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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

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

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

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?

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


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


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-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)

  • 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

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

Ventral mesh: Lichten- stein

Dorsal mesh: Stoppa

Shoul-dice

Other open sutures

TAPP

TEP


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

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

Lap append-ectomy

Dia-gnostic laparo-scopy

with or without

Open appendectomy


Results: Operation time

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

-50 min

0

+50 min

Pro laparoskopisch

Pro konventionell


Wound infection

Intraabd. Abszess


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

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

-10

-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, 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

http://www.irdes.fr/En_ligne/Rapport/rap2000/rap1303.pdf


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

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


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

  • 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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