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UvA-DARE (Digital Academic Repository)
Optimizing strategies in gastrointestinal surgery
Vlug, M.S.
Link to publication
Citation for published version (APA):Vlug, M. S. (2010). Optimizing strategies in gastrointestinal surgery.
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Download date: 04 Dec 2020
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LAparoscopy in combination with FAst track multimodal management is the best perioperative strategy in patients undergoing colonic surgery: A Randomized Clinical Trial (LAFA-study)
Malaika S. VlugJan Wind
Markus W. HollmannDirk T. UbbinkHuib A. Cense
Alexander F. EngelMichael F. Gerhards
Bart A. van WagensveldEdwin S. van der Zaag
Anna A.W. van GelovenMirjam A.G. Sprangers
Miguel A. CuestaWillem A. Bemelman
on behalf of the collaborative LAFA study group
Accepted for publication in Ann Surg
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Abstract
ObjectiveTo investigate which perioperative treatment, i.e. laparo-scopicoropen surgerycombinedwith fast track (FT)orstandardcare,istheoptimalapproachforpatientsunder-goingsegmentalresectionforcoloncancer.Summary background dataImportantdevelopments inelectivecolorectal surgeryaretheintroductionoflaparoscopyandimplementationofFTcare,bothfocusingonfasterrecovery.MethodsInanine-centretrial,patientseligibleforsegmentalcolec-tomywererandomizedtolaparoscopicoropencolectomy,and to FT or standard care, resulting in four treatmentgroups.Primaryoutcomewastotalpostoperativehospitalstay.Secondaryoutcomeswerepostoperativehospitalstay,morbidity, reoperation rate, readmission rate, in-hospitalmortality,qualityoflifeattwoandfourweeks,patientsat-isfactionandin-hospitalcosts.Fourhundredpatientswererequiredtofindaminimumdifferenceofonedayinhos-pitalstay.Results Median total hospital stay in the laparoscopic/fast trackgroupwas5(inter-quartilerange:4-8)days;open/fasttrack7(5-11)days;laparoscopic/standard6(4.5-9.5)days,andopen/standard7(6-13)days(P<0.001).Medianpostopera-tivehospitalstayinthelaparoscopic/fasttrackgroupwas5(4-7)days;open/fast track6 (4.5-10)days; laparoscopic/standard6(4-8.5)daysandopen/standard7(6-10.5)days(P<0.001).Secondaryoutcomesdidnotdiffersignificantlyamongthegroups.Regressionanalysisshowedthatlaparos-copywastheonlyindependentpredictivefactortoreducehospitalstayandmorbidity.Conclusions Optimalperioperativetreatmentforpatientsrequiringseg-mentalcolectomyforcoloncancerislaparoscopicresectionembeddedinaFTprogram.Ifopensurgeryisapplied,itispreferentiallydoneinFTcare.
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IntroductionWorldwide,coloncanceristhesecondmostcommoncancer.Itsincidenceisexpectedtorisewiththe increasing longevityof theWesternpopulation.Surgical resection is thefirst linestrategy to treat coloniccancerand the implementationof screeningprograms is likely tofurtherincreasethenumberofpatientsrequiringcolonicsurgery. Overthepasttwentyyearstherehavebeentwoimportantdevelopmentsinelectivemajorabdominalsurgery;theintroductionoflaparoscopicsurgeryandtheimplementationofanenhancedrecoveryaftersurgery(ERAS)program,alsoreferredtoas‘fasttrack’(FT)periop-erativecare,bothfocusingonacceleratedrecoveryresultinginshorterhospitalstay.1;2Laparo-scopicresectionofbowelcancerwasfirstdescribedin1991.1Randomizedclinicaltrialshaveshownthatthistechniqueissafeandeffectiveformalignantdisease,andresultsinahospitalstayshorterbyabout1-4days,andlessmorbidityandpostoperativepainthanopencolorectalsurgery.3-5
During themid-ninetiesFTperioperative carewaspioneeredbyHenrikKehlet.2;6-8FTprogramsconsistofamultidisciplinaryapproach,involvingdieticians,nurses,surgeonsandanesthesiologistsandareaimedatreducingsurgicalstressresponse,organdysfunctionandmorbidity, therebypromotinga faster recoveryafter surgery.7;9FTperioperativecarecom-prisesextensivepreoperativecounseling,nobowelpreparation,nosedativepremedication,carbohydrate-loadedliquidsuptotwohoursbeforesurgery,effectivemultimodalpainman-agement,shortactinganaesthetics,adequateperioperativefluidmanagement,smallincisions,andnoroutineuseofdrainsandnasogastrictubes.Postoperativecareincludesearlyoralfeed-ing,enforcedmobilization,earlyremovalofurinarycatheter,andstandardlaxatives. Similar or even faster rates of recovery have been reported for FT open colectomy oncomparisonwith laparoscopiccolectomyina standardperioperativecare setting.10-12Sincetheleadingtrials3-5comparinglaparoscopicwithopensurgeryhavebeendoneinatraditionalperioperativecaresetting,thiscomparisonneedstobere-evaluatedwithinanenhancedre-coveryprogram. TherearenotrialstobefoundinliteratureaddressingthefourcombinationsofstandardorFTcarewithlaparoscopicoropensurgery.Thelongstandingquestionofwhichofthefourperioperativetreatmentoptionsistheoptimaloneforthepatientwithrespecttopostopera-
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tiverecoveryremainsunanswered.13;14TwosystematicreviewslookedatallavailablestudiescomparingopensurgerywithlaparoscopicsurgerywithinaFTprogram,butnofirmconclu-sioncouldbemadeduetolackofdata.15;16
Hypothetically,combiningthetwonewdevelopments,i.e.FTcareandlaparoscopy,willresultinthefastestpostoperativerecovery.Atthesametime,itisquestionableifbothofthemareasimportantwithrespecttopostoperativerecovery. Hence,ouraimsweretodeterminewhichformofperioperativetreatment,laparoscopicoropensurgerycombinedwithFTorstandardcare,istheoptimalapproachforpatientsunder-goingsegmentalresectionforcoloncancer,andtoinvestigateifeitherlaparoscopy,FTcare,orthecombinationofbothisthemainpredictivefactorforafasterpostoperativerecovery.
