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1 Journal of Minimally Invasive Surgery Vol. 15. No. 4, 2012 전복막외복강경탈장교정술시행시예방적항생제미사용에대한전향적분석 Original Article 한양대학교의과대학외과학교실 이영훈ㆍ하태경 A Prospective Study of Non-Prophylatic Antibiotics for Totally Extraperitoneal Laparoscopic Repair of Inguinal Hernia Young Hoon Lee, M.D., Tae Kyung Ha, M.D., Ph.D. Department of Surgery, College of Medicine, Hanyang University, Seoul, Korea Purpose: The role of prophylactic antibiotics in totally extraperitoneal (TEP) laparoscopic repair of inguinal hernia is unclear. This study was conducted to evaluate the effects of antibiotic therapy for surgical site infection (SSI) in post TEP laparoscopic repair of inguinal hernia. Methods: We prospectively reviewed data collected from patients with inguinal hernias who were treated by TEP laparoscopic repair between August 2008 and July None of the patients received prophylactic antibiotics. Patients with a history of recurrent hernias, immune suppressive disease or diabetes mellitus were excluded from the study. Results: There were 265 male patients and 15 female patients aged 19 to 82 years. There were 240 indirect, 38 direct, and 2 pantaloon hernias. The mean operating time was 49 minutes, and the mean length of hospital stay was 1.4 days. The most frequent complications of TEP laparoscopic repair of inguinal hernia were ecchymosis (32.85%), followed by wound pain (16.42%). Surgery related complications occurred in two cases (0.71%) of SSI and 13 cases (8.65%) of wound hematoma. No additional surgical treatment for complications were required. No mesh infection occurred in patients during the follow up period. Conclusion: Non-prophylactic antibiotics for elective TEP laparoscopic repair of inguinal hernia appear to be acceptable. Randomized controlled trials of the efficiency of antibiotic therapy in SSI in patients with inguinal hernia should be conducted. Key words: Laparoscopic surgical procedure, Inguinal hernia, Antibiotic prophylaxis, Hernia repair 서 서혜부탈장교정술은외과에서가장흔하게시행되는수술중하나이다. 전세계적으로매년 3백만건이상이시행되고있으며, 1 서혜부탈장은무균수술 (clean surgery) 로서예방적항생제투여가반드시필요한것은아니지만상처감염의빈도는 0% 에서 9% 정도로보고되고있다. 2,3 무긴장성그물망사용이보편화되면서이물질에대한감염의두려움으로예방적항생제를보편적으로사용하고있다. 최근최소침습적인복강경수술의여러가지장점이인식되면서복강경수술을서혜부탈장수술에적용하려는 Received August 16, 2012, Revised 1st, September 28, 2012; 2nd, October 23, 2012, Accepted October 25, 2012 Corresponding author:tae Kyung Ha Department of Surgery, College of Medicine, Hanyang University, 17, Haengdang-dong, Seongdong-gu, Seoul , Korea Tel: , Fax: missurgeon@hanyang.ac.kr 론 시도가적극적으로행해지고있다. 