S P CIENTIFIC APER The Implementation of a Standardized Approach to Laparoscopic Rectal Surgery Katrine Kanstrup Aslak, MD, Orhan Bulut, MD ABSTRACT INTRODUCTION BackgroundandObjectives:Thepurposeofthisstudy Over the last 10 years, studies have shown the positive was to audit our results after implementation of a stan- effect of fast-track (FT) rehabilitation programs on the dardized operative approach to laparoscopic surgery resultsofsurgicaltreatment.1,2Theintroductionoflapa- for rectal cancer within a fast-track recovery program. roscopic colorectal surgery (LCRS) and the implemen- tation of FT programs have been focusing on shorter Methods: From January 2009 to February 2011, 100 con- hospital stay and less morbidity and surgical stress.3,4 secutive patients underwent laparoscopic surgery on an Several large randomized trials5-8 and Cochrane re- intention-to-treat basis for rectal cancer. The results were views9,10 have concluded that LCRS has better short- retrospectively reviewed from a prospectively collected term outcomes and that oncological outcomes were database. Operative steps and instrumentation for the comparable to those of the conventional open ap- procedure were standardized. A standard perioperative proach. These trials comparing laparoscopic and open care plan was used. surgery have been performed in a traditional perioper- Results: The following procedures were performed: low ative care setting. However, it remains controversial, anterior resection (n(cid:1)26), low anterior resection with whether the combination of LCRS and FT programs can loop-ileostomy (n(cid:1)39), Hartmann’s operation (n(cid:1)14), produceadramaticeffectonperioperativeoutcomesin and abdominoperineal resection (n(cid:1)21). The median colorectal surgery. length of hospital stay was 7 days; 9 patients were read- The laparoscopic rectal procedures can be technically mitted.Therewere9casesofconversiontoopensurgery. challenging and are associated with a steep learning The overall complication rate was 35%, including 6 cases curve, longer operative time, expensive equipment, (9%) of anastomotic leakages requiring reoperation. The and the risk of conversion, which can result in signifi- 30-day mortality was 5%. The median number of har- cant increases in cost and morbidity. The optimum vested lymph nodes was 15 (range, 2 to 48). There were laparoscopic resection of rectal cancer necessitates us- 6 cases of positive circumferential resection margins. The ing a wide spectrum of efficient and safe operative median follow-up was 9 (range, 1 to 27) months. One approaches to ensure oncological clearance and good patientwithdisseminatedcancerdevelopedport-siteme- clinical outcomes, regarding medical and surgical com- tastasis. plications. During the implementation of LCRS in our Conclusions: The results confirm the safety of a stan- department, we have standardized our operative ap- dardized approach, and the oncological outcomes are proachtolaparoscopicrectalsurgeryandperioperative comparable to those of similar studies. care of the patients. The purpose of this article is to audit the clinical, surgical, and oncological results dur- Key Words: Laparoscopic colorectal surgery, Rectal can- ing this standardization of the operative technique cer, Low anterior resection, Fast-track surgery. within a FT recovery setting. DepartmentofSurgicalGastroenterology,HvidovreUniversityHospital,University MATERIALS AND METHODS ofCopenhagen,Copenhagen,Denmark(allauthors). ThispaperwaspresentedattheESCP6thScientificandAnnualMeeting,Copen- hagen,Denmark,September2011. Patient Selection Addresscorrespondenceto:OrhanBulut,DepartmentofSurgicalGastroenterol- ogy,HvidovreUniversityHospital,CopenhagenUniversity,Copenhagen,Kette- From January 2009 to February 2011, 100 consecutive gaardsAlle´30,DK-2650Hvidovre,Copenhagen,Denmark.Telephone:(cid:2)453862 6951;Fax:(cid:2)4538623760;E-mail:[email protected] patients underwent laparoscopic surgery in our depart- ment on an intention-to-treat basis for rectal cancer. The DOI:10.4293/108680812X13517013316672 clinical,operative,andpathologicaldataofthesepatients ©2012byJSLS,JournaloftheSocietyofLaparoendoscopicSurgeons.Publishedby theSocietyofLaparoendoscopicSurgeons,Inc. were retrospectively