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Journal of Minimally Invasive Surgery Vol. 16. No. 3, 2013 Original Article pissn 2234-778X, eissn 2234-5248 http://dx.doi.org/10.7602/jmis.2013.16.3.39 복강경결직장암수술에서 EnSeal TM System의유용성에관한 LigaSure TM 와의예비무작위비교연구 충남대학교의학전문대학원외과학교실 1, 동래봉생병원외과 2 박준범 1 ㆍ송민상 2 ㆍ이경하 1 ㆍ김진수 1 ㆍ김지연 1 Effectiveness of the EnSeal TM System in Colorectal Cancer Surgery: A Pilot Randomized Study for Comparison with LigaSure TM Jun Beom Park, M.D. 1, Min Sang Song, M.D. 2, Kyung Ha Lee, M.D. 1, Jin Soo Kim, M.D. 1, Ji Yeon Kim, M.D., Ph.D. 1 Department of Surgery, 1 Chungnam National University School of Medicine, Daejeon, 2 Dong Rae Bong Seng Hospital, Busan, Korea Purpose: Use of bipolar electocoagulation devices becomes popular in the laparoscopic surgical field. However, several studies comparing energy-based devices for use in performance of mechanical sealing and cutting techniques have reported various results. The aim of this study was to evaluate feasibility and efficacy of new com m ercially available bipolar electocoagulation devices: EnSeal TM device (Ethicon Endo- Surgery, Cincinnati, OH, USA) by comparison with LigaSure TM atlas 5 mm (COVIDIEN, Boulder, CO, USA), for use in perform - ance of coagulation and cutting techniques during performance of laparoscopic colorectal cancer surgery. Methods: Between June 2010 and February 2011, 50 consecutive patients who underwent curative laparoscopic surgery for right colon cancer or rectal cancer were enrolled. Time and number of device activations were compared during omentectomy in cases of right colectomy and mesorectal trimming procedure in cases of anterior resection. Pathologic data and short-term clinical outcomes were also compared. Results: No significant differences in term s of clinicopathologic comparison were observed between the EnSeal and LigaSure groups. No significant difference in m ean operative time (207.6±45.3 vs. 198.9±57.2; p=0.558), mean time of omentectomy (11.0±4.5 vs. 12.6±8.6; p=0.293), mean time of mesorectal trimming (18.6±10.0 vs. 16.1±6.9; p=0.418), mean number of device activations during omentectomy (43.5±10.2 vs. 51.6±39.2; p=0.586), and mean number of device activations during performance of mesorectal trimming (44.8±22.3 vs. 49.1±23.7; p=0.597) were observed between the two groups. Conclusion: Bipolar electocoagulation devices were adapted for use in laparoscopic surgery, resulting in reduced operative time and blood loss. EnSeal TM Device and LigaSure TM atlas 5 mm were useful during performance of sealing and cutting techniques in laparoscopic colorectal cancer surgery. Key words: Laparoscopic surgery, Surgical instrum ent, Tissue sealing, EnSeal TM, LigaSure TM 서 현재외과의수술은많은부분이복강경수술을포함하는최소침습수술로시행되고있고, 앞으로도이러한수술방법은점차증가될것으로예상된다. 