Comparison of hand assisted laparoscopic surgery and conventional laparotomy for rectal cancer: Interim results from a single center

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1 MOLECULAR AND CLINICAL ONCOLOGY 3: Comprison of hnd ssisted lproscopic surgery nd conventionl lprotomy for rectl cncer: Interim results from single center TAKAYUKI TAJIMA 1, MASAYA MUKAI 2, WATARU NOGUCHI 2, SHIGEO HIGAMI 2, SHUUJI UDA 2, SOUICHIROU YAMAMOTO 2, SAYURI HASEGAWA 2, EIJI NOMURA 2, SOTARO SADAHIRO 1, SEIEI YASUDA 1 nd HIROYASU MAKUUCHI 1,2 1 Deprtment of Surgery, Toki University School of Medicine, Isehr, Kngw ; 2 Deprtment of Surgery, Toki University Hchioji Hospitl, Hchioji, Tokyo , Jpn Received December 12, 2014; Accepted Jnury 27, 2015 DOI: /mco Abstrct. Minimlly invsive lproscopic surgery hs become widespred nd the indictions for such surgery hve recently been extended to vrious conditions, including rectl cncer. The objective of this study ws to compre the clinicl outcome of hnd ssisted lproscopic surgery (HALS) nd conventionl lprotomy (CL) in ptients with rectl cncer. Ptients who underwent rdicl resection of stge I III primry rectl cncer (n=111) were clssified into those receiving HALS (n=57) nd those receiving CL (n=54); the two groups were mtched for stge nd postopertive tretment. The 3 yer relpse free survivl (3Y RFS) nd 3 yer overll survivl (3Y OS) were clculted nd compred between the two groups. Intropertive blood loss, operting time, postopertive hospitl sty nd complictions were lso compred between the two groups. There were no significnt differences in 3Y RFS or 3Y OS between the HALS nd CL groups for ptients with ll stge (I, II nd III) rectl cncer. The men (medin) intropertive blood loss ws (247.0) ml in the HALS group vs (555.5) ml in the CL group (P<0.001). The men (medin) postopertive hospitl sty ws 19.8 (17) nd 25.5 (18.3) dys, respectively (P=0.039). There were no significnt differences in the operting time or the incidence of complictions between the two groups. Bsed on these results, HALS ws found to be comprble to CL regrding survivl, while chieving less Correspondence to: Dr Tkyuki Tjim, Deprtment of Surgery, Toki University School of Medicine, 143 Shimoksuy, Isehr, Kngw , Jpn E mil: tkyukitjim1970@yhoo.co.jp Abbrevitions: HALS, hnd ssisted lproscopic surgery; CL, conventionl lprotomy; LACS, lproscopy ssisted colorectl surgery Key words: rectl cncer, hnd ssisted lproscopic surgery, conventionl lprotomy, lproscopy ssisted colorectl surgery, lproscopic surgery blood loss nd superior cosmetic outcome. However, longer follow up is required to confirm these findings. Introduction Over the lst few yers, minimlly invsive lproscopic surgery hs become widespred. The indictions for such surgery hve been extended to vrious conditions, including dditionl bowel resection for stge I rectl cncer, rdicl resection of stge II or III rectl cncer nd pllitive surgery in ptients with stge IV rectl cncer (1 6). With conventionl lprotomy (CL) for rectl cncer, it is difficult to visulize res such s the pelvic floor, the ventrl prt of the bldder nd the posterior to picl regions of the prostte nd lmost blind mnipultion is required. By contrst, endoscopic mgnifiction nd viewing monitor llows procedures to be performed more sfely, lthough the difficulty of rectl cncer surgery increses with the depth of the lesion in the pelvis, prticulrly lower rectl cncer locted t the