Transcript PowerPoint Presentation - Laparoscopic Colorectal Surgery

CURRENT STATUS OF
LAPAROSCOPY FOR
COLORECTAL DISORDERS
Steven D. Wexner, M.D., FACS, FRCS, FRCS(Ed)
Cleveland Clinic Florida
Chairman, Department of Colorectal Surgery
Professor of Surgery, Ohio State University Health Sciences Center at the
Cleveland Clinic Foundation
Clinical Professor of Surgery, University of South Florida
College of Medicine
Cleveland Clinic Florida
Weston
Laparoscopy: Colorectal cancer
 Short term benefits
– Bowel function recovery
– Quality of life (including pain)
– Hospital stay
 Costs
 Long term benefits
– Recurrence
– Survival
Laparoscopy: Colorectal cancer
Levels of evidence*
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
Opinion of respected authorities based on clinical
experience, descriptive studies, or reports of expert
committees
III
*Can Med Assoc, 1979
Laparoscopy: Colorectal cancer
Bowel Function Recovery
Author
Retrospective
Melotti
Schiedeck
Zhou
Prospective
Morino
Tsang
Year
N of
patients
Bowel function recovery
(mean/median n of days)
1999
2000
2003
163
399
82
2.9
3
1-2
2003
2003
100
44
2.9
2
Laparoscopy: Colorectal cancer
Bowel Function Recovery
Case-control/Cohort
Author
Seow-Choen
Ramos
Goh
Schwandner
Hartley
Champault
p<0.05
Year
1997
1997
1997
1999
2001
2002
N of patients
Lap
16
18
20
32
21
74
Open
11
18
20
32
22
83
Bowel function
(mean/median n of days)
Lap
2
1.9
3
4.1
3
1.4
Open
2.5
3.0
3
5.1
4
3.2
Laparoscopy: Colorectal cancer
Bowel Function Recovery
Randomized
Author
Year
N of patients
Lap Open
Bowel function
(mean/median n of days)
Lap
Open
Milsom
1998
54
53
3
4
Curet
2000
18
18
2.7
4.4
Lacy
2002
111
108
1.5
2.3
Hasegawa
2003
29
30
2
3.3
p<0.05
Laparoscopy: Colorectal cancer
Bowel Function Recovery
 The evidence that laparoscopy offers faster bowel
function recovery than the traditional open
approach may be considered high (Level I)
Laparoscopy: Colorectal cancer
Quality of Life - Pain
Case-control/Cohort
Author
Seow-Choen
Ramos
Goh
Psaila
Schwandner
Year
1997
1997
1997
1998
1999
N of patients
Lap
16
18
20
29
32
Open
11
18
20
25
32
Less pain/analgesic
requirement (days)?
Lap
No
Yes
No
Yes
No
p value
<0.005
0.002
-
Laparoscopy: Colorectal cancer
Quality of Life - Pain
Randomized
Author
Stage
Schwenk
Milsom
Weeks
Hasegawa
Year
1997
1998
1998
2002
2003
N of patients
Lap
15
30
54
168
29
Open
14
30
53
221
30
Less pain/analgesic
requirement (days)?
