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1 대한내분비외과학회지 : 제9권제4호 Vol. 9, No. 4, December 2009 원저 갑상선수술에서 Harmonic TM, Ligasure TM 혈관결찰술의유용성및안전성비교 전통적봉합사매듭에의한 충남대학교의과대학외과학교실 유정미ㆍ한재은ㆍ김용훈ㆍ김제룡 A Comparison of the Usefulness and Safety of the Harmonic TM Scalpel, Ligasure TM System, and Classic Clamp-and-Tie Technique for Hemostasis during Thyroid Surgery Jeong-Mi Yu, M.D., Jae-Eun Han, M.D., Yong-Hoon Kim, M.D. and Je-Ryong Kim, M.D., Ph.D. Purpose: The aim of this study was to compare the outcome of total thyroidectomy performed with the Ligasure TM system, Harmonic TM scalpel, and the conventional clampand-tie technique. Methods: Between November 2006 and July 2009, the data were retrospectively collected from 600 consecutive total thyroidectomies by one surgeon. All cases were divided into 3 groups based on the method of hemostasis: classic group patients underwent total thyroidectomy with the conventional clamp-and-tie technique Ligasure group patients underwent total thyroidectomy with the Ligasure TM system (electrothermal bipolar vessel sealing system) and the Harmonic group patients underwent total thyroidectomy with a Harmonic TM scalpel (ultrasonic cutting and coagulating surgical device). We compared the clinical outcomes with respect to the operative time, amount and duration of drainage, hospital stay, and post-operative complications. Results: The three groups were similar with respect to clinical and demographic characteristics, with the exception of invasiveness. The mean operative time of the Harmonic group was significantly shorter than the other 2 groups (P <0.001) specifically, 75 min in the Harmonic group, 87 min in the Ligasure group, and 120 min in the classic group. The amount of drainage in the Harmonic group was greater than the other groups (P<0.001). Similarly, the duration of drainage and hospital stay of the Harmonic group were 책임저자 : 김제룡, 대전시중구대사동 , 충남대학교병원외과 Tel: , Fax: kimjr@cnuh.co.kr 게재승인일 :2009 년 11 월 2 일 longer than the other groups. There was no significant difference in the incidence of complications between the three groups. Conclusion: Hemostasis during thyroidectomy by the Harmonic TM scalpel or Ligasure TM system was safe and timesaving. Therefore, the Harmonic TM scalpel and Ligasure TM system will be available for thyroid surgery as alternative techniques for the clamp-and-tie technique. (Korean J Endocrine Surg 2009;9: ) Key Words: Thyroidectomy, Harmonic, Ligasure 중심단어 : 갑상선절제술, Harmonic, Ligasure Department of Surgery, College of Medicine, Chungnam National University, Daejeon, Korea 서 갑상선수술에서수술후합병증을예방하기위해지혈은매우중요하며정교한기술을요하는과정으로수술시간의대부분을차지하게된다. 다양한지혈장비들이안전하고빠른지혈을위해개발되었고최근다양한수술영역에서사용되고있으며, 이들지혈장비들 (Electrothermal bipolar vessel sealer, ultrasonic cutting and coagulation device) 의유효성과안전성이인정되고있다. 