Transcript Document

Laparoscopic Treatment of Crohn’s
Disease: Is It the Standard Approach?
Steven D Wexner, MD, FACS, FRCS, FRCS (Ed)
Chairman, Department of Colorectal Surgery
Century Oncology Chair in Colorectal Surgery
Chief of Staff
Cleveland Clinic Florida
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
Clinical Professor of Biomedical Science
Department of Biomedical Science
Florida Atlantic University College of Medicine
21st
Marat Khaikin, MD
Clinical Research Fellow
Cleveland Clinic Florida
Laparoscopy for Crohn’s disease
Case Series
Author
N
Conversion
(%)
Morbidity
(%)
Hospital Stay
(days)
Milsom, Surg Laparosc Endosc ‘93
9
0
0
7
Bauer, DCR ‘95
18
22
11
6.6
Reissman,
51
14
14
5.1
31
19
3
6
88
1
8
4.2
110
40
13
6
130
18
11
8.8
84
18
10.7
5.6
Surg Endosc ‘96
Ludwig,
Am J Surg ‘96
Canin-Endres,
Surg Endosc ‘99
Schmidt,
Ann Surg ‘01
Hamel,
Am Surg ‘02
Evans, DCR ‘02
Laparoscopy for Crohn’s disease
Comparative Studies
Author
Study
Lap/Open
Oper.time
Conversion
Morbidity
(n)
(min)
(%)
(%)
Hospital
stay (days)
Bemelman, 2000
Case-control
30/48
138/104
6.6
10/14.6
5.7/10.2
Alabaz, 2000
Case-control
26/48
150/90.5
11.5
15.4/16.7
7/9.6
Milsom, 2001
RCT
31/29
140/85
6
12.9/27.6
5/6
Young-Fadok,
Case-match
33/33
147/124
5.9
-
4/7
Msika, 2001
Prospective
Case-control
20/26
302/244.7
0
9.5/18.5
8.3/13.2
Duepree, 2002
Case-control
21/24
75/98
4.8
14.3/16.7
3/5
Bergamaschi, 2003
Case-control
39/53
185/105
0
10.2/9.4
5.6/11.2
Shore, 2003
Case-control
20/20
145/133.5
5
0/5
4.25/8.25
Benoist, 2003
Case-match
24/32
179/198
17
20/10
7.7/8
Huilgol, 2004
Case-control
21/19
136/119.5
4.8
19/15.8
6.4/8.2
2001
Bold, statistically significant difference (p<0.05)
Laparoscopy for Crohn’s Disease
Variable
N
Laparotomy Laparoscopy
P Value
48
26
Age (years)
41.6
40
NS
Gender (m/f)
31/17
18/8
NS
Duration (years)
Operative time (min)
6.8
90.5
5.9
150
NS
<0.0001
Hospital Stay (days)
9.6
7
<0.05
28,259
34,657
NS
Charges ($)
Alabaz et al. Eur J Surg 2000
Laparoscopy for Crohn’s Disease
Variable
Laparotomy
Laparoscopy
P Value
6.3
2.1
<0.001
13 (42%)
5 (16%)
14 (88%)
8 (50%)
0.004
0.02
Return to normal
activity (weeks)
8.2
3.7
<0.05
Return to work
(weeks)
9.3
4.4
<0.05
Postoperative
narcotics (days)
“Good cosmesis”
Social/Sexual
(vs preoperative)
Alabaz et al. Eur J Surg 2000
Laparoscopy for Crohn’s Disease
Variable
Laparotomy
Laparoscopy
P Value
Bowel obstruction
15 (31%)
2 (8%)
<0.05
4 (8%)
1 (4%)
NS
Adhesions
2
1
Recurrence
2
0
(symptomatic)
Relaparotomy
Alabaz et al. Eur J Surg 2000
Laparoscopy for Crohn’s Disease
Conclusion
• Better cosmesis
• Lower incidence of postoperative bowel obstruction
• Greater than 50% reduction in the disability duration
• More rapid return to social and sexual interaction
Alabaz et al. Eur J Surg 2000
Laparoscopy for Crohn’s Disease
Variable
p
N
Laparoscopy
Laparotomy
21
24
Age (years)
<0.05
31
39
Male (%)
<0.05
57
37
Hospital (days)
<0.05
3
5
30-day readmission
NS
9.6
0
Morbidity (%)
NS
14.3
16.7
Reoperation (%)
NS
9.6
0
Direct Cost ($)
<0.05
2,547
2,985
Duepree et al. DCR 2002
Laparoscopy for Crohn’s Disease
• Prospective randomized trial
• January 1994 – March 1998
• 60 patients
• Ileal +/- Cecal Crohn’s Disease