Lap
Yes
Yes
Yes
Yes
Yes
p value
< 0.05
< 0.01
0.02
0.03
0.002
Laparoscopy: Colorectal cancer
Quality of life





Randomized trial (COST trial)
449 patients
228 Laparoscopy (Lap) , 221Open
Pain, hospital stay
Quality of life (2 days, 2 weeks, 2 months)
– Symptom distress scale
– Quality of life index
– Global rating scale (1-100)
Weeks, JAMA 2002
Results
Age (years)
Gender M:F
Tumor stage
I
II
III
IV
ASA classification
I or II
III
P=NS
Lap
n = 228
68.2
Open
n = 221
69.4
108:120
108:113
88
77
57
5
69
78
62
11
198
32
189
32
Weeks, JAMA 2002
Results
Oral analgesics
IV narcotics/analgesics
Hospital stay
Lap
n = 228
Open
n = 221
p value
1.9
3.2
5.6
2.2
4.0
6.4
0.03
<0.001
<0.001
Values are means
 Patients in the Lap group had only greater mean
global rate scores at 2 weeks after surgery (76.9 vs. 74.4;
p=.0009)
 No other differences in quality of life
Weeks, JAMA 2002
Laparoscopy: Colorectal cancer
 The superiority of laparoscopy in reducing pain
during the same length of the postoperative period
seems evident (Level I)
 Other aspects of quality of life warrant further
investigation
Laparoscopy: Colorectal cancer
Hospital Stay
Author
Year
Patients
Hospital Stay
Retrospective
Melotti
Schiedeck
1999
2000
163
399
10.9
14
Zhou
Prospective
Yamamoto
Anderson
2003
82
8
2002
2002
70
100
8
8.3
Morino
Tsang
2003
2003
100
44
16.6
8
Laparoscopy: Colorectal cancer
Hospital Stay
Cohort/case-control studies
Author
Year
N of patients
Lord
Franklin
1996
1996
Lap
32
224
Open
32
224
Seow-Choen
Ramos
Goh
1997
1997
1997
16
18
20
11
18
20
Khalili
Psaila
p<0.05
1998
1998
80
29
90
25
Hospital Stay
(mean n of days)
Lap
Open
5.8
8.2
5.7
9.7
6.5
8
7.4
12.9
5
5.5
6.2
8.2
10.7
17.8
Laparoscopy: Colorectal cancer
Hospital Stay
Cohort/case-control studies (cont)
Author
Year
N of patients
Schwandner
1999
Lap
32
Open
32
Fleshman
Leung
Hartley
Baker
1999
2000
2001
2002
152
59
21
28
33
34
22
61
Anthuber
Champault
p<0.05
2002
2002
101
74
334
83
Hospital Stay
(mean n of days)
Lap
Open
15.3
21.9
7.4
8.7
16
25.5
13.5
15
13
18
14.4
19.9
8.2
12.3
Laparoscopy: Colorectal cancer
Hospital Stay
Randomized
Author
Year
N of patients
Hospital Stay
(mean n of days)
Lap
Open
5
8
10.1
11.6
Stage
Schwenk
1997
1998
Lap
15
30
Open
14
30
Milsom
Curet
Lacy
1998
2000
2002
54
18
111
53
18
108
6
5.2
5.2
7
7.3
7.9
Weeks
Hasegawa
p<0.05
2002
2003
168
29
221
30
5.6
7.1
6.4
12.7
Laparoscopy: Colorectal cancer
Hospital stay
 There is high evidence (Level I) that laparoscopy
for malignancy is associated with an earlier
discharge compared to laparotomy
Laparoscopy: Colorectal cancer
 Retrospective study
Costs
Lap
n = 28
Open
n = 33
p
Direct costs
OR/recovery
Ward
ICU
Total
Indirect costs
2631
2663
202
5496
3568
1623
2641
514
4778
3103
< 0.001
<0.001
Overall total costs
9064
7881
<0.001
(Australian $)
Philipson, Wold J Surg 1997
Laparoscopy: Colorectal cancer
Costs
 Retrospective study
OR costs ($)
Total costs ($)
Lap
n = 80
2,100
14,800
Open
n = 90
1,200
14,200
p
0.01
0.48
Khalili, DCR 1998
Laparoscopy: Colorectal cancer
Costs
 Retrospective study
Disposable equipment (lb)