reviewed from a prospectively col- 264 JSLS(2012)16:264–270 lecteddatabase.Everypatientwhowasoperatedonlapa- umbilicalportforestablishmentofpneumoperitoneumand roscopically for rectal cancer in an elective setting in the peritonealinspection.Thepatientwasthenplacedinasteep period was included. There were no exclusion criteria. Trendelenburgpositionandtheoperatingtablewasrotated towards the right side. (2) Placement of 3 or 4 ports at Preoperative Workup variable sites: a 10-mm to 12-mm port is inserted into the rightlowerquadrantapproximately2cmto3cmmedialand The preoperative workup included biopsy, endoscopy, superiortotheanteriorsuperioriliacspine.A5-mm port is computedtomography(CT),liverultrasound,chestX-ray, theninsertedintherightupperquadrantatleastahand’s and magnetic resonance imaging (MR). All patients were breath superior to the lower quadrant port. A 5-mm left stagedaccordingtonationalguidelines.Eachpatientwas upper quadrant port is also inserted to aid the traction of reviewedatourmultidisciplinarycolorectalcancer(MDT) meetings before and after surgery. Patients with (cid:1)T3 tu- rectosigmoid colon or splenic flexure mobilization. All of theseportsareinsertedlateraltotheepigastricvessels.An mors and those with a threatened circumferential resec- optional5-mmportcanalsobeinsertedatthesuprapubic tion margin (CRM) underwent neoadjuvant chemoradio- site, in which a Pfannenstiel incision is anticipated. therapy.Surgerywascarriedout6weeksto8weeksafter (3) Mesocolic dissection and inferior mesenteric pedicle completion of treatment. Patient characteristics, tumor isolation was achieved with a medial approach, and the sizeandlocation,aswellasperioperativedata,patholog- inferior mesenteric artery was ligated close to its origin icalresults,morbidity,lengthofhospitalstay(LOS),read- with clips or Endo-GIA. The superior rectal artery was mission rate, 30-day mortality, and follow-up were re- divided just below the inferior mesenteric artery after corded prospectively. All procedures were performed by application of 5-mm clips in the cases of abdominoperi- the same surgical team. neal resection (APR) and Hartmann’s operation (HO). Tumorswereconsideredrectalcancersiflocatedbelow (4)Theleftureterwasrecognizedandsubsequently,with 15cm from the anal verge measured with a rigid recto- thepatientplacedsupineandrotatedleftsideup,medial- scope.Rectalcancersuitableforsurgerywasdefinedas to-lateral dissection was continued cranially up until the a biopsy-proven adenocarcinoma. Patients were con- left colon was mobilized. (5) The patient was returned to sidered suitable for laparoscopic surgery if they had no the Trendelenburg position, and the small bowel was serious health conditions precluding a laparoscopic reflected cranially after the completion of mobilization of procedure. Patients with CT or MR evidence of tumor theleftcolon.Agrasperwasusedtoelevatetherectosig- infiltration of adjacent organs and T4 cancers were moidcolonoutofthepelvisandawayfromtheretroperi- considered unsuitable for laparoscopic surgery. All pa- toneum and sacral promontory, to enable entry into the tients were informed about possible risks and benefits presacral space. (6) The posterior aspect of the mesorec- of laparoscopic surgery, and informed written consent tum was easily identified, and the mesorectal plane dis- was obtained. A phosphate enema was given as bowel sected with Harmonic scalpel, preserving the hypogastric preparation prior to surgery. Stoma sites were marked nerves. Dissection was continued down to the presacral preoperatively. All patients received epidural anesthe- space in this avascular plane toward the pelvic floor. sia (bupivacaine/fentanyl) or intravenous morphine as (7) Dissection proceeded laterally on both sides of the postoperative pain relief. Perioperative care was previ- rectum until circumferential mobilization of the lower ously described and primarily developed for open co- rectum was accomplished. (8) Digital examination was lonic surgery in FT settings.1,2,11 The FT settings in- performed to verify the distance between the inferior cluded initiation of mobilization and full oral feeding margin of the tumor and the line of resection, and the (minimal oral intake of 1500mL of fluid but a full diet adequacyofthedistalmarginwasmarkedwithaclip.