Original Paper Eur Surg Res 2009;43:235–240 DOI: 10.1159/000226219 Received: October 1, 2008 Accepted after revision: April 1, 2009 Published online: June 26, 2009 How to Prevent Lateral Thermal Damage to Tissue Using the Harmonic Scalpel: Experimental Study on Pig Small Intestine and Abdominal Wall Z. Pogorelić a Z. Perko b N. Družijanić b S. Tomić c I. Mrklić c a Departments of Pediatric Surgery, b Surgery and c Pathology, Split University Hospital and Split University School of Medicine, Split, Croatia Key Words Harmonic scalpel ⴢ UltraCision ⴢ Thermal injury ⴢ Pig Abstract Introduction: When using a harmonic scalpel, the lower amount of energy that is transduced to the tissue reduces the chance of lateral thermal damage. Methods: Pigs (weight: 40 kg) were used as the experimental model. After anesthesia, tissue was coagulated using different application regimens for each group. The width of tissue necrosis was measured from the point of incision by the harmonic scalpel. Results: The pig abdominal tissues suffered mean thermal damage of 0.0825 (output power 3) and 0.2969 mm (output power 5) when used for 5 s; at 10 s these values were 0.3850 and 0.4793 mm, respectively. In a third experimental condition, with 10 s of application broken down into 2 parts of 5 s with a 5-second pause in-between, these values were 0.1876 and 0.2013 mm, respectively. The small intestine tissues suffered mean thermal damage of 0.1302 (output power 3) and 0.1771 mm (output power 5) at a duration of 5 s. After 10 s of application, these values changed to 0.2655 (output power 3) and 0.2983 mm (output power 5). In the third condition (activity for 5 s, pause for 5 s, activity for 5 s), they were 0.2011 and 0.2258 mm, respectively. Conclusion: Coagulation necrosis is bigger if the usage is continuous rather than if it is disconnected/reconnected. Copyright © 2009 S. Karger AG, Basel © 2009 S. Karger AG, Basel 0014–312X/09/0432–0235$26.00/0 Fax +41 61 306 12 34 E-Mail [email protected] www.karger.com Accessible online at: www.karger.com/esr Introduction In laparoscopic surgery, it is essential to maintain an operation field with minimal bleeding. High-power ultrasonic dissection systems for cutting and coagulating tissues have been introduced in both open and endoscopic surgery. Use of the harmonic scalpel for tissue cutting and hemostasis is a potential alternative to high-frequency current techniques, which can be associated with thermal tissue injuries [1–3]. It is generally assumed that ultrasonic dissection systems disperse less energy to surrounding tissue during activation, and have a reduced propensity to cause collateral or proximity thermal damage [2, 3]. The harmonic scalpel incorporates piezoelectric transducers that induce a vibration frequency at the functional tip. The generated vibration frequency is between 23.5 and 55 kHz, and the movement of the working part is between 25 and 200 m. At this level, the ultrasonic energy can cut and coagulate, especially when the functional end consists of shears where the tissue is compressed between the sharp and blunt blades [4]. The harmonic scalpel transduces a lower amount of energy to the tissue than high-frequency current or laser techniques, resulting in reduced lateral thermal damage and penetration depth due to lower temperatures (50– 100 ° C) [5]. With the use of high-frequency current techniques, potentially toxic and carcinogenic quantities of Zenon Pogorelić, MD, PhD Department of Pediatric Surgery, Split University Hospital Spinčićeva 1 HR–21 000 Split (Croatia) Tel. +385 2155 6182, Fax +385 2155 6225, E-Mail [email protected] Table 1. Protocol of the experiment and descriptive statistics values for all groups (surface area of thermal tis- sue damage) Group Level Duration, s Mean value, mm Minimum value, mm Maximum value, mm Standard deviation, mm Abdominal wall 1 3 2 3 4 5 5 6 5 10 5–(5)–5 5 10 5–(5)–5 0.0825 0.3850 0.1876 0.2969 0.4793 0.2013 0.0520 0.2660 0.1140 0.1580 0.2950 0.1240 0.1440 0.4980 0.3070 0.4360 0.6170 0.4430 0.0234 0.0590 0.0652 0.0848 0.1047 0.0810 Small intestine 7 3 8 9 10 5 11 12 5 10 5–(5)–5 5 10 5–(5)–5 0.1302 0.2655 0.2011 0.1771 0.2983 0.2258 0.0910 0.1830 0.1160 0.1330 0.2240 0.1230 0.1730 0.3610 0.3040 0.1771 0.2983 0.2258 0.0238 0.0533 0.0447 0.0198 0.0689 0.0373 CS-14C coagulation shears were used for all groups. smoke and dust particles are released within a confined space. Use of the harmonic scalpel significantly reduces these emissions, although this instrument does cause the