특히대장항문분야에서, 복강경수술은양성질환은물론악성종양에대한수술까지거의모든영역에서적용되고있다. 1 그러나, 이러한복강경수술에서는통상적인개복수술에비해출혈시 Received June 8, 2013, Revised 1st, August 4, 2013; 2nd, August 19, 2013, Accepted August 20, 2013 Corresponding author:ji Yeon Kim Department of Surgery, Chungnam National University Hospital, 282, Munhwa-ro, Jung-gu, Daejeon 301-721, Korea Tel:+82-42-280-7175, Fax:+82-42-257-8024 E-mail:jykim@cnu.ac.kr 론 지혈의어려움으로혈관의결찰및조직을박리할때 energy-based devices (EBDs) 를많이사용하게된다. 특히주요혈관의결찰과정이나직장간막 (mesorectum) 의절제및다듬기 (trimming), 그리고우반또는좌반결장절제술중시행되는대망절제 (omentectomy) 과정에서수술시간의단축및출혈감소를목적으로 EBDs를통상적으로많이사용했다. 2 EnSeal TM device (Ethicon Endo-Sugery, Cincinnati, OH, USA) 및 LigaSure TM atlas 5 mm (COVIDIEN, Boulder, CO, USA) 는여러 EBDs 중에전기에너지를이용하는기구로이전기에너지를열에너지로변환하여혈관벽과주변의결합조직내의콜라겐 (collagen), 엘라스틴 (elastin) 등의단백질의변성을가져오고양측 jaw의압력으로조직을압착시켜혈관벽의재편성및유착으로지혈효과를나타내며, 내부의칼날 (blade) 을이용하여조직을분리하게되는기구이다. 3,4 이중 LigaSure TM atlas 5 mm의경우그동안저자들의 This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/ by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

40 Journal of Minimally Invasive Surgery Vol. 16. No. 3, 2013 병원을비롯한여러다른센터에서도많이사용되어져왔던기구로, 많은연구결과에서그안정성이나유용성이보고되었다. 2,5-8 최근 EnSeal TM device가새로도입되어기구선택의폭이넓어지게되었는데, 이 EnSeal TM device의임상적인적용에대한연구는비교적적은상태이다. 따라서본연구에서는이제까지많이사용되어져왔고그효용성이나안정성이입증된 EBDs중기존의 LigaSure TM atlas 5 mm와최근개발되어승인도입된 EnSeal TM device의절제기능및지혈성능을비교하여 EnSeal TM device의안정성을알아보고실제적인임상적유용성을평가해보고자하였다. 대상및방법 1) 연구대상 2010년 6월부터 2011년 2월까지충남대학교병원에내원하여대장암으로진단받은후복강경수술을시행한환자들중에좌측및우측결장암으로좌반결장절제술및우반결장절제술과정중부분대망절제술을시행하였거나구불결장암및직장암으로전방절제술또는저위전방절제술시직장간막다듬기과정을시행한 50명을대상으로하였다. 이중부분대망절제술은 16예에서, 직장간막다듬기는 34 예에서시행하였다. 수술전연구동의를하지않은환자, 근위부구불결장암으로직장간막절제를시행하지않고결장간막절제만시행한환자, 중하부직장암으로전직장간막절제를시행하여직장간막다듬기과정이필요없는환자, 원위부전이를보이는환자, 개복술로전환된환자, 이전복부수술을시행하여유착이심한환자들은연구에서제외되었다. 2) 연구방법본연구는무작위비교연구로계획된임상연구로지금까지이두기구를비교한임상연구가보고된바가없어선행연구 (pilot study) 로계획되었다. 각환자들은난수표에의해수술시행전두그룹 (Group A: Enseal group, Group B: LigaSure group) 으로각각 30명씩임의로배정되어수술을진행하였다. 수술방법은단일술자에의해표준화된동일한방법으로시행되었고, 대부분의수술과정은단극성전기소작기 (monopolar elctrocautery) 를이용하여진행되었으며, 대망절제술혹은직장간막다듬기처럼둔적박리 (Blunt dissection: non-anatomical plane dissection) 시 EBDs를사용하였다. 수술중녹화된동영상을수술후에검토하여전방절제술또는저위전방절제술을시행한경우에는종양특이직장간막절제술 (tumor-specific mesorectal excision) 후직장간막다듬기과정에서, 그리고우반또는좌반결장절제술을시행한경우에는부분대망절제시행과정에서기구의활성화횟수와소요된시간을측정하여비교하였다. 이과정 에서초기동영상녹화불량및동영상기록의분실로 10명의환자가제외되어 50명의환자를대상으로연구가진행되었다. 직장간막다듬기과정의시간은직장고유근막의외연을따라종양의하방까지충분히박리후절제연을결정하고, 직장간막다듬기를위한기구의첫번째활성화시점부터, 직장근층만남기고모든직장간막을박리하여다듬기과정의마지막활성화가종료되는시점까지측정했으며, 이시간동안활성화된횟수를직장간막다듬기과정의활성화횟수로산정하였다. 부분대망절제의경우대망을절제하기위해펼친후, 횡행결장에붙어있는대망의절제연을선택하고소망낭 (lesser sac) 에들어간다음위대망혈관 (gastroepiploic vessels) 의하연을따라절제를하였으며, 우측의경우간결장인대, 좌측의경우비결장인대를완전히절제하는되는시점까지로, 본연구에서측정한대망절제시간은대망절제를위해 EBDs를처음활성화시킨시점부터대망절제가끝나는마지막기구의활성화가종료되는시점까지측정했으며이시기의활성화횟수를기록하였다. 