(9) was allowed) on the evening of surgery, removal of An EndoGIA 45-mm Roticulator stapler (Covidien Ltd., epiduralcatheterandurinaryorsuprapubiccatheteron Norwalk, CT, USA) was fired twice to divide the lower the third day of surgery and planning of discharge as rectum safely. The abdomen was then deflated, and a soon as possible hereafter. During the hospital stay, all suprapubic incision of 4cm to 6cm performed to extract patients received thromboembolic prophylaxis. Naso- theleftcolonandresectthespecimen.Awoundprotector gastric tubes and drains were not used routinely. (Alexis OTM, Applied Medical Rancho Santo Margarita, CA) was placed at the incision. (10) Extracorporal prepa- Surgical Method ration of the proximate colon was completed with place- We used 5 port sites. The standardized operative steps ment of the anvil of a 29-mm circular stapler (Proximate forlaparoscopicrectalresectionare(1)openinsertionofthe ILS circular stapler, Ethicon, Endo-surgery, Cincinnati, JSLS(2012)16:264–270 265 TheImplementationofaStandardizedApproachtoLaparoscopicRectalSurgery,AslakKKetal. OH, USA) in position to perform a side-to-end or end-to- RESULTS end colorectal anastomosis in the cases of low anterior Patient characteristics are summarized in Table 1, and resection(LAR).Bowelanastomosiswasperformedintra- perioperative data are shown in Table 2. Nine patients corporeally by the double staple technique. The splenic (9%) were readmitted for a median of 3 days (range, 1 to flexure was not routinely mobilized. For tension-free 13). There were 9 operations where conversion to open anastomosis, full splenic flexure mobilization was per- surgery were necessary. Indications for conversion in- formedincaseoflackofredundancyofthesigmoidcolon cluded fixation of the tumor to the surrounding organs during surgery. The low pelvic dissection in APR was (n(cid:1)6), dense adherences (n(cid:1)1), tumor growth into the performed first posteriorly, then anteriorly, and finally bladder (n(cid:1)1), and progressive respiratory insufficiency with lateral dissection. The remainder of the deep pelvic related to establishment of pneumoperitoneum. dissection was performed through a perineal approach, includingremovalofthetipofoscoccyxtogetherwiththe Intraoperative complications occurred in 3 cases. One specimen ad modum Holm.12 In cases of HO and APR, a bladderinjuryandonesuperficiallacerationoftherectum stoma was placed in the lower left quadrant according to occurred during laparoscopic resections. These injuries the preoperatively marked stoma-site. A standardized were repaired laparoscopically without conversion. Fi- perioperative care protocol was used. Conversion to an nally, one perforation of the anal canal occurred during open procedure was defined as any abdominal incision perineal dissection in an APR-procedure. largerthantheabove-mentionedtoextractthespecimen. In the postoperative period, we registered 11 cases of A protective loop ileostomy was performed for the anastomoticleaksinaccordancewithourpreviouslymen- patients needing anastomosis within 5cm of the anal tionedcriteriaamongthe65patientswhounderwentlow verge.Intestinalcontinuitywasre-established3months anteriorresection.Amongthose,6patients(9%)required lateroraftercompletionofpostoperativeadjuvantther- reoperation. The remaining 5 patients (8%) were treated apy. conservatively or with endoscopic vacuum-assisted clo- sure. Table 3 outlines all postoperative complications Follow-up encountered. We found a 30-day mortality rate of 5% (5 patients). Mean follow-up was 9 months (range, 1 to 27). Postoperativecomplicationsweredefinedasanymorbid- ity, including wound infection, in the postoperative pe- The oncologic outcomes are shown in Table 4. Twenty- riod in the hospital or in the outpatient clinic within 30 fourpatientsunderwentneoadjuvanttreatmentbeforethe days after the operation. Perioperative death was defined surgical procedure. Five of these (20.8%) had a complete as death occurring within 30 days after surgery. Anasto- pathological response with no residual tumor detectable motic leaks were defined as any dehiscence of the