pelvic floor (4). In Jpn, pure lproscopy ssisted colorectl surgery (LACS) is frequently performed using 5 6 ports, including cmer port nd smll incision of mm for nstomosis. However, 4 forceps re required for severl procedures in pure LACS; therefore, t lest 2 surgeons skilled in LACS must prticipte in the opertion, while the long operting time puts significnt pressure on the nesthesiologists nd the vilbility of operting theters. In ddition, LACS requires dditionl eduction nd technicl guidnce, s well s costly equipment nd surgicl mterils; thus, performing pure LACS t medium sized hospitls with beds is ssocited with vrious problems (4 8). The mjority of the studies compring pure LACS with CL demonstrted tht the former method is ssocited with lower incidence of wound infections nd shorter hospitl sty, while chieving comprble or superior survivl, with more cceptble cosmetic outcome (7 10). However, hnd ssisted lproscopic surgery (HALS) nd hybrid HALS (HH), which re bsed on mnipultion under direct vision, re more populr compred to pure LACS in Europe nd the United Sttes. HH hs the following dvntges: i) It llows sfe plption nd grsping with the left

2 534 TAJIMA et l: HALS VS. LAPAROTOMY FOR RECTAL CANCER hnd ccording to the techniques lerned for lprotomy, which llows smooth hndling of lrge, hevy tumors nd lso llows the surgeon to rpidly nd esily pull the resected intestines wy from the pelvic floor under direct vision, s in lprotomy; ii) since HH is bsed on lprotomy, the operting time is reltively short; nd iii) it does not require long time to lern the skills necessry to perform HH (8,9,11 17). In Jpn, CL ccounts for ~50% of rectl cncer surgery nd pure LACS ccounts for ~30 40%, with HALS nd smll incision surgery constituting the remining 10 20% (18). The mjority of the studies compring HALS nd pure LACS hve demonstrted tht the operting time is shorter with HALS nd the rte of conversion to open lprotomy is low; HALS my thus be considered s surgicl technique between CL nd pure LACS (8,9,19 23). In Jpn, HALS ws widely used s n djunctive method for brief period until pure LACS ws introduced in 2000; however, the use of HALS hs noticebly decresed since the stndrdiztion of pure LACS. Therefore, lthough certin single center studies on HALS hve been performed overses, no such report hs been published in Jpn (9,24,25). Accordingly, the objective of this study ws to compre the clinicl outcome of HALS nd CL in ptients with rectl cncer treted t single center in Jpn. Ptients nd methods Ptients. A totl of 850 ptients underwent curtive resection of primry colorectl cncer t Toki University Hchioji Hospitl (Tokyo, Jpn) between April, 2002 nd December, HALS ws employed to tret colorectl cncer from July, 2007 onwrds nd ws used in t lest 350 ptients. A totl of 54 ptients who underwent conventionl CL prior to the introduction of HALS were selected from the 850 ptients s stge mtched historicl controls, wheres the HALS group comprised 57 ptients. The men/medin ge ws 65.4/65.0 yers (rnge, yers) in the HALS group nd 67.0/68.5 yers (rnge, yers) in the CL group (P=0.095) (Tble IA). Of the 57 ptients in the HALS group, 43 (75.4%) were mle nd 14 (24.6%) were femle; of the 54 CL ptients, 35 (64.8%) were mle nd 19 (35.2%) were femle, with no significnt differences between the two groups (P=0.221) (Tble IB). As regrds tumor loction, the tumor ws locted t the rectosigmoid region in 20 ptients (35.1%) from