Evoluzione della Chirurgia Mini-invasiva: La Day Surgery
Vittorio Veneto, March 31, 2006
Evidence-based medicine in
laparoscopic day surgery:
the European perspective
Dr. Stefan Sauerland, MD MPH
Institute for Research in Operative Medicine, University of
Witten/Herdecke, Ostmerheimer Str. 200, D 51109 Cologne
stefan.sauerland@ifom-uni-wh.de
The general aim of surgery
The right patient should
receive the right operation,
done in the right clinic,
Laparoscopic or
conventional?
In a hospital
or ambulatory?
performed by the right surgeon.
Basic concept of evidence-based medicine
Doctor
(Experience,
expertise,
costs,
ethics)
Patient
(Experience,
expectations,
culture,
values)
Evidence
(Medical and
methodological
relevance)
Sackett D et al., Br Med J 1996; 312: 71-72
Haynes RB, et al., ACP Journal Club 1996;125:A-14-16
How much in medicine is evidence-based?
Autor
Baraldini
Djulbegovic
Ellis
Galloway
Geddes
Gill
Howes
Jemec
Kenny
Lee
Michaud
Myles
Nordin-J.
Rudolf
Slim
Suarez-V.
Summers
Tsuruoka
Discipline
Paed. Surg.
Oncology
General Med.
Haematology
Psychiatry
General Med
General Surg.
Dermatology
Paed. Surg.
General Surg.
Internal Med.
Anaesthes.
Internal Med.
Paediatrics
Variable discipl.
General Med.
Psychiatry
General Med.
Evidence
RCT Other
26% 71%
24% 21%
53% 29%
70%
65%
30% 51%
24% 71%
38% 33%
11% 66%
14% 64%
65%
32% 65%
50% 34%
40% 7%
50% 28%
38% 4%
53% 10%
21% 60%
None
3%
55%
18%
30%
19%
5%
23%
23%
22%
3%
12%
58%
37%
19%
Number of
Treatm. Pat.
70
49
154
n.a.
108
108
n.a.
83
40
40
101
122
100
100
n.a.
115
281
281
50
n.a.
150
150
n.a.
n.a.
369
197
1149
247
428
n.a.
2341
1990
160
158
53
49
We just found a study
saying that you can go
home now immediately.
What influences surgical behaviour?
A survey of 418 Australian surgeons:
• Surgical training
• Published study results
• Congress visits
• Quality management data
• Practice guidelines
• Mass media
Young JM et al., Arch Surg 2003; 138: 785-791
71%
46%
44%
27%
24%
<1%
Evidence-based guidelines as a bridge
between science and practice
Clinical
studies
Animal studies
Evidencebased
Guidelines
Patient
Care
Basic sciences
Science
Practice
Guidelines of the European Association for
Endoscopic Surgery (EAES)
•
•
•
•
•
•
•
•
•
•
•
Cholecystolithiasis
Appendicitis
Inguinal hernia
Gastrooesophageal reflux disease
Common bile duct stones
Diverticular disease
The pneumoperitoneum
Lap surgery in colonic cancer
Measuring quality-of-life in lap surgery
Obesity surgery
Acute abdominal pain
Levels of Evidence and Grades of Recommendation
A
B
1a Systematic review of randomised controlled trials
1b Individual randomised controlled trial
1c All or none series
2a Systematic review of cohort studies
2b Individual concurrent cohort study
2c Outcomes research
3a Systematic review of case-control-studies
3b Individual case-control-study
C
4
Case-series (uncontrolled trials)
5
Expert opinion without explicit critical appraisal,
animal studies, bench research
Centre for Evidence-based Medicine Oxford: http://www.cebm.net/levels_of_evidence.asp
Inguinal hernia repair in adults:
Choice of endoscopic and control group
Ventral
mesh:
Lichtenstein
Dorsal
mesh:
Stoppa
Shouldice
TAPP
TEP
Other
open
sutures
What's the evidence?