formation of bioaerosols or very small particles in the air that can be breathed in. Furthermore, bioaerosols can sustain biologic activity. They can contain live organisms or cells posing as potentially contaminated material [5–7]. The harmonic scalpel is used in many different operations, including cholecystectomy [2, 5, 8], appendectomy [2, 9], fenestration of abdominal cysts [2, 10], reflux esophagitis procedures [11], large bowel operations [12– 14], stomach resection [15–17], liver resection [18], splenectomy [19], and fenestration of non-parasitic spleen and liver cysts [20–22]. Recently, the harmonic scalpel has been used in transanal endoscopic microsurgery [23– 25], endoscopic inguinal and abdominal wall hernia operations [2, 26, 27], and hemorrhoidectomy [28]. The harmonic scalpel is used in head and neck surgery [29] and gynecology [30], except for abdominal surgery. Recent studies have shown the possibility of tissue exposition at higher temperatures and the dependence of lateral thermal damage on instrument application time and output energy [3, 4]. However, exactly how we should use the harmonic scalpel to achieve ideal tissue cutting and hemostasis while minimizing thermal damage is currently unknown. The aim of this study was to determine the effects of different harmonic scalpel application times and 236 Eur Surg Res 2009;43:235–240 levels of output energy on the different tissues. We used an experimental model of the pig small intestine and fibromuscular layer at the abdominal wall. Materials and Methods The high-energy ultrasonic dissection system used was UltraCision (Ethicon Endosurgery, Cincinnati, Ohio, USA), which consists of a high-frequency vibration generator, a foot switch (or adapter for hand activation), and a hand piece with cable and various instruments for open and laparoscopic operations. In this experiment, we used the generator 300 at outputs level 3 and 5, a hand piece, and flat short coagulation shears CS-14C. We used 40-kg pigs as the experimental model. One day before the experiment, the animals were brought into the laboratory for experimental surgery. For 8 h before the experiment, the animals were not given any food or water. The animals were anesthetized using the following sedation, relaxation, and narcosis regimen: ketamine (Ketanest 10%, 20 mg/kg intramuscularly), xylazine (Xylazin 2%, 2 mg/kg intramuscularly), atropine sulfate (1%, 3 ml/animal), and propofol (Disoprivan 1%, 2–5 ml/animal). Endotracheal anesthesia was induced with isoflurane (1–1.5 vol%), nitrous oxide (max. 75 vol%), and oxygen (25 vol%). After anesthesia, the animals were fixed to an operative table, and a laparotomy was performed. Using CS-14C coagulation shears, we coagulated the muscular part of the abdominal wall without skin or small intestine using different application regimens for each group. Depending on experimental group, the application time was 5 s, 10 s, or 5 s followed by 5 s of inactivity and another 5 s of application. The level of output energy was set at 3 or 5 depending on experimental group (table 1). Ten individual Pogorelić /Perko /Družijanić /Tomić / Mrklić Fig. 1. Histologic specimen illustrating lateral thermal damage of the pig abdominal wall. HE. !200. The black line represents the lateral damage measured by the pathologist using a computer around the instrument’s jaw. Fig. 2. Histologic specimen illustrating lateral thermal damage of the pig small intestine. HE. !40. The black line represents the lateral damage measured by the pathologist using a computer around the instrument’s jaw. lesions were performed for each experimental group using the harmonic scalpel. The lesions were performed by compressing tissue (muscular part of the abdominal wall or whole intestinal wall) in the instrument’s jaw. After the experiment, the animals were euthanized with 7.4% solution of KCl. The parts of abdominal wall and small intestine were removed and fixed in 4% buffered formalin for 24 h. The preparations were dehydrated in growing concentrations of alcohol, clarified in xylol, and embedded in paraffin. The paraffin blocks were cut in 5-m slides and stained with HE. We could clearly see the width of lateral thermal damage from the point of harmonic scalpel application to the margins of unchanged nearby tissue (fig. 1, 2). Using an Olympus BX41 light microscope and morphometric computer imaging analysis (Soft Imaging System, Münster, Germany), the width of the lateral thermal damage was measured at the application area. The