MethodsPatientstreatedinnineDutchhospitals(threeUniversityhospitalsandsixteachinghospi-tals)wereeligibleiftheywerebetween40and80yearsofage,hadanAmericanSocietyofAnesthesiologists(ASA)gradeofI,IIorIII,weretoundergoelectivesegmentalcolectomyforhistologicallyconfirmedadenocarcinomaoradenoma,andwithoutevidenceofmetastaticdisease.Exclusioncriteriawerepriormidlinelaparotomy,unavailabilityofalaparoscopicsur-geon,emergencysurgery,oraplannedstoma.ThestudywasconductedinaccordancewiththeprinciplesoftheDeclarationofHelsinkiandaccordingtotheCONSORTstatement.17
The independentmedical ethics reviewboardsof theparticipatinghospitals approved thestudyprotocol.ThestudywasregisteredunderNTR222.18
DesignArandomizedtrialofa2x2balancedfactorialdesignwasperformed.Afterwritteninformedconsenthadbeenobtained,patientswererandomizedbymeansofaninternetrandomizationmodule.Block-randomizationwasusedandrandomizationwasstratifiedfortherandomizingcenters.Patientswererandomizedtolaparoscopicoropencolectomy,andtotheFTprogramorstandardcare.Thisresultedinfourtreatmentgroups:(a)laparoscopiccolectomywithFTcare(Lap/FT)(b)opencolectomywithFTcare(Open/FT)(c)laparoscopiccolectomywithstandardcare(Lap/Standard),and(d)opencolectomywithstandardcare(Open/Standard).Patientsandnursingstaffwereroutinelyinformedabouttheperioperativecareprogram,i.e.FTcareorstandardcare,butwereblindedtothetypeofintervention,i.e.laparoscopicoropensurgery.OutcomesPrimaryoutcomewastotalpostoperativehospitalstay(THS),measuredindays.THSwasdefinedaspostoperativehospitalstayplustheadditionalhospitalizationperiodincasepa-tientswerereadmittedwithin30daysofsurgery.Allpatientsweredischargediftheycompliedwiththefollowingpredefineddischargecriteria:(1)adequatepaincontrolwithparacetamoland/ornon-steroidalanti-inflammatorydrugs(2)abilitytotoleratesolidfood(3)absenceofnausea(4)passageoffirstflatusand/orfirststool(5)mobilizationaspreoperative,and(6)acceptanceofdischargebythepatient.
