current status of laparoscopy for colorectal disorders steven d. wexner, m.d., facs, frcs, frcs(ed)...

CURRENT STATUS OF CURRENT STATUS OF LAPAROSCOPY FOR LAPAROSCOPY FOR

COLORECTAL DISORDERSCOLORECTAL DISORDERS

Steven D. Wexner, M.D., FACS, FRCS, FRCS(Ed)Steven D. Wexner, M.D., FACS, FRCS, FRCS(Ed)Cleveland Clinic FloridaCleveland Clinic Florida

Chairman, Department of Colorectal SurgeryChairman, Department of Colorectal SurgeryProfessor of Surgery, Ohio State University Health Sciences Center at the Professor of Surgery, Ohio State University Health Sciences Center at the

Cleveland Clinic FoundationCleveland Clinic FoundationClinical Professor of Surgery, University of South Florida Clinical Professor of Surgery, University of South Florida

College of MedicineCollege of Medicine

Cleveland Clinic FloridaCleveland Clinic FloridaWestonWeston

Cleveland Clinic FloridaCleveland Clinic FloridaWestonWeston

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancer Short term benefitsShort term benefits

– Bowel function recoveryBowel function recovery– Quality of life (including pain)Quality of life (including pain)– Hospital stayHospital stay

CostsCosts Long term benefitsLong term benefits

– RecurrenceRecurrence– SurvivalSurvival

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancer

I Evidence obtained from at least one properly randomized controlled trial

II-1 Evidence obtained from well-designed controlled trials without randomization

II-2 Evidence obtained from well-designed cohort or case control analytic studies, preferable from more than one center or research group

II-3 Evidence obtained from comparisons between times or places with or without the intervention; dramatic results in uncontrolled experiments were also included in this category

III Opinion of respected authorities based on clinical experience, descriptive studies, or reports of expert committees

Levels of evidence*Levels of evidence*

*Can Med Assoc, 1979*Can Med Assoc, 1979

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerBowel Function RecoveryBowel Function Recovery

AuthorAuthor YearYear N ofN of

patientspatients

Bowel function recoveryBowel function recovery

(mean/median n of days)(mean/median n of days)

RetrospectiveRetrospective

MelottiMelotti 19991999 163163 2.92.9

SchiedeckSchiedeck 20002000 399399 33

ZhouZhou 20032003 8282 1-21-2

ProspectiveProspective

MorinoMorino 20032003 100100 2.92.9

TsangTsang 20032003 4444 22

AuthorAuthor YearYear N of patientsN of patients Bowel function Bowel function (mean/median n of days)(mean/median n of days)

LapLap OpenOpen LapLap OpenOpen

Seow-ChoenSeow-Choen 19971997 1616 1111 22 2.52.5

RamosRamos 19971997 1818 1818 1.91.9 3.03.0

GohGoh 19971997 2020 2020 33 33

SchwandnerSchwandner 19991999 3232 3232 4.14.1 5.15.1

HartleyHartley 20012001 2121 2222 33 44

ChampaultChampault 20022002 7474 8383 1.41.4 3.23.2


p<0.05p<0.05

Case-control/CohortCase-control/Cohort

AuthorAuthor YearYear N of patientsN of patients Bowel function Bowel function (mean/median n of days)(mean/median n of days)


MilsomMilsom 19981998 5454 5353 3 4

CuretCuret 20002000 1818 1818 2.7 4.4

LacyLacy 20022002 111111 108108 1.5 2.3

HasegawaHasegawa 20032003 2929 3030 2 3.3

p<0.05p<0.05


RandomizedRandomized


The evidence that laparoscopy offers faster bowel The evidence that laparoscopy offers faster bowel function recovery than the traditional open function recovery than the traditional open approach may be considered high (Level I)approach may be considered high (Level I)

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerQuality of Life - PainQuality of Life - Pain

AuthorAuthor YearYear N of patientsN of patients Less pain/analgesic Less pain/analgesic requirement (days)?requirement (days)?