the HALS group nd 20 (37.0%) from the CL group (P=0.831); in the upper rectum in 21 ptients (36.8%) from the HALS group nd 14 (25.9%) from the CL group (P=0.216); nd in the lower rectum in 16 ptients (28.1%) from the HALS group nd 20 (37.0%) from the CL group (P=0.313). There were no significnt differences between the two groups (Tble IC). A totl of 11 ptients (19.3%) in the HALS group nd 12 (22.2%) in the CL group underwent nterior resection (P=0.704); 39 ptients (68.4%) in the HALS group nd 33 (61.1%) in the CL group underwent low nterior resection (P=0.420); nd 7 ptients (12.3%) in the HALS group nd 9 (16.7%) in the CL group underwent Miles' opertion (P=0.511). There were no significnt differences between the two groups (Tble. IIA). The CL group included 54 ptients who underwent rdicl resection (stge I, 10 ptients; stge II, 20 ptients; nd stge III, 24 ptients) prior to August, 2007 nd received the sme postopertive djuvnt chemotherpy nd follow up Tble I. Comprison of ptient ge, gender nd tumor loction between the HALS (n=57) nd CL (n=54) groups. A, Comprison of ptient ge Age (yers) HALS CL P-vlue Averge Medin (rnge) 65.0 (55-81) 68.5 (35-92) B, Comprison of ptient gender Gender HALS, no. (%) CL, no. (%) P-vlue b Mle 43 (75.4) 35 (64.8) Femle 14 (24.6) 19 (35.2) C, Comprison of tumor loction Loction HALS, no. (%) CL, no. (%) P-vlue b RS 20 (35.1) 20 (37.0) R 21 (36.8) 14 (25.9) Rb 16 (28.1) 20 (37.0) Mnn-Whitney U test. b Chi-squre test. There were no significnt differences in ptient ge, gender nd tumor loction between the two groups. HALS, hnd ssisted lproscopic surgery; CL, conventionl lprotomy; RS, rectosigmoid; R, rectum bove peritonel reflection; Rb, rectum below peritonel reflection. s the those in the HALS group (Tble IIB). These historicl controls were mtched for stge with the 57 ptients who underwent HALS (stge I, 17 ptients; stge II, 14 ptients; nd stge III, 26 ptients) from 2007 onwrds. For ll ptients in both groups, the opertive indictions were s follows: A performnce sttus of 0 2, no severe crdiopulmonry complictions, no lterl lymph node metstsis or invsion of multiple orgns nd tumor not filling the pelvic cvity prior to surgery (4,26,27). The present study ws pproved by the Institutionl Review Bord of Toki University Hchioji Hospitl nd ll the ptients provided written informed consent. Tretment. CL involved midline lprotomy with n incision of 30 cm or longer, wheres HALS ws performed with 3 ports (rectum, 5/12/5 mm) nd verticl incision of ~45 55 mm in the umbilicl region (4,26,27). In ccordnce with the Jpnese Generl Rules for Clssifiction of Colorectl Crcinom, D2,3 resection ws performed nd t lest 12 lymph nodes were hrvested in ll the ptients from both groups (28 30). No postopertive djuvnt chemotherpy ws dministered to stge I ptients; orl nticncer gents were dministered to stge II ptients (400 mg/m 2 tegfur/urcil nd 3 g of polyscchride K 5 dys/week for t lest 6 months); nd modified 5 fluorourcil/leucovorin (5 FU/LV) or modified FOLFIRI (5 FU/LV + irinotecn: 85 mg/m 2 of irinotecn twice month nd 350 mg/m 2 of 5 FU plus 150 mg/m 2 LV on 5 consecutive