data was analyzed using Student’s t test and Excel for Windows 11.0 (Microsoft, Redmond, Wash., USA) and Statistica for Windows 12.0 (Statsoft, Tulsa, Okla., USA). To perform this experiment, we obtained the approval of the Ethical Committee of Split University Hospital. Table 2. Comparison between groups Compared groups Tissue damage (group 1) mm Tissue damage (group 2) mm t (Student’s) 1:2 1:3 2:3 4:5 4:6 5:6 7:8 7:9 8:9 10:11 10:12 11:12 0.0825 0.0825 0.3850 0.2969 0.2969 0.4793 0.1302 0.1302 0.2655 0.1771 0.1771 0.2983 0.3850 0.1876 0.1876 0.4793 0.2013 0.2013 0.2655 0.2011 0.2011 0.2983 0.2258 0.2258 –21.286 –73.874 9.74 –7.715 4.516 10.211 –11.675 4.365 –7.178 –7.724 3.685 –5.076 p <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 <0.001 0.002 Tissue damage presented as mean values. See table 1 for detailed description of treatment received by the groups. Results The levels of lateral thermal damage to the pig abdominal wall and small intestine tissues are presented in tables 1 and 2. Abdominal Wall At output level 3, the abdominal wall sustained thermal damage over a mean width of 0.0852 8 0.0234 mm Preventing Lateral Thermal Damage Using the Harmonic Scalpel for group 1, as compared with 0.3850 8 0.0590 mm for group 2. On the other hand, the application regimen of 5 s with 5 s of inactivity and another 5 s of activity (group 3) resulted in a mean thermal damage width of 0.1876 8 0.0652 mm. The difference in thermal damage between all the individual experimental groups (1:2, 2:3, 1:3) was statistically significant (p ! 0.001). At output levEur Surg Res 2009;43:235–240 237 el 5, we found more thermal damage, which was expected (group 4: 0.2969 8 0.0848 mm vs. group 5: 0.4793 8 0.1047 mm). Like at output level 3, in group 6 (the application regimen of 5 s with 5 s of inactivity and another 5 s of activity) we found a mean thermal damage width of 0.2013 8 0.0810 mm. The difference in thermal damage between all the individual experimental groups (4:5, 5:6, 4:6) was statistically significant (p ! 0,001; table 2). Figure 1 shows how the damaged tissue of the abdominal wall was measured. Small Intestine At output level 3, the small intestine sustained thermal damage over a mean width of 0.1302 8 0.0238 mm for group 7, as compared with 0.2655 8 0.0533 mm for group 8. On the other hand, the application regimen of 5 s with 5 s of inactivity and another 5 s of activity (group 9) resulted in a mean thermal damage width of 0.2011 8 0.0447 mm. The difference in thermal damage between all the individual experimental groups (7:8, 8:9, 7:9) was statistically significant (p ! 0.001). At output level 5, as expected, we found greater thermal damage in group 11 (group 10: 0.1771 8 0.0198 mm vs. group 11: 0.2983 8 0.0689 mm). Like at output level 3, in group 12 (5 s activity, 5 s inactivity, 5 s activity) we found a mean thermal damage width of 0.2258 8 0.0373 mm. The difference in thermal damage between all the individual experimental groups (10:11, 11:12, 10:12) was statistically significant (table 2). Figure 2 shows how the small intestine damaged tissue was measured. Discussion The development of dissecting systems based on highpower ultrasonic energy, especially for laparoscopic surgery, was instigated by the need for an alternative to highfrequency monopolar electrosurgery and to enable the use of multifunctional instruments (e.g. shears that can be used for mechanical dissection as well as energized cutting and coagulation). The perception has been that these high-power ultrasonic systems would improve the efficiency of laparoscopic dissections and at the same time reduce the morbidity from collateral/proximity iatrogenic injuries, well-documented with high-frequency electro surgery [3, 4, 31, 32]. In addition, ultrasonic systems abolish smoke production, which, aside from obscuring the view, contains highly toxic and mutagenic polycyclic hydrocarbons produced by the high-temperature pyrolysis of fat and protein [6]. 