전복막외복강경탈장교정술은통증이적을뿐아니라, 짧은시간내에수술이가능하며, 상처감염을포함한수술후합병증의발생률또한낮으며, 술후회복력이빠르며재원기간이짧아정상적인사회복귀가빠르다. 4 합병증의발생률이낮지만여전히외과상처감염 (Surgical Site Infection) 에대한두려움으로전복막외복강경탈장교정술에서도예방적항생제를사용해오고있다. 외과상처감염의빈도는여러연구에서연구계획, 조사방법, 상처감염의정의, 추적관찰기간, 수술의종류에따라다양한차이를보인다. 5 예방적항생제의사용이인조그물망을이용한개방적탈장교정술에서효과가있는지에대하여무작위대조군연구가있었지만전복막외복강경탈장교정술에서외과상처감염의빈도에관한정확한연구결과는없는실정이다. 3 본연구에서는전복막외복강경탈장교정술에있어서예방적항생제를사용하지않은경우외과상처감염에어떠한영향을주는지에대하여전향적자료를통해조사하였다. This is an open-access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( by-nc/3.0) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

2 Young Hoon Lee and Tae Kyung Ha: Prophylatic Antibiotics in TEP 157 대상및방법 결 과 2008년 8월부터 2012년 7월까지한양대학교병원외과학교실에서집도의한명에의해시행한 365예의전복막외복강경탈장교정술을시행한환자를대상으로항생제를수술전후에사용하지않고수술후발생하는합병증에대하여외래추적검사를통하여조사하였다. 본연구에서수술후감염의위험성이높아제외한환자는다음과같았다. 전복막외복강경탈장교정술을시행중개방적으로전환한 1명, 타질환과동시에수술한 17명, 재발성탈장 24명, 제2형당뇨병을동반한 37명, 암 5명, 면역억제질환 1명을포함한 85명은대상에서제외하였다. 대상군은 명으로연령, 성별, 체질량지수, 수술시간, 재원기간, 수술후합병증항목을분석하였다. 모든환자에서전복막외복강경탈장교정술을시행한경우예방적항생제를사용하지않았으며, 수술전날수술부위면도를시행하였고, 수술중피부소독은포비돈또는 chlorohexidine을사용하여시행하였다. 수술방법은본원에서한명의전문의에의해서시행되었으며복강경을이용한전복막외접근법을사용하였다. 투관침 (Trochar) 의위치는배꼽, 치골상방과그사이 3 군데를사용하였으며, 풍선투관침 (Spacemaker TM Plus) 을이용하여복벽근육의뒷면과복막사이에공간을만들어탈장부위에접근하였다. 탈장낭을박리하고복벽근육의후면으로부터복막을분리한후인조그물망을평평하게편후인조그물망의고정을위해서 tacker 또는 fibrin glue는사용하지않았다. 인조그물망은 Polyester mesh (Parietex) 를사용하였으며, 수술후상처봉합은 histoacryl 또는 dermabond를사용하였다. 식이는당일 8시간후부터물부터시작하였으며, 퇴원은수술후당일퇴원도가능하다고하였지만대부분수술다음날내지는이틀후에하게되었다. 수술후일주일후외래에서합병증유무를확인하였다. 모든환자는상처감염발생시생길수있는증상이나징후에대하여퇴원전교육하였다. 그다음외래추적관찰은 1개월후로하였으며외과상처감염 (SSI) 의정의는수술후 30일이내에발생하는감염으로 Center for Disease Control (CDC) criteria를사용하였다. 6 그정의는아래와같다. SSI was grouped as follows (using CDC criteria): Superficial SSI: Wound cellulitis/erythema/purulent discharge from the wound Deep SSI: Mesh infection 1) 성별및연령 전복막외복강경탈장교정술을실시하였던 명의환자중남자는 265명이었고, 여자는 15명이었고, 연령분포는 10대부터 80대로분포하였으며, 50대에서 60대가 44.8% 로비교적높은분포를보이며, 상대적으로젊은 20 30대에비해많았다. 2) 체질량지수 (Body Mass Index) 전체 예에대하여체질량지수를산출하였고평균체질량지수는 25.34±3.5 kg/m 2 이었으며, 정상체중과과체중은각각 215예, 60예였다. 과체중의기준은 WHO 기준 7 에따라체질량지수 25 이상으로하였다. 3) 동반질환유무 과거력에서고혈압, 협심증, 천식, 만성폐쇄성폐질환, 뇌졸중등내과적질환이동반되어있는경우는 175예 (62.5%) 였으며, 급성충수돌기염, 담낭수술, 위절제술, Whipple씨수술, 방광암수술등외과적복부수술을시행받았던경우는 44예 (15.71%) 였다 (Table 1). 4) 탈장의형태 탈장의형태는간접탈장 240예 (85.71%), 직접탈장 38예 (13.57%), 양측성이 2예 (0.07%) ( 각각좌, 우탈장의형태가달랐음 ) 였다 (Table 2). 5) 수술시간 환자의수술시간은전체 예중 230예 (82%) 에서 60분이하를나타내었으며, 특히 30분미만의경우도 92예 (32%) 를차지하였다 분이가장높은빈도 (49.28%) 를차지하였으며, 평균수술시간은 49±30분이었다 (Table 3). 수술시간은피부절개에서창상봉합까지의시간으로산정하였다. Table 1. Previous abdominal operation history Acute appendicitis Acute cholecystitis Stomach cancer Bladder cancer Whipple operation Total Patients (%) % 5.35% 1.78% 1.07% 0.35% 15.71%

