evidence-based medicine in laparoscopic day surgery: the european perspective dr. stefan sauerland,...

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

Dr. Stefan Sauerland, MD MPH

Institute for Research in Operative Medicine, University of Witten/Herdecke, Ostmerheimer Str. 200, D 51109 Cologne

[email protected]

Evoluzione della Chirurgia Mini-invasiva: La Day Surgery

Vittorio Veneto, March 31, 2006

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

Sackett D et al., Br Med J 1996; 312: 71-72Haynes RB, et al., ACP Journal Club 1996;125:A-14-16

Doctor Patient

Evidence

(Experience, expertise,costs, ethics)

(Experience, expectations,

culture, values)

(Medical and methodological

relevance)

How much in medicine is evidence-based?

Autor Discipline Evidence Number ofRCT Other None Treatm. Pat.

Baraldini Paed. Surg. 26% 71% 3% 70 49Djulbegovic Oncology 24% 21% 55% 154 n.a.Ellis General Med. 53% 29% 18% 108 108Galloway Haematology 70% 30% n.a. 83Geddes Psychiatry 65% 40 40Gill General Med 30% 51% 19% 101 122Howes General Surg. 24% 71% 5% 100 100Jemec Dermatology 38% 33% 23% n.a. 115Kenny Paed. Surg. 11% 66% 23% 281 281Lee General Surg. 14% 64% 22% 50 n.a.Michaud Internal Med. 65% 150 150Myles Anaesthes. 32% 65% 3% n.a. n.a.Nordin-J. Internal Med. 50% 34% 12% 369 197Rudolf Paediatrics 40% 7% 1149 247Slim Variable discipl. 50% 28% 428 n.a.Suarez-V. General Med. 38% 4% 58% 2341 1990Summers Psychiatry 53% 10% 37% 160 158Tsuruoka General Med. 21% 60% 19% 53 49

We just found a study saying that you can

go home now immediately.

What influences surgical behaviour?

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

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%

Evidence-based guidelines as a bridge between science and practice

Basic sciences

Animal studies

Clinicalstudies

PatientCare

Science Practice

Evidence-based

Guidelines

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

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

Ventral mesh:

Lichten- stein

TAPP TEP

Shoul-dice

Other open

sutures

Dorsal mesh: Stoppa

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

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]

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 282Test 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

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

Appendectomy: Choice of laparoscopic approach and control group

Lap append-ectomy

with or without

Open appendectomy

Dia-gnostic laparo-scopy

Results: Operation timeReview: Laparoscopic vs open surgery for suspected appendicitisComparison: 01 Laparoscopic versus conventional appendectomy in adults Outcome: 03 Operation time (minutes)

Study Laparoscopic Conventional WMD (random)or sub-category N Mean (SD) N Mean (SD) 95% CI

01 Studies reporting mean dataKum 1993a 52 43.40(17.10) 57 40.10(15.50) Tate 1993a 70 70.30(21.90) 70 46.50(25.90) Eichen 1994 97 39.00(39.00) 96 35.80(35.80) Frazee 1994 38 87.00(26.25) 37 65.00(47.50) Hebebrand 1994 34 54.50(34.00) 23 42.00(22.50) Macarulla 1995 106 55.20(26.16) 104 44.68(16.63) Martin 1995 81 102.20(35.00) 88 81.70(35.00) Settmacher 1995 12 48.00(11.00) 11 32.00(9.00) Cox 1996 33 58.90(22.50) 31 50.60(20.50) Hart 1996 40 73.80(23.20) 37 45.00(12.90) Mutter 1996 50 45.00(15.90) 50 25.00(12.60) Ortega 1996 167 68.00(32.00) 86 58.00(27.00) Williams 1996 19 93.00(52.30) 18 87.00(33.90) Kazemier 1997 97 61.00(24.00) 104 42.00(18.00) Laine 1997 25 56.00(21.00) 25 32.00(19.00) Reiertsen 1997 42 51.00(16.50) 42 25.00(13.20) Schippers 1997 20 60.00(17.30) 20 53.00(14.90) Sezeur 1997 15 71.00(21.18) 17 48.00(12.72) Stare 1998 48 81.00(81.00) 26 60.00(60.00) Sun 1998 50 38.40(12.60) 100 44.10(16.20) Witten 1998 100 50.70(19.90) 100 51.70(21.90) Zhang 1998 50 23.50(7.40) 53 28.60(6.80) Bauwens 1999 26 59.20(15.80) 28 59.80(24.40) Özmen 1999 35 38.00(38.00) 35 28.00(28.00) Bruwer 2000 18 67.20(27.50) 16 53.10(25.20) Navarra 2000 75 86.27(38.31) 73 65.21(38.31) Nordentoft 2000 12 58.20(58.20) 11 49.60(49.60) Huang 2001 49 65.50(38.30) 26 55.40(28.00) Ignacio 2003 26 77.40(27.10) 26 66.90(21.60) Karadayi 2003 30 42.00(41.10) 30 40.80(35.60) Vallribera 2003 35 58.00(30.00) 30 56.00(26.00) van Dalen 2003 32 35.70(35.70) 31 39.50(39.50)