이연구에포함된모든환자들은수술전에사전동의를받았으며충남대학교병원의임상시험심사위원회 (Institutional Review Board) 에서승인을얻어연구가진행되었다 (CNUH IRB No. 1006-D-05). 3) 통계처리통계분석은 SPSS (ver 12.0 for window, SPSS Inc., Chicago, USA) 을이용하여, 변수의특징에따라 Chi-square test와 Student s T-test로통계적유의성을검정하였고, 유의수준이 0.05 미만인경우를유의한것으로간주하였다. 결과 1) 환자의특성전체 50명의환자를대상으로연구가진행되었고, EnSeal TM device 사용군은 23명, LigaSure TM atlas 5 mm 사용군은 27명이었다. 부분대망절제과정을비교한우반또는좌반결장절제를시행한경우 EnSeal TM device 사용군 8명, LigaSure TM atlas 5 mm 8명이었으며, 직장간막다듬기과정을비교한 ( 저위 ) 전방절제술을시행한경우는 EnSeal TM device 사용군 15명, LigaSure TM atlas 5 mm 19명으로통계적으로유의한차이는없었다 (p=0.767). 두군간의연령분포 (p=0.255) 나평균체질량지수 (p=0.529), American society of anesthesiologists (ASA) score (p=1.000) 에서도유의한통계적차이를보이지않았으며, 그외종양관련인자 (Preoperative carcinoembryonic antigen [CEA], Tumor size, T stage, N stage, retrieved lymph nodes의개수, TNM stage) 에서도두군간의

Jun Beom Park et al.: Effectiveness of the EnSeal TM System in the Colorectal Cancer Surgery 41 Table 1. Clinical characteristics EnSeal TM LigaSure TM 5 mm n=23 (%) n=27 (%) p value Sex Male Female Age, years 65 >65 Mean body mass index, kg/m 2 25 >25 ASA 1 2 3 4 Operation (Low) Anterior resection Hemicolectomy Preoperative CEA 5 ng/ml >5 ng/ml Tumor size, cm 3 >3 Pathologic T stage pt1-2 pt3-4 Pathologic N stage pn0 pn1-2 Number of retrieved lymph nodes 15 >15 TNM stage I II III IV 17 (73.9) 6 (26.1) 13 (56.5) 10 (43.5) 18 (78.3) 5 (21.7) 20 (87.0) 3 (13.0) 15 (65.2) 8 (34.8) 15 (65.2) 8 (34.8) 8 (34.8) 15 (65.2) 6 (26.1) 17 (73.9) 12 (52.2) 11 (47.8) 14 (60.9) 9 (39.1) 12 (52.2) 11 (47.8) 15 (55.6) 12 (44.4) 10 (37.0) 17 (63.0) 18 (66.7) 9 (33.3) 24 (88.9) 3 (11.1) 19 (70.4) 8 (29.6) 20 (74.1) 7 (25.9) 14 (51.9) 13 (48.1) 11 (40.7) 16 (59.3) 18 (66.7) 9 (33.3) 17 (63.0) 10 (37.0) 18 (66.7) 9 (33.3) 0.241 0.255 0.529 1.000 0.767 0.548 0.264 0.372 0.388 1.000 0.388 통계적유의한차이는없었다 (Table 1). 2) 사용기구에따른수술후결과 EnSeal TM device군과 LigaSure TM atlas 5 mm군의평균수술시간은각각 207.6±45.3분, 198.9±57.2분으로나타났고 (p=0.558), 평균재원일수는 EnSeal TM device군에서는 7.8± 2.7일, LigaSure TM atlas 5 mm군에서는 9.2±6.2일로나타났다 (p=0.293). 두군에서통계적으로차이는나타나지않았다. 부분대망절제과정에서걸린시간은 EnSeal TM device군에서 11.0±4.5분, LigaSure TM atlas 5 mm군에서 12.6±8.6분으로유의한차이는보이지않았고, 기구의활성화횟수는 EnSeal TM device군에서 43.5±10.2회, LigaSure TM atlas 5 mm군에서 51.6±39.2회로통계적유의성은없었지만 EnSeal TM device군의 활성화횟수가 LigaSure TM atlas 5 mm에비해적게나타나는경향을보였다. 직장간막의다듬기과정에서소요된시간은 EnSeal TM device군이 18.6±10.0분, LigaSure TM atlas 5 mm군이 16.1±6.9분으로큰차이가없었고, 활성화횟수또한 EnSeal TM device군이 44.8±22.3회, LigaSure TM atlas 5 mm군이 49.1±23.7회로통계적인유의한차이는나타나지않았다. 수술중주혈관결찰이실패한경우는충분한기구의활성화후에혈관을절단한후절단면에서출혈이일어난경우로, EnSeal TM device군에서 1예, LigaSure TM atlas 5 mm군의경우에서 2예에서발생했으나모두재활성화를통해지혈이되었고, 두군간의통계적인유의성은없었다. 이외수술후 2일째배액량또한서로의미있는차이를보이지않았다 (Table 2).