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Secondaryoutcomeswerepostoperativehospital stay(PHS),overallmorbidity,reopera-tionrate,readmissionrate,in-hospitalmortality,qualityoflifeattwoandfourweeks,patientsatisfactionfourweekspostoperativelyandin-hospitalcosts. Generalqualityoflifewasassessedwiththevalidatedandwidely-usedShortForm-36(SF-36).19Bowel-relatedqualityoflifewasassessedwiththevalidatedGastro-IntestinalQualityofLifeIndex(GIQLI).20Physicalfunctioning,bodilypainandsocialfunctioningscales(SF-36),andsocialfunctioningscale(GIQLI)weresecondaryoutcomes. Additionally,aself-reportedpatientsatisfactionquestionnaire,routinelyusedatourcenter,wassenttoallpatients.Itcomprises16items,addressingissuesincludingsatisfactionwithpersonalattentionfromthesurgeonandnursesandmedicalinformation.Totalpatientsatis-factionscoresrangedfrom16(lowestpatientsatisfaction)to80(highestpatientsatisfaction). Themarginaldirectmedicalin-hospitalcostswerecalculatedperpatientforthefourtreat-mentstrategies.Thesecosts includedoutpatientcare,operatingtime,patient-days,thead-ditional costs of laparoscopy and of fast track care, as well as the costs of complications,reoperationsandreadmissionswithin30daysaftertheindexoperation.FT care versus standard careInordertoavoidcross-overtreatmentbythenursingstaff,patientswereadmittedeithertoawardprovidingFTcareorawardprovidingstandardcare,dependingonrandomization.Thesetreatmentprotocolsaredescribedindetailelsewhere.18Nursingandmedicalstaffwork-ingontheFTcarewardwerealreadyfamiliarwithFTcarepriortothisstudy.Surgical techniqueThetechniqueoftheopenorlaparoscopicprocedurewasatthediscretionofthelocalsur-geon.Participatinglaparoscopicsurgeonswererequiredtohaveperformedaminimumof20laparoscopiccolectomiesforbenigndiseaseasstatedintheproclamationoftheAmericanSo-cietyoftheColonandRectumSurgeonsin2004,beforetheywereallowedtoperformlaparo-scopiccolectomyforcancer.Alaparoscopicprocedurewasconsideredconvertediftherewasanunplannedenlargementoftheincision.Noqualityrequirementsweresetforopensurgeryasthiswasstandardcareinallcenters.Arightcolectomywastypicallydoneviamidlinelapa-rotomy.Attheendofsurgerytheabdomenwascoveredwithalargedressingtohidethetypeofapproachinordertoblindthepatient,doctorsandnursesontheward.Data collection Datawerecollectedviaasecureddedicatedwebsite.Uptodischarge,nursingstaffreporteddailyonthepatient’sprogress,i.e.intake,passageofflatus,andpredefineddischargecriteriawerechecked.After30daysoffollow-up,theanestheticandclinicaldossiers(nursingandmedical)werecheckedformissingdata.Outpatientmedicaldossierswerecheckedforanycomplicationthathadoccurredafterdischargewithin30daysoftheoperation.TheSF-36andGIQLIweremailedto thepatientsprior toandat twoandfourweeks followingtheoperation.Thepatientsatisfactionquestionnairewasmailedfourweekspostoperatively.Allqualityoflifedatafrompatientswhohadreturnedbaselinequestionnaireswereincorporatedintotheanalysis,evenifoneortwofollow-upmeasurementsweremissing.
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Sample size calculationSincebothFTcareandlaparoscopyaimatfasterrecoveryresultinginareductionofhospitalstay,hospitalstaywasusedastheprimaryefficacyparameter.Usinga5%significancelevel,atotalsamplesizeof400hadapowerof>95%todetectaminimumreductioninTHSofonedaybetweenlaparoscopicandopensurgery,onedayreductioninTHSbetweenFTandstandardcare,andapowerof80%todetectthesamedifferencebetweenthecombinationofFTwithlaparoscopicsurgeryandopensurgerywithstandardcare.18
Statistical analysisStatisticalanalysesofanydifferencesbetweenthe fourgroupswereperformedusingSPSSforWindowsversion16(SPSSInc.Chicago,III.,USA).Datawereanalyzedinaccordingtothe intentiontotreatprinciple.Datawerepresentedasmeans±standarddeviationsorasmediansandinter-quartilerangeswhereappropriate.Fordichotomousoutcomes,treat-mentgroupswere comparedbymeansof theChi-square test.TheMann-WhitneyU testandKruskalWallistestswereusedforcontinuous,notnormallydistributedoutcomes.Forcontinuousnormallydistributeddata,theANOVAtestwasused.Univariateandmultiplelinearorlogisticregressionanalyseswereperformedtoanalyzetheeffectoflaparoscopy,FTcareandthecombinationofbothontheprimaryandsecondaryendpoints.Asthelengthofhospital staywasnotnormallydistributed, thesedatawere log-transformed.Qualityoflifewasinvestigatedthroughmultilevelmodeling,withfixedmeasurementoccasions(levelone)nestedwithinpatients(leveltwo).Theappropriatecovariancestructureforthedatawasunstructuredandallmodelsincludedtimeandtreatmentinteractions.In-hospitalcostswereseparatelyanalyzedfortheuniversityandteachinghospitals.Atwo-sidedP-value<0.05wasconsideredtobestatisticallysignificant.
ResultsBetweenJuly2005andAugust2009,427patientswererandomlyassignedtooneofthefourtreatmentgroups(Figure1).Baselinecharacteristicsbetweenthefourtreatmentgroupsdidnotdiffersignificantly(Table1).
