Background: Efficient hemostatic techniques are essential in laparoscopic surgery for ideal intraoperative and postoperative results. A variety of advanced devices are available for the sealing of major vascular structures. The aim of this study is to assess effectiveness and safety of major vessel sealing with a radiofrequency device during laparoscopic colorectal resections for cancer based on the experience of a single hospital. Methods: Early outcomes of a consecutive series of patients who received elective laparoscopic colorectal resections for cancer over a 10-year period (January 2008–September 2017) are analyzed. In all procedures, the Ligasure® electrothermal bipolar device was used for the closure of the major colonic vessels and the dissection of all the structures. No other products such clips, staplers, hemostatic products, or other devices were used. Results: Seven-hundred fifty-nine procedures were performed in laparoscopy: 179 rectal resections, 247 sigmoidectomies and left hemicolectomies, 240 right hemicolectomies, 33 resections of the splenic flexure, 35 transverse colonic resections, and 25 other procedures. In 39 cases, the laparoscopic procedure was converted to open surgery, and in these cases, vessel sealing was also achieved with the radiofrequency device alone. Vessel dissection and sealing was realized in all cases without any intraoperative or postoperative bleeding. No reoperations for bleeding from major vessels were performed in any patients. One case of reoperation was recorded postoperatively, at 3 h after right hemicolectomy, due to a small bleeding from the fat of the transverse colon stump. Conclusions: The use of Ligasure® radiofrequency device for sealing and dividing the major colonic vessels is safe, fast, and effective during laparoscopic colorectal resections. Keywords: Colon cancer, Laparoscopic surgery, Vessel sealing Introduction bipolar graspers, sutures, and clips, to achieve efficient Laparoscopic colorectal resection has become wide- hemostasis and vessel sealing. spread due to the well-known benefits that it provides. Currently, new energy-based devices are available to Simultaneously, the use of energy-based devices is in- reduce the length of surgery and minimize blood loss creasing worldwide alongside with decreases in the use while producing a major hemostatic effect. Most of these of electrical monopolar and bipolar devices. devices use radiofrequency (i.e., electrothermal bipolar Conventional monopolar tools increase the risk of vessel sealers; EBVSs), ultrasound (i.e., ultrasonic shears; thermal injury, make hemostasis difficult, produce USs), or even combine these energies with conventional smoke, and often require additional tools, such as bipolar energy . The main advantage of these modern technologies is enhanced sealing capability, especially in blood vessels * Correspondence: email@example.com larger than 2–4 mm in diameter . These technologies General Surgery Department, S. Eugenio Hospital, P.le dell’Umanesimo 10, are particularly efficient for the sealing of large vessels of 00144 Rome, Italy Full list of author information is available at the end of the article © The Author(s). 2018 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Grieco et al. World Journal of Surgical Oncology (2018) 16:101 Page 2 of 5 up to 5–7 mm in diameter through compression and ef- previous activation. The final application and cutting ficient energy delivery to the tissue . were performed in the middle of the sealed artery. Radiofrequency (Ligasure®) and ultrasound (Ultracision®) The major venous branches were sealed after three ac- devices are the most popular in general surgery . tivations while leaving a thin layer of fatty tissue around Surgical hemostasis with EBVSs is accomplished by deliv- the structures to reinforce the sealed tissue line with the ering high-frequency and low-voltage electricity that is rearrangement of the components of the connective tis- converted into thermal energy. This technology is able to sue. Electrothermal energy alone was applied during the measure the impedance of the tissue between the jaws first two consecutive applications, and the cutting was and