Most recent meta-analyses
Main results of meta-analysis
•
Meta-analysis of 34 trials with 7223 patients
Schmedt CG, Sauerland S, Bittner R: Comparison of endoscopic procedures vs Lichtenstein and other open mesh
techniques for inguinal hernia repair. A meta-analysis of randomised controlled trials. Surg Endosc 2005;19:188-199
Cost-effectiveness
•
Higher in-hospital cost, but similar costs on the society
level due to earlier return to work
Study
or sub-category
Heikkinen 1997
Liem 1997
Beets 1998
Dirksen 1998
N
Laparoscopic
Mean (SD)
20
134
42
86
4796(4796)
4918(3350)
2004(2004)
5750(5750)
282
Total (95% CI)
Test for heterogeneity: Chi² = 1.27, df = 3 (P = 0.74), I² = 0%
Test for overall effect: Z = 0.29 (P = 0.77)
N
Open
Mean (SD)
18
139
37
88
5360(5360)
4665(4352)
2045(2045)
6678(6678)
SMD (fixed)
95% CI
282
-1
-0.5
Favours treatment
0
0.5
1
Favours control
Sauerland S, Eypasch E: Kosten. In: Bittner R "laparoskopische/Endoskopische Chirurgie der Leistenhernie".
Karger, Stuttgart, 2005 [in press]
Gholghesaei M et al.: Costs and quality of life after endoscopic repair of inguinal hernia vs open tension-free repair: a
review. Surg Endosc 2005 [in press]
Appendectomy: Choice of laparoscopic
approach and control group
Lap
appendectomy
Open
append
ectomy
with or
without
Diagnostic
laparoscopy
Review :
Comparison:
Outcome:
Laparoscopic vs open surgery for suspected appendicitis
01 Laparoscopic versus conventional appendectomy in adults
03 Operation time (minutes)
Results: Operation time
Study
or sub-category
N
Laparoscopic
Mean (SD)
01 Studies reporting mean data
52
43.40(17.10)
Kum 1993a
70
70.30(21.90)
Tate 1993a
97
39.00(39.00)
Eichen 1994
38
87.00(26.25)
Frazee 1994
34
54.50(34.00)
Hebebrand 1994
106
55.20(26.16)
Macarulla 1995
81
102.20(35.00)
Martin 1995
12
48.00(11.00)
Settmacher 1995
33
58.90(22.50)
Cox 1996
40
73.80(23.20)
Hart 1996
50
45.00(15.90)
Mutter 1996
167
68.00(32.00)
Ortega 1996
19
93.00(52.30)
Williams 1996
97
61.00(24.00)
Kazemier 1997
25
56.00(21.00)
Laine 1997
42
51.00(16.50)
Reiertsen 1997
20
60.00(17.30)
Schippers 1997
15
71.00(21.18)
Sezeur 1997
48
81.00(81.00)
Stare 1998
50
38.40(12.60)
Sun 1998
100
50.70(19.90)
Witten 1998
50
23.50(7.40)
Zhang 1998
26
59.20(15.80)
Bauw ens 1999
35
38.00(38.00)
Özmen 1999
18
67.20(27.50)
Bruw er 2000
75
86.27(38.31)
Navarra 2000
12
58.20(58.20)
Nordentoft 2000
49
65.50(38.30)
Huang 2001
26
77.40(27.10)
Ignacio 2003
30
42.00(41.10)
Karadayi 2003
35
58.00(30.00)
Vallribera 2003
32
35.70(35.70)
van Dalen 2003
1584
Subtotal (95% CI)
Test for heterogeneity: Chi² = 268.20, df = 31 (P < 0.00001), I² = 88.4%
Test for overall effect: Z = 4.92 (P < 0.00001)
N
57
70
96
37
23
104
88
11
31
37
50
86
18
104
25
42
20
17
26
100
100
53
28
35
16
73
11
26
26
30
30
31
1501
Conventional
Mean (SD)
40.10(15.50)
46.50(25.90)