3 MOLECULAR AND CLINICAL ONCOLOGY 3: Tble II. Comprison of opertive method nd tumor stge between the HALS (n=57) nd CL (n=54) groups. A, Comprison of opertive method Opertive HALS, CL, method no. (%) no. (%) P-vlue Anterior 11 (19.3) 12 (22.2) resection Low nterior 39 (68.4) 33 (61.1) resection Miles' 7 (12.3) 9 (16.7) opertion B, Comprison of tumor stge HALS, CL, Tumor stge no. (%) no. (%) P-vlue I 17 (29.8) 10 (18.5) II 14 (24.6) 20 (37.0) III 26 (45.6) 24 (44.4) Figure 1. The 3 yer relpse free survivl rte (3Y RFS) of the HALS group nd the CL group were clculted by the Kpln Meier method nd compred with the log rnk test nd hzrd rtio with 95% confidence intervl (CI). The 3 yer men follow up rte ws 97.3%. HALS, hnd ssisted lproscopic surgery; CL, conventionl lprotomy. Chi-squre test. There were no significnt differences in opertive method nd tumor stge between the two groups. HALS, hnd ssisted lproscopic surgery; CL, conventionl lprotomy. dys/month) ws dministered to stge III ptients for t lest 6 months (31 36). Survivl. To identify metstsis/recurrence, we performed ultrsound scn/computerized tomogrphy (US/CT) nd mesured tumor mrkers 3 4 times/yer. If metstsis/recurrence ws identified by both US nd CT, this ws defined s metstsis/recurrence in the present study (31 36). For ptients t ech stge (I, II nd III) from the two groups, the 3 yer relpse free survivl (3Y RFS) nd 3 yer overll survivl (3Y OS) were clculted. The men nd medin vlues of blood loss, operting time nd postopertive hospitl sty, s well s the rte of conversion to open lprotomy (only in the HALS group) were lso clculted. Furthermore, we compred postopertive complictions, such s wound infection, ileus, nstomotic lekge nd re opertion, between the two groups. Sttisticl nlysis. The Kpln Meier method ws employed to estimte 3Y RFS nd 3Y OS, while the log rnk test nd hzrd rtio (HR) [(95% confidence intervl (CI)] were used for comprisons between the two groups. For other nlyses, the χ 2 test nd Mnn Whitney U test were used. P<0.05 ws considered to indicte sttisticlly significnt difference. Anlyses were performed with SPSS 21.0 sttisticl softwre (IBM Corportion, Armonk, NY, USA). Results Comprison of survivl between the two groups. The 3Y RFS of ptients with stge I, II nd III disese (n=111) ws 80.7% Figure 2. The 3 yer overll survivl rte (3Y OS) of the HALS group nd the CL group were clculted by the Kpln Meier method nd compred with the log rnk test nd hzrd rtio with 95% confidence intervl (CI). The 3 yer men follow up rte ws 97.3%. HALS, hnd ssisted lproscopic surgery; CL, conventionl lprotomy. in the HALS group (n=57) nd 77.4% in the CL group (n=54) [P=0.628; HR=0.87 (95% CI: )] (Fig. 1). In ddition, the 3Y OS ws 96.5% in the HALS group (n=57) vs. 86.8% in the CL group (n=54) [P=0.064; HR=0.27 (95% CI: )] (Fig. 2). The 3 yer follow up rte ws 98.3% in the HALS group nd 96.3% in the CL group (men, 97.3%). Intropertive fctors nd hospitl sty. The men/medin intropertive blood loss ws 344.0/247.0 (rnge, ) ml in the HALS group (n=57) nd 807.5/555.5 ( ) ml in the CL group (n=54) (P<0.001) (Tble III). The men/medin operting time ws 3 h 51 min/3 h 34 min (1 h 57 min 7 h 49 min) in the HALS group (n=57) nd 3 h 52 min/3 h 38 min