anas- intheresectedspecimen.Themedianlengthofthespec- tomosisobservedbyendoscopy,digitalexamination,CT- imen was 17cm (range, 10 to 35), the median DRM was scan,orGastrografinenema.Allpatientswerereferredfor 30mm (range, 2.5 to 35), the median CRM was 10mm colonoscopy and CT-scan after the first and third year of surgery. Table1. PatientDemographics Pathologic Method Sex,m/f(n) 61/39 All specimens were examined by local pathologists with Age,median(years) 66(range30–88) specialattentiontothenumberofharvestedlymphnodes, circumferential resection margin (CRM), distal resection BodyMassIndex,median(kg/m2) 24(range17–40) margin (DRM) and completeness of the mesorectal fascia ASA-score,median* 2(range1–3) (MRF). Tumorlocation,median(cmfrom 10(range2–15) analverge) Statistical Analysis Previousintraabdominalsurgery(n) 31 Data were collected in an SPSS worksheet (SPSS version Preoperativechemo-radio-therapy 19; SPSS INC. Chicago, IL). All values are presented as None 76 median (range). When appropriate, Fisher’s exact test Chemo-andradiotherapy 24 (chi-square test) was used for nonparametric data. P(cid:3).05 *ASA(cid:1)AmericanSocietyofAnesthesiologists. was considered statistically significant. 266 JSLS(2012)16:264–270 (range, 0 to 55), and CRM was positive in 6 patients. The in84casesandnotcompletein14cases.TheMRFwasnot overallmediannumberofharvestedlymphnodeswas15 describedinthehistopathologicalreportsin2cases.One (range, 2 to 48). The median lymph node harvest in patientwithdisseminatedcancerdevelopedport-siteme- patients who underwent preoperative neoadjuvant treat- tastasis. ments(n(cid:1)24)was12(range,4to35),andinpatientswho underwent primary resection without neoadjuvant treat- DISCUSSION ment (n(cid:1)76), the median lymph node harvest was 16 (range,2to28).TheMRFwascompleteornearcomplete The increasing amount of available data on laparoscopic resection of the rectum suggests that the method is feasi- ble and safe for select patients with favorable short- and Table2. mid-term outcomes.13,14 Nonetheless, laparoscopic rectal PerioperativeData surgery has been viewed with significant skepticism by Surgicalprocedure (n) the surgical community, and the majority of rectal resec- tions continue to be carried out using the conventional Lowanteriorresection 26 open approach. Currently, several multicenter random- Lowanteriorresectionwith 39 ized controlled trials comparing laparoscopic and open loop-ileostomy surgery for rectal cancer are registered, and until these Hartmann’soperation 14 data become available, some surgeons believe that open Abdominoperinealresection 21 totalmesorectalexcisionisregardedasthegoldstandard Operativetime,median(min) 250(range,51–397) treatment of rectal cancer. The limited access to experi- Lowanteriorresection 181(range,51–353) enced laparoscopic colorectal surgeons may also play a role in this turnover process. The resection of low rectal Lowanteriorresectionwith 261(range,100–376) loop-ileostomy tumors is technically challenging, and the learning curve toachieveanadequateclearancemarginissteep.Training Hartmann’soperation 186(range,114–345) inadvancedcolorectalworkshopsthatutilizebothanimal Abdominoperinealresection 280(range,131–397) and human cadaver models is extremely helpful to Lossofblood,median(mL) 100(range,0–1145) shorten this learning curve. Appropriate patient selection Hospitalstay,median(days) 7(range,3–80) is also an essential component of surgical practice at the Re-admission(n) 9 beginning of training and ideal cases to start on to help Table3. PostoperativeComplications Complication Numberofpatients(n) Treatment Urinetractinfection 5 Antibiotics Gastrointestinalbleeding 1 Self-resolved Superficialwoundinfection 2 Drainage Leakageoftherectal“stump” 3 Ultrasound-guideddrainage Compartmentsyndrome 2 Fasciotomy Necrosisofthestoma 2 Stomarefashioned Ileus(adhesions) 1 Lysisoftheadherences Earlyport-sitehernia 1 Repaired Peritonitis 2 Laparotomy Parastomalhernia 2 Repaired Presacralabscess 3 Ultrasound-guideddrainage Anastomoticleak 5 Conservativetreatment/Endo-VACa Anastomoticleak 6 Reoperation Total 35 aEndo-VAC(cid:1)Endoscopicvacuum-assistedclosure. JSLS(2012)16:264–270 267 TheImplementationofaStandardizedApproachtoLaparoscopicRectalSurgery,AslakKKetal. scopicmethodforalmostallpatients,onlyexclusionsbeingT4 