adapt the electrical power to obtain the most efficient performed at the end of the third application in the mid- final sealing. The energy, combined with the compression dle of the sealed vein. of the jaws, collapses the vessel walls and denatures the The device was applied perpendicularly to the vessel to collagen and elastin to form rearranged tissue that pro- minimize the length of the seal and to improve the seal vides a hemostatic seal [5, 6]. strength . The dissections of all the non-vascular struc- In this study, experiences of major vessel sealing dur- tures (i.e., the mesocolic root, ligaments, peritoneum, and ing laparoscopic surgeries for colorectal cancer using the omentum) were performed with single applications. Ligasure® radiofrequency device are reported. It is a very large series of a single center that support the safety and Data collection effectiveness of EBVS for vessel sealing. Each type of vessel closure, the time and the number of applications were assessed. The use of additional Methods hemostatic products was noted. The type of colectomy, Patient selection surgery time, intraoperative and postoperative bleeding, In this retrospective, observational, clinical study, the early length of hospital stay, and medical and surgical morbid- outcomes of colorectal laparoscopic resections in 759 ities and mortalities were recorded. unselected consecutive cases during operations at the Post-operative morbidity was defined and classified ac- S. Eugenio Hospital (Rome, Italy) over a 10-year period cording to the Clavien-Dindo Classification . from January 2008 to September 2017 are reported. The major colonic vessels were closed and divided with a Outcomes 5-mm Ligasure®. The primary outcomes were major post-operative bleed- Eligible patients included unselected adults who ing and reoperations for bleeding. The secondary out- underwent elective laparoscopic colorectal resection for comes were the overall 30-day morbidity and mortality. cancer for whom the dissection, sealing, and sectioning of major colorectal vessels were obtained with the exclu- Statistical analysis sive use of the Ligasure® radiofrequency device. Patients Quantitative data are reported as the mean ± the stand- who were converted to open surgery were included if no ard deviation (range). Qualitative data are reported as other devices were used to seal the major vessels. the numbers of patients (percentages of patients). The exclusion criteria were the use of other devices All analyses were performed using SPSS software ver- for the vessel sealing. In all cases, the radiofrequency de- sion 23 (IBM Co., Armonk, NY, USA). vice was used in every step of the procedure. Results Surgical technique Study population In the right hemicolectomies, the ileocolic vessels and The population was composed of 759 consecutive the right branch of the middle colic artery were sealed. unselected patients (339 males and 420 females) The The middle colic vessels were closed and divided in mean age was 68.2 ± 10.92 (22–89) years, the mean BMI transverse colectomies. The left branch of the middle was 26.0 ± 3.77 (18.7–35.9) kg/m , the rate of previous in- colic vessels and the left colic artery were sealed and dis- traperitoneal surgery (laparoscopic or laparotomic and sected during resections of the splenic flexure. The infer- major or minor) was 30.8%, 150 patients were ASA I, 419 ior mesenteric artery was sealed and dissected during patients were ASA II, and 190 patients were ASA III left colectomies, sigmoidectomies, and rectal resections. (Table 1). The major arterial branches were closed and cut after The operative procedures included the following: 240 five consecutive activations of the device using bipolar right hemicolectomies, 179 rectal resections (105 proximal energy alone for the first four applications, and add- rectums, 74 middle and distal rectums), 180 sigmoidec- itional cutting was performed at the end of the final ap- tomies, 67 left hemicolectomies, 35 transverse colonic re- plication. The first four applications were performed sections, 33 resections of the splenic flexure, 5 along the vessel, and each activation overlapped with the abdomino-perineal amputations, 