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Chapter7
Table 1 Baseline characteristics and surgical aspects of the included patients per group
Laparoscopy
&
Fast Track
(n = 100)
Open
&
Fast Track
(n = 93)
Laparoscopy
&
Standard care
(n = 109)
Open
&
Standard care
(n = 98)
P
Age – yr* 66±8.6 66±10.3 68±8.8 66±7.1 0.548≠
Male sex – % 53 58 62 60 0.562∂
BMI – kg/m2* 26.8±4.0 26.3±4.2 25.5±3.9 26.5 ±5.0 0.177
≠
ASA – %
- Grade I or II
82
81
80
77
0.436∂
Co-morbidity – % 71 59 68 68 0.331∂
Type of colectomy – %
- Right-sided
- Left-sided
45
55
35
65
44
56
55
45
0.055∂
T stage – %
- T0
- T1
- T2
- T3
- T4
13
10
24
48
5
16
7
19
55
3
15
5
27
50
3
16
5
21
53
5
0.879∂
N stage – %
- N0
- N1
- N2
64
29
7
61
31
8
68
25
7
70
24
6
0.893∂
M stage – %
- M0
- M1
98
2
96
4
94
6
94
6
0.509∂
Conversion – n (%) 12 (12) 12 (11)
Duration of surgery
Median [IQR]
171
139 – 198
129
101 – 175
165
135 – 204
129
110 – 151
<0.001±
Blood loss
Median [IQR]
50
0 – 150
200
100 – 306
100
0 – 200
200
100 – 350
<0.001±
*Values are mean ± standard deviation / BMI = Body Mass Index / ASA = American Society of Anesthesiologists / IQR =
inter-quartile range / ≠ANOVA test /
∂Chi-square test /
±Kruskal-Wallis test
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Protocol complianceFifteenFTelementswereevaluatedperpatient.Thefollowingelementswerescoredifsuccess-fullyapplied;preoperativecounseling,omissionofbowelpreparation,intakeofcarbohydrate-loadeddrinksatthedaybeforesurgery,intakeofcarbohydrate-loadeddrinksatthemorningbeforesurgery,nopreoperativefastingsincemidnight,omissionofpremedication,thoracicepiduralanalgesia,preventionofhypothermia,adequateperioperativefluidloading,removalof nasogastric tube before extubation, omission of abdominal drains, suprapubic catheterornocatheter,morethan500mlofintakeatpostoperativeday(POD)0including200mlcarbohydrate-loadeddrink,morethan15minutesmobilizationatPOD0,andstartingwithlaxativeatPOD1.IntheLap/FTgroup11.2±2.2outofthe15elementsandintheOpen/FTgroup11.1±2.2elementsweresuccessfullyappliedperpatient(Table2). AsillustratedinTable2someFTelementshavealsobeenimplementedinthestandardcaregroup;intheLap/Standard6.0±1.5elementsandintheOpen/Standard5.8±1.4ele-mentsperpatient.Otherappliedelementswere;preventionofhypothermiain97%ofthepatients,removalofthenasogastrictubebeforeextubationin82%,andomissionofabdomi-naldrainsin93%.Althoughthoracicepiduralanalgesiawasappliedatanequalrateinallgroups,theepiduralcatheterremainedsignificantlylongerinsituinthestandardcaregroups(amedian(IQR)i.e.3(2-4)dayscomparedwith2(2-3)daysintheFTgroups(P<0·001)).Primary outcomeTHSandPHSinpatientsrandomizedtotheLap/FTgroupwassignificantly(median1day)shorterthanintheotherthreetreatmentgroups(P<0.001).Therewasnosignificantdiffer-enceinTHSorPHSbetweenpatientstreatedwithOpen/FTandpatientstreatedwithLap/Standard.PatientswhounderwentOpen/StandardtreatmenthadasignificantlylongerPHSthanLap/FT,Open/FT,andLap/Standard.THSafterOpen/Standardtreatmentwassignifi-cantlylongerthanLap/FTandLap/Standard(Table3). Linearregressionanalysisidentifiedlaparoscopyastheonlyindependentfactortoinflu-enceTHS(B=0.79,confidenceinterval(CI):0.69-0.91,P=0.001),i.e.laparoscopicsurgerywouldleadtoareductioninTHSof21%(CI:9-31%).FTcareshowedatrendtowardashorterTHS (B=0.88,CI: 0.77-1.01,P=0.070), but the combinationofboth showednoadditionalbenefit.PHSwassignificantlyinfluencedbybothlaparoscopy(B=0.80,CI:0.70-0.91,P=0.001),i.e.leadingtoareductioninPHSof20%(CI:9-30%),andFTcare(B=0.86,CI:0.76-0.98,P=0.025),i.e.areductionof14%(CI:10-20%).Thecombinationofbothdidnotaddanybenefit.