Table4. tumorsorlocalgrowthintoneighboringorgans. OncologicResults Circumferentialresectionmargin, 10(range0–55) Amedianpostoperativehospitalstayofonly7daysinthis median(mm) series is short compared to that in other studies with a Distalresectionmargin,median(mm) 30(range2,5–70) median hospital stay of 8 days to 15 days.8,16,19-22 This great variety of results is probably due to cultural and Lengthofspecimen,median(cm) 17(range10–35) economic differences in health care systems between Harvestedlymph-nodes,median(n) 15(2–48) countries. In our department, there are very well-estab- Mesorectalfascia(n) lishedroutinesinourfast-tracksurgeryprogramthatwas Complete 68 originally developed for postoperative care after colon Nearcomplete 16 surgery.1,2 It has over the years been adjusted for rectal Incomplete 14 surgery. Hence, all patients were already prepared for stoma self-care prior to surgery by one of the specialist R0resection 94 nurses from our ward. Furthermore, all patients, if possi- ble,receivedepiduralanalgesiaupto3daysaftersurgery, climb the learning curve. However, permanent supervi- andallpatientswereencouragedtoearlyoralfeedingand sion and training with experienced surgeons who rou- mobilizationassoonaspossibleaftersurgery,atthelatest tinelyperformasignificantnumberoflaparoscopicrectal thefirstdayaftersurgery,anddrainsandcatheterswerewith- procedures,inouropinion,isthebestwaytoacquirethe drawnthethirdpostoperativeday.Ourreadmissionrateof9% requiredskillsinthisprocedure,becausethereislesscase withamediansecondaryhospitalstayof3daysiscomparable selectionwithvaryingdifficultyoftheoperationsandthe tothatinsimilarstudieswhereupto23%ofthepatientswere multitude of factors that effect the outcomes in laparo- readmittedafterfast-trackrectalcancersurgery.23 scopic rectal surgery in the later period of training. Lind- Table 3 shows that the majority of complications were setmoandDelaney15describedastandard,stepwiselapa- surgical. There is no difference in complication rates be- roscopicprocedureforrectalresections.Wehaveadapted tween the first and the last 50 patients in this series. Our this technique, which makes the operation predictable overall complication rate of 35% matches results of other andreproducibleforthewholesurgicalteam.Theprocess studies.8,16,21Thereisasmalltendencytowardsincreased ofadaptingthisstandardizedtechniqueisprobablyoneof risk of complications, if the patient had received preop- the causes for the median operative time of 250 minutes, erative radiotherapy, as 40.9% of the radiated patients whichislongerthantimeincomparablestudies.8,16Other experienced complications versus 35.9% of the nonradi- causes could be that a new surgical setting was imple- ated patients. The tendency is however not statistically mented and that 2 new surgeons in our team were edu- significant (P(cid:1).803). Although a total of 15 reoperations cated to perform laparoscopic rectal surgery during the seem to be a high figure, it is comparable to that in other study period. Furthermore there were a high number of reported series of laparoscopic rectal surgery.24,25 patientswithahistoryofpreviousabdominalsurgeriesin our series (31%). Much depends on the author’s definition of anastomotic leakage when it comes to calculating leakage rates. We There have been reports about increasing complication have used wide-spanning criteria for our definition of rates in patients converted from laparoscopic to open anastomotic leaks. Our rate of leakages that required re- surgery.17 Our rate of conversion was 9%, which is lower operation (9%) is acceptable in comparison with that in thanthatinotherstudies.8,18Thismayreflectsomedegree other series.8,16,22 Neither conversion nor neoadjuvant ofbias,becauseourpatientswereselectedcandidatesfor therapy resulted in higher risk of development of anasto- laparoscopic surgery and not randomized to either open motic leakage in this series. However, Figure 1 shows or laparoscopic surgery. Morbidity and length of hospital that there is a decreasing tendency in the leakage rate in stayforconvertedpatientswerehoweversimilartothose thelatterpartofthestudyperiod(studyperiodB),where completed laparoscopically. Our data therefore confirm the standardized