42 Journal of Minimally Invasive Surgery Vol. 16. No. 3, 2013 Table 2. Comparison of operative results between EnSeal TM and Ligasure TM 5 mm EnSeal TM LigaSure TM 5 mm n=23 (%) n=27 (%) p value Mean operative time, min Mean hospital stay Mean time of omentectomy, min* Mean number of device activation during omentectomy* Mean time of mesorectal trimming, min Mean number of device activation during mesorectal trimming Mean amount of drainage on POD 2 Cases of coagulation failure 207.6±45.3 7.8±2.7 11.0±4.5 43.5±10.2 18.6±10.0 44.8±22.3 163.9±162.5 1 (4.3) 198.9±57.2 9.2±6.2 12.6±8.6 51.6±39.2 16.1±6.9 49.1±23.7 127.6±105.0 2 (7.4) 0.558 0.293 0.645 0.586 0.418 0.597 0.352 1.000 *Patients who received anterior resection (EnSeal TM 15 cases vs. LigaSure TM 5 mm 19 cases), Patients who received right or left colectomy (EnSeal TM 8 cases vs. LigaSure TM 5 mm 8 cases. 고 Harvey Cushing과 William Bovie에의해전기소작기가보편화된이후에고전적인결찰및절제술보다출혈을줄이고수술시간을절약하기위해여러형태의에너지를이용해혈관을결찰하고조직을절단하는 EBDs의사용이점차늘어나게되었고, 현대외과수술에서이러한 EBDs의사용은필수가되었다. 9 이러한 EBDs들은복강경수술의도입과더불어급속도로발전하게되었고, 특히그동안문제가되었던단극성전기소작기, 양극성전기소작기, 초음파소작기등의초기 EBDs에서나타난주변조직의열손상및결찰된혈관의재출혈등은컴퓨터에의해제어되는양극성전기소작기의도입으로많은개선이이루어져주변조직의손상을최소화시키면서수술시간의단축및출혈의감소를가져오게되었다. 5-8,10 본연구는이러한컴퓨터에의해제어되는양극성전기소작기인 LigaSure TM atlas 5 mm와 EnSeal TM device의유용성을비교하여각기구의장단점을파악하고나아가수술시적절한기구선택에도움을주어수술의효율성및술후합병증의최소화에기여하고자하였다. 이러한 EBDs에서고려해야할중요한기능은 1) 혈관결찰의신뢰성 ( 출혈의감소 ), 2) 사용의유용성 ( 활성시간단축, 조작의편의성 ), 3) 열퍼짐으로인한주변조직열손상의최소화등이있다. 혈관결찰의신뢰성은여러연구에서도많이보고되고있는데이전에사용했던봉합사결찰이나금속클립을사용하는것과동등한임상실험결과를나타내는것은물론, 11 동물실험에서도대부분의 EBDs를사용한다양한크기의혈관에서보여주는파열압 (bursting pressure) 은생리적인혈관압력보다높은압력을나타내고있어혈관결찰의신뢰성은충분히검증되었다고할수있다. 12,13 특히이번연구에서사용한 EnSeal TM device의경우 jaw에적용된 I형칼날 찰 (I-blade) 로인해전반적인부분에걸쳐동일한압력을유지할수있어조직의봉합품질 (sealing quality) 의향상을보여주며, 4 LigaSure TM 를포함한다른 EBDs보다높은파열압을보여주고있다. 13,14 본연구에서도하장간막동맥 (IMA) 이나우결장동맥 (RCA), 회결장동맥 (ICA) 의결찰에서일차적으로이기구를이용했는데기구사용후출혈이되었던경우는 EnSeal TM device에서총 1 (4.3%) 예, LigaSure TM atlas 5 mm 총 2 (7.4%) 예에서활성화후약간의출혈이보여다시기구의활성화를통해지혈시켰고이후수술종료후에도재출혈의경우는보이지않아상당히신뢰할만한수준의혈관지혈결과를보여주었다. 