Milsom et al. DCR 2001
Laparoscopy for Crohn’s Disease
Variable
Laparoscopy
(+)
(-)
31
29
Blood loss (mean; ml)*
173
133
Operative time (min)*
140
85
Incision (cm)*
5.3
12.7
N
*p<0.0001
Milsom et al. DCR 2001
Laparoscopy for Crohn’s Disease
Laparoscopy
Variable
Analgesic use
Morphine sulfate
mg/kg/day *
(+)
(-)
Day 0
1.3
1.4
Day 1
0.9
1.0
Day 2
0.8
0.6
Day 3
0.5
0.6
Hospital Stay (days) **
5.0
6.0
*p>0.3 all days, **p=0.14
Milsom et al. DCR 2001
Laparoscopy for Crohn’s Disease
Type of Function
Laparoscopic Group Conventional Group
(n=31)
(n=29)
Flatus
3*
3.3
Bowel Movement
4
4
Figures – median (range) days
*p=0.07, log-rank test
Milsom et al. DCR 2001
Laparoscopy for Crohn’s Disease
• Prospective randomized 3-center trial
• January 2000 – October 2003
• 60 patients
• Ileocecal Crohn’s Disease
Maartense et al. Ann Surg Feb 2006
Laparoscopy for Crohn’s Disease
• Inclusion Criteria
– Elective surgery
– Terminal ileum ± cecum disease
• Exclusion Criteria
– Prior median laparotomy
– Fixed palpable inflammatory mass
– Prior bowel resection
Maartense et al. Ann Surg Feb 2006
Laparoscopy for Crohn’s Disease
Variable
Laparoscopy
(n=30)
Laparotomy
(n=30)
P Value
14:16
12:18
0.602
Age (years)
28
31
0.137
BMI (kg/m²)
21.9
22.5
0.994
Steroids
15
19
0.183
5-ASA
7
7
0.874
Immunosuppressive
medications
5
13
0.017
Gender (m:f)
Maartense et al. Ann Surg Feb 2006
Laparoscopy for Crohn’s Disease
Variable
Laparoscopy
(n=30)
Laparotomy
(n=30)
P Value
Operative time (min)
115
90
0.003
Conversions (n)
3 (10%)
-
Additional
procedures (n)
7 (23%)
5 (17%)
0.519
Hospital stay (days)
5
7
0.008
Complications (pts)
3 (10%)
10 (33%)
0.028
Maartense et al. Ann Surg Feb 2006
Laparoscopy for Crohn’s Disease
Variable
Laparoscopy
(n=11)
Laparotomy
(n=12)
P value
28
7
45
19
0.15
0.18
0
29
N=30
2
3.8
5
62
N=30
3
5
0.68
0.27
Morphine (mg)
0 – 24 (hrs)
24 – 48 (hrs)
48 – 72 (hrs)
0 – 72 (hrs)
Diet
Liquid >1000 ml (days)
Normal (days)
Maartense et al. Ann Surg Feb 2006
0.039
0.003
Laparoscopy for Crohn’s Disease
Direct Costs
Laparoscopy
Laparotomy
P Value
Operative
1,103
744
<0.001
6,412
8,196
0.042
(Euro)
Overall*
(Euro)
*Relaparotomies,hospital stay, and readmission costs
Maartense et al. Ann Surg Feb 2006
Laparoscopy for Crohn’s Disease
• Quality of life in both groups (SF-36/GIQLI*)
• Decline in the 1 week
• Return to baseline after 2 weeks
• Improvement during the 3-month follow-up
compared to preoperative levels
(SF-36, p<0.001; GIQLI, p<0.001)
*Gastrointestinal Quality of Life Index
No significant differences between laparoscopic and
open groups
Maartense et al. Ann Surg Feb 2006
Laparoscopy for Recurrent
Crohn’s Disease
Variable
Primary
Recurrent
n
45
16
Age (years)
30
32
19.8
19.7
Enteric fistula
24
6
Conversion
3
2
Median Time (min)
180
210
Hospital stay (days)
8
8
BMI (kg/m2)
Hasegawa et al. Br J Surg 2003
Laparoscopy for Complicated
Crohn’s Disease
• 20 Patients – 31 Fistulas
• Follow-up - 48 (5 – 77) months
• Morbidity - 16%
• Conversion - 16%
• Median hospital stay - 8 days
Watanabe et al. DCR 2002
Laparoscopy for Complicated
Crohn’s Disease
• 73 resections: 90% - Crohn’s fistulas (10% - diverticular disease)
• Multiple fistulas – 30%