4 536 TAJIMA et l: HALS VS. LAPAROTOMY FOR RECTAL CANCER Tble III. Intropertive fctors nd hospitl sty in the HALS nd CL groups. HALS CL Vribles (n=57) (n=54) P-vlue Blood loss b <0.001 Men ml ml Medin (rnge) (15-1,969) ml (121-4,293) ml Operting time Men 3 h 51 min 3 h 52 min Medin (rnge) 3 h 34 min (1 h 57 min-7 h 49 min) 3 h 38 min (2 h 06 min-7 h 12 min) Postopertive hospitl sty Men 19.8 dys 25.5 dys Medin (rnge) 17.0 (8-55) dys 18.5 (12-97) dys Mnn-Whitney U test. b Dt unknown for 1 ptient in the HALS nd 4 ptients in the CL group. HALS, hnd ssisted lproscopic surgery; CL, conventionl lprotomy. (2 h 06 min 7 h 12 min) in the CL group (n=54) (P=0.454) (Tble III). The men/medin postopertive hospitl sty ws 19.8/17.0 (8 55) dys in the HALS group (n=57) nd 25.5/18.5 (12 97) dys in the CL group (n=54) (P=0.039) (Tble III). Postopertive complictions. In the HALS group (n=57), the postopertive complictions included wound infection in 4 ptients (7.0%), ileus in 4 ptients (7.0%), nstomotic lekge in 3 ptients (5.3%), urinry trct injury in 1 ptient (1.8%) nd re opertion in 2 ptients (3.5%). There were no cses of conversion to open lprotomy (0.0%) (Tble IV). In the CL group (n=54), these complictions occurred in 9 (16.7%), 2 (3.7%), 3 (5.6%), 4 (7.4%) nd 3 ptients (5.6%), respectively; there were no significnt differences in the incidence of complictions between the two groups (Tble IV). Discussion In Jpn, ~30 40% of rectl cncer surgeries re performed by pure LACS, CL ccounts for ~50%, while HALS nd smll incision surgery re used for the remining 10 20% (18). Since pure LACS hs rpidly been dopted over the lst few yers, severl studies compring pure LACS with CL or HALS hve been reported (8,9,19 23). However, there is mjor problem with the mjority of the studies. Usully, single center comprison of surgicl procedures employs the CL group s control; however, it is difficult to void bis of bckground fctors in studies of pure LACS or HALS, s these procedures tend to be used for low risk ptients with reltively good generl condition, who re ble to tolerte the oblique position with the hed down, or ptients with erly stge disese. In ddition, it my be difficult to chieve unifiction of second line tretment, including postopertive chemotherpy nd rdiotherpy, s well s tretment following recurrence (4 10). Moreover, if ntionl clinicl dtbses or guidelines re used s controls, the study becomes stge strtified comprison of outcomes with the ntionl stndrds, which is not pproprite for compring surgicl procedures. In our study, the CL group ws selected from ptients who underwent surgery prior to the Tble IV. Postopertive complictions in the HALS nd CL groups. HALS, no (%) CL, no (%) Complictions (n=57) (n=54) P-vlue Wound 4 (7.0) 9 (16.7) infection Ileus 4 (7.0) 2 (3.7) Anstomotic 3 (5.3) 3 (5.6) lekge Urinry 1 (1.8) 4 (7.4) trct injury Re-opertion 2 (3.5) 3 (5.6) Others 3 (5.3) 5 (9.3) Conversion 0 (0.0) to CL Chi-squre test. HALS, hnd ssisted lproscopic surgery; CL, conventionl lprotomy. introduction of HALS nd we ensured tht they were mtched for stge nd received the sme postopertive djuvnt chemotherpy s the HALS group. All opertions in both groups were performed by Muki et l (4,27), so the mngement of stge I, II nd III rectl cncer ws stndrdized nd t lest 6 months of tretment ws completed by >80% of the ptients in the two groups (dt not shown). In ddition, <20% of the ptients were censored from our dtbse, including those with unknown detils/dropout, which conforms to the Jpnese Society for Cncer of the Colon nd Rectum Guidelines 2010 for the Tretment of Colorectl Cncer nd the dtbse used in this study hd totl censored rte of 11.9% for the HALS group vs. 1.8% for the CL group (P=0.001, dt not shown). Furthermore, ll the ptients were followed up for 3 yers, with 3 yer follow up rte of 98.3% for the HALS group nd 96.3% for the CL group. We re plnning to perform finl nlysis in the next 2 yers.