10 Hartmann Grieco et al. World Journal of Surgical Oncology (2018) 16:101 Page 3 of 5 Table 1 Demographic features open surgery. In these cases, vessel sealing was also achieved with the radiofrequency device alone. Patients (n) 759 In all of the procedures, tissue dissection was achieved Gender (n,%) with no thermal injuries to the surrounding structures. Male 339 (44.7) The mean blood loss was 37.5 ± 18.4 (10–300) ml. Female 420 (55.3) Only one reintervention for hemostasis was performed Age, years (mean ± SD, range) 68.2 ± 10.92 (22–89) at 3 h after a right hemicolectomy for venous bleeding BMI, kg/m2 (mean ± SD, range) 26.0 ± 3.77 (18.7–35.9) from the pericolic fat of the transverse stump due to an epiploic fringe that was grabbed in the staple line. The ASA Classification (n,%) reoperation was performed with a minimally invasive I 150 (19.8) approach. II 419 (55.2) The mean operative time was 123.0 ± 36.3 (65–240) III 190 (25.0) min. Regarding postoperative morbidity, Clavien-Dindo Previous abdominal surgery (n, %) 234 (30.8) scores of II, III, or IV occurred in 161 patients (rate 21.2%). Anastomotic leaks occurred in 30 patients (4%). procedures, 3 total colectomies, and 7 multiple resections Nine perioperative deaths (1.2%) were recorded (Table 3). (Table 2). The number of device applications used to seal the Discussion ileocolic, middle colic, and inferior mesenteric arteries In this clinical study, the Ligasure® device was success- was 5. No thermal injuries to other structures were re- fully used to divide and seal the ileocolic, middle colic, corded. Moreover, no other energy devices, clips, sta- and inferior mesenteric vessels in a variety of laparo- plers, or additional hemostatic products were necessary scopic colorectal procedures. to achieve hemostasis. The average time required to seal In this series, three or five activations of the device and transect the arteries was 25 ± 3.77 (20–32) s. were sufficient to provide and maintain adequate For the veins, complete hemostasis was also obtained hemostasis of the major veins and arteries in all cases. in all cases. No further hemostatic products or add- The exposure of the colorectal vessels varied among itional devices were required. Usually, the inferior mes- the patients and procedures, but this did not appear to enteric vein was skeletonized while leaving a thin layer be a critical factor in vessel sealing. Although the cap- of fatty tissue surrounding it to reinforce the sealed tis- acity of the device to seal large vessels is undoubted, the sue line with the rearrangement of the components of veins were prepared leaving a thin layer of fatty tissue the connective tissue. The average major vein transec- around them to achieve more fibers that were sealed on tion time was 15 ± 2.77 (10–18) s. the transection line and to ensure a safe seal [5, 6]. To optimize the performance of the device, verification Outcomes of the appropriate size of the vessel and its complete in- Vessel sealing was effective in 100% of cases without any clusion in the jaws of the device is suggested. The re- intraoperative or postoperative bleeding from the major lease of the tension on the vessel during sealing is colonic vessels. All of the procedures began with lapar- recommended to allow for the completion of the sealing oscopy, and 39 procedures (5.1%) were converted to cycle before cutting. Essential factors mandatory for blood vessel sealing in- Table 2 Procedures clude homogeneously distribution of compression and Right hemicolectomy 240 precise temperatures and times to permit for the optimal Transverse colon resection 35 formation of strong sealed vascular tissue. Perpendicular Splenic flexure resection 33 Table 3 Outcomes Left hemicolectomy 67 Operative time, min (mean ± SD, range) 123.0 ± 36.3 (65–240) Sigmoidectomy 180 Conversions (n, %) 39 (5.1%) Rectal resection with PME 105 Estimated intraoperative blood loss, ml 37.5 ± 18.4 (10–300) Low rectal resection with TME 74 (mean ± SD, range) Hartmann procedure 10 Intraoperative hemorrhaging (n, %) 0 (0%) Miles procedure 5 Early reoperation for minor bleeding (n, %) 1 (0.1%) Multiple resection 7 Morbidity: Clavien-Dindo score ≥ 2(n, %) 