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Chapter7
Table 2 Protocol compliance
Laparoscopy
&
Fast Track
(n = 100)
Open
&
Fast Track
(n = 93)
Laparoscopy
&
Standard care
(n = 109)
Open
&
Standard care
(n = 98)
Cross-over1 – n (%) 3
a (3) 3
b (3) 3
c (2) 2
d (2)
Preoperative phase – Yes, n (%)
Preoperative counseling*
Omission of bowel preparation
Intake of CHL – day before surgery
Median [IQR] – liter
96 (96)
96 (96)
0.8 (0.3-0.8)
92 (99)
90 (97)
0.8 (0-0.8)
6 (6)
85 (78)
0.0 (0-0)
1 (1)
83 (85)
0.0 (0-0)
Day of surgery – Yes, n (%)
Intake of CHL – 2 hours before surgery
Median [IQR] – liter
No preoperative fasting since midnight
Omission of premedication
Thoracic epidural analgesia
Intraoperative fluid loading
Median [IQR] – liter
Suprapubic catheter or no catheter
Intake of CHL – after surgery
Median [IQR] – liter
Total oral intake – after surgery
Median [IQR] – liter
Mobilization – after surgery
Median [IQR] – minutes
0.4 (0.2-0.4)
87 (87)
69 (69)
87 (87)
2.2 (1.6 – 3)
47 (47)
0.0 (0-0.2)
0.5 (0.1-0.8)
0.0 (0-19)
0.4 (0-0.4)
77 (83)
61 (66)
84 (90)
2.5 (2 – 3)
54 (58)
0.0 (0-0.2)
0.3 (0-0.8)
0.0 (0-20)
0.0 (0-0)
29 (27)
23 (21)
72 (66)
2.5 (2 – 3.1)
42 (39)
0.0 (0-0)
0.05(0-0.2)
0.0 (0-0)
0.0 (0-0)
28 (29)
20 (20)
74 (76)
2.6 (2 – 3.5)
30 (31)
0.0 (0-0)
0.0 (0-0.2)
0.0 (0-0)
Start laxative POD 1 – Yes, n (%) 85 (85) 77 (83) 9 (8) 7 (7)
Intake of CHL – liter (median [IQR])
- POD 1
- POD 2
- POD 3
0.2 (0-0.4)
0.2 (0-0.4)
0.0 (0-0.4)
0.2 (0-0.4)
0.2 (0-0.4)
0.0 (0-0.4)
0.0 (0-0)
0.0 (0-0)
0.0 (0-0)
0.0 (0-0)
0.0 (0-0)
0.0 (0-0)
Total oral intake – liter (median [IQR])
- POD 1
- POD 2
- POD 3
1.5 (0.9-1.9)
1.7 (1.0-2.0)
1.8 (1.2-2.0)
1.1 (0.7-1.6)
1.4 (0.8-2.0)
1.8 (1.0-2.0)
0.9 (0.5-1.5)
1.2 (0.8-1.7)
1.5 (1.0-2.0)
0.7 (0.3-1.0)
1.0 (0.4-1.5)
1.0 (0.7-1.8)
Mobilization – minutes (median [IQR])
- POD 1
- POD 2
- POD 3
120 (50-240)
200 (90-360)
300 (120-400)
120 (60-215)
120 (60-240)
220 (100-360)
30 (15-60)
90 (45-180)
135 (60-240)
20 (0-60)
60 (20-115)
100 (53-195)
a2 pt. received Open FT / 1 pt. received Lap Standard ;
b2 pt. received Lap FT / 1 pt. received Open Standard ;
c1 pt. received Open
Standard / 1 pt. received Lap FT ; d2 pt. received Open FT ;
1Analysis according to intention to treat /
*Preoperative counseling =
separate consultation before admission with a ‘fast track’ trial nurse to discuss the essence of the fast track program / CHL =
carbohydrate-loaded drink / IQR = inter-quartile range / POD = postoperative day
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Chapter7
Tab
le 3 P
osto
perativ
e data
L
ap
aro
scop
y
&
Fast T
rack
(n =
100)
Op
en
&
Fast T
rack
(n =
93)
Lap
aro
scop
y
&
Sta
nd
ard
care
(n =
109)
Op
en
&
Sta
nd
ard
care
(n =
98)
P
Total h
osp
ital stay –
day
s 5
(4 –
8)
7 (5
– 1
1)
6 (4
.5 –
9.5
) 7
(6 –
13
) <
0.0
01
±≠
Posto
perativ
e hosp
ital stay –
day
s 5
(4 –
7)
6 (4
.5 –
10
) 6
(4 –
8.5
) 7
(6 –
10
.5)
<0
.00
1±∂
Day
s to fu
lfill disch
arge criteria
-
Pain
con
trol w
ith o
ral
med
ication
-
To
lerate solid
foo
d
-
Ab
sence o
f nau
sea
-
Passag
e of first flatu
s
-
Passag
e of first sto
ol
-
Mo
bilizatio
n as p
re-op
erative
-
Accep
tance o
f disch
arge
2 (2
-3)
1 (1
-2)
1 (1
-3)
1 (1
-2)
2 (1
-4)
3 (2
-5)
4 (3
-6)
2 (2
-4)
1 (1
-3)
2 (1
-5)
1 (1
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etween
Lap
/FT
& O
pen
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); Lap
/FT
& L
ap/S
tand
ard (0
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6); L
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tand
ard (0
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2); L
ap/S
tand
ard &
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ard (0
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4)