5 MOLECULAR AND CLINICAL ONCOLOGY 3: Studies compring pure LACS with CL hve identified problems with the former, including longer operting time nd incresed cost, lthough the hospitl sty is shorter nd nlgesic use is decresed (7 10). There re lso other problems with performing pure LACS t medium sized hospitls with beds, including the need for skilled surgeons, the trining requirements, the pressure on the nesthesiologists due to longer opertions, longer occuption of operting theters nd greter consumption of mterils. The comprison of pure LACS with HALS hs lso identified problems, such s the slower lerning curve for pure LACS, dditionl time required nd differences in the conversion rte to open surgery (8,9,19 23). It hs been reported tht HALS is ssocited with mrkedly lower conversion rte compred to pure LACS, with the rte being 0.0% (0/57 ptients) in our study. This result indictes tht preopertive dignosis nd our indictions for HALS were strict nd pproprite (2,4,7). In ddition, there ws less blood loss nd shorter hospitl sty with HALS compred to CL, suggesting tht HALS my be performed sfely bsed on strict indictions by employing the mgnified view obtined with lproscopy. In conclusion, HALS is sfe nd relible procedure tht utilizes the sme left hnd mnipultion s CL nd llows plption/touch s it is positioned between pure LACS nd CL. Since HALS my be performed reltively esily t low cost, we consider it to be n excellent therpeutic option tht deserves re evlution, prticulrly in Jpn, due to the decresing vilbility of surgeons nd nesthesiologists. Acknowledgements This study ws supported by grnt from the Hnd Assisted Lproscopic Surgery Reserch Group (grnt no ; Toki University Hchioji Hospitl, Hchioji, Tokyo, Jpn) nd the Reserch nd Study Progrm of Toki University Eductionl System Generl Reserch Orgniztion (grnt no ; Toki University Hospitl, Isehr, Kngw, Jpn). References 1. 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6 538 TAJIMA et l: HALS VS. LAPAROTOMY FOR RECTAL CANCER 28. Muki M, Ito I, Mukoym S, Tjim T, Sito Y, Nkski H, Sto S nd Mkuuchi H: Improvement of 10 yer survivl by Jpnese rdicl lymph node dissection in ptients with Dukes' B nd C colorectl cncer: A 17 yer retrospective study. Oncol Rep 10: , Jpnese Society for Cncer of the Colon nd Rectum (JSCCR): Generl Rules for Clinicl nd Pthologicl Studies on Cncer of the Colon, Rectum nd Anus. 7th edition, revised version. Knehr Shuppn, Tokyo, Jpn, Jpnese Society for Cncer of the Colon nd Rectum: JSCCR Guidelines 2010 for the Tretment of Colorectl Cncer. Knehr & Co., Ltd., Tokyo, Jpn, Muki M, Tjim T, Nkski H, Sto S, Ogoshi K nd Mkuuchi H: Efficcy of postopertive djuvnt orl immunochemotherpy in ptients with Dukes' B colorectl cncer. Ann Cncer Res Therp 11: , Muki M, Tjim T, Nkski H, Sto S, Ogoshi K nd Mkuuchi H: Efficcy of postopertive djuvnt orl immunochemotherpy in ptients with Dukes' C colorectl cncer. Ann Cncer Res Therp 11: , Ito I, Muki M, Ninomiy H, Kishim K, Tsuchiy K, Tjim T, Oid Y, Nkmur M nd Mkuuchi H: Comprison between intrvenous nd orl postopertive djuvnt immunochemotherpy in ptients with stge II colorectl cncer. Oncol Rep 20: , Ito I, Muki M, Ninomiy H, Kishim K, Tsuchiy K, Tjim T, Nkmur M nd Mkuuchi H: Comprison between intrvenous nd orl postopertive djuvnt immunochemotherpy in ptients with stge III colorectl cncer. Oncol Rep 20: , Muki M, Okd K, Fukumitsu H, Yzw N, Hoshikw T, Tjim T, Hirkw H, Ogoshi K nd Mkuuchi H: Efficcy of 5 FU/LV plus CPT 11 s first line djuvnt chemotherpy for stge III colorectl cncer. Oncol Rep 22: , Muki M, Kishim K, Uchiumi F, Ishibshi E, Fuksw M, Tjim T, Nkmur M nd Mkuuchi H: Clinicl comprison of QOL nd dverse events during postopertive djuvnt chemotherpy in outptients with node positive colorectl cncer or gstric cncer. Oncol Rep 21: , 2009.