手术时间、术中出血量、术后引流情况、引流管放置时间、以及并发症的发生率。结果超声刀／电刀联合组手术时间、术中出血量、术后24h引流量、引流管放置时间均明显优于单用电刀组（P〈0．05）;而术后皮下积液的发生率两组差异无统计学意义（P〉0．05）。结论在乳腺癌全乳切除和腋窝淋巴结解剖术中超声刀／电刀联合应用比单用电刀有明显的优势。     

Development of an ultrasonically activated trocar system

BACKGROUND: Although rare, visceral and vascular injuries related to the insertion of conventional laparoscopic trocars may have disastrous consequences. Most of these injuries are due to the high puncture force applied to the trocar. We present the results of an animal laboratory evaluation of a newly developed ultrasonically activated trocar. METHODS: A total of 40 punctures were made in four pigs with an average weight of 53 kg. An 11-mmHg pneumoperitoneum was created through a Veress needle. A 10-mm diameter trocar was inserted in the midline for a laparoscope. A series of five trocars were then inserted on each lateral wall under laparoscopic control. Twenty punctures were made with a conventional reusable 11-mm trocar (CT) whose tip was sharp and conical. Twenty punctures were made with an 11-mm ultrasonically activated trocar (UT), whose fequency was 23.5 KHz and amplitude 150 mm. The cutaneous incision was made large enough so that the skin did not interfere with the trocar insertion. The force applied to the trocar was measured with a push-pull gauge connected to a computer. The following data were recorded: maximal force applied to the trocar to obtain insertion of the tip through the abdominal wall, maximum abdominal pressure increase during trocar insertion, and time for abdominal penetration. RESULTS: The average time needed for trocar penetration was 12.8 s with CT and 4.5 s with UT (p < 0.001). The average maximal force was 6.8 kgF with CT and 0.4 kgF with UT (p < 0.001). The average abdominal pressure increase was 7.6 mmHg with CT and 0.8 mmHg with UT (p < 0.001). At 30 days, no necrosis was found. Pathological findings were similar in both groups. CONCLUSION: Ultrasonically activated trocars required less time and much less force to be inserted. This may be a breakthrough in the safety of trocar insertion.     

LigaSure in total thyroidectomy

PURPOSE: LigaSure is a bipolar diathermy system, which achieves vessel sealing with reduced thermal spread. The device has been used successfully in abdominal operations and because of its features, it has been applied recently in thyroid surgery to minimize the risk of complications such as laryngeal nerve palsy and hypocalcemia, and also to reduce the operating time. METHODS: Between June and December 2005, we performed total thyroidectomy for various disorders in 105 patients. We used the LigaSure diathermy system in 53 patients and traditional hemostatic procedures in the other 52. We evaluated the demographic features, histopathological diagnosis, operating times, and relevant postoperative complications. RESULTS: The two study groups had similar demographic and histopathological features. The mean operating time +/- SD was not significantly shorter in the LigaSure group than in the traditional group (104 +/- 12.7 vs 110 +/- 15.6 min). None of the patients in either group suffered hemorrhage, definitive hypocalcemia, or definitive laryngeal nerve palsy. Transient hypocalcemia and transient laryngeal nerve palsy developed in 7.54% and in 1.88%, respectively, of the patients in the LigaSure group, and in 7.69% and 1.92%, respectively, of the patients in the traditional group; these differences were not significant. CONCLUSIONS: LigaSure is a safe and effective method of hemostasis control, but it did not reduce the incidence of complications or operating times compared with traditional hemostatic procedures; moreover, the operative costs were higher.     

Video-assisted total thyroidectomy

During the last few years, video-assisted neck surgery (VANS) became one option for thyroid and parathyroid surgery. Reports on VANS were limited to partial resection of the thyroid gland. In this study, we described total thyroidectomy in a patient with Graves' disease. The patient had a thyrotoxic periodic paralysis and methimazole-induced hepatic toxicity as well as hepatitis B virus. Two incisions of 3.5 and 3 cm were placed in the right and left subclavicular regions, respectively. A third incision of 0.5 cm was made just to the right of the midline for the camera. Devascularization of the thyroid gland was performed by using ultrasonically activated shear. Tubal drains were inserted on both sides. The patient suffered from temporary postoperative hoarseness with the voice but had a normal calcium level. The drains were removed on the first postoperative day. The use of VANS may provide a new method for total thyroidectomy with a better cosmetic outcome.     