또한, 전통적인지혈방법에비해수술시간을단축시킨다는장점을보여주고있다.(1,2) 이러한지혈장비들은주로복부수술에서사용되었으나,(3) 최근갑상선수술에서도전통적인봉합사매듭에의한결찰술 (clamp-and-tie technique) 을대신하여사용되고있으며그유용성에대한비교연구가다수보고되었다.(1,4-7) 본원에서는복강경수술이늘어남에따라위의기구들이보편적으로사용되고있는상황이었으나, 갑상선수술에서는 2007년 12월에 Ligasure TM vessel sealing system (Valleylab, Covidien, Boulder, CO, USA), 2008년 5월에 Harmonic TM ultrasonic cutting and coagulation device (Ethicon Endo-surgery, Cincinnati, OH, USA) 가각각본격적으로도입되어사용되었다. Ligasure의경우 2009년 3월본원에서발표한논문에서이미그유용성과안전성이확인되었다.(8) 그후도입된 론 206

2 유정미외 : 갑상선수술에서 Harmonic TM, Ligasure TM 전통적봉합사매듭에의한혈관결찰술의유용성및안전성비교 207 Harmonic에대해서는수술현장에서느낀바로는 Ligasure 만큼빠르고안전하게지혈이되는것으로생각되어, 이번연구에서는 Harmonic에의한지혈방법을전통적인봉합사매듭지혈방법그리고 Ligasure에의한지혈방법을각각비교하여그유용성에대하여알아보고자하였다. 방법이연구는수술전세침흡인검사에서갑상성암으로나온환자를대상으로 2006년 11월부터 2009년 7월까지단일술자에의한갑상선전절제술및중심부림프절절제술을시행받은환자들의의무기록을통하여후향적으로시행되었다. 갑상선전절제술을시행받은환자들중내시경하갑상선절제술을시행받은환자, 이전수술후재발되어추가적으로수술받은환자, 중심부림프절절제술외에추가적인림프절절제술 ( 변형근치경부림프절절제술, 선택적림프절절제술 ) 을시행받은환자들의경우는연구대상에서제외되었다. 수술방법으로피부절개는하경부절개 (lower collar incision) 를시행하여갑상선전절제술및중심부림프절절제술을시행하였다. 갑상선제거후미세혈관지혈을위해섬유소접착제 (fibrin glue) 를수술부위에도포하였고, 기관 (trachea) 과근육과의유착을방지하기위하여항유착물질을도포하였다. 마지막으로배액관을위치시킨후절개창을닫고수술을종료하였다. 환자들은지혈방식에따라봉합사매듭에의한결찰을시행한전통군 (classic group), 전기-열에너지를이용하는 Ligasure군, 그리고초음파진동에너지를이용하는 Harmonic 군으로나뉘었다. 전통군에서는혈관결찰시대상혈관의양끝을겸자로잡고그사이를절단한후절단된양쪽끝을 봉합사로묶는방식을사용하였고, Ligasure군에서는결찰하고자하는혈관을가위형태의기구로잡고열을가하여굳히고굳은혈관조직의가운데부분을가위로절단하는방식을사용하였다. 한편 Harmonic군에서는역시가위형태인기구의끝으로혈관을잡고초음파에의한진동에너지가전달되면혈관이굳어진후절단되는방식이었다. 이때, Ligasure군과 Harmonic군에서혈관을잡고굳힐인접한두지점을연속적으로잡고굳힌후갑상선조직에가까운쪽에서혈관을절단하는방법을사용하여혹시있을지모르는결찰부위누출에대비하였다. 일부환자에서회귀후두신경이근접한베리인대 (Ligament of Berry) 주변에서는열에의한신경손상을피하기위해봉합사로결찰하는방식을채택하기도하였다. 모든증례에서인구통계학적특성, 수술시간, 조직학적진단, 재원기간, 수술후배액량, 배액관유지기간 ( 제거기준은일일배액량 10 ml 미만 ), 수술후합병증에대하여조사하여통계학적분석을실시하였다. 모든통계학적분석은 SPSS 12.0으로명목변수에대하여 Chi-square test 및연속변수에대하여 One-way ANOVA를이용하여시행하였다. 결과연구기간동안단일술자에의하여갑상선전절제술을시행받은총 600명의환자가포함되었다. 지혈방법에따라전통군, Ligasure군, Harmonic군 으로나뉘었다. 각그룹의인구통계학적특성및임상적특성을비교한결과암의주변조직침윤을제외하고나이, 성별, 병변의위치및크기, 진단, 그리고수술후 thyroglobulin 수치에서는유의한차이를보이지않았다 (Table 1). Classic Ligasure Harmonic P value Age (years) 48.09± ± ± * Gender Male Female 18 (9.0%) 182 (91.0%) 21 (10.5%) 179 (89.5%) 16 (8.0%) 184 (92.0%) Site of the lesion Unilateral Bilateral 162 (81.0%) 38 (19.0%) 155 (77.5%) 45 (22.5%) 161 (80.5%) 39 (19.5%) Size of the mass (cm) 1.00± ± ± * Cases with the invasion 30 (15.0%) 21 (10.5%) 118 (59.0%) <0.001 Diagnosis Benign Malignancy 21 (10.5%) 179 (89.5%) 31 (15.5%) 169 (84.5%) 19 (9.5%) 181 (90.5%) Postoperative Tg level (ng/ml) 1.04± ± ± * *One-way ANOVA; Chi-square test; Capsular invasion. Table 1. Clinical and demographic characteristics of our patients