161 (21.2%) Complete colectomy 3 Anastomotic leak (n, %) 30 (4%) Total 759 Mortality (n, %) 9 (1.2%) Grieco et al. World Journal of Surgical Oncology (2018) 16:101 Page 4 of 5 closure and uniform tissue compression of the jaws min- with a significantly shorter operative time and less intra- imizes the length of the sealed tissue and improves its operative blood loss than US (p < 0.05) in laparoscopic strength for very consistent sealing . colorectal surgery. However, these results should be During laparoscopic procedures, due to the wide and interpreted with caution due to the high heterogeneity blunt jaws of the radiofrequency device, it can be used as of the trials and the limited number of studies with a a non-traumatic grasping instrument. This feature pro- high level of evidence. vides the surgeon the possibility of maintaining the same Janssen et al.  compared 7 RCTs in a systematic review, surgical device in his right hand throughout the procedure including 554 patients in total. The use of US (n =139) were until the final step of stapling and sectioning the bowel. compared to those that used of EBVS (n = 264), mono- The availability of such a multifunctional device may polar (n = 20) or bipolar devices (n = 130). Two studies also be of particular value in complex laparoscopic pro- were in favor of EBVS with shorter operating time, re- cedures, such as colorectal resections, because it reduces duced intraoperative blood loss, and lower cost. How- the number of devices necessary to achieve safe and reli- ever, in the other studies no differences were observed. able hemostasis and avoids the continuous changing of The authors confirm that, vessel sealing with advanced tools. The avoidance of multiple instruments is a time- devices such EBVS and US may be considered relatively and cost-saving strategy. safe, and their use may reduce costs of surgery for the Radiofrequency devices are often compared with two reduction of blood loss and the operating times in many other main categories, ultrasonic instruments and ad- abdominal surgical procedures compared to mono- or vanced bipolar systems. The effects of sealing of these bipolar devices. two technologies are limited compared with radiofre- Martin et al.  examined a large retrospective series quency devices; however, both devices can efficiently seal of 802 cases who underwent elective laparoscopic colo- structures as vessels (≤ 5 and ≤ 7 mm of vessel diameter, rectal cancer resections that were performed with EBVS. respectively). Effective vessel sealing was achieved in 99.8% of the All these technologies are the main topic of few com- cases. Another recent study by Cassini et al.  under- parative studies, to confront their relative advantages lined the benefits of radiofrequency devices in terms of and disadvantages. Currently, there is no consensus on lower intraoperative blood loss and shorter operative the superiority of a device above the other [4, 9, 10]. times in obese patients with colorectal cancer. In a review study of the Cochrane Database, Tou S  Similar results have also been reported for pancreatic, analyzed six randomized controlled trials that included biliary, and lung surgeries [15–17]. 446 participants. All of the patients underwent elective The bursting pressures of arteries sealed with US, laparoscopic or laparoscopic-assisted right, left or total EBVS, titanium laparoscopic clips (LC), and plastic lap- colectomies or anterior resections for either benign or aroscopic clips, were measured in an experimental ani- malignant diseases. mal study . Arteries were divided in three size Few trials have compared three types of instruments, groups (2–3, 4–5, and 6–7 mm) and were harvested i.e., monopolar electrocautery shears (MES), ultrasonic from freshly euthanized animals. The EBVSs mean burst shears (US), and EBVS. Significantly less blood loss has pressures was significantly higher compared to the US at been observed with US compared to MES (MD 42 ml, 4–5mmand 6–7 mm, with a pressure of 601 vs 95% CI 22–62) and no significant difference comparing 205 mmHg and 442 vs 175 mmHg, respectively. The EBVS with US or MES. In terms of operating, time is burst pressures of the