• Previous surgery – 39.7%
• Multiple resections – 12.3%
• Conversion – 4.1%
• Overall complication rate – 11%
• Hospital stay – 5.2 days
Regan et al. Surg Endosc 2004
Laparoscopy for Crohn’s disease
Long-term Outcome
• Alabaz et al. Eur J Surg 2000
Mean follow-up – 30 months
Bowel obstructions
Laparoscopy
Laparotomy
8%
31%
(p=0.02)
• Bergamaschi et al. DCR 2003
Follow-up – 5 years
11.1%
35.4%
(p=0.02)
Recurrence rate - no difference (27.7% vs. 29.1%)
Laparoscopy for Crohn’s Disease
Surgical Recurrence
• Lowney et al
DCR Jan 2006
- Retrospective study
- Laparoscopic vs. open ileocolic resection
- Long-term follow-up (62.9/81.8 months)
Laparoscopy for Crohn’s Disease
Surgical Recurrence
LICR (n=63) OICR (n=50)
Age at surgery (yrs)
35.2
37.1
Disease duration (yrs)
7.2
7.6
26/37
17/33
Previous abdominal surgery
7
11
Preoperative medical treatment
None
Steroids
23
29
17
25
Immunosuppressive agents
15
13
Male/female ratio
Lowney et al, DCR Jan 2006
Laparoscopy for Crohn’s Disease
Surgical Recurrence
LICR (n=63) OICR (n=50)
Surgical recurrence (%)
P value
6 (9.5)
12 (24)
0.18
59.7
61.6
NS
Re-recurrence (%)
0
4 (33)
NS
Third recurrence
0
1
Postoperative
chemoprophylaxis (%)
25 (39)
27 (54)
0.61
No. of pts with recurrence while
taking chemoprophylaxis (%)
4 (67)
5 (42)
NS
Median time to recurrence (mo)
Lowney et al, DCR Jan 2006
Laparoscopy for Crohn’s Disease
Benefits
• Pulmonary function
• Length of hospital stay
• Duration of postoperative ileus
• Cosmesis
• Postoperative small bowel obstructions
• Early morbidity
• Overall hospitalization costs
Laparoscopy and Open Ileocecal
Resection for Crohn’s Disease:
a Metaanalysis
• 20 studies identified by literature review
• 15 satisfied inclusion criteria
• 783 patients
• 338 (43.2%) underwent laparoscopic resection
Tilney et al, Surg Endosc 2006
Laparoscopy and Open Ileocecal Resection
for Crohn’s Disease: a Metaanalysis
Outcome of
Interest
No of
No. of
studies patients
OR/WMD
95% CI
P
Value
HG
chi-square
HG
p Value
569
29.59
11.27, 47.90
0.002
128.30
<0.001
Operative outcomes
Operative time
10
Postoperative recovery
Tolerates oral
fluid
2
106
-2.66
-3.44, -1.89
<0.001
2.15
0.14
Tolerates oral
diet
7
340
-1.47
-2.18, -0.76
<0.001
16.08
0.01
Time to first
flatus
4
191
-0.68
-1.20, -0.17
0.009
5.91
0.12
Length of stay
11
588
-2.97
-3.89, -2.04
<0.001
50.32
<0.001
Tilney et al, Surg Endosc 2006
Laparoscopy and Open Ileocecal Resection for
Crohn’s Disease: a Metaanalysis
•Overall conversion rate of 6.8%
•Operative time was significantly longer in the
laparoscopic group
•Blood loss and complications in the two groups
were similar
•Laparoscopic patients had a significantly shorter
time for enteric function recovery and shorter
hospital stay
Tilney et al, Surg Endosc 2006
Laparoscopy and Open Ileocecal Resection for
Crohn’s Disease: a Metaanalysis
•Laparoscopic ileocecal resection is associated with equal adverse
events than open surgery
•Postoperative recovery was enhanced
•Length of hospital stay was reduced
•Short incision was associated with improvement in perceived
cosmetic results
•Long-term follow-up evaluation is required
•Contraindications to laparoscopy for Crohn's disease remain
poorly defined