LapLap OpenOpen LapLap p valuep value

Seow-ChoenSeow-Choen 19971997 1616 1111 NoNo --

RamosRamos 19971997 1818 1818 YesYes <0.005<0.005

GohGoh 19971997 2020 2020 NoNo --

PsailaPsaila 19981998 2929 2525 YesYes 0.0020.002

SchwandnerSchwandner 19991999 3232 3232 NoNo --

Case-control/CohortCase-control/Cohort

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerQuality of Life - PainQuality of Life - Pain

AuthorAuthor YearYear N of patientsN of patients Less pain/analgesic Less pain/analgesic requirement (days)?requirement (days)?

LapLap OpenOpen LapLap p valuep value

StageStage 19971997 1515 1414 YesYes < 0.05< 0.05

SchwenkSchwenk 19981998 3030 3030 YesYes < 0.01< 0.01

MilsomMilsom 19981998 5454 5353 YesYes 0.020.02

WeeksWeeks 20022002 168168 221221 YesYes 0.030.03

HasegawaHasegawa 20032003 2929 3030 YesYes 0.0020.002


Randomized trial (COST trial)Randomized trial (COST trial) 449 patients 449 patients 228 Laparoscopy (Lap) , 221Open228 Laparoscopy (Lap) , 221Open Pain, hospital stayPain, hospital stay Quality of life (2 days, 2 weeks, 2 months)Quality of life (2 days, 2 weeks, 2 months)

– Symptom distress scale Symptom distress scale – Quality of life indexQuality of life index– Global rating scale (1-100)Global rating scale (1-100)

Weeks, JAMA 2002

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerQuality of lifeQuality of life

ResultsResultsLap Lap

n = 228n = 228

Open Open

n = 221n = 221

Age (years)Age (years) 68.268.2 69.469.4

Gender M:FGender M:F 108:120108:120 108:113108:113

Tumor stageTumor stage

I I

II II

III III

IVIV

88 88

77 77

57 57

55

69 69 78 78

62 62

11 11

ASA classificationASA classification

I or II I or II

IIIIII

198 198

32 32

189 189

3232P=NS Weeks, JAMA 2002

ResultsResults

Lap Lap n = 228n = 228

Open Open n = 221 n = 221

p valuep value

Oral analgesicsOral analgesics 1.91.9 2.22.2 0.030.03

IV narcotics/analgesicsIV narcotics/analgesics 3.23.2 4.04.0 <0.001<0.001

Hospital stayHospital stay 5.65.6 6.46.4 <0.001<0.001

Weeks, JAMA 2002

Patients in the Lap group had only greater mean global Patients in the Lap group had only greater mean global rate scores at 2 weeks after surgery (76.9 vs. 74.4; rate scores at 2 weeks after surgery (76.9 vs. 74.4; p=.0009)p=.0009) No other differences in quality of lifeNo other differences in quality of life

Values are means

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancer

The superiority of laparoscopy in reducing pain The superiority of laparoscopy in reducing pain during the same length of the postoperative period during the same length of the postoperative period seems evident (Level I)seems evident (Level I)

Other aspects of quality of life warrant further Other aspects of quality of life warrant further investigation investigation

AuthorAuthor YearYear PatientsPatients Hospital Stay Hospital Stay


MelottiMelotti 19991999 163163 10.910.9

SchiedeckSchiedeck 20002000 399399 1414

ZhouZhou 20032003 8282 88


YamamotoYamamoto 20022002 7070 88

AndersonAnderson 20022002 100100 8.38.3

MorinoMorino 20032003 100100 16.616.6

TsangTsang 20032003 4444 88

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerHospital StayHospital Stay

AuthorAuthor YearYear N of patientsN of patients Hospital Stay Hospital Stay (mean n of days)(mean n of days)


LordLord 19961996 3232 3232 5.85.8 8.28.2

FranklinFranklin 19961996 224224 224224 5.75.7 9.79.7

Seow-ChoenSeow-Choen 19971997 1616 1111 6.56.5 88

RamosRamos 19971997 1818 1818 7.47.4 12.912.9

GohGoh 19971997 2020 2020 55 5.55.5

KhaliliKhalili 19981998 8080 9090 6.26.2 8.28.2

PsailaPsaila 19981998 2929 2525 10.710.7 17.817.8p<0.05p<0.05

Cohort/case-control studiesCohort/case-control studies



AuthorAuthor YearYear N of patientsN of patients Hospital Stay Hospital Stay

(mean n of days)(mean n of days)