US and EBVS at 2 or 3 mm were significantly shorter with the use of EBVS than MES not significantly different. (MD 40 min, 95% CI 17–63) and shorter but not signifi- The EBVS showed a higher burst pressures for the cant between US and MES, no differences between US 4–5 mm group and the 6–7 mm group, compared with and EBVS have been observed. Hemostatic control with the 2–3 mm group were the pressure was 128 mmHg US and EBVS is better than that of MES. The authors (p = 0.0001). state an overall better hemostasis and shorter operating Clips were statistically stronger than the two devices time of US and EBVS over MES, but there was no differ- in 2–3 mm group and 6–7 mm group, but not in the ence in outcomes between these two instruments. EBVS 4–5 mm group where the EBVS was as strong as the LC appeared just to be easier to handle than US. (601 vs 593 mmHg). No conclusions regarding cost differences between EBVS was safe and effective in vessels up to 7 mm these three instruments have been noted. where can be used confidently. Concerning the thermal In 2012, Di Lorenzo et al.  published a spread to the surrounding tissues, no differences were meta-analysis that included four studies comparing showed between the EBVS and US devices. EBVS and US in 397 patients (200 EBVS vs. 197 US In another study by Noble et al. , 93 vessels from patients). The findings indicated that EBVS is associated 18 patients were sealed with Lotus™ (33 patients), Grieco et al. World Journal of Surgical Oncology (2018) 16:101 Page 5 of 5 Harmonic Ace® (30 patients), and Ligasure® (30 patients). colorectal laparoscopic surgery: a prospective, randomized study. Dis Colon Rectum. 2009;52:657–61. The mean bursting pressures were 1170 for the Lotus™, 5. Wallwiener CW, Rajab TK, Zubke W, Isaacson KB, Enderle M, Schäller D, 1470 for the Harmonic Ace®, and 1510 mmHg for the Wallwiener M. Thermal conduction, compression, and electrical current - an Ligasure®. Therefore, the bursting pressure seems really evaluation of major parameters of electrosurgical vessel sealing in a porcine in vitro model. J Minim Invasive Gynecol. 2008;15(5):605–10. high should be considered that the bursting pressures of 6. Reyes DAG, Brown SL, Cochrane L, Motta LS, Cuschieri A. Thermal fusion mesenteric vessels, sealed with the bipolar instruments, effects and interactions of temperature, compression and duration variables. are significantly higher than physiological pressures, as Surg Endosc. 2012;26(12):3626–33. 7. Voegele AC, Korvick DL, Gutierrez M, Clymer JW, Amaral JF. Perpendicular also documented in a study by Bibi S . blood vessel seal are stronger than those made at an angle. J Laparoendosc Adv Surg Tech A. 2013;23(8):669–72. 8. Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Conclusions Santibañes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury The results of this large single-center series demon- R, Cameron JL, Makuuchi M. The Clavien–Dindo classifications of surgical strates that use of the Ligasure® radiofrequency device to complica- tions. Five-years experiences. Ann Surg. 2009;250:187–96. 9. Tou S, Malik AI, Wexner SD, Nelson RL. Energy source instruments for seal and divide the major vessels in laparoscopic colorec- laparoscopic colectomy. Cochrane Database Syst Rev. 2011;11(5):CD007886. tal resections is safe, fast and effective, and associated 10. Hotta T, Takifuji K, Yokoyama S, Matsuda K, Higashiguchi T, Tominaga T, Oku with a very high success rate, as already demonstrated in Y, Watanabe T, Nasu T, Hashimoto T, Tamura K, Ieda J, Yamamoto N, Iwamoto H, Yamaue H. Literature review of the energy sources for existing literature. This device reduces the operative performing laparoscopic colorectal surgery. J World Gastrointest Surg. 2012; time, number of surgical instruments, and costs. 4(1):1–8. 11. Di Lorenzo N, Franceschelli L, Allaix ME, Asimakopoulos AD, Sileri P, Gaspari Abbreviations AL. Radiofrequency versus ultrasonic energy in laparoscopic colorectal ASA: American Society of Anesthesiology Score; EBVS: Electrothermal bipolar surgery: a metaanlysis of operative time and blood loss. Surg Endosc. 