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Secondary outcomesTherewerenosignificantdifferencesbetweenthefourtreatmentgroupsregardingoverall-,major-, or minor morbidity, reoperation rate, readmission rate and in-hospital mortality(Table4).Logisticregressionanalysisshowedthatlaparoscopicresectionresultedinasignifi-cantlyloweroverall-andmajormorbidity(OR1.53,CI:1.02-2.29,P=0.041,andOR1.73,CI:1.01-2.95,P=0.045,respectively).NeitherFTcarenorthecombinationofbothreducedoverall-andmajormorbidity.Minormorbidity,reoperationandreadmissionratewerenotsignificantlyinfluencedbythedifferentsurgicalregimens. Therewerenostatisticallysignificantdifferences,adjustedforthetypeofhospital,inin-hospitalcostsamongthetreatmentgroupsastestedwiththeKruskallWallistestandlinearregressionanalysis(Table3). Thedischargecriterion‘absenceofnausea’wasachievedatthesamepostoperativedayinallgroups.Lap/FTpatientshadasignificantlyfasterrecovery,i.e.achievedfivedischargecriteriaearlier,thanpatientsintheLap/StandardorOpen/Standardgroups.Lap/FTpatientsshowedasignificantlyquicker‘passageoffirststool’and‘acceptanceofdischarge’thanthoseintheOpen/FTgroup(Table3). Five discharge criteria were achieved significantly earlier in Open/FT than in Open/Standardtreatment;thecriteria‘toleratesolidfood’and‘mobilizationaspreoperative’wereachievedsignificantlyearlierinOpen/FTthaninLap/Standard. Apartfromthecriteria‘absenceofnausea’,‘toleratesolidfood’and‘passageoffirstflatus’,Lap/Standardpatients achievedallotherdischargecriteria significantlyearlier thanOpen/Standardpatients. Duetomissingdataatbaseline,theoverallanalysisofdatageneratedbytheSF-36andGIQLIwasconductedin352patients(88%).Atfollow-uptherewasanoverallresponserateof80%and84%attwoandfourweekspostoperatively.Qualityoflifeatbaselinewasnotsignificantlydifferentamongthegroupsforthescalesassessed.Overall,physicalfunctioning,bodilypain,andsocialfunctioningmeasuredwiththeSF-36,andsocialfunctioningmea-suredwiththeGIQLI,significantlydeclinedattwoweekspostoperatively.Fourweeksfollow-ingsurgerybodilypainandsocialfunctioningmeasuredwiththeSF-36returnedtobaselinevalues.Theotherfunctioningscalesremainedsignificantlylower.Therewerenostatisticallysignificantdifferencesonanyofthescalesamongthefourtreatmentgroupsatanytimepoint.Patientsatisfactionwassimilaracrossallgroups.
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DiscussionThistrialshowedthatthecombinationoflaparoscopicsurgerywithFTcareresultedinasig-nificantlyfasterrecoveryaftercolonicsurgerythanallothercombinations,i.e.Open/FT,Lap/Standard,orOpen/Standard.PatientstreatedwithOpen/FTorLap/Standardhadasimilarpostoperativerecovery;Open/Standardtreatmentresultedintheworstoutcome.Treatment
Chapter7
Table 4 Postoperative data Laparoscopy
&
Fast Track
(n = 100)
Open
&
Fast Track
(n = 93)
Laparoscopy
&
Standard care
(n = 109)
Open
&
Standard care
(n = 98)
P
Overall morbidity < 30 days – n
(%)
34 (34.0) 43 (46.2) 37 (33.9) 41 (40.8) 0.203¶
Patients with one or more major
complications – n (%)
15 (15.0) 18 (19.4)
12 (11.0) 21 (21.4) 0.185¶
Total No. of major complications - Intra-operative complication
- Anastomotic leakage
- Mechanical ileus requiring
reoperation
- Iatrogenic bowel perforation
- Abdominal wall dehiscence
- Other surgical complication¥
- Myocardial infarction
- Respiratory
- Infectious
- Cerebral vascular accident
- Acute tubular necrosis
18 2
7
3
0
0
2
0
2 of which 1 †
0
1 which 1 †
1
25 0
8 which 2 †
2
2
6
2
1
2 which 1 †
2 which 1 †
0
0
17 1
6 which 1 †
0
2 which 1 †
1
2
0
2
3
0
0
29 1 which 1 †
7
5
1
3
2
0
4
3
2 which 1 †
1
Patients with one or more minor
complications – n (%)
19 (19.0) 25 (26.8) 25 (23.8) 20 (19.4) 0.575¶
Total No. of minor complications - Prolonged postoperative ileus
*