Lap Open Lap Open

Schwandner 1999 32 32 15.3 21.9

Fleshman 1999 152 33 7.4 8.7

Leung 2000 59 34 16 25.5

Hartley 2001 21 22 13.5 15

Baker 2002 28 61 13 18

Anthuber 2002 101 334 14.4 19.9

Champault 2002 74 83 8.2 12.3

p<0.05p<0.05

Cohort/case-control studies (cont)Cohort/case-control studies (cont)


AuthorAuthor YearYear N of patientsN of patients Hospital Stay Hospital Stay

(mean n of days)(mean n of days)

Lap Open Lap Open

Stage 1997 15 14 5 8

Schwenk 1998 30 30 10.1 11.6

Milsom 1998 54 53 6 7

Curet 2000 18 18 5.2 7.3

Lacy 2002 111 108 5.2 7.9

Weeks 2002 168 221 5.6 6.4

Hasegawa 2003 29 30 7.1 12.7


p<0.05p<0.05

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerHospital stayHospital stay

There is high evidence (Level I) that laparoscopy There is high evidence (Level I) that laparoscopy for malignancy is associated with an earlier for malignancy is associated with an earlier discharge compared to laparotomy discharge compared to laparotomy

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerCostsCosts

Retrospective studyRetrospective study

Philipson, Wold J Surg 1997Philipson, Wold J Surg 1997

LapLap

n = 28n = 28

OpenOpen

n = 33n = 33

pp

Direct costsDirect costs

OR/recoveryOR/recovery

WardWard

ICUICU

TotalTotal

26312631

26632663

202202

54965496

16231623

26412641

514514

47784778 < 0.001< 0.001

Indirect costsIndirect costs 35683568 31033103 <0.001<0.001

Overall total costsOverall total costs 90649064 78817881 <0.001<0.001

(Australian $)(Australian $)



Khalili, DCR 1998Khalili, DCR 1998

LapLap

n = 80n = 80

OpenOpen

n = 90n = 90

pp

OR costs ($)OR costs ($) 2,1002,100 1,200 1,200 0.010.01

Total costs ($)Total costs ($) 14,80014,800 14,20014,200 0.480.48



Psaila, Br J Surg 1998Psaila, Br J Surg 1998

LapLap

n = 29n = 29

OpenOpen

n = 25n = 25

pp

Disposable equipment (lb)Disposable equipment (lb) 140 (200)140 (200) 400 (220)400 (220) 0.050.05

Total cost (lb)Total cost (lb) 3300 (1700)3300 (1700) 2900 (1500)2900 (1500) NSNSValues are mean (s.d)Values are mean (s.d)


The data available does not provide adequate The data available does not provide adequate evidence on whether total costs differ between evidence on whether total costs differ between laparoscopy and laparotomy in the treatment of laparoscopy and laparotomy in the treatment of malignancy malignancy

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerRecurrenceRecurrence

Author, yearAuthor, year N of N of patientspatients

Mean FU time Mean FU time (months)(months)

Recurrence (%)Recurrence (%)

OverallOverall LocalLocal DistantDistant


Huscher, 96Huscher, 96 146146 1616 11.711.7 4.14.1 6.16.1

Schiedek, 00Schiedek, 00 399399 3030 7.27.2 1.51.5 6.26.2


Lumley, 02Lumley, 02 154154 7171 13.613.6 1.91.9 10.310.3

Anderson, 02Anderson, 02 100100 4343 16.116.1 -- --

Scheidbach, 02Scheidbach, 02 206206 25.225.2 11.611.6 3.43.4 8.28.2



Author,yearAuthor,year N of N of patientspatients

Mean FU Mean FU (months)(months)

Recurrence (%)Recurrence (%)

OverallOverall LocalLocal DistantDistant

LapLap OpenOpen LapLap OpenOpen LapLap OpenOpen LapLap OpenOpen

Franklin, 96Franklin, 96 165165 212212 6060 12.212.2 2222 -- -- -- --

Ramos, 97Ramos, 97 1616 1616 2020 12.512.5 2525 6.26.2 18.718.7 6.26.2 6.26.2

Khalili, 98Khalili, 98 7676 8282 21/1821/18 13.113.1 18.318.3 33 66 1010 1111

Schwandner, 99Schwandner, 99 3232 3232 33.1/32.133.1/32.1 15.615.6 15.615.6 3.13.1 00 12.512.5 15.615.6