Subtotal (95% CI) 1584 1501Test for heterogeneity: Chi² = 268.20, df = 31 (P < 0.00001), I² = 88.4%Test for overall effect: Z = 4.92 (P < 0.00001)

02 Studies reporting median dataAttwood 1992 30 61.00(0.00) 32 51.00(0.00) Hansen 1996 79 63.00(0.00) 72 40.00(0.00) Henle 1996 87 35.00(0.00) 82 31.00(0.00) Mutter 1996 50 45.00(0.00) 50 25.00(0.00) Heikkinen 1998 18 31.50(0.00) 21 41.00(0.00) Stare 1998 48 81.00(0.00) 26 60.00(0.00) Hellberg 1999 244 60.00(0.00) 256 35.00(0.00) Kald 1999 49 65.00(0.00) 50 45.00(0.00) Helmy 2001 50 49.00(0.00) 50 23.00(0.00) Pedersen 2001 282 60.00(0.00) 301 40.00(0.00) Al-Mulhim 2002 30 65.00(0.00) 30 50.00(0.00)

Subtotal (95% CI) 0 0Test for heterogeneity: not applicableTest for overall effect: not applicable

-100 -50 0 50 100

Favours laparoscopic Favours conventional

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

-50 min 0 +50 min

Pro laparoskopisch Pro konventionell

Review: Laparoscopic vs open surgery for suspected appendicitisComparison: 01 Laparoscopic versus conventional appendectomy in adults Outcome: 01 Wound infections

Study Peto ORor sub-category 95% CI

Attwood 1992 Kum 1993a Tate 1993a Eichen 1994 Frazee 1994 Hebebrand 1994 Macarulla 1995 Martin 1995 Cox 1996 Hansen 1996 Hart 1996 Henle 1996 Mutter 1996 Ortega 1996 Williams 1996 Kazemier 1997 Laine 1997 Minné 1997 Reiertsen 1997 Schippers 1997 Sezeur 1997 Heikkinen 1998 Stare 1998 Sun 1998 Witten 1998 Zhang 1998 Barth 1999 Bauwens 1999 Hellberg 1999 Kald 1999 Özmen 1999 Bruwer 2000 Hall Long 2000 Navarra 2000 Huang 2001 Pedersen 2001 Al-Mulhim 2002 Ignacio 2003 Karadayi 2003 Vallribera 2003

Total (95% CI)Total events: 89 (Laparoscopic), 178 (Conventional)Test for heterogeneity: Chi² = 36.46, df = 38 (P = 0.54), I² = 0%Test for overall effect: Z = 6.17 (P < 0.00001)

0.001 0.01 0.1 1 10 100 1000


Wound infection

Review: Laparoscopic vs open surgery for suspected appendicitisComparison: 01 Laparoscopic versus conventional appendectomy in adults Outcome: 02 Intraabdominal abscesses

Study Peto ORor sub-category 95% CI

Attwood 1992 Kum 1993a Tate 1993a Eichen 1994 Frazee 1994 Hebebrand 1994 Macarulla 1995 Martin 1995 Cox 1996 Hansen 1996 Hart 1996 Henle 1996 Mutter 1996 Ortega 1996 Williams 1996 Kazemier 1997 Laine 1997 Minné 1997 Reiertsen 1997 Schippers 1997 Sezeur 1997 Heikkinen 1998 Stare 1998 Sun 1998 Witten 1998 Zhang 1998 Bauwens 1999 Hellberg 1999 Kald 1999 Özmen 1999 Bruwer 2000 Hall Long 2000 Navarra 2000 Helmy 2001 Huang 2001 Pedersen 2001 Al-Mulhim 2002 Ignacio 2003 Karadayi 2003 Vallribera 2003

Total (95% CI)Total events: 41 (Laparoscopic), 15 (Conventional)Test for heterogeneity: Chi² = 17.58, df = 16 (P = 0.35), I² = 9.0%Test for overall effect: Z = 3.34 (P = 0.0008)

0.001 0.01 0.1 1 10 100 1000


Intraabd. Abszess

Lap appendectomy: Pain on day 1

Difference 0.9 cm VAS[0.5 to 1.3]

Review: Laparoscopic vs open surgery for suspected appendicitisComparison: 01 Laparoscopic versus conventional appendectomy in adults Outcome: 05 Pain intensity on day 1 (cm VAS)

