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

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

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  1. 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 stefan.sauerland@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?

  3. 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

  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 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

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

  6. 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 <1% Young JM et al., Arch Surg 2003; 138: 785-791

  7. Evidence-basedGuidelines Evidence-based guidelines as a bridge between science and practice Clinical studies PatientCare Animal studies Basic sciences Science Practice

  8. 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

  9. 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

  10. 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

  11. What's the evidence? Most recent meta-analyses

  12. 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

  13. 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]

  14. Appendectomy: Choice of laparoscopic approach and control group Lap append-ectomy Dia-gnostic laparo-scopy with or without Open appendectomy

  15. Results: Operation time Difference +12 Minutes [95%KI 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 VAS[0.5 to 1.3] -4 -2 0 2 4 Pro laparoskopisch Pro konventionell

  18. Lap appendectomy: Length of stay Difference 1.1 Days[95%CI0.6 to 1.5] -10 -5 0 5 10 Pro laparoskopisch Pro konventionell

  19. 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

  20. 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

  21. Day surgery in the U.S.A. and Europe: Inguinal hernia repair in France http://www.irdes.fr/En_ligne/Rapport/rap2000/rap1303.pdf

  22. 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

  23. 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

  24. 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.

  25. 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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