Total cost (lb)
Lap
n = 29
140 (200)
Open
n = 25
400 (220)
3300 (1700) 2900 (1500)
p
0.05
NS
Values are mean (s.d)
Psaila, Br J Surg 1998
Laparoscopy: Colorectal cancer
Costs
 The data available does not provide adequate
evidence on whether total costs differ between
laparoscopy and laparotomy in the treatment of
malignancy
Laparoscopy: Colorectal cancer
Recurrence
Author, year
N of
patients
Mean FU time
(months)
Recurrence (%)
Overall Local Distant
Retrospective
Huscher, 96
Schiedek, 00
Prospective
Lumley, 02
Anderson, 02
Scheidbach, 02
146
399
16
30
11.7
7.2
4.1
1.5
6.1
6.2
154
71
13.6
1.9
10.3
100
206
43
25.2
16.1
11.6
3.4
8.2
Laparoscopy: Colorectal cancer
Cohort/case-control studies
Author,year
N of
patients
Recurrence
Mean FU
(months)
Recurrence (%)
Overall
Lap Open
Local
Distant
Lap
Open
Lap
Open
Lap
Open
Franklin, 96
165
212
60
12.2
22
-
-
-
-
Ramos, 97
16
16
20
12.5
25
6.2
18.7
6.2
6.2
Khalili, 98
76
82
21/18
13.1
18.3
3
6
10
11
Schwandner, 99
32
32
33.1/32.1 15.6
15.6
3.1
0
12.5
15.6
Santoro, 99
40
43
24-60
20
23
2.5
2.3
15
18.6
Lezoche, 00
99
109
32.2/34.2
16
20.2
3
9.2
11
11
Hartley, 01
21
22
38
5
4.5
5
4.5
5
0
Feliciotti, 02
p=NS
74
75
48.9
12.7
13.3
1.3
2.7
10.8
10.7
Laparoscopy: Colorectal cancer
Survival
Author, year
Retrospective
Fleshman, 96
Color trial, 00
Poulin, 02
Lechaux, 02
Prospective
Scheidbach, 02
Anderson, 02
Morino, 03
N of
patients
Mean FU
(months)
Survival time
Overall survival (%)
TNM/Dukes stages
372
513
22.6
-
3-year
2-year
I-93; II-72; III-53
I-95; II-98; III-93
70
166
31
65
5-year
3-year
72.1
79
214
100
70
25.2
40.3
45.7
5-year
5-year
5-year
80.9
A-100; B-76; C-51
I-92; II-79; III-67
Laparoscopy: Colorectal cancer
Cohort/case-control studies
Author, year
N of
patients
Survival
Mean FU Survival
(months)
Lap Open
Overall survival (%)
TNM Stage
Lap
Open
Franklin, 96
165
212
34/48
5-year
89.7
92.4
Leung, 97
50
50
32.8
5-year
67.2
64.1
Khalili, 98
76
82
21
5-year
87.5
85
Schwandner, 99
32
32
33.1
3-year
93
93
Santoro, 99
40
43
24-60
5-year
73.2
70.1
Leung, 00
19
24
30/28
4-year
84.2
77.8
Hartley, 01
21
22
38
3-year
71
77
Lujan, 02
102
641
64.4
5-year
I-73; II-61;III-55
I-75;II-65; III-46
Champault, 02
62
66
60
5-year
75.8
74.2
Pantakar, 03
161
174
52
5-year
I-76; II-68; III-53 I-80; II-64; III-50
Laparoscopy: Colorectal cancer
Randomized Controlled Trial




111 Laparoscopy vs. 106 Laparotomy
Non metastatic colon cancer
Median follow-up time: 43 (27-85) months
Postoperative chemotherapy for all suitable
patients with Stage II or III rectal cancer
 Intention-to-treat analysis
Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancer
Recurrence
Tumor recurrence
Type of recurrence
Distant metastasis
Locoregional relapse
Peritoneal seeding
Port-site metastasis
Laparoscopy
(n=106)
Open
(n=102)
Hazard ratio
(95% CI)
p
18 (17%)
28 (27%)
0.72 (0.49-1.06)
0.07
0.57
7
7
3
1
9
14
5
0
-----
Time to recurrence (months)
15 (14)
17 (12)
--
0.66
Surgical treatment of
recurrence with curative
intention
6 (33%)
9 (32%)
--
1.00
Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancer
Survival
Laparoscopy Open
(n=106)
(n=102)
Hazard ratio
(95% CI)
p
Overall mortality
19 (18%)
27 (26%)
0.77 (0.53-1.12)
1.04
Cancer-related mortality
10 (9%)
21 (21%)
0.68 (0.50-0.90)
0.03
Causes of death
Perioperative mortality
Tumor progression
Others
0.19
1
9
9
3
18
6
----
Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancer
Predictive factors
Hazard ratio
(95% CI)
p
Probability of being free of recurrence
Lymph node metastasis (presence or absence)
Surgical procedure (Open vs. Lap)
Preoperative serum CEA (> ng/ml vs. < 4 ng/ml)
0.31 (0.16-0.60)
0.39 (0.19-0.82)
0.43 (0.22-0.87)
0.0006
0.012
0.018
Overall survival
Surgical procedure (open vs. Lap)
Lymph-node metastasis (presence vs. absence)
0.48 (0.23-1.01)
0.49 (0.25-0.98)
0.052
0.044
Cancer-related survival
Lymph-node metastasis (presence vs. absence)
Surgical procedure (open vs. Lap)
0.29 (0.12-0.67)
0.38 (0.16-0.91)
0.004
0.029
Cox’s regression model
Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancer
Overall survival
Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancer
Cancer-related survival
Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancer
Recurrence free – by Stage
Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancer
Overall survival- by Stage
Lacy et al, The lancet 2002
Laparoscopy: Colorectal cancer
Cancer related survival – by Stage
Lacy et al, The lancet 2002
Laparoscopic Colectomy: Cancer
 Laparoscopic resection of colorectal malignancies
 a systematic review
 English language
 Randomized controlled trials
 Controlled clinical trials
 Case series/reports
Chapman et al. Ann Surg 2001
Laparoscopic Colectomy : Cancer
• 52 papers met inclusion criteria
– “Little high level evidence was available”
– “The evidence base for laparoscopic-assisted reection of
colorectal malignancies is inadequate to determine the
procedures safety and efficacy”
Chapman et al. Ann Surg 2001
Laparoscopic Colectomy : Cancer
Disadvantages vs. Open Colectomy
• Significantly longer operative times
• Possibly more expensive
• Possibly worse short term immune effects
Chapman et al. Ann Surg 2001
Laparoscopic Colectomy : Cancer
• “Laparoscopic resection of colorectal malignancy was
more expensive and time-consuming”
• The new procedure’s advantages revolve around early
recovery from surgery and reduced pain”
Chapman et al. Ann Surg 2001
Laparoscopic Colectomy : Cancer
Advantages vs. Open Colectomy
• Improved cosmesis (no data but appears uncontentious)
• Quicker hospital discharge
• Less narcotic use, though possibly larger benefits for certain
types of colectomy (low colonic)
• Possibly less pain at rest, at least for patients who have
uncovered procedures
• Possibly earlier return of bowel function and resumption of
normal diet
Chapman et al. Ann Surg 2001
Laparoscopic Colectomy : Cancer
 Short term Quality-of-Life outcomes Following
Laparoscopic-Assisted Colectomy vs Open
Colectomy for Colon Cancer (COST Study)
 AIMS
– Are disease free and overall survival equivalent ?
– Is laparoscopic approach associated with better QOL ?