35.80(35.80)
65.00(47.50)
42.00(22.50)
44.68(16.63)
81.70(35.00)
32.00(9.00)
50.60(20.50)
45.00(12.90)
25.00(12.60)
58.00(27.00)
87.00(33.90)
42.00(18.00)
32.00(19.00)
25.00(13.20)
53.00(14.90)
48.00(12.72)
60.00(60.00)
44.10(16.20)
51.70(21.90)
28.60(6.80)
59.80(24.40)
28.00(28.00)
53.10(25.20)
65.21(38.31)
49.60(49.60)
55.40(28.00)
66.90(21.60)
40.80(35.60)
56.00(26.00)
39.50(39.50)
61.00(0.00)
Difference
+12 Minutes
[95%KI 7 bis 16]
-50 min
02 Studies reporting median data
30
WMD (random)
95% CI
32
51.00(0.00)
Pro laparoskopisch
0
+50 min
Pro konventionell
Study
or sub-category
Peto OR
95% CI
Wound infection
Study
or sub-category
Peto OR
95% CI
Intraabd. Abszess
Attw ood 1992
Kum 1993a
Tate 1993a
Eichen 1994
Frazee 1994
Hebebrand 1994
Macarulla 1995
Martin 1995
Cox 1996
Hansen 1996
Hart 1996
Henle 1996
Mutter 1996
Ortega 1996
Williams 1996
Kazemier 1997
Laine 1997
Minné 1997
Reiertsen 1997
Schippers 1997
Sezeur 1997
Heikkinen 1998
Stare 1998
Sun 1998
Witten 1998
Zhang 1998
Barth 1999
Bauw ens 1999
Hellberg 1999
Kald 1999
Özmen 1999
Bruw er 2000
Hall Long 2000
Navarra 2000
Huang 2001
Pedersen 2001
Al-Mulhim 2002
Ignacio 2003
Karadayi 2003
Vallribera 2003
Attw ood 1992
Kum 1993a
Tate 1993a
Eichen 1994
Frazee 1994
Hebebrand 1994
Macarulla 1995
Martin 1995
Cox 1996
Hansen 1996
Hart 1996
Henle 1996
Mutter 1996
Ortega 1996
Williams 1996
Kazemier 1997
Laine 1997
Minné 1997
Reiertsen 1997
Schippers 1997
Sezeur 1997
Heikkinen 1998
Stare 1998
Sun 1998
Witten 1998
Zhang 1998
Bauw ens 1999
Hellberg 1999
Kald 1999
Özmen 1999
Bruw er 2000
Hall Long 2000
Navarra 2000
Helmy 2001
Huang 2001
Pedersen 2001
Al-Mulhim 2002
Ignacio 2003
Karadayi 2003
Vallribera 2003
Total (95% CI)
Total events: 89 (Laparoscopic), 178 (Conventional)
Test for heterogeneity: Chi² = 36.46, df = 38 (P = 0.54), I² = 0%
Test for overall effect: Z = 6.17 (P < 0.00001)
Total (95% CI)
Total events: 41 (Laparoscopic), 15 (Conventional)
Test for heterogeneity: Chi² = 17.58, df = 16 (P = 0.35), I² = 9.0%
Test for overall effect: Z = 3.34 (P = 0.0008)
0.001 0.01
0.1
1
10
100
1000
0.001 0.01
0.1
1
10
100
1000
Lap appendectomy: Pain on day 1
Review :
Comparison:
Outcome:
Study
or sub-category
Laparoscopic vs open surgery for suspected appendicitis
01 Laparoscopic versus conventional appendectomy in adults
05 Pain intensity on day 1 (cm VAS)
N
Laparoscopic
Mean (SD)
01 Studies reporting mean data
70
4.70(2.10)
Tate 1993a
97
5.21(1.49)
Eichen 1994
34
2.87(1.50)
Hebebrand 1994
50
4.70(1.97)
Mutter 1996
89
3.05(2.35)
Ortega 1996
97
3.53(2.37)
Kazemier 1997
27
3.70(3.70)
Minné 1997
42
5.00(2.00)
Reiertsen 1997
20
4.18(2.33)
Schippers 1997
95
5.20(5.20)
Witten 1998
244
3.60(2.10)
Hellberg 1999
26
3.50(2.10)
Ignacio 2003
34
2.94(1.37)
Vallribera 2003
925
Subtotal (95% CI)
Test for heterogeneity: Chi² = 41.78, df = 12 (P < 0.0001), I² = 71.3%
