Evidence-based medicine in laparoscopic day surgery: the European perspective

1
Evidence-based medicine in laparoscopic day
surgerythe European perspective
Evoluzione della Chirurgia Mini-invasiva La Day
Surgery Vittorio Veneto, March 31, 2006
Dr. Stefan Sauerland, MD MPH Institute for
Research in Operative Medicine, University of
Witten/Herdecke, Ostmerheimer Str. 200, D 51109
Cologne stefan.sauerland_at_ifom-uni-wh.de
2
The general aim of surgery

• The right patient should
• receive the right operation,
• done in the right clinic,
• performed by the right surgeon.

Laparoscopic or conventional?
In a hospital or ambulatory?
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Basic concept of evidence-based medicine
Doctor
Patient
(Experience, expertise,costs, ethics)
(Experience, expectations,culture, values)
Evidence
(Medical and methodologicalrelevance)
Sackett D et al., Br Med J 1996 312
71-72 Haynes RB, et al., ACP Journal Club
1996125A-14-16
4
How much in medicine is evidence-based?
Autor Discipline Evidence Number
of RCT Other None Treatm. Pat. Baraldini Paed.
Surg. 26 71 3 70 49 Djulbegovic Oncology 24 21
55 154 n.a. Ellis General Med. 53 29 18 108
108 Galloway Haematology 70 30 n.a. 83 Ged
des Psychiatry 65 40 40 Gill General
Med 30 51 19 101 122 Howes General
Surg. 24 71 5 100 100 Jemec Dermatology 38 33
23 n.a. 115 Kenny Paed. Surg. 11 66 23 281 28
1 Lee General Surg. 14 64 22 50 n.a. Michaud In
ternal Med. 65 150 150 Myles Anaesthes. 32 65
3 n.a. n.a. Nordin-J. Internal
Med. 50 34 12 369 197 Rudolf Paediatrics 40 7
1149 247 Slim Variable discipl. 50 28 428 n.a
. Suarez-V. General Med. 38 4 58 2341 1990 Summ
ers Psychiatry 53 10 37 160 158 Tsuruoka Genera
l Med. 21 60 19 53 49
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We just found a study saying that you can go home
now immediately.
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What influences surgical behaviour?

• A survey of 418 Australian surgeons
• Surgical training 71
• Published study results 46
• Congress visits 44
• Quality management data 27
• Practice guidelines 24
• Mass media lt1

Young JM et al., Arch Surg 2003 138 785-791
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Evidence-based guidelines as a bridge between
science and practice
Clinical studies
PatientCare
Animal studies
Basic sciences
Science
Practice
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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

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Levels of Evidence and Grades of Recommendation
A B C
1a Systematic review of randomised controlled
trials1b Individual randomised controlled
trial1c All or none series 2a Systematic review
of cohort studies2b Individual concurrent cohort
study2c Outcomes research 3a Systematic review
of case-control-studies3b Individual
case-control-study 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
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Inguinal hernia repair in adultsChoice of
endoscopic and control group
Ventral mesh Lichten- stein
Shoul-dice
Other open sutures
Dorsal mesh Stoppa
TAPP
TEP
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What's the evidence? Most recent meta-analyses
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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 200519188-199
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Cost-effectiveness

• Higher in-hospital cost, but similar costs on the
  society level due to earlier return to work

Study
Laparoscopic
Open
SMD (fixed)
or sub-category
N
Mean (SD)
N
Mean (SD)
95 CI
Heikkinen 1997
20 4796(4796) 18 5360(5360)
Liem 1997
134 4918(3350) 139 4665(4352)
Beets 1998
42 2004(2004) 37 2045(2045)
Dirksen 1998
86 5750(5750) 88 6678(6678)
Total (95 CI)
282 282
Test for heterogeneity Chi² 1.27, df 3 (P
0.74), I² 0
Test for overall effect Z 0.29 (P 0.77)
-1
-0.5
0
0.5
1
Favours treatment
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
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Appendectomy Choice of laparoscopic approach and
control group
Lap append-ectomy
Dia-gnostic laparo-scopy
with or without
Open appendectomy
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Results Operation time
Difference 12 Minutes 95KI 7 bis 16
-50 min
0
50 min
Pro laparoskopisch
Pro konventionell
16
Wound infection
Intraabd. Abszess
17
Lap appendectomy Pain on day 1
Difference 0.9 cm VAS0.5 to 1.3
-4
-2
0
2
4
Pro laparoskopisch
Pro konventionell
18
Lap appendectomy Length of stay
Difference 1.1 Days95CI0.6 to 1.5
-10
-5
0
5
10
Pro laparoskopisch
Pro konventionell
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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

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Day surgery in the U.S.A. and Europe Overall
rates of application

• Country, Year All elective Cholecyst- Inguinal o
  perations ectomy 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 lt1 6
• Portugal, 2003 15 ? ?
• Switzerland, 2000 20 ? ?

http//www.audit-scotland.gov.uk/publications/pdf/
2004/04pf04ag.pdf http//www.irdes.fr/En_ligne/Rap
port/rap2000/rap1303.pdf http//www.mao-bao.de/art
ikel/2005JB_ZahlOperationen.htm
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Day surgery in the U.S.A. and Europe Inguinal
hernia repair in France
http//www.irdes.fr/En_ligne/Rapport/rap2000/rap13
03.pdf
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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_ZahlOperation
en.htm
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Day surgery vs. hospital admissionrandomised
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 197865456-9 Favretti
et al., Trop Doct 19902018-20 Keulemans Y et
al., Ann Surg 1998228734-40 Dirksen CD et al.,
Ned Tijdschr Geneeskd 20011452434-9 Hollington
P et al., Aust NZ J Surg 199969841-3 Young
O'Connell, J Qual Clin Pract. 2001212-8
Johansson M et al., Br J Surg 20069340-5
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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
  evidence-based.
• The time constraints of day surgery often prevent
  effective surgical teaching of residents.

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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.