Santoro, 99Santoro, 99 4040 4343 24-6024-60 2020 2323 2.52.5 2.32.3 1515 18.618.6

Lezoche, 00Lezoche, 00 9999 109109 32.2/34.232.2/34.2 1616 20.220.2 33 9.29.2 1111 1111

Hartley, 01Hartley, 01 2121 2222 3838 55 4.54.5 55 4.54.5 55 00

Feliciotti, 02Feliciotti, 02 7474 7575 48.948.9 12.712.7 13.313.3 1.31.3 2.72.7 10.810.8 10.710.7p=NSp=NS

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerSurvivalSurvival

Author, yearAuthor, year N ofN of

patientspatients

Mean FUMean FU

(months)(months)

Survival timeSurvival time Overall survival (%)Overall survival (%)

TNM/Dukes stagesTNM/Dukes stages


Fleshman, 96Fleshman, 96 372372 22.622.6 3-year3-year I-93; II-72; III-53I-93; II-72; III-53

Color trial, 00Color trial, 00 513513 -- 2-year2-year I-95; II-98; III-93I-95; II-98; III-93

Poulin, 02Poulin, 02 7070 3131 5-year5-year 72.172.1

Lechaux, 02Lechaux, 02 166166 6565 3-year3-year 7979


Scheidbach, 02Scheidbach, 02 214214 25.225.2 5-year5-year 80.980.9

Anderson, 02Anderson, 02 100100 40.340.3 5-year5-year A-100; B-76; C-51A-100; B-76; C-51

Morino, 03Morino, 03 7070 45.745.7 5-year5-year I-92; II-79; III-67I-92; II-79; III-67


Author, yearAuthor, year N ofN of

patientspatients

Mean FUMean FU

(months)(months)

SurvivalSurvival Overall survival (%)Overall survival (%)

TNM StageTNM Stage


Franklin, 96Franklin, 96 165165 212212 34/4834/48 5-year5-year 89.789.7 92.492.4

Leung, 97Leung, 97 5050 5050 32.832.8 5-year5-year 67.267.2 64.164.1

Khalili, 98Khalili, 98 7676 8282 2121 5-year5-year 87.587.5 8585

Schwandner, 99Schwandner, 99 3232 3232 33.133.1 3-year3-year 9393 9393

Santoro, 99Santoro, 99 4040 4343 24-6024-60 5-year5-year 73.273.2 70.170.1

Leung, 00Leung, 00 1919 2424 30/2830/28 4-year4-year 84.284.2 77.877.8

Hartley, 01Hartley, 01 2121 2222 3838 3-year3-year 7171 7777

Lujan, 02Lujan, 02 102102 641641 64.464.4 5-year5-year I-73; II-61;III-55I-73; II-61;III-55 I-75;II-65; III-46I-75;II-65; III-46

Champault, 02Champault, 02 6262 6666 6060 5-year5-year 75.875.8 74.274.2

Pantakar, 03Pantakar, 03 161161 174174 5252 5-year5-year I-76; II-68; III-I-76; II-68; III-5353

I-80; II-64; III-50I-80; II-64; III-50


Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerRandomized Controlled TrialRandomized Controlled Trial

111 Laparoscopy vs. 106 Laparotomy111 Laparoscopy vs. 106 Laparotomy Non metastatic colon cancerNon metastatic colon cancer Median follow-up time: 43 (27-85) monthsMedian follow-up time: 43 (27-85) months Postoperative chemotherapy for all suitable Postoperative chemotherapy for all suitable

patients with Stage II or III rectal cancerpatients with Stage II or III rectal cancer Intention-to-treat analysisIntention-to-treat analysis

Lacy et al, The lancet 2002Lacy et al, The lancet 2002



LaparoscopyLaparoscopy

(n=106)(n=106)

OpenOpen

(n=102)(n=102)

Hazard ratioHazard ratio

(95% CI)(95% CI)

pp

Tumor recurrenceTumor recurrence 18 (17%)18 (17%) 28 (27%)28 (27%) 0.72 (0.49-1.06)0.72 (0.49-1.06) 0.070.07