3 208 대한내분비외과학회지 : 제 9 권제 4 호 2009 Table 2. Comparisons of the operation outcomes Classic Ligasure Harmonic P value Operation time (min) Amount of drainage (ml) Duration of drainage (day) Hospital stay (day) ica (mmol/l) ± ± ± ± ± ± ± ± ± ± ± ± ± ± ± * *One-way ANOVA. Table 3. Comparisons of the complications Classic Ligasure Harmonic P value Numbness 120 (60.0%) 107 (53.5%) 124 (64.0%) ica (mmol/l) 1.04± ± ± * Hoarseness 2 (1.0%) 0 (0.0%) 6 (3.0%) Hematoma 2 (1.0%) 0 (0.0%) 0 (0.0%) *One-way ANOVA; Chi-square test. 모든증례에서갑상선전절제술및중심부림프절절제술이시행되었다. 수술시간, 이온화칼슘농도, 수술후배액량및배액관의유지기간, 재원기간을조사하였으며수술후합병증에대해서도조사하였다. 이중, 수술시간에대해서전통군, Ligasure군및 Harmonic군에서각각 120분, 87분, 그리고 75분으로전통군과 Ligasure군, 전통군과 Harmonic군사이에서뿐만아니라 Ligasure군과 Harmonic군사이에서도통계학적으로유의한차이를보여주었다 (Table 2). 수술후배액량, 배액관유지기간및재원기간에대한비교에서전통군과 Ligasure군사이에서는통계학적차이가없는것으로나타났지만 Harmonic군과다른두군과의사이에서는통계적으로유의한차이를보였다 (Table 2). 즉, Harmonic군에서수술후배액량이전통군의 66 ml와 Ligasure군의 80 ml보다많은 116 ml로나타났고, 배액관의유지기간도 2.87일과 2.99일보다긴 4.37일로나타났다. 또한이에비례하여재원기간에서도 6.9일로전통군의 4.73일과 Ligasure군의 5.02일보다긴것으로나타났다. 수술후합병증에대해서는회귀후두신경손상에대해서만통계학적차이를보였고, 수술후출혈이나이온화칼슘농도, 저칼슘혈증에의한손발저림의경우유의한차이를나타내지않았다 (Table 3). 고 근래에기계공학과에너지원그리고장비의혁신적인 찰 발달이지혈, 조직결찰및박리등수술과정을단축시키는데주된역할을하고있다. 이러한전기열에너지와초음파에너지를사용한혈관결찰기구들이수술시간을줄이고수술후합병증을감소시킨다는것이심장수술, 흉부외과수술, 비뇨기과수술, 부인과수술, 외과수술에서확인되었다.(9-14) 나아가최근에는갑상선수술에서이러한기구를사용하여그안전성과유용성에대한연구들이다수보고되었다.(2,15-20) 갑상선수술에서의가장흔한합병증인회귀후두신경마비와수술후부갑상선기능저하증의경우그발생률은회귀후두신경마비가 0 23% 로다양하게나타나는반면, 무증상의일시적인저칼슘혈증의경우전절제술후에 63% 까지도나타난다고한다.(21) 본연구에서도역시수술직후회귀후두신경마비는 0 6%, 저칼슘혈증은 53 64% 로비슷한결과를보여주고있으며, 이들중대부분은수개월간의추적검사결과회복되었다. 일반적인전기소작기구들은갑상선수술에서측방열전도에의한주변조직의손상과그로인한합병증때문에안전하지않다는단점이있었다. 이에비해 Harmonic scalpel의경우진동 (55.5 khz) 에의한단백질의물리적변성에의해응고가진행되므로상대적으로낮은열을발생시킨다.(22) 또한, Harmonic scalpel은이미다양한두경부수술에서그사용에있어안전성이입증되었으며,(3,7-9,18,23,24) 표준전기소작기에비해수술시간단축, 적은측방열전도, 그리고연기발생이없다는것과환자의몸에전기에너지관통이필요치않다는장점이있다.(25,26) Ligasure는혈관벽의콜라겐과엘라스틴을녹여플라스틱과유사한형태로만들어융합시켜지혈하는방식으로지혈이필요한조직을가위형태의기구로잡고에너지를전달함으로써, 능동적인귀환조절 (feedback control) 이가능하기때문에과도한에너지전달을막을수있다. 또한연구에사용된 Ligasure Precise R 의경우기구의끝이매우작게고안되어갑상선수술과같이좁은공간의수술에서유용하게되었다.(27) 단, Ligasure는열에의한단백질의변성으로혈관을폐쇄시키므로지혈에는유용하나이후가위로지혈된부분을잘라주어야하는번거로움이있다. 이에비해 Har-

4 유정미외 : 갑상선수술에서 Harmonic TM, Ligasure TM 전통적봉합사매듭에의한혈관결찰술의유용성및안전성비교 209 monic은가위형태의기구로잡고에너지를가하면지혈과동시에조직이절단되어기구교체를덜하게되므로수술시간단축에있어서 Ligasure군에비해좀더유리하다. Manouras 등 (28) 과 Sartori 등 (29) 이각각발표한논문에서위에서말한두가지의새로운수술기구와전통적방법에의한갑상선절제술에대해서전자는후향적그리고후자는전향적으로비교연구하였는데, 그결과후향적연구에서는 Ligasure군과 Harmonic군모두전통적방법에비해수술시간은유의하게감소하였으며, 이두개의그룹간에는차이가없었고합병증발생률이나재원기간에있어서는세개의그룹모두유의한차이를보이지않았다. 따라서두가지기구를전통적인봉합사결찰법이나클립을대체하여사용할수있으리라생각되고, 또그선택은술자의선호도에따라달라질수있다. 한편, 전향적연구에서는조금다른결과를보였는데수술시간에있어서 Harmonic군에서만다른두군에비해유의하게감소한것을볼수있었고, Ligasure군에서는통계적유의성은없지만전통적방법에비해오히려수술시간이긴것을볼수있다. 수술중출혈량이나회귀후두신경마비에서는모든그룹에서유의한차이가없었던반면에, 저칼슘혈증의경우 Harmonic군에서높은발생률을보이고있어수술중부갑상선조직에가까운부분을박리할때에는특히세심한주의를기울여야한다고주장하였다.(29) 이번연구에서도역시수술시간의단축에있어서는 Harmonic군이월등한것으로나타났다. 수술후합병증발생률에서는단지회귀후두신경마비에서약간의차이를보였다. 