3 158 Journal of Minimally Invasive Surgery Vol. 15. No. 4, 2012 Table 2. Baseline characteristics Table 3. Operative data Age (years) Sex Male Female BMI Underweight (<18.50) Normal range (18.50 BMI<25) Overweight (25 BMI<30) Obese (30 BMI) ASA grade ASA I ASA II ASA III Comorbidity Absent Present Type of hernia Direct Indirect Both Side of hernia Rght Left Both Drain use Absent Present Number of patients (%) (58.88) 265 (94.64%) 15 (5.35%) 5 (1.78%) 215 (76.78%) 52 (18.57%) 8 (2.85%) 152 (54.28%) 113 (40.35%) 15 (5.35%) 105 (37.52%) 175 (62.51%) 38 (13.57%) 240 (85.71%) 2 (0.07%) 145 (51.78%) 94 (33.57%) 41 (14.64%) 277 (98.92%) 3 (0.01%) ASA grade = American Society of Anesthesiologists grade; BMI = body mass index. Duration of operation (min) < Mean Anesthesia GA LA RA Post op stay (day) Number of patients 92 (32.85%) 138 (49.28%) 50 (17.85%) 49±30 (100.00%) 0 (0%) 0 (0%) 1.43±1.25 GA = general anesthesia; LA = local anesthesia; RA = regional anesthesia. Table 4. Complication after totally extraperitoneal laparoscopic repair of hernia Ecchymosis Wound pain Scrotal swelling Hematoma Urinary problem* Wound swelling Wound infection Seroma Mesh infection Total Number of patients (%) % 16.42% 8.57% 4.64% 3.21% 1.07% 0.71% 0% 0% 62.14% *Urinary problem = Urinary retention. 6) 재원기간 재원기간은평균 1.43일이었으며, 대부분이 (94.3%) 1일이내에퇴원하였다 (Table 3). 7) 수술후합병증전체 예중합병증은 174예 (62%) 에서발생하였고, 합병증은반상출혈 77예 (32.85%), 상처통증 46예 (16.42%), 음낭종창 24예 (8.57%), 혈종 13예 (4.64%), 비뇨기과적장애 9예 (3.21%), 상처부종 3예 (1.07%), 상처감염 2예 (0.71%) 가나타났다 (Table 4). 재수술한경우는없었다. 1주일후외래진료는대상환자모두진료를보았으며, 상처부종, 혈종, 음낭종창등의합병증발생이후다른합병증으로진행한경우는없었다. 상처감염은 2예에서배꼽투관침부위에발생하였고퇴원후 1주일후외래에서발견하였으며, 항생제를사용하지않고창상절개후배농만으로도각각 5일, 8일간의외래처치로치료가능하였다. 2예에서성별은모두남자였으며, 연령은각각 45세, 57세체질량지수는각각 28.5 kg/m 2, 26.3 kg/m 2 이었으며, 수술시간은각각 50분, 60분이었다. 다른동반질환은없었다. 수술후통증은입원부터퇴원할때까지관찰하였고, 진통제는데메롤 (pethidine, Demerol R ) 과비스테로이드성소염제 (carol-f R ) 를사용하였다. 고 서혜부탈장은가장흔한외과수술중의하나이다. 비록대부분의환자들이무증상이거나국소적인증상을호소하지만교액이나감돈등의심각한합병증을유발할수있다. 수술의방법은전복막외복강경탈장교정술과개방적탈장교정술이시행되고있으며, 인공삽입물등이사용되기도한다. 1975년이후로인조그물망을사용하고있으며, 무긴장성탈장교정술의중요한요소가되고있다. 8 찰

4 Young Hoon Lee and Tae Kyung Ha: Prophylatic Antibiotics in TEP 159 최근에는외과영역에서복강경수술에대한장점이널리인정되면서복강경탈장교정술에대한관심이고조되어이미여러기관에서전복막외복강경탈장교정술이활발하게시행되고있다. 현재수술술기의발전으로최근연구에서는전복막외복강경탈장교정술의재발률은 % 로낮게보고되고있으며, 수술후통증이적고, 회복기간이빨라조기직장복귀가가능하며, 재발성탈장의교정이쉽고, 동시에진단적복강경을실시할수있어서혜부탈장교정술의표준술식으로자리잡을수있을지에대한연구들이많이진행되고있다. 4 복강경수술은개복수술에비해외과상처감염의발생비율을낮춘다. 