- Other surgical complication
#
- Wound infection
- Other infectious complication
- Urine retention
- Cardiac
- Central nervous system
- Renal failure
- Other
36 7
2
6
8
4
3
4
2
0
46 5
2
16
11
6
4
2
0
0
43 8
2
8
9
6
3
4
0
3
43 5
2
10
14
1
3
4
1
3
Reoperations – n (%) 10 (10.0) 13 (14.0) 11 (10.1) 18 (18.4) 0.242¶
Readmission < 30 days – n (%) 6 (6.0) 7 (7.5) 7 (6.4) 7 (7.1) 0.974¶
In-hospital mortality – n (%) 2 (2.0) 4 (4.3) 2 (1.8) 2 (2.0) 0.645¶
¶Chi-square test / † = died /
¥Other surgical complication, e.g. postoperative bleeding and abdominal abscess requiring intervention,
bowel necrosis / *Prolonged postoperative ileus = unable to tolerate food with abdominal distension and had no bowel sounds,
flatus and defecation after 5 days / #Other surgical complication, e.g. intraperitoneal haematoma, suprapubic catheter sutured into
laparotomy wound, postoperative bleeding with expectative policy
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groupshadsimilarmorbidity,reoperationandreadmissionrates,equal in-hospitalmortal-ity,comparablelevelsofqualityoflifeandpatientsatisfaction,andsimilarin-hospitalcosts.Laparoscopywasfoundtobetheonlysignificantindependentfactortoreducepostoperativehospitalstayandmorbidity. ThemaingoaloftheFTconceptisnottodischargepatientsearlier,buttoacceleratethepatient’spostoperativerecoveryresultinginashorterhospitalstay.Theprimaryoutcome,to-talpostoperativehospitalstay,wasstandardizedbypredefinedobjectivelyquantifieddischargecriteria,whichisincontrasttootherstudieswheredischargecriteriahavenotbeendefinedproperly.9;13;21-23Inourstudy,dischargecriteriawerescoreddaily. LengthofhospitalstayafteraLap/FTorOpen/FTtreatmentinourstudywasinaccor-dancewiththeliterature,13;22;24;25butlongerthanthatreportedbyKehletetal.9;21;26ItshouldbepointedoutthatKehlet’sresultswereachievedatthecenterwhereFTwasdeveloped,andattheexpenseofahigherreadmissionrate.Ourstudymightthereforereflectdailypracticemoreaccurately. On comparison with the literature overall morbidity in the four treatment groups wasrelativelyhigh.Thiscanbeexplainedbythefactthatallcomplicationsbothintra-andex-tramural,werescoredprospectivelyandbytheinclusionofpatientsagedupto80.Twosys-tematicreviewscomparingFTwithstandardcaresuggestreducedmorbidityandmortalityinFT.10;11Wefoundnosignificantdifferenceinoverallmorbidityandmortalitybetweenthefourgroups.However,lessmorbiditywasassociatedwithlaparoscopicsurgery,whilethiswasnotthecaseforFTcare.Itisremarkableandyetunexplained,thatinthistrialpatientstreatedintheOpen/Standardgroupunderwentreoperationmorefrequently(18%)thanliteraturereports.IntheNetherlandsthemeanfigureis11%. Qualityoflifetwoandfourweekspostoperativelyweresimilaracrossthegroups,whichisinaccordancewitharecentlypublishedsystematicreview.27Thisisprobablyexplainedbythefactthatallpatientswereoperatedforcancerandthereforethemostimportantaimforthemwastogetcured.Anotherexplanationisthatdifferencesinqualityoflifeareexpectedtobethemostprominentinthefirstweekaftersurgery. Moststudies investigatingtheeffectivenessofFTprotocolsdidnotassesshowmanyoftheFTelementswereactuallyimplementedinpractice.Itisimportanttoevaluatethis,par-ticularlyasimplementationofthismultidisciplinaryprotocolinclinicalpracticehasprovendifficult.7;28-30Elevenofthe15predefinedFTelementsweresuccessfullyappliedinourFTgroups.Four systematic reviews10-12;16 reportedmeansofbetween8.5and13FTelementsapplied,wherebyapplieddoesnotnecessarilymeanachieved.Thereductioninhospitalstayofonly1day,asfoundintheLap/FTgroup,isprobablyduetothefactthatstandardcareactuallymeantmoderncare.Intheparticipatingcenters,standardcareincluded6ofthe15predefinedFTitems.Basedonexistingevidencewefeltthatitwouldhavebeenunethicalandunrealtowithholdtheseintrialsetting.31;32