Ultrasonically activated shears in thyroidectomies: a randomized trial

OBJECTIVE: To test whether the advantages of the ultrasonically activated shears (UAS) observed in thyroidectomies in a previous matched-pair study could be repeated in a randomized trial. SUMMARY BACKGROUND DATA: The UAS has been documented, mainly in nonrandomized studies, to be a safe and fast device in video-assisted and conventional surgery. METHODS: Thyroidectomies and lobectomies performed for benign or malignant thyroid disease between August 1997 and January 1999 were included in this series. Separate randomization, resulting in four sets of envelopes, was done for one consultant endocrine surgeon and for senior residents for both lobectomies and for total thyroidectomies. The operations performed with the UAS were compared with operations performed with the conventional method, using ligatures as the main hemostatic method. Main outcome measures were operating time, postoperative serum calcium level, palsy of the recurrent laryngeal nerve, and amount of intraoperative and postoperative bleeding. Possible bias that could have been caused by imbalance between treatment groups for surgeon experience was tested by two-way analysis of covariance. RESULTS: Thirty-six patients were randomized, 19 to the UAS and 17 to the conventional group. Mean operating time was 99.1 minutes in the UAS group and 134.9 minutes in the conventional group. The average savings in operating time with the UAS was thus 35.8 minutes. There was no difference in complications between the groups. The estimated savings in operating time would have been 1.66 times that observed in this study if the groups had been unbalanced with reference to surgeon experience. CONCLUSION: The UAS is a usable device in total thyroidectomies and lobectomies.     

Nearly total thyroidectomy: versus total thyroidectomy: our experience

AIM: Generally, the classification of thyroidectomy as benign pathology is: multinodular toxic goitre, simple goitre, toxic adenoma, Base-dow disease, Hashimoto's tyroiditis Subtotal thyroidectomy provides for the removal of the gland except for a bilateral residue of about 6-10 g, near total thyroidectomy provides for the near total removal of the gland except for a residue inferior to 5 grams. Near total thyroidectomy has taken the place of the subtotal thyroidectomy. METHODS: In two years, in our institute, there have been exeuted: 96 near total thyrodectomies, 96 total thyroidetomies, 8 lobectomies ad two revues for recurrencies. RESULTS: In 2 cases there have been haemorrhagies after nearly total thyroidetomy. Only in 1 case we practiced tracheotomy for follicular carcinoma infiltering thiroidic cartilage. In 2 cases treated with nearly total thyroidetomy and in 4 cases treated with total thyroidetomy, there has been temporary hypoparathyroidism. In no case treared wih nearly total thyroidetomy and in 2 cases treated with total thyroidetomy, there has been permanent hypo-parathyroidism. In 5 cases treated with total thyroidetomy and in no case treated with nearly total thyroidetomy, there has been, monolateral, temporary paralysis of the inferior laryngeal nerve that solved in 6 months for 3 patients and in 2 months for 2 patients. CONCLUSIONS: There has not been permanent paralysis of the mono or bilateral inferior laryngeal nerve. Even if the surgical approach to the benign disease is now orientated to the total thyroidectomy, a more conservative surgery is, in our opinion, justified when a malignant pathology is excluded and considering also the low effect of recurrencies and hypothyroidism.     

Safety of total thyroidectomy

BACKGROUND: Total thyroidectomy is the preferred operation for multinodular goitre, Graves' disease and thyroid cancer. This study reviewed prospectively collected data on a personal consecutive series of 336 total thyroidectomies to assess whether results reported in world centres of excellence could also be achieved elsewhere. METHODS: Between 1991 and 2004, 336 total thyroidectomies (85% over the last 6 years) of median age 53 years (13-86 years) and male : female ratio of 1:4.3 were undertaken for multinodular goitre 232 (69%), Graves' disease 26 (7.7%), thyroid cancer 60 (17.9%) and other benign conditions 17 (5.4%). Thirty-nine patients had 2-stage procedures. No patient required median sternotomy. Parathyroid autotransplantation was carried out in 43 (12.8%). RESULTS: Permanent unilateral recurrent laryngeal nerve palsy occurred in 0.3% and permanent hypoparathyroidism in 1.8%. Significant temporary hypocalcaemia occurred in 13.4%. Non-significant temporary hypocalcaemia occurred in 23.8%, resulting in an overall rate of hypocalcaemia of 38.9% for the total series. Hypocalcaemia was more common after 1-stage compared with 2-stage surgeries (P < 0.001). Temporary hypocalcaemia was commoner after surgery for Graves' disease than surgery for other conditions. The rate of postoperative haemorrhage was 0.9% and wound infection, 1.5%. There was no postoperative mortality. CONCLUSION: Total thyroidectomy removes the disease process completely, lowers local recurrence rates and avoids the substantial risks of reoperative surgery. Total thyroidectomy is safe and can be carried out with low complication rates that are equal to world centres of excellence.