Type of recurrenceType of recurrence

Distant metastasis Distant metastasis

Locoregional relapse Locoregional relapse

Peritoneal seeding Peritoneal seeding

Port-site metastasisPort-site metastasis

77

77

33

11

99

1414

55

00

----

----

----

----

0.570.57

Time to recurrence (months)Time to recurrence (months) 15 (14)15 (14) 17 (12)17 (12) ---- 0.660.66

Surgical treatment of Surgical treatment of recurrence with curative recurrence with curative intentionintention

6 (33%)6 (33%) 9 (32%)9 (32%) ---- 1.001.00



LaparoscopyLaparoscopy

(n=106)(n=106)

OpenOpen

(n=102)(n=102)


(95% CI)(95% CI)

pp

Overall mortalityOverall mortality 19 (18%)19 (18%) 27 (26%)27 (26%) 0.77 (0.53-1.12)0.77 (0.53-1.12) 1.041.04

Cancer-related mortalityCancer-related mortality 10 (9%)10 (9%) 21 (21%)21 (21%) 0.68 (0.50-0.90)0.68 (0.50-0.90) 0.030.03

Causes of deathCauses of death

Perioperative mortalityPerioperative mortality

Tumor progressionTumor progression

OthersOthers

11

99

99

33

1818

66

----

----

----

0.190.19

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerPredictive factorsPredictive factors



(95% CI)(95% CI)

pp

Probability of being free of recurrenceProbability of being free of recurrence

Lymph node metastasis (presence or absence)Lymph node metastasis (presence or absence)

Surgical procedure (Open vs. Lap)Surgical procedure (Open vs. Lap)

Preoperative serum CEA (Preoperative serum CEA (>> ng/ml vs. < 4 ng/ml) ng/ml vs. < 4 ng/ml)

0.31 (0.16-0.60)0.31 (0.16-0.60)

0.39 (0.19-0.82)0.39 (0.19-0.82)

0.43 (0.22-0.87)0.43 (0.22-0.87)

0.00060.0006

0.0120.012

0.0180.018

Overall survivalOverall survival

Surgical procedure (open vs. Lap)Surgical procedure (open vs. Lap)

Lymph-node metastasis (presence vs. absence)Lymph-node metastasis (presence vs. absence)

0.48 (0.23-1.01)0.48 (0.23-1.01)

0.49 (0.25-0.98)0.49 (0.25-0.98)

0.0520.052

0.0440.044

Cancer-related survivalCancer-related survival

Lymph-node metastasis (presence vs. absence)Lymph-node metastasis (presence vs. absence)

Surgical procedure (open vs. Lap)Surgical procedure (open vs. Lap)

0.29 (0.12-0.67)0.29 (0.12-0.67)

0.38 (0.16-0.91)0.38 (0.16-0.91)

0.0040.004

0.0290.029

Cox’s regression modelCox’s regression model

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerOverall survivalOverall survival


Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerCancer-related survivalCancer-related survival


Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerRecurrence free – by StageRecurrence free – by Stage


Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerOverall survival- by StageOverall survival- by Stage


Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerCancer related survival – by StageCancer related survival – by Stage


Laparoscopic Colectomy: CancerLaparoscopic Colectomy: Cancer

Laparoscopic resection of colorectal malignancies Laparoscopic resection of colorectal malignancies a systematic reviewa systematic review

English languageEnglish language Randomized controlled trialsRandomized controlled trials Controlled clinical trialsControlled clinical trials Case series/reportsCase series/reports

Chapman et al. Ann Surg 2001Chapman et al. Ann Surg 2001

Laparoscopic Colectomy : CancerLaparoscopic Colectomy : Cancer

• 52 papers met inclusion criteria52 papers met inclusion criteria– ““Little high level evidence was available”Little high level evidence was available”– ““The evidence base for laparoscopic-assisted reection of The evidence base for laparoscopic-assisted reection of

colorectal malignancies is inadequate to determine the colorectal malignancies is inadequate to determine the procedures safety and efficacy”procedures safety and efficacy”


Laparoscopic Colectomy : CancerLaparoscopic Colectomy : CancerDisadvantages vs. Open ColectomyDisadvantages vs. Open Colectomy

• Significantly longer operative timesSignificantly longer operative times

• Possibly more expensivePossibly more expensive

• Possibly worse short term immune effectsPossibly worse short term immune effects