surgical approach had been fully imple- that careful selection of patients for laparoscopic surgery mented.Thedifferencebetweentheseratesofleakagesis makestheprocedurepracticableandtheneedtoconvertsmall. however not significant (P(cid:1).094). Thisstudyalsoconfirmsthatourstrategytoconvertwhenever thereisfailuretoprogressintheverydifficultoperativefieldis Our 30-day mortality was 5%, which is relatively high safe. At present, our approach is to initially plan the laparo- compared to that in other studies.18,20 The postoperative 268 JSLS(2012)16:264–270 from the mesorectum during surgery is also an important predictorofprognosis.30Inourstudy,therewasamedian harvest of 15 lymph nodes, and 80% of the specimens contained 12 lymph nodes or more, which is equal to results of several studies.14,16,18,20 The mesorectal fascia was not complete in 16% of our patients. Macroscopic evaluation of the mesorectal fasciae is considered an im- portantqualitymeasureinrectalcancersurgery.Tearsand shallow breaks in the mesorectum, however, are difficult to avoid, particularly when dealing with large bulky tu- morsinLCRS.Otherfactorslikeanarrowpelvisandafatty mesorectumincreasetheriskofdamagingthemesorectal Figure1.Anastomoticleakagerates.InstudyperiodA,patients fascia with the laparoscopic instruments as well. For that no.1–50underwentsurgeryand9hadanastomoticleak(25%). reason, the grading of the mesorectal fasciae was charac- InstudyperiodB,patientsno.51–100underwentsurgery,and2 terized as only nearly complete in some cases, even hadanastomoticleaks(6.9%)(P(cid:1).094). though dissection was carried out in the correct plane. Nagtegaal et al30 have shown that a complete or nearly morbidityandmortalityinFTsettingsremainchallenging complete mesorectal fascia is prognostic for good long- and controversial due to mainly a nonselected, high-risk termoncologicaloutcomes,whereasanincompletefascia elderly population with coexisting illnesses.26-28 In the is prognostic for unfortunate oncological long-term out- presentseries,the5patientswhodiedwere78to88years comes. Because of the short follow-up period, it is not of age at the time of the operation. They all suffered possible to conclude whether our oncologic result influ- preoperativelyfromseveredegreesofischemicheartfail- encesthelong-termoncologicoutcome.Onlyonepatient ure. Moreover, one of the patients suffered from severe withdisseminatedcancerdevelopedaport-sitemetastasis. chronic obstructive lung disease and non-insulin depen- dent diabetes mellitus, one patient suffered from renal Themainlimitationsofthisstudyarefurthermorethatthis failure and obesity (BMI(cid:1)33), and one patient had re- retrospective series with prospectively registered data cently been hospitalized due to lung embolia. After pri- doesnotincludealargenumberofpatients.Moredataare mary surgery, all 5 patients experienced surgical compli- neededfromlargerandomizedcontrolledtrialsregarding cations and underwent reoperations. In 2 patients, long-term oncological outcome. reoperationwasneededbecauseoffecalperitonitis(anas- tomotic leak and small bowel perforation), in 2 cases CONCLUSION because of severe ischemia of the stoma, and in 1 case because of nonfecal peritonitis of unknown origin. All 5 Our data support the view that standardization of the patientsdiedduetosepsisandfailureofmultipleorgans. operative steps in laparoscopic rectal surgery seems to limit the risk of anastomotic complications and provides Large randomized trials comparing laparoscopic versus clear indications for early and safe conversion to open open resection for colorectal cancer have shown an surgery. This stepwise technique can be used to train equivalent oncological outcome.6,7 Adequate surgical colorectal surgeons in the future. Oncological outcomes margin clearance remains crucial for local recurrence arecomparabletothoseofsimilarstudies,butweneedto rates.TheresultsoftheCLASICCtrialwithatrendtowards optimize the short-term outcome further. increasedrateofinvolvedCRM(6%openvs.12%laparo- scopic) for anterior resection were initially alarming.8 References: However,arecentmetaanalysissuggeststhatthereareno differences between laparoscopic and open surgery for 1. 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