또한복강경대장수술시주요혈관의결찰에대한연구에의하면지혈실패의중요한요인으로환자의동맥경화성변화 (atherosclerotic change) 를들고있고이러한환자의경우 EBDs보다는클립등을이용하는것을권유하고있는데, 5 본연구에서도지혈실패를보인세환자의경우수술전시행한컴퓨터단층촬영에서각주혈관을비롯한주변분지에서석회화를보이는동맥경화성변화가보였던환자로수술전혈관상태를미리파악해두면수술중발생할수있는출혈의위험성에미리대비할수있을것으로생각된다. 수술기구사용의유용성은모든수술기구에서아주중요한요소라할수있다. 이번연구에서도수술의일정술기에한해서얼마만큼빠르게효율적으로기구가작동하는지를알아보고자대장수술과정중무혈관면박리가아닌둔적박리 (blunt dissection) 를시행하게되는수술과정인대망절제과정및직장간막다듬기 (trimming) 과정을수술중에녹화된비디오를확인하여기구의지혈효과, 조직의절단능, 또소요시간등을알아보고자해당술기가진행되는동안소요된시간및기구의활성화횟수를측정하였다. 결론적으로대부분비슷한결과를나나냈고, 통계적인유의성은없었으나 EnSeal TM device의경우대망절제나직장간막다듬기과정에서활성화횟수가 LigaSure TM atlas 5 mm에비

Jun Beom Park et al.: Effectiveness of the EnSeal TM System in the Colorectal Cancer Surgery 43 해적게나타났다. 이는 EnSeal TM device의경우일정시간더적은활성화횟수로조직을절단할수있어기구가한번에절단할수있는길이는 EnSeal TM device의경우 LigaSure TM atlas 5 mm에비해더길게느껴지나상대적으로긴활성화시간이필요한것으로보이며, 반대로기구가활성화되고지혈이완성된후절단까지이루어져기구사용이종료되는시점까지는 LigaSure TM atlas 5 mm가짧아기구를더자주사용하게되고, 절단되는길이는상대적으로 EnSeal TM device의경우보다짧은것으로생각된다. 그러나절단을고려하지않은혈관봉합시간 (Vessel sealing time) 만을측정한한동물연구에의하면 EnSeal TM device의봉합속도는 LigaSure TM atlas 5 mm의경우보다더빠르게보고하고있다. 13 이는실제적으로혈관의봉합이이루어지는시간은길지않은데봉합과절단이구분되어있는 LigaSure TM atlas 5 mm와다르게 EnSeal TM device의경우절단이이루어진후봉합이완료되는구조로, 컴퓨터에의해통제되지않고조직상태에따라술자의판단에의해임의로결정되는절단시간이 EnSeal TM device의경우활성화시간의변수로작용하게되며, 본연구에서는길게이루어졌다고볼수있다. 실제로수술시칼날의전진이 LigaSure TM atlas 5 mm는순식간에이루어지는반면에 EnSeal TM device의경우천천히전진하게되는경향을보이는데, 이는사용하는술자에따라달라질수있을것이라생각된다. 주변조직의열손상에대해서는 EnSeal TM device의경우 LigaSure TM 보다자체온도조절기능으로인해중심온도도낮고, 주변의열퍼짐도적게보고하고있으나, 15 동물조직실험에서는유의한차이를보이지는않고있다. 다만최근에도많이사용되고있는초음파소작기나되먹임기전 (feedback mechanism) 이없는양극성전기소작기에비해서는열퍼짐이훨씬적게보고되고있다. 13 본연구에서는고려되지않았으나복강경수술에서사용되는기구는비용효율성 (cost effectiveness) 에대한고려가중요한데특히우리나라보험환경에서는특히더그러하다. 대장절제술시클립과초기 EBDs 등을사용해서수술을시행한경우와, LigaSure TM 를이용해서수술한경우를비교한연구에의하면초음파전기소작기나일반전기소작기에비해 LigaSure TM 를사용해서수술한경우사용클립의숫자도적고수술시간의감소, 입원기간의감소등으로비용적인장점이있다고보고되고있다. 물론연구대상의숫자도적고외국환경에서이루어진연구라서우리실정에그대로적용하기는어렵지만하나의비용적인장점으로생각해볼수있을것이다. 2,16 결 본연구에서 EnSeal TM device는그동안안전하게사용되어왔던 LigaSure TM atlas 5 mm와유의한차이를보이지않 론 았다. 따라서, 다른 EBDs들과마찬가지로복강경대장수술에서안전하고유용하게이용될수있을것이다. 앞으로도 EnSeal TM device를비롯한다양한 EBDs이개발되고있어이에따른외과의사의선택의폭은계속넓어질것이다. 이러한기구들은각기가지는장점및특징이있으므로, 기구를사용하는외과의사는각기구의장점및특징을정확히파악하고특성에맞게적절히사용해야할것이다. 