• ““Laparoscopic resection of colorectal malignancy was Laparoscopic resection of colorectal malignancy was more expensive and time-consuming”more expensive and time-consuming”

• The new procedure’s advantages revolve around early The new procedure’s advantages revolve around early recovery from surgery and reduced pain”recovery from surgery and reduced pain”


Laparoscopic Colectomy : CancerLaparoscopic Colectomy : CancerAdvantages vs. Open ColectomyAdvantages vs. Open Colectomy

• Improved cosmesis (no data but appears uncontentious)Improved cosmesis (no data but appears uncontentious)

• Quicker hospital dischargeQuicker hospital discharge

• Less narcotic use, though possibly larger benefits for certain Less narcotic use, though possibly larger benefits for certain types of colectomy (low colonic)types of colectomy (low colonic)

• Possibly less pain at rest, at least for patients who have Possibly less pain at rest, at least for patients who have uncovered proceduresuncovered procedures

• Possibly earlier return of bowel function and resumption of Possibly earlier return of bowel function and resumption of normal dietnormal diet



Short term Quality-of-Life outcomes Following Short term Quality-of-Life outcomes Following Laparoscopic-Assisted Colectomy vs Open Laparoscopic-Assisted Colectomy vs Open Colectomy for Colon Cancer (COST Study)Colectomy for Colon Cancer (COST Study)

AIMSAIMS– Are disease free and overall survival equivalent ?Are disease free and overall survival equivalent ?– Is laparoscopic approach associated with better QOL ?Is laparoscopic approach associated with better QOL ?

Weeks et al. JAMA 2002Weeks et al. JAMA 2002

Laparoscopic Colectomy : CancerLaparoscopic Colectomy : Cancer Randomized control trial Randomized control trial 449 patients 449 patients

– Adenocarcinoma of single segment of colonAdenocarcinoma of single segment of colon– Excluded: Acute presentation, rectal and transverse Excluded: Acute presentation, rectal and transverse

colon cancers, advanced local disease, those lesions colon cancers, advanced local disease, those lesions with evidence of metastatic disease, ASA IV or Vwith evidence of metastatic disease, ASA IV or V

Quality of surgery:Quality of surgery:– All surgeons with > 20 cases; Random audit of casesAll surgeons with > 20 cases; Random audit of cases



Outcomes:Outcomes:– Survival: still pendingSurvival: still pending– QOL at 2days, 2 weeks and 2 months using: QOL at 2days, 2 weeks and 2 months using:

» Symptom Distress Scale, Global QOL Scale, QOL indexSymptom Distress Scale, Global QOL Scale, QOL index

Results: Intention to Treat AnalysisResults: Intention to Treat Analysis– Shorter use of narcoticsShorter use of narcotics– Shorter length of stay by 0.8 days (p<0.01)Shorter length of stay by 0.8 days (p<0.01)– Quality of life: no differenceQuality of life: no difference



ConclusionsConclusions– ““The modest benefits in short term QOL measures we The modest benefits in short term QOL measures we

observed are not sufficient to justify the use of this observed are not sufficient to justify the use of this procedure in the routine care setting”procedure in the routine care setting”

Unresolved Issues:Unresolved Issues:– Blunting of QOL differences via analgesic use Blunting of QOL differences via analgesic use – QOL differences between POD 2 and POD 14QOL differences between POD 2 and POD 14– Recurrence and survival outcomesRecurrence and survival outcomes– Incidence of small bowel obstruction Incidence of small bowel obstruction


Laparoscopic Colectomy : Laparoscopic Colectomy : Prospective, Randomized, ControlledProspective, Randomized, Controlled

48 institutions, 872 patients48 institutions, 872 patients

Prospective, randomizedProspective, randomized

Follow-up 4.4 yearsFollow-up 4.4 years

Conversion 21%Conversion 21%

Endpoint was time to tumor recurrenceEndpoint was time to tumor recurrence

Nelson, NEJM 2004Nelson, NEJM 2004

Prospective, Randomized, ControlledProspective, Randomized, Controlled

Laparoscopic Laparoscopic (n=435)(n=435)

Open Open

(n=425)(n=425)