8 하지만외과상처감염은전복막외복강경탈장교정술의합병증중의하나이며예방적항생제의사용이가장효과적이라고생각되어왔으며, 예방적항생제의사용은무균오염수술 (Clean-contaminated surgery) 로분류되는수술에폭넓게사용되고있다 Celdrán 등 12 과 Tzovara 등 11 의연구에의하면외과상처감염환자들중 93% 가표면외과상처감염 (superficial SSI) 인것으로보고되었으며, 인조그물망감염은 % 내외인것으로보고되고있다. 8,13,14 그러나전복막외복강경탈장교정술같은무균수술에반드시필요한지는의문이다. 전복막외복강경탈장교정술후에생기는합병증으로장골혈관의손상, 대퇴신경의손상으로인한감각이상과무감각, 다리근육의위축, 음낭의혈종및부종, 외과상처감염, 드물게방광의손상, 이산화탄소주입으로유발된피하기종등이있다. 15 본연구에서수술후합병증은반상출혈 (77예), 상처통증 (46예), 음낭종창 (24예), 혈종 (13예), 비뇨기과적장애 (9예), 상처부종 (3예), 상처감염 (2예) 이나타났다. 일부연구에서는탈장이나유방수술의경우예방적항생제의사용이외과상처감염을예방하는데효과가분명하다고하였고, 8,16,17 또다른연구에서는탈장수술에있어서외과상처감염의예방에효과적인지는분명하지않다고하였다. 13,18,19 일부연구에서는예방적항생제의사용이상처감염의 8 1.7% 까지줄일수있다고하였다. 20,21 본연구에서는전복막외복강경탈장교정술에서예방적항생제를사용하지않고생긴상처감염의빈도는 2예 (0.71%) 였으며, 적절한배농과상처소독으로처치가가능하였다. 감염이생길확률은인조그물망을사용한경우와그렇지않은경우에차이는없다. 22 인조그물망을사용한경우에생긴감염의경우적절한배액과상처관리, 균배양검사에서적절한항생제의사용으로치료가가능하며, 인조그물망의구멍크기 (pore size) 가항생제의침투가용이할정도로크기때문에감염된인조그물망의제거는필요없다. 23 상처감염의경우에도대부분의경우항생제를사용하지않고창상절개후배농만으로도처치가가능하다. 본연구에서단지 2명만이상처감염이발생하였으며, 첫번째외래방문에서발견하게되었다. 예방적항생제를사용한다른연구에서도모든감염환자는퇴원후외래에서감염을확인하였다고한다. 16 이는상처감염의발견에외래추적관찰이가장중요하다는것을말해준다. 복강경수술이개복수술에비하여외과상처감염이적다고많은연구에서보고되었기때문에예방적항생제를사용하여수술한경우에대한비교연구가필요할것이며, 감염의위험성이있는고위험군을연구대상에서제외한결과이므로고위험군에대한추적관찰도필요할것이다. 결 전복막외복강경탈장교정술은무균수술로분류되며, 외과적수술술기향상과더불어수술시간의단축등을통해상처감염의기회가줄어들었다. 본연구에서는항생제를사용하지않았음에도불구하고외과상처감염의발생은 2 명만발생하였으며, 이는전복막외복강경탈장교정술시외과상처감염의위험성은높지않은것으로생각되며모든환자에서예방적항생제를사용하는것은적절치않을것으로사료된다. 론 참고문헌 1) Deysine M. Postmesh herniorrhaphy infection control. Int Surg 2004;8: ) Stephenson BM. Complications of open groin hernia repair. Surg Clin North Am 2003;83: ) Yerdel MA, Akın EB, Dolalan S, et al. Effect of single-dose prophylactic ampicillin and sulbactam on wound infection after tension-free inguinal hernia repair with polypropylene mesh. Ann Surg 2001;233: ) Kim SG, Park SH, Choi SY, Kim HS, Kim TH. Laparoscopic totally extraperitoneal hernia repair for inguinal hernia patients: results of 92 cases. J Korean Soc Endosc Laparosc Surg 2011;14: ) Cheek CM, Williams MH, Farndon JR. Trusses in the management of hernia today. Br J Surg 1995;82: ) Horan TC, Gaynes RP, Martone WJ, Jarvis WR, Emori TG. CDC definitions of nosocomial surgical site infections, 1992: a modification of CDC definitions of surgical wound infections. Infect Control Hosp Epidemiol 1992;13: ) WHO (World Health Organization). Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. WHO Technical Report Series 854. Geneva: World Health Organization; ) Patino JF, Garcia-Herreros LG, Zundel N. Inguinal hernia repair: the Nyhus posterior preperitoneal operation. Surg Clin North Am 1998;78:

5 160 Journal of Minimally Invasive Surgery Vol. 15. No. 4, ) D Amico DF, Parimbelli P, Ruffolo C. Antibiotic prophylaxis in clean surgery: breast surgery and hernia repair. J Chemother 2001;13: ) Perez AR, Roxas MF, Hilvano SS. A randomized, double-blind, placebocontrolled trial to determine effectiveness of antibiotic prophylaxis for tensionfree mesh herniorrhaphy. J Am Coll Surg 2005;200: ) Tzovaras G, Delikoukos S, Christodoulides M, et al. The role of antibiotic prophylaxis in elective tension-free mesh inguinal hernia repair: results of a single-centre prospective randomised trial. Int J Clin Pract 2007;61: ) Celdrán A, Frieyro O, de la Pinta JC, et al. The role of antibiotic prophylaxis on wound infection after mesh repair under local anesthesia on an ambulatory basis. Hernia 2004;8: ) Gupta R, Sinnett D, Carpenter R, Preece PE, Royle GT. Antibiotic prophylaxis for post-operative wound infection in clean elective breast surgery. Eur J Surg Oncol 2000;26: ) Delikoukos S, Tzovaras G, Liakou P, Mantzos F, Hatzitheofilou C. Late-onset deep mesh infection after inguinal hernia repair. Hernia 2007;11: ) Corbitt JD Jr. Transabdominal preperitoneal herniorrhaphy. Surg Laparosc Endosc 1993;3: ) Lewis RT, Weigand FM, Mamazza J, Lloyd-smith W, Tataryn D. Should antibiotic prophylaxis be used routinely in clean surgical procedures: a tentative yes. Surgery 1995;118: ) Platt R. Antibiotic prophylaxis in clean surgery. New Horiz 1998;6: ) Knight R, Charbonneau P, Ratzer E, Zeren F, Haun W, Clark J. Prophylactic antibiotics are not indicated in clean general surgery cases. Am J Surg 2001;182: ) Leaper DJ, Melling AG. Antibiotic prophylaxis in clean surgery: clean non-implant wounds. J Chemother 2001;13: ) Kinirons B, Mimoz O, Lapendi LP, Naas T, Meunier JF, Nordmann P. Chlorhexidine versus povidone iodine in preventing colonization of continuous epidural catheters in children: a randomized. Anesthesiology 2001;94: ) Aufenacker TJ, van Geldere D, van Mesdag T, et al. The role of antibiotic prophylaxis in prevention of wound infection after Lichtenstein open mesh hernia repair of primary inguinal hernia. A multicenter double-blind randomized controlled trial. Ann Surg 2004;240: ) Perez AR, Roxas MF, Hilvano SS. A randomized, doubleblind, placebo-controlled trial to determine effectiveness of antibiotic prophylaxis for tension-free mesh herniorrhaphy. J Am Coll Surg 2005;200: ) Petersen S, Henke G, Freitag M, Faulhaber A, Ludwig K. Deep prosthesis infection in incisional hernia repair: predictive factors and clinical outcome. Eur J Surg 2001;167:

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