참고문헌 1) Veldkamp R, Kuhry E, Hop WC, et al. Laparoscopic surgery versus open surgery for colon cancer: short-term outcomes of a randomised trial. Lancet Oncol 2005;6:477-484. 2) Hubner M, Demartines N, Muller S, Dindo D, Clavien PA, Hahnloser D. Prospective randomized study of monopolar scissors, bipolar vessel sealer and ultrasonic shears in laparoscopic colorectal surgery. Br J Surg 2008;95:1098-1104. 3) Covidien I. Available at: http://www.ligasure.com/pages/seal. htm. accessed on February 23, 2013. [cited 2013 February 23]. 4) Ethicon I. Available at: http://www.ethicon.com/healthcareprofessionals/products/energy-devices/enseal-g2-tissue-sealers Acessed on February 23, 2013. [cited 2013 February 23]. 5) 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 vessels during laparoscopic colorectal resection. Tech Coloproctol 2011;15:285-289. 6) Rimonda R, Arezzo A, Garrone C, Allaix ME, Giraudo G, Morino M. Electrothermal bipolar vessel sealing system vs. harmonic scalpel in colorectal laparoscopic surgery: a prospective, randomized study. Dis Colon Rectum 2009;52:657-661. 7) Campagnacci R, de Sanctis A, Baldarelli M, Rimini M, Lezoche G, Guerrieri M. Electrothermal bipolar vessel sealing device vs. ultrasonic coagulating shears in laparoscopic colectomies: a comparative study. Surg Endosc 2007;21:1526-1531. 8) Janssen PF, Brolmann HA, Huirne JA. Effectiveness of electrothermal bipolar vessel-sealing devices versus other electrothermal and ultrasonic devices for abdominal surgical hemostasis: a systematic review. Surg Endosc 2012;26:2892-2901. 9) Massarweh NN, Cosgriff N, Slakey DP. Electrosurgery: history, principles, and current and future uses. J Am Coll Surg 2006;202:520-530. 10) Di Lorenzo N, Franceschilli L, Allaix ME, Asimakopoulos AD, Sileri P, Gaspari AL. Radiofrequency versus ultrasonic energy in laparoscopic colorectal surgery: a metaanalysis of operative time and blood loss. Surg Endosc 2012;26:2917-2924. 11) Marcello PW, Roberts PL, Rusin LC, Holubkov R, Schoetz DJ. Vascular pedicle ligation techniques during laparoscopic colectomy. a prospective randomized trial. Surg Endosc 2006;

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