AgeAge 7070 6969

FemaleFemale 212212 220220

LocationLocation

RightRight

LeftLeft

SigmoidSigmoid

237237

3232

166166

232232

3232

164164

TNM StageTNM Stage

00

11

22

33

44

UnknownUnknown

2020

153153

136136

112112

1010

44

3333

112112

146146

121121

1616

00


Prospective, Randomized, Prospective, Randomized, Controlled: Outcome at Surgery Controlled: Outcome at Surgery

Laparoscopic Laparoscopic (N=435)(N=435)

Open Open

(N=425)(N=425)

P valueP value

Bowel margins (cm)Bowel margins (cm) 10-1310-13 11-1211-12 0.4-0.90.4-0.9

Lymph nodesLymph nodes 1212 1212 1.01.0

Surgery time (min)Surgery time (min) 150 150 9090 <0.001<0.001

ConversionConversion 9090 -- --

Intraoperative Intraoperative complicationscomplications

88 1515 NSNS

Length of incision (cm)Length of incision (cm) 1818 66 <0.001<0.001


Prospective, Randomized, Prospective, Randomized, Controlled: Post-operativeControlled: Post-operative

LaparoscopicLaparoscopic

(n=435)(n=435)

Open Open

(n=425)(n=425)

IV narcotics (days)IV narcotics (days) 33 44 <0.001<0.001

PO narcotics (days)PO narcotics (days) 11 22 0.020.02

Length of StayLength of Stay 55 66 <0.001<0.001

30-day mortality30-day mortality 22 44 NSNS

ComplicationsComplications 9292 8585 NSNS

Rates of readmissionRates of readmission 1010 1212 NSNS

Rates of reoperationRates of reoperation <2%<2% <2%<2% NSNS


Prospective, Randomized, Prospective, Randomized, Controlled: Outcome Controlled: Outcome

LaparoscopicLaparoscopic

(n=435)(n=435)

OpenOpen

(n=425)(n=425)

P valueP value

Recurrence*(4.4yrs)Recurrence*(4.4yrs) 7676 8484 0.830.83

Wound recurrenceWound recurrence 1%1% 1%1% P=0.50 NSP=0.50 NS

3yr survival3yr survival 86%86% 85%85% P=0.51 NSP=0.51 NS


**Laparoscopic procedure not significantlyLaparoscopic procedure not significantly inferior to Open Procedure.inferior to Open Procedure.

Cumulative Incidence of Recurrence at Any SatgeCumulative Incidence of Recurrence at Any Satge

Overall Survival at Any StageOverall Survival at Any Stage

Prospective, Randomized, Prospective, Randomized, Controlled: ConclusionsControlled: Conclusions

No difference between: No difference between: – Time to recurrenceTime to recurrence

– Disease-free survival Disease-free survival

– Overall survivalOverall survival

Oncologic outcome of laparoscopic resection is similar to Oncologic outcome of laparoscopic resection is similar to that of open resectionthat of open resection

Laparoscopic Approach is associated with less pain and a Laparoscopic Approach is associated with less pain and a shorter hospital stay than conventional surgeryshorter hospital stay than conventional surgery


Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerConclusionConclusion

Laparoscopy for colorectal cancer has shown to be Laparoscopy for colorectal cancer has shown to be potentially superior to laparotomy in regard to short-term potentially superior to laparotomy in regard to short-term benefits and equivalent with regard to long term benefitsbenefits and equivalent with regard to long term benefits

Available data appear to support that laparoscopic Available data appear to support that laparoscopic colectomy and conventional open colectomy have either colectomy and conventional open colectomy have either similar or superior long-term outcomes (Level 1 similar or superior long-term outcomes (Level 1 evidence)evidence)

Laparoscopy: Colorectal cancerLaparoscopy: Colorectal cancerConclusionConclusion

Surgeons with sufficient expertise and ongoing Surgeons with sufficient expertise and ongoing peer-reviewed data collection may offer this peer-reviewed data collection may offer this therapy to appropriately selected patientstherapy to appropriately selected patients

International Colorectal Disease SymposiumInternational Colorectal Disease Symposium

16th Annual

An International Exchange of Medical and Surgical Concepts

Marriott’s Harbor Beach Resort & Spa

Fort Lauderdale, Florida

February 17 – 19, 2005February 17 – 19, 2005

current status of laparoscopy for colorectal disorders steven d. wexner, m.d., facs, frcs, frcs(ed)...

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