LaparoscopyaswellasFTcare ismoreexpensive thanopensurgeryandstandardcare.Nevertheless,in-hospitalcostsweresimilarbetweenthegroups.Acost-effectivenessanalysis
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wasthereforenotperformed.ThehighercostsoflaparoscopyandFTcareweremostlikelycounterbalancedbyashorterhospitalstayand,althoughnotsignificant,lessoverallmorbid-ity.Moreover,saving1-2dayspertreatedpatient,hospitalbedutilizationwillbereducedby20%. Apartfromthesetofitemsapplied,thediscriminatingfeatureoftheFTprogramisthere-habilitationprocesswhichisalwaysimplementedinthesameway.Forexample,theprotocolprecludedthediscussionof,if,andwhenthepatientcouldeatandmobilizeaftersurgery,orthetimeofremovaloftheepidural.Itislikelytobethefactthatperioperativecareispro-tocolized,ratherthanthecombinationandnumberofappliedFTelements,thatisthetruesourceofthesuccessoftheFTprogram.FurtherstudyisrequiredtodistinguishwhichoftheFTitemsareessentialforenhancedrecovery. The limitationsofour studywere theblindingof the treatment,whichwasdifficult toachieveasthemajorityofthepatientscouldnotresistlookingundertheabdominaldress-ing.Woundinspectionwasnotalimitingfactorasthiswasnotcarriedoutuntilthedayofdischarge,butobviouslyonlyinthosepatientswithoutwoundcomplaintsorcomplications.Nonetheless,thispossiblefailurehasnotinfluencedourprimaryoutcomeasdischargewasclearlydefinedbyapplyingstrictdischargecriteria.Secondly,afterrandomizationmorepa-tientsintheopengroups(n=20)thaninthelaparoscopicgroups(n=7)wereexcluded,nev-erthelesswecanassumethatthisiscoincidental.Thirdly,aspatientshavebeenenrolledforoverfouryears,theremighthavebeenindriftincare,i.e.patientsincludedinalaterphaseofthestudy,allocatedtostandardcare,mighthavereceivedmoreFTelementsthanpatientsincludedatthestartofthestudy.WetriedtoavoidthisthoughbyadmittingpatientstoawardprovidingFTcareorawardprovidingstandardcare. Inconclusion,theoptimaltreatmentcombinationforpatientsrequiringsegmentalcolec-tomyformalignancyisalaparoscopicapproachwithinaFTperioperativecareprogram.Ifopensurgeryhastobeperformed,forexamplebecauseofthelackoflaparoscopicexpertiseorpatient-relatedfactors,thenthisshouldpreferentiallybeembeddedinaFTprotocol.
AcknowledgementsTheauthorswouldliketothankallinvestigatorsoftheLAFAstudygroupandallpatientsthatparticipatedintheLAFA-trial,withoutthemthestudywouldnothavebeenpossible.Furtherwearegratefulforthegovernmentalsubvention(ZonMW)andthefinancialsupportofJohnsonandJohnsonInternationalandNutricia.
Collaborative LAFA study group BenediktPreckel,MD,MA,DEAA,PatrickBossuyt,PhD,DirkGouma,MD,PhD,MarkvanBergeHenegouwen,MD,PhD,JanFuhring,BSc,InekePicard-vanLenthe,BSc,ChrisBakker, BSc, Bellinda King-Kalimanis, MSc, (Academic Medical Center, Amsterdam TheNetherlands),JanHofland,MD,PhD,(ErasmusMedicalCenter,Rotterdam,TheNether-lands),CornelisDejong,MD,PhD,RonaldvanDam,MD,PhD,(AcademicCenterMaas-
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tricht,Maastricht,TheNetherlands),DonaldvanderPeet,MD,PhD,EdithvanZalingen,MD, Astrid Noordhuis, BSc, Dick de Jong, BSc, (VU Medical Center, Amsterdam, TheNetherlands),T.HauwyGoei,MD,EricadeStoppelaar,MD,MarjonvandenDongen,BSc,(ZaansMedicalCenter,Zaandam,TheNetherlands),WillemvanTets,MD,PhD,MaartenvandenElsen,MD,AnnemiekSwart,BSc,(SintLucasAndreasHospital,Amsterdam,TheNetherlands),LaurensdeWit,MD,PhD,MurielSiepel,MD,GlaresaMolly,BSc,(OnzeLieveVrouweGasthuis,Amsterdam,TheNetherlands),JanJuttmann,MD,PhD,WilfredClevers, MD, Andrea Bieleman, BSc, (Tergooi Hospitals, Hilversum, The Netherlands),LudoCoenen,MD,EllyBonekamp,BSc,(GelreHospitals,Apeldoorn,TheNetherlands),JacobusvanAbeelen,MD,DianavanIterson-deJong,MD,andMargrietKrombeen,BSC,(RedCrossHospital,Beverwijk,TheNetherlands).
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