2012; vessel sealer; LC: Laparoscopic clip; MES: Monopolar electrocautery shears; 26(10):2917–24. US: Ultrasonic shears 12. Janssen PF, Brolmann HA, Huirne JA. Effectiveness of electrothermal bipolar vessel-sealing devices versus other electrothermal and ultrasonic devices for Availability of data and materials abdominal surgical hemostasis: a systematic review. Surg Endosc. 2012; All data regarding this clinical study are available on the online database of 26(10):2892–901. S. Eugenio Hospital. Please contact author for data requests. 13. Martin ST, Heeney A, Pierce C, O'Connell PR, Hyland JM, Winter DC. Use of an electrothermal bipolar sealing device in ligation of major mesenteric Authors’ contributions vessels during laparoscopic colorectal resection. Tech Coloproctol. 2011; MG, DS, DA, and MC were involved for clinical activity and data collection 15(3):285–9. regarding this study. EG was involved for data collection and analysis. All authors 14. Cassini D, Miccini M, Gregori M, Manoochehri F, Baldazzi G. Impact of read and approved the final manuscript. radiofrequency energy on intraoperative outcomes of laparoscopic colectomy for cancer in obese patients. Updat Surg. 2017;69(4):471–7. Ethics approval and consent to participate 15. Seng O, Goswami J, Moore D, Chen C, Brumbaugh J, Gannon CJ, August This study was approved by the ethical standards of the institutional Ethics DA, Carpizo DR. Safety and efficacy of Ligasure usage in Committee of S. Eugenio Hospital and was conducted according to the pancreaticoduodenectomy. HPB (Oxford). 2013;15(10):747–52. declaration of Helsinki. Informed consent was obtained from all patients 16. Hope WH, Padma S, Newcomb WL, Schmelzer TM, Heath JJ, Lincourt AE, giving their consent for publication. Heniford BT, Norton HJ, Martinie JB, Iannitti DA. An evaluation of electrosurgical vessel–sealing devices in biliary tract surgery in a porcine Competing interests model. HPB. 2013;12:703–8. Dr. Michele Grieco, Dr. Domenico Spoletini, Dr. Daniela Apa, Dr. Emanuela 17. Thoishi M, Yoshida K, Agatsuma H, Sakaizawa T, Eguchi T, Saito G, Grattarola, and Prof. Massimo Carlini have no competing interests or financial Hashizume M, Hamanaka K, Shiina T. Usefulness of vessel–sealing devices ties that are relevant to this article to disclose. for </− 7 mm diameter vessels: a randomized controlled trial for human thoracoscopic lobectomy in primary lung cancer. Interact Cardiovasc Thorac Surg. 2014;19(3):446–55. Publisher’sNote 18. Harold KL, Pollinger H, Matthews BD, Kercher KW, Sing RF, Heniford BT. Springer Nature remains neutral with regard to jurisdictional claims in published Comparation of ultrasonic energy, bipolar thermal energy, and vascular clips maps and institutional affiliations. for the hemostasis of small, medium and large-sized arteries. Surg Endosc. 2003;17(8):1228–30. Author details 19. Noble EJ, Smart NJ, Challand C, Sleigh K, Oriolowo A, Hosie KB. Experimental General Surgery Department, S. Eugenio Hospital, P.le dell’Umanesimo 10, comparison of mesenteric vessel sealing and thermal damage between one 00144 Rome, Italy. Statistical and Big Data Department, Elis Consulting and bipolar and two ultrasonic shears devices. Br J Surg. 2011;98(6):794–800. Labs, Via S. Sandri 81, 00159 Rome, Italy. 20. Bibi S, Coralic J, Velchuru V, Quinteros F, Marecik S, Park J, Prasad LM. A prospective study of in vivo and ex vivo sealing of the human inferior Received: 20 March 2018 Accepted: 21 May 2018 mesenteric artery using an electrothermal bipolar vessel-sealing device. J Laparoendosc Adv Tech A. 2014;24(7):471–4. References 1. Lyons SD, Law KSK. Laparoscopic vessel sealing technologies. J Minim Invasive Gynecol. 2013;20(3):191–5. 2. Chekan EG, Davison MA, Singleton DW, Mennone JZ, Hinoul P. Consistency and sealing of advanced bipolar tissue sealers. Med Devices Evid Res. 2015; 8:193–9. 3. Kondrup JD, Anderson E, Quick B. Use of the Enseal® G2 tissue sealer in gynecologic surgery. Surg Technol Int. 2013;23:191–5. 4. Rimonda R, Arezzo A, Garrone C, Allaix ME, Giraudo G, Morino M. Electrothermal bipolar vessel sealing system vs harmonic scalpel in
World Journal of Surgical Oncology – Springer Journals
Published: Jun 1, 2018
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