Evidence based medicine in laparoscopic day surgery the european perspective
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Evidence-based medicine in laparoscopic day surgery: the European perspective. Evoluzione della Chirurgia Mini-invasiva: La Day Surgery Vittorio Veneto, March 31, 2006. Dr. Stefan Sauerland, MD MPH

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Evidence based medicine in laparoscopic day surgery the european perspective l.jpg
Evidence-based medicine in laparoscopic day surgery:the 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

[email protected]


The general aim of surgery l.jpg
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?


Basic concept of evidence based medicine l.jpg
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 1996;125:A-14-16


How much in medicine is evidence based l.jpg
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

Geddes 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% 281 281

Lee General Surg. 14% 64% 22% 50 n.a.

Michaud Internal 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

Summers Psychiatry 53% 10% 37% 160 158

Tsuruoka General Med. 21% 60% 19% 53 49



What influences surgical behaviour l.jpg
What influences surgical behaviour? immediately.

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 <1%

Young JM et al., Arch Surg 2003; 138: 785-791


Evidence based guidelines as a bridge between science and practice l.jpg

Evidence- immediately.basedGuidelines

Evidence-based guidelines as a bridge between science and practice

Clinical

studies

PatientCare

Animal studies

Basic sciences

Science

Practice


Guidelines of the european association for endoscopic surgery eaes l.jpg
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 l.jpg
Levels of Evidence and Grades of Recommendation Surgery (EAES)

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


Inguinal hernia repair in adults choice of endoscopic and control group l.jpg
Inguinal hernia repair in adults: Surgery (EAES)Choice of endoscopic and control group

Ventral mesh: Lichten- stein

Dorsal mesh: Stoppa

Shoul-dice

Other open sutures

TAPP

TEP


What s the evidence most recent meta analyses l.jpg
What's the evidence? Surgery (EAES)Most recent meta-analyses


Main results of meta analysis l.jpg
Main results of meta-analysis Surgery (EAES)

  • 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 l.jpg
Cost-effectiveness Surgery (EAES)

  • 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]


Appendectomy choice of laparoscopic approach and control group l.jpg
Appendectomy: Choice of laparoscopic approach and control group

Lap append-ectomy

Dia-gnostic laparo-scopy

with or without

Open appendectomy


Results operation time l.jpg
Results: Operation time group

Difference +12 Minutes [95%KI 7 bis 16]

-50 min

0

+50 min

Pro laparoskopisch

Pro konventionell


Slide16 l.jpg

Wound infection group

Intraabd. Abszess


Lap appendectomy pain on day 1 l.jpg
Lap appendectomy: Pain on day 1 group

Difference 0.9 cm VAS[0.5 to 1.3]

-4

-2

0

2

4

Pro laparoskopisch

Pro konventionell


Lap appendectomy length of stay l.jpg
Lap appendectomy: Length of stay group

Difference 1.1 Days[95%CI0.6 to 1.5]

-10

-5

0

5

10

Pro laparoskopisch

Pro konventionell


Laparoscopic abdominal surgery l.jpg
Laparoscopic abdominal surgery group

  • 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 l.jpg
Day surgery in the U.S.A. and Europe: Overall rates of application

Country, Year All elective Cholecyst- Inguinal operations 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% <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 l.jpg
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 l.jpg
Day surgery in Germany: Who does it? in France

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 l.jpg
Day surgery vs. hospital admission: in Francerandomised 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 l.jpg
The role of surgical training in France

  • 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.


Summary l.jpg
Summary in France

  • 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.


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