Test for overall effect: Z = 4.29 (P < 0.0001)
02 Studies reporting median data
0
Subtotal (95% CI)
Test for heterogeneity: not applicable
Test for overall effect: not applicable
Conventional
Mean (SD)
N
70
96
23
50
45
104
23
42
20
100
256
26
28
883
0
WMD (random)
95% CI
5.30(2.30)
5.90(1.34)
4.15(2.50)
4.40(1.65)
4.80(2.05)
5.87(2.50)
4.00(4.00)
5.40(1.40)
4.79(2.20)
5.80(5.80)
4.20(2.10)
4.00(1.90)
4.32(1.44)
Difference
0.9 cm VAS
[0.5 to 1.3]
-4
-2
0
2
4
Pro laparoskopisch
Pro konventionell
-4
-2
Favours laparoscopic
0
2
4
Favours conventional
Review :
Comparison:
Outcome:
Laparoscopic vs open surgery for suspected appendicitis
01 Laparoscopic versus conventional appendectomy in adults
06 Length of hospital stay
Lap appendectomy: Length of stay
Study
or sub-category
Laparoscopic
N
Mean (SD)
01 Studies reporting mean data
52
3.20(0.60)
Kum 1993a
70
3.50(0.89)
Tate 1993a
97
6.20(6.20)
Eichen 1994
38
2.00(2.00)
Frazee 1994
34
6.30(3.50)
Hebebrand 1994
106
3.42(1.86)
Macarulla 1995
81
2.20(3.90)
Martin 1995
33
2.90(1.70)
Cox 1996
40
3.23(5.55)
Hart 1996
167
2.63(2.91)
Ortega 1996
19
2.38(2.18)
Williams 1996
97
3.70(2.50)
Kazemier 1997
25
2.70(1.50)
Laine 1997
42
3.50(2.60)
Reiertsen 1997
15
4.00(4.00)
Sezeur 1997
50
4.50(1.50)
Sun 1998
100
7.78(3.14)
Witten 1998
50
5.30(1.10)
Zhang 1998
26
5.30(1.80)
Bauw ens 1999
35
1.60(1.60)
Özmen 1999
18
3.00(1.60)
Bruw er 2000
93
2.90(3.30)
Hall Long 2000
75
2.64(1.47)
Navarra 2000
49
2.60(1.20)
Huang 2001
26
0.90(0.78)
Ignacio 2003
35
4.37(3.24)
Vallribera 2003
1473
Subtotal (95% CI)
Test for heterogeneity: Chi² = 239.16, df = 25 (P < 0.00001), I² = 89.5%
Test for overall effect: Z = 4.76 (P < 0.00001)
Conventional
N
57
70
96
37
23
104
88
31
37
86
18
104
25
42
17
100
100
53
28
35
16
105
73
26
26
30
1427
WMD (random)
95% CI
Mean (SD)
4.20(1.00)
3.60(0.87)
7.90(7.90)
2.80(2.80)
7.60(3.50)
4.75(2.65)
4.30(3.90)
3.90(2.20)
3.03(1.24)
2.83(1.60)
2.75(1.77)
4.40(3.90)
2.30(0.50)
3.20(2.80)
7.60(7.60)
8.50(2.10)
9.71(3.30)
7.60(1.30)
5.10(1.40)
3.70(3.70)
3.70(1.10)
3.50(3.30)
3.95(1.47)
3.60(1.80)
1.21(0.69)
7.00(4.63)
Difference
1.1 Days
[95%CI
0.6 to 1.5]
-10
02 Studies reporting median data
Attw ood 1992
Hansen 1996
30
79
2.50(0.00)
3.00(0.00)
32
72
3.80(0.00)
3.00(0.00)
-5
0
5
10
Pro laparoskopisch Pro konventionell
Laparoscopic abdominal surgery
•
•
•
Medical perspectives
 Less surgical trauma: Shorter length of stay
 General anaesthesia: Day surgery difficult
Patients' perspectives
Organizational and reimbursement issues
 Longer duration of surgery: Less income per day
 Reduction of hospital bed capacity
 "Cherry-picking" by selecting easy patients
Day surgery in the U.S.A. and Europe:
Overall rates of application
Country, Year
All elective
operations
Cholecystectomy
Inguinal
hernia
U.S.A.