Tilney et al, Surg Endosc 2006
Laparoscopy for Crohn’s Disease
Cosmesis and Body Image
• 34 patients, age - 32 (17-52) years
– Open ileocolic resection - 11
– Laparoscopic - 11
– No resection - 12
• 7 day outpatient diary
– Crohn’s disease index (CDAI)
– Activity index (AI)
– Inflammatory bowel disease questionnaire (IBDQ)
In clinic
• Hospital experience questionnaire (HEQ)
• Photo series questionnaire (PSQ)
Dunker et al. Surg Endosc 1998
Laparoscopy for Crohn’s Disease
Cosmesis and Body Image
No differences in
• CDAI scores
• AI scores
• Age
• Gender
• Colonic involvement
• Perianal disease
Dunker et al. Surg Endosc 1998
Laparoscopy for Crohn’s Disease
Cosmesis and Body Image
Laparoscopy - significantly better:
• Body image scale
• Cosmetic scale
• Self-confidence after surgery
Only 3/34 (8.8%) patients preferred open surgery:
(for cosmetic advantage)
• 2/12 - no resection group
• 1/11 - open group
• 0/11 - laparoscopic group
Dunker et al. Surg Endosc 1998
Laparoscopy for Crohn’s Disease
Cosmesis and Body Image
Even with a hypothetical risk to ureter of 5%
during laparoscopy:
• 21/132 (82%) preferred laparoscopy
• 7/12 - no resection group
• 4/11 - open group
• 10/11 - laparoscopic group
24/32 (75%) would pay more even if the only difference
was cosmetic:
• 10/12 - no resection group
• 7/10 - open group
• 7/10 - laparoscopy group
Dunker et al. Surg Endosc 1998
Laparoscopy for Crohn’s Disease
Cost Analysis
Variable
Laparoscopy
Laparotomy
P
Hospital Stay (days)
4.0
7.0
0.0001
Direct Costs ($)
8,684
11,373
<0.01
Indirect Costs ($)
1,358
2,349
<0.001
Total Costs ($)
9,895
13,268
<0.001
Young-Fadok et al. Surg Endosc 2001
Laparoscopy for Crohn’s Disease
Cost Analysis
Direct Cost ($)
Laparoscopy
Laparotomy
p
2,547
2,985
<0.05
Laparoscopy
Laparotomy
p
9,614
17,079
<0.05
Duepree et al. DCR 2002
Mean Hospital
Charges ($)
Shore et al. Arch Surg 2003
Laparoscopy for Crohn’s Disease
Influence of Experience
Group
Time interval (months)
Patients (n)
*Complex (%)
**Multiple difficulties (%)
Mean Operative Time (min)
Conversion (%)
Hospital Stay (days)
Morbidity (%)
1
2
3
24
28
64
21
166
32
5.9
7
15
28
46
10
129
4
6.4
14
12
28
64
43
141
21
4.9
11
*Fistula, mass, abscess, or previous resection
**Any two or more of fistula, mass, abscess, or previous resection
p
0.296
0.005
0.001
0.007
0.025
0.68
Evans et al. DCR 2002
Laparoscopy for Crohn’s Disease
Influence of Experience
• Evans et al.
DCR 2002
No differences in patients outcome, complication, or
conversion rates between early and late experience
• Hamel et al.
Am Surg 2002
Plateau after initial experience - no differences in
morbidity or conversion rates
Laparoscopy for Crohn’s Disease
CONCLUSIONS
• Feasible and safe
even in cases complicated by fistulas or in patients with previous
surgery or recurrent disease
• Disadvantages
increased operative time
Laparoscopy for Crohn’s Disease
CONCLUSIONS
• Benefits
pulmonary function
length of hospital stay
duration of postoperative ileus
cosmesis
postoperative small bowel obstructions
early morbidity
overall hospitalization costs
Laparoscopy for Crohn’s Disease
Laparoscopic approach is the preferred
approach for patients with Crohn’s
disease