238 Eur Surg Res 2009;43:235–240 When using the harmonic scalpel, a lower amount of energy is transduced to the tissue than when a high-frequency current or laser is used, and there is less possibility of lateral thermal damage or deep penetration because lower temperatures are generated (only 50–100 ° C) [5]. Use of the harmonic scalpel has the additional benefit of not passing any electrical energy through the body. Lateral thermal damage is reduced because less energy is transduced to the tissue, and this is the basis for the potentially lower surgical stress associated with use of the harmonic scalpel [3, 4]. Recent studies have explained the phenomenon of tissue expansion at higher temperatures, and the manner in which lateral thermal damage can depend on instrument application time and output energy [3, 4]. High-power ultrasonic dissection may result in considerable heat production and collateral tissue damage, especially when the activation time exceeds 10 s. In these cases, studies on rabbits have shown a lasting fibroblastic reaction and delayed healing process [4, 31]. Regarding the rare occurrence of complications that arise from overheating the working part of the instrument, a lower activation level will help avoid these [33, 34]. One reported in vivo study on pigs demonstrated proximity injury detected by histological examination to important structures, such as the bile duct, aorta, and inferior vena cava, during high-power ultrasonic dissection [35]. In certain structures, the extent of the damage was marked: up to 80% of the thickness of the bile duct was coagulated in most areas, and there was 30% transmural necrosis/injury to the ureter, aorta, and inferior vena cava. Of even greater concern was the observation that this damage was not macroscopically apparent at the time of surgery, but was apparent only on histologic examination of the structures harvested at the time of sacrifice of the animals. This study, however, did not give information on the power level (excursion of the vibrating tip) and the activation time used. These 2 variables determine the extent of frictional heat production. Other reported in vivo studies in pigs analyzed extreme and equivalent temperature gradients that were generated by ultrasonic dissection [4]. Heat production was directly proportional to the power setting and the activation time. The core body temperature of the animals after completion of the laparoscopic dissections rose by an average of 2.3 ° C. The zone around the jaws that exceeded 60 ° C with continuous ultrasonic dissection for 10–15 s at level 5 measured 25.3 and 25.7 mm for Ultracision and Autosonix, respectively. At this power Pogorelić /Perko /Družijanić /Tomić / Mrklić setting and an activation time of 15 s, the temperature 1.0 cm away from the tips of the instrument exceeded 140 ° C. Although there was no discernible macroscopic damage, these thermal changes were accompanied by significant histological injury that extended to the media of large vessels and caused partial- to full-thickness mural damage of the cardia, ureter, and bile duct. Collateral damage was absent or insignificant after dissections at power level 3 for both systems with the activation time not exceeding 5 s. In this study, we showed that the degree of thermal damage is commensurate to the duration of application, i.e. the damage was 2–3 times higher in the groups with a usage time of 10 s. Within the 10 s groups, those with 5 s of inactivity between the 2 applications had significantly less damage. In all experimental groups, lateral thermal damage that was inflicted using the instrument at output power of 5 was 0.5–2 times higher (depending on the experiment group) than those at output power 3. Statistical analysis of the data showed that the differences among all experimental groups were statistically significant. Our past research on rat abdominal walls showed greater lateral thermal damage when the cutting time was continuous rather than briefly interrupted [3]. Nevertheless, exactly how we should best use the harmonic scalpel to achieve ideal tissue cutting and hemostasis with minimal thermal damage is still unknown. The aim of this study was to determine the effects of using different harmonic scalpel application times on the in vivo experimental model of pig small intestines and abdominal walls. We have tried this before using the small intestine of rats, but this model is not applicable here, so we chose pigs as they are closer to humans. Conclusion The aforementioned findings lead us to conclude that lateral thermal damage at standard output power is greater after a longer application time. Lateral thermal damage is also greater if the cutting time is continuous rather than briefly interrupted. The harmonic scalpel is a useful tool in both open and endoscopic surgery. The minimization of lateral thermal injury is very important for minimizing lateral thermal damage, and it is particularly important for operations near vital areas. 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