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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?

AutorDiscipline EvidenceNumber ofRCTOtherNoneTreatm.Pat.

BaraldiniPaed. Surg.26%71%3%7049

DjulbegovicOncology24%21%55%154n.a.

EllisGeneral Med.53%29%18%108108

GallowayHaematology 70%30%n.a.83

GeddesPsychiatry65%4040

GillGeneral Med30%51%19%101122

HowesGeneral Surg.24%71%5%100100

JemecDermatology38%33%23%n.a.115

KennyPaed. Surg.11%66%23%281281

LeeGeneral Surg.14%64%22%50n.a.

MichaudInternal Med.65%150150

MylesAnaesthes.32%65%3%n.a.n.a.

Nordin-J.Internal Med.50%34%12%369197

RudolfPaediatrics40%7%1149247

SlimVariable discipl.50%28%428n.a.

Suarez-V.General Med.38%4%58%23411990

SummersPsychiatry53%10%37%160158

TsuruokaGeneral Med.21%60%19%5349


Slide5 l.jpg

We just found a study saying that you can go home now immediately.


What influences surgical behaviour l.jpg

What influences surgical behaviour?

A survey of 418 Australian surgeons:

  • Surgical training71%

  • Published study results46%

  • Congress visits44%

  • Quality management data27%

  • Practice guidelines24%

  • 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-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

A

B

C

1aSystematic review of randomised controlled trials1bIndividual randomised controlled trial1cAll or none series

2aSystematic review of cohort studies2bIndividual concurrent cohort study2cOutcomes research

3aSystematic review of case-control-studies3bIndividual case-control-study

4Case-series (uncontrolled trials)

5Expert 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: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? 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 2005;19:188-199


Cost effectiveness l.jpg

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]


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

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

-50 min

0

+50 min

Pro laparoskopisch

Pro konventionell


Slide16 l.jpg

Wound infection

Intraabd. Abszess


Lap appendectomy pain on day 1 l.jpg

Lap appendectomy: Pain on day 1

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

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

  • 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, YearAll elective Cholecyst-Inguinaloperationsectomyhernia

U.S.A.~75%50%88%

Sweden, 1996~50%?68%

Great Britain, 2004~45%1%39%

Germany, 2006~37%2%3%

France, 199913%<1%6%

Portugal, 200315%??

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?

Hospital surgery7.965.000 operations

Ambulatory surgery4.700.000 operations

  • In a hospital setting239.000 operations

  • In a practice setting3.831.000 operations

  • In private practice352.000 operations

  • Cosmetic surgery270.000 operations

    Total12.665.000 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:randomised controlled trials

Author, YearOperationNASADischargeCosts

Ruckley, 1978Hernia, Vein360?100%-30£

Favretti, 1990Hernia73NA100%NA

Keulemans, 1998Cholec.80I - II92%-75%

Dirksen, 2001Cholec.86I - II74%-22%

Young, 2001Cholec.28

Hollington, 1999Cholec.131I - II82%-4%

Johansson, 2006Cholec.100I - II92%-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


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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.


Summary l.jpg

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.


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