Dirk J. Gouma Afdeling Chirurgie Academisch Medisch Centrum Amsterdam

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1 Dirk J. Gouma Afdeling Chirurgie Academisch Medisch Centrum Amsterdam
Laparoscopische Cholecystectomie: een operatie voor iedere chirurg? Dirk J. Gouma Afdeling Chirurgie Academisch Medisch Centrum Amsterdam

2 Bile duct injury

3 Bile duct injury ERC

4 Bile duct injury ERC

5 Bile duct injury

6 Methode Evidence /bronnen
Evidence Based Richtlijn: behandeling galstenen 2007 Certificering oncologisch-chirurgische en Gastro-Intestinaal chirurgische aandoeningen (NVCO / NVGIG 2009) Minimaal invasieve chirurgie: plan van aanpak (2009) www. SAGES. org literatuur: surgeon volume cholecystectomy 6

7 Methode Evidence Based Richtlijn:
Onderzoek en behandeling galstenen 2007 Afhankelijk van lokale expertise de SIC of de LC techniek Er is geen gouden standaard Acute cholecystitis bij voorkeur direct (binnen 1 week) Per operatief letsel alleen ervaren chirurg 7

8 Methode Certificering Oncologisch-Chirurgische en
Gastro-Intestinaal chirurgische aandoeningen (NVCO / NVGIG 2009) IV: Gastro intestinale chirurgie in de dienst: Eisen chirurg kwalitatief en kwantitatief Uitgangsprincipe: Ingrepen specifieke expertise/ ervaring (B) overdag niet – niet tijdens dienst eisen chirurg : cholecystectomie B ingrepen of Chirurg A , chirurg specifieke ervaring (B) oproepbaar 8

9 oproepbaar / overleg Dirk; Ik heb de Critical View of Safety
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. 9

10 oproepbaar / overleg Dirk; Ik heb de Critical View of Safety  clippen
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. 10

11 oproepbaar / overleg Dirk; Ik heb de Critical View of Safety
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. 11

12 Metal stent in benign disease
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Steven Strasberg 12

13 Methode Minimaal Invasieve Chirurgie Plan van aanpak en beleid
(NVEC/NVGIC/WEC februari 2009) incidenteel laparoscopisch opererende chirurgen dienen hiermee te stoppen bewust geen getal gekoppeld aan incidenteel richtlijn laparoscopische cholecystectomie (CVS) 13

14 www. SAGES.org To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. 14

15 www. SAGES.org To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. 15

16 www. SAGES.org To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. 16

17 Methode Evidence /bronnen  Specifieke ervaring / laparoscopic skills
Evidence Based Richtlijn: behandeling galstenen 2007 Certificering oncologisch-chirurgische en Gastro-Intestinaal chirurgische aandoeningen (NVCO / NVGIG 2009) minimaal invasieve chirurgie: plan van aanpak www. SAGES. org  Specifieke ervaring / laparoscopic skills 17

18 Surgeon / Hospital volume Outcome - Relationship
Should operations be regionalized ? “Practice makes perfect” hypothesis Luft HS et al NEJM 1979,301: To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. 18

19 Surgeon volume Lee, Dig Surg; 2004 :21:406-412
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Lee, Dig Surg; 2004 :21: 19

20 Surgeon volume Surgeons 4  4.4 years ; 916 elective cholecystectomies
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Surgeons 4  4.4 years ; 916 elective cholecystectomies 20

21 Surgeon volume Conclusion:
Volume of individual surgeon impact on outcome Lowest complication rate Shortest hospital stay Great effect on conservation of health care resources Costs: TWD:  To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Lee, Dig Surg; 2004 :21: 21

22 Surgeon volume Csikesz, Dig Dis Sci; 2009 :online
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Csikesz, Dig Dis Sci; 2009 :online 22

23 Surgeon volume Csikesz, Dig Dis Sci; 2009 :online
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Csikesz, Dig Dis Sci; 2009 :online 23

24 Surgeon volume Surgeons volume Low < 15 Yr High > 15 Yr
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Csikesz, Dig Dis Sci; 2009 :online 24

25 Surgeon volume Surgeons volume Low < 15 Yr High > 15 Yr
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Csikesz, Dig Dis Sci; 2009 :online 25

26 Surgeon volume Conclusion:
Increasing Volume associated with improved outcome Fewer conversion rate Lower incidence prolonged LOS (Lower BDI / lower in-hospital mortality) Referral to HV surgeons has improved outcome (for urgent cholecystectomy) To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Csikesz, Dig Dis Sci; 2009 :online 26

27 Surgeal Subspecialization
To evaluate the impact of surgical sub-specialization on the outcome of laparoscopic cholecystectomy Elective surgery cholecystolithiasis Emergency surgery acute cholecystitis conversion rate; operating time; complications; LOS Aim: To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Kortram et al, Surg Endo; 2010: In press 27

28 Surgeal Subspecialization
Results: Electief Laparoscopisch Chirurg (n=445) Overig Chirurg (n=277) p-waarde Operatieduur (min) Conversie Complicaties wv galwegletsel Opnameduur (dag) 56±25 25(3.2%) 76(9.7%) 1(0.2%) 2.0±6.2 58±24 11(2.2%) 35(6.9%) 2(0.7%) 1.6±2.1 NS 0.04 To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Kortram et al, Surg Endo; 2010: In press 28

29 Surgeal Subspecialization
Results: Cholecystitis Laparoscopisch Chirurg (n=47) Overig Chirurg (n=49) p-waarde Operatieduur (min) Conversie Complicaties wv galwegletsel Opnameduur (dag) 68±27 4(3.6%) 14(12.6%) 4.5±4.4 76±24 17(15.6%) 16(14.7%) 5.4±6.3 0.02 0.003 NS To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Kortram et al, Surg Endo; 2010: In press 29

30 Surgeal Subspecialization
Conclusion: Patients who present with acute cholecystitis have a greater chance of a laparoscopically completed cholecystectomy if operated on by a laparoscopic surgeon To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Kortram et al, Surg Endo; 2010: In press 30

31 Surgical Subspecialization
To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. 31

32 Surgical Subspecialization
Emergency admissions N = N=1325 To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Simpson, World J Surg; 2008: 32; 32

33 Surgeal Subspecialization
Deliver definitive treatment during index admission high proportion of acute gallstone-related admissions No increase complication or mortality Significant saving hospital bed occupancy Early laparoscopic cholecystectomy is cost effective for appropriately trained surgeons Conclusion: To exclude bias in evaluating potential complications, a blinded adjudication committee reviewed all events and classified these as severe complications or not, according to the definitions in the study protocol. A safety committee was appointed, consisting of a gastroenterologist, a surgeon and clinical epidemiologist. At 50% of the targeted inclusions, they performed a blinded interim-analysis of the primary outcome measure, for which the nominal significance level was lowered to a more restrictive two-sided p< 0.01. Simpson, World J Surg; 2008: 32; 33

34 Samenvatting Laparoscopische cholecystectomie vereist specifieke expertise:  dus niet voor iedere chirurg Criteria expertise zijn niet goed gedefinieerd Training en best practice volgen (CVS) Directe Evidence zeer beperkt Aantal operaties per jaar minimaal 15 Acute cholecystectomie door “ervaren” chirurg leidt tot betere resultaten 34