~75%
50%
88%
Sweden, 1996
~50%
?
68%
Great Britain, 2004
~45%
1%
39%
Germany, 2006
~37%
2%
3%
France, 1999
13%
<1%
6%
Portugal, 2003
15%
?
?
Switzerland, 2000
~20%
?
?
http://www.audit-scotland.gov.uk/publications/pdf/2004/04pf04ag.pdf
http://www.irdes.fr/En_ligne/Rapport/rap2000/rap1303.pdf http://www.mao-bao.de/artikel/2005JB_ZahlOperationen.htm
Day surgery in the U.S.A. and Europe:
Inguinal hernia repair in France
http://www.irdes.fr/En_ligne/Rapport/rap2000/rap1303.pdf
Day surgery in Germany: Who does it?
Hospital surgery
7.965.000 operations
Ambulatory surgery
4.700.000 operations
•
•
•
•
In a hospital setting
239.000 operations
In a practice setting
3.831.000 operations
In private practice
352.000 operations
Cosmetic surgery
270.000 operations
Total
12.665.000 operations
http://www.mao-bao.de/artikel/2005JB_ZahlOperationen.htm
Day surgery vs. hospital admission:
randomised controlled trials
Author, Year
Operation
N
ASA
Discharge
Costs
Ruckley, 1978
Hernia, Vein
360
?
100%
-30£
Favretti, 1990
Hernia
73
NA
100%
NA
Keulemans, 1998
Cholec.
80
I - II
92%
-75%
Dirksen, 2001
Cholec.
86
I - II
74%
-22%
Young, 2001
Cholec.
28
Hollington, 1999
Cholec.
131
I - II
82%
-4%
Johansson, 2006
Cholec.
100
I - II
92%
-9%
Ruckley et al., Br J Surg 1978;65:456-9; Favretti et al., Trop Doct 1990;20:18-20; Keulemans Y et al., Ann Surg
1998;228:734-40; Dirksen CD et al., Ned Tijdschr Geneeskd 2001;145:2434-9; Hollington P et al., Aust NZ J Surg
1999;69:841-3; Young & O'Connell, J Qual Clin Pract. 2001;21:2-8; Johansson M et al., Br J Surg 2006;93:40-5
The role of surgical training
•
•
•
•
The effects of surgical expertise is often larger than those
of surgical technique.
EBM is complementing rather than conflicting with
surgical training and intuition.
Training methods itself can (and should) be evidencebased.
The time constraints of day surgery often prevent effective
surgical teaching of residents.
Summary
•
•
•
Day surgery is largely evidence-based, but still not a
commonplace in most European countries.
Much less data is available on day surgery operative
techniques and patient after-care.
The future of abdominal day surgery will now depend
mostly on organisational and financial circumstances.