Study Laparoscopic Conventional WMD (random)or sub-category N Mean (SD) N Mean (SD) 95% CI

01 Studies reporting mean dataTate 1993a 70 4.70(2.10) 70 5.30(2.30) Eichen 1994 97 5.21(1.49) 96 5.90(1.34) Hebebrand 1994 34 2.87(1.50) 23 4.15(2.50) Mutter 1996 50 4.70(1.97) 50 4.40(1.65) Ortega 1996 89 3.05(2.35) 45 4.80(2.05) Kazemier 1997 97 3.53(2.37) 104 5.87(2.50) Minné 1997 27 3.70(3.70) 23 4.00(4.00) Reiertsen 1997 42 5.00(2.00) 42 5.40(1.40) Schippers 1997 20 4.18(2.33) 20 4.79(2.20) Witten 1998 95 5.20(5.20) 100 5.80(5.80) Hellberg 1999 244 3.60(2.10) 256 4.20(2.10) Ignacio 2003 26 3.50(2.10) 26 4.00(1.90) Vallribera 2003 34 2.94(1.37) 28 4.32(1.44)


02 Studies reporting median dataSubtotal (95% CI) 0 0Test for heterogeneity: not applicableTest for overall effect: not applicable

-4 -2 0 2 4


-4 -2 0 2 4


Lap appendectomy: Length of stayReview: Laparoscopic vs open surgery for suspected appendicitisComparison: 01 Laparoscopic versus conventional appendectomy in adults Outcome: 06 Length of hospital stay

Study Laparoscopic Conventional WMD (random)

or sub-category N Mean (SD) N Mean (SD) 95% CI

01 Studies reporting mean dataKum 1993a 52 3.20(0.60) 57 4.20(1.00) Tate 1993a 70 3.50(0.89) 70 3.60(0.87) Eichen 1994 97 6.20(6.20) 96 7.90(7.90) Frazee 1994 38 2.00(2.00) 37 2.80(2.80) Hebebrand 1994 34 6.30(3.50) 23 7.60(3.50) Macarulla 1995 106 3.42(1.86) 104 4.75(2.65) Martin 1995 81 2.20(3.90) 88 4.30(3.90) Cox 1996 33 2.90(1.70) 31 3.90(2.20) Hart 1996 40 3.23(5.55) 37 3.03(1.24) Ortega 1996 167 2.63(2.91) 86 2.83(1.60) Williams 1996 19 2.38(2.18) 18 2.75(1.77) Kazemier 1997 97 3.70(2.50) 104 4.40(3.90) Laine 1997 25 2.70(1.50) 25 2.30(0.50) Reiertsen 1997 42 3.50(2.60) 42 3.20(2.80) Sezeur 1997 15 4.00(4.00) 17 7.60(7.60) Sun 1998 50 4.50(1.50) 100 8.50(2.10) Witten 1998 100 7.78(3.14) 100 9.71(3.30) Zhang 1998 50 5.30(1.10) 53 7.60(1.30) Bauwens 1999 26 5.30(1.80) 28 5.10(1.40) Özmen 1999 35 1.60(1.60) 35 3.70(3.70) Bruwer 2000 18 3.00(1.60) 16 3.70(1.10) Hall Long 2000 93 2.90(3.30) 105 3.50(3.30) Navarra 2000 75 2.64(1.47) 73 3.95(1.47) Huang 2001 49 2.60(1.20) 26 3.60(1.80) Ignacio 2003 26 0.90(0.78) 26 1.21(0.69) Vallribera 2003 35 4.37(3.24) 30 7.00(4.63)


02 Studies reporting median dataAttwood 1992 30 2.50(0.00) 32 3.80(0.00) Hansen 1996 79 3.00(0.00) 72 3.00(0.00) Henle 1996 87 3.00(0.00) 82 4.00(0.00) Mutter 1996 50 5.30(0.00) 50 4.90(0.00) Minné 1997 27 1.10(0.00) 23 1.20(0.00) Heikkinen 1998 19 2.20(0.00) 21 2.00(0.00) Stare 1998 48 3.00(0.00) 26 7.00(0.00) Hellberg 1999 244 2.00(0.00) 256 2.00(0.00) Kald 1999 49 2.00(0.00) 50 3.00(0.00) Helmy 2001 50 5.30(0.00) 50 4.90(0.00) Pedersen 2001 301 2.00(0.00) 282 2.00(0.00) Karadayi 2003 30 1.00(0.00) 30 1.56(0.00)

Subtotal (95% CI) 0 0Test for heterogeneity: not applicableTest for overall effect: not applicable

-10 -5 0 5 10


-10 -5 0 5 10


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

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, Year All elective Cholecyst- Inguinaloperations 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

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

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

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

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.

evidence-based medicine in laparoscopic day surgery: the european perspective dr. stefan sauerland,...

Documents