Weeks et al. JAMA 2002
Laparoscopic Colectomy : Cancer
 Randomized control trial
 449 patients
– Adenocarcinoma of single segment of colon
– Excluded: Acute presentation, rectal and transverse
colon cancers, advanced local disease, those lesions
with evidence of metastatic disease, ASA IV or V
 Quality of surgery:
– All surgeons with > 20 cases; Random audit of cases
Weeks et al. JAMA 2002
Laparoscopic Colectomy : Cancer
 Outcomes:
– Survival: still pending
– QOL at 2days, 2 weeks and 2 months using:
» Symptom Distress Scale, Global QOL Scale, QOL index
 Results: Intention to Treat Analysis
– Shorter use of narcotics
– Shorter length of stay by 0.8 days (p<0.01)
– Quality of life: no difference
Weeks et al. JAMA 2002
Laparoscopic Colectomy : Cancer
 Conclusions
– “The modest benefits in short term QOL measures we
observed are not sufficient to justify the use of this
procedure in the routine care setting”
 Unresolved Issues:
–
–
–
–
Blunting of QOL differences via analgesic use
QOL differences between POD 2 and POD 14
Recurrence and survival outcomes
Incidence of small bowel obstruction
Weeks et al. JAMA 2002
Laparoscopic Colectomy :
Prospective, Randomized, Controlled
48 institutions, 872 patients
Prospective, randomized
Follow-up 4.4 years
Conversion 21%
Endpoint was time to tumor recurrence
Nelson, NEJM 2004
Prospective, Randomized, Controlled
Laparoscopic
(n=435)
Open
(n=425)
Age
70
69
Female
212
220
Location
Right
Left
Sigmoid
237
32
166
232
32
164
TNM Stage
0
1
2
3
4
Unknown
20
153
136
112
10
4
33
112
146
121
16
0
Nelson, NEJM 2004
Prospective, Randomized,
Controlled: Outcome at Surgery
Laparoscopic
(N=435)
Open
(N=425)
P value
Bowel margins (cm)
10-13
11-12
0.4-0.9
Lymph nodes
12
12
1.0
Surgery time (min)
150
90
<0.001
Conversion
90
-
-
Intraoperative
complications
8
15
NS
Length of incision (cm)
18
6
<0.001
Nelson, NEJM 2004
Prospective, Randomized,
Controlled: Post-operative
Laparoscopic
(n=435)
Open
(n=425)
IV narcotics (days)
3
4
<0.001
PO narcotics (days)
1
2
0.02
Length of Stay
5
6
<0.001
30-day mortality
2
4
NS
Complications
92
85
NS
Rates of readmission
10
12
NS
Rates of reoperation
<2%
<2%
NS
Nelson, NEJM 2004
Prospective, Randomized,
Controlled: Outcome
Laparoscopic
(n=435)
Open
(n=425)
P value
Recurrence*(4.4yrs)
76
84
0.83
Wound recurrence
1%
1%
P=0.50 NS
3yr survival
86%
85%
P=0.51 NS
*Laparoscopic procedure not significantly inferior to Open Procedure.
Nelson, NEJM 2004
Cumulative Incidence of Recurrence at Any Satge
Overall Survival at Any Stage
Prospective, Randomized,
Controlled: Conclusions
 No difference between:
– Time to recurrence
– Disease-free survival
– Overall survival
 Oncologic outcome of laparoscopic resection is similar to
that of open resection
 Laparoscopic Approach is associated with less pain and a
shorter hospital stay than conventional surgery
Nelson, NEJM 2004
Laparoscopy: Colorectal cancer
Conclusion
 Laparoscopy for colorectal cancer has shown to be
potentially superior to laparotomy in regard to short-term
benefits and equivalent with regard to long term benefits
 Available data appear to support that laparoscopic
colectomy and conventional open colectomy have either
similar or superior long-term outcomes (Level 1
evidence)
Laparoscopy: Colorectal cancer
Conclusion
 Surgeons with sufficient expertise and ongoing
peer-reviewed data collection may offer this
therapy to appropriately selected patients
16th Annual
International Colorectal
Disease Symposium
An International
Exchange of Medical
and Surgical Concepts
Marriott’s Harbor Beach Resort
& Spa
Fort Lauderdale, Florida
February 17 – 19, 2005