한편, 배액량과배액관유지및재원기간에서는 Harmonic군이다른두개의그룹보다많고, 긴것으로나타났는데이는외과의가 Harmonic을선택하는것을망설이도록하는요소가될수있다. Harmonic의편리성을생각하면당연한선택일수있으나재원기간이길어진다면비용-효과측면에서그유용성이떨어질것이기때문이다. 결론본연구에서는 Ligasure에의한지혈방법이전통적인지혈방법보다, Ligasure에의한지혈방법보다는 Harmonic에의한지혈방법이각각수술시간을단축시키면서도합병증의발생에서는유의한차이를보이지않아유용하면서도그안전성에있어서는동등하다는것을알수있었다. 한편, Harmonic군에서수술후배액량이상대적으로많고재원기간이길어지는단점에대해서는림프관결찰을전통적지혈방법으로배액량의감소시킨다거나배액량에관계없이출혈의징후가없다면배액관을조기에제거하는것으로보완할수있을것으로생각된다. 그러나수술후합병증에관한통계학적증명에서는그유의성을의심하게되는것은본연구의한계라고할수 있다. 특히, 배액량과의관계에있어서암조직의주변조직에대한침윤여부와갑상선비대증의동반여부를고려하지않은점이지적될수있을것이다. 이번연구를바탕으로앞으로의연구에서는동일한디자인으로조직형태및침윤여부에따라더욱세부적으로그룹을나누어연구를시행한다면좀더신뢰성있는결과를얻을수있을것이라생각한다. REFERENCES 1) Siperstein AE, Berber E, Morkoyun E. The use of the harmonic scalpel vs conventional knot tying for vessel ligation in thyroid surgery. Arch Surg 2002;137: ) Manouras A, Lagoudianakis EE, Antonakis PT, Filippakis GM, Markogiannakis H, Kekis PB. Electrothermal bipolar vessel sealing system is a safe and time-saving alternative to classic suture ligation in total thyroidectomy. Head Neck 2005;27: ) Gelmini R, Romano F, Quaranta N, Caprotti R, Tazzioli G, Colombo G, et al. Sutureless and stapleless laparoscopic splenectomy using radiofrequency: Ligasure device. Surg Endosc 2006;20: ) Defechereux T, Rinken F, Maweja S, Hamoir E, Meurisse M. Evaluation of the ultrasonic dissector in thyroid surgery. A prospective randomised study. Acta Chir Belg 2003;103: ) Manouras A, Lagoudianakis EE, Antonakis PT, Filippakis GM, Markogiannakis H, Kekis PB. Electrothermal bipolar vessel sealing system is a safe and time-saving alternative to classic suture ligation in total thyroidectomy. Head Neck 2005;27: ) Miccoli P, Berti P, Dionigi GL, D Agostino J, Orlandini C, Donatini G. Randomized controlled trial of harmonic scalpel use during thyroidectomy. Arch Otolaryngol Head Neck Surg 2006;132: ) Kiriakopoulos A, Tsakayannis D, Linos D. Use of a diathermy system in thyroid surgery. Arch Surg 2004;139: ) Lee CM, Kang DY, Kim JR. A comparison of conventional thyroidectomy and LVSS thyroidectomy: The feasibility of the LVSS in the thyroid operation. Korean J Surg Soc 2009;76: ) Ohtsuka T, Wolf RK, Wurnig P, Park SE. Thoracoscopic limited pericardial resection with an ultrasonic scalpel. Ann Thorac Surg 1998;65: ) Shigemura N, Akashi A, Nakagiri T. New operative method for a giant bulla: sutureless and stapleless thoracoscopic surgery using the Ligasure system. Eur J Cardiothorac Surg 2002; 22: ) Daskalopoulos G, Karyotis I, Heretis I, Delakas D. Electrothermal bipolar coagulation for radical prostatectomies and cystectomies: a preliminary case-controlled study. Int Urol

5 210 대한내분비외과학회지 : 제 9 권제 4 호 2009 Nephrol 2004;36: ) Tamussino K, Afschar P, Reuss J, Perschler M, Ralph G, Winter R. Electrosurgical bipolar vessel sealing for radical abdominal hysterectomy. Gynecol Oncol 2005;96: ) Deo SV, Shukla NK. Modified radical mastectomy using harmonic scalpel. J Surg Oncol 2000;74: ) Lee WJ, Chen TC, Lai IR, Wang W, Huang MT. Randomized clinical trial of Ligasure versus conventional surgery for extended gastric cancer resection. Br J Surg 2003;90: ) Cordon C, Fajardo R, Ramirez J, Herrera MF. A randomized, prospective, parallel group study comparing the Harmonic Scalpel to electrocautery in thyroidectomy. Surgery 2005;137: ) Dror A, Salim M, Yoseph R. Sutureless thyroidectomy using electrothermal system: a new technique. J Laryngol Otol 2003; 117: ) Lachanas VA, Prokopakis EP, Mpenakis AA, Karatzanis AD, Velegrakis GA. The use of Ligasure Vessel Sealing System in thyroid surgery. Otolaryngol Head Neck Surg 2005;132: ) Voutilainen PE, Haglund CH. Ultrasonically activated shears in thyroidectomies: a randomized trial. Ann Surg 2000;231: ) Shemen L. Thyroidectomy using the harmonic scalpel: analysis of 105 consecutive cases. Otolaryngol Head Neck Surg 2002;127: ) Ortega J, Sala C, Flor B, Lledo S. Efficacy and cost-effectiveness of the Ultracision harmonic scalpel in thyroid surgery: an analysis of 200 cases in a randomized trial. J Laparoendosc Adv Surg Tech A 2004;14: ) Rosato L, Avenia N, Bernante P, De Palma M, Gulino G, Nasi PG, et al. Complications of thyroid surgery: analysis of a multicentric study on 14,934 patients operated on in Italy over 5 years. World J Surg 2004;28: ) Anonymous (2001) Ultracision Harmonic Scalpel user s manual. Ehticon Endosurgery, Cincinnati. 23) Miccoli P. Minimally invasive surgery for thyroid and parathyroid diseases. Surg Endosc 2002;16: ) Dralle H, Sekulla C, Haerting J, Timmermann W, Neumann HJ, Kruse E, et al. Risk factors of paralysis and functional outcome after recurrent laryngeal nerve monitoring in thyroid surgery. Surgery 2004;136: ) Gossot D. Ultrasonic dissectors in endoscopic surgery. Ann Chir 1998;52: ) Boddy SA, Ramsay JW, Carter SS, Webster PJ, Levison DA, Whitfield HN. Tissue effects of an ultrasonic scalpel for clinical surgical use. Urol Res 1987;15: ) Anonymous (1999) Ligasure vessel sealing system user s manual. Valleylab, Covidien, Boulder. 28) Manouras A, Markogiannakis H, Koutras AS, Antonakis PT, Drimousis P, Lagoudianakis EE. Thyroid surgery: comparison between the electrothermal bipolar vessel sealing system, harmonic scalpel, and classic suture ligation. Am J Surg 2008;195: ) Sartori PV, De Fina S, Colombo G, Pugliese F, Romano F, Cesana G, et al. Ligasure versus Ultracision in thyroid surgery: prospective randomized study. Langenbecks Arch Surg 2008; 393:655-8.

황지웅

황지웅 Comparison of Laparoscopy and Exploration in the Distal Pancreatectomy BACKGROUND: To determine the benefits of laparoscopic surgery compared with exploration, the clinical outcomes of open and laparoscopic