Appendix 1 (19) Appendix 1 Tables of included studies. Surgery to treat gallstones and acute inflammation of the gallbladder Report 259 (2016)

Transcription

1 Appedix 1 (19) Surgery to treat gallstoes ad acute iflammatio of the gallbladder Report 259 (2016) Appedix 1 Tables of icluded studies SBU States beredig för medicisk och social utvärderig Telefo Fax Orgaisatiosummer Besöksadress S:t Eriksgata 117, Stockholm Postadress Box , Stockholm

2 Table 14.1 Cholecystectomy versus o cholecystectomy i symptomatic gall stoe decease. Author Referece Cholecystect omy / o cholecystecto my Age Type of Exclusios Op tech Outcome measures Follow up Harms Over all death Schmidt et al Norway 2011 [16] Schmidt et al Norway 2011 [17] Iclusio Iclusio /69 Mea rage) 49.7 (20-79) years 31/33 Vetrhus et al 2005 [19] RCT ucomplica ted gallstoe disease Same populatio as Sødeaa et al 1997 [18] but here is also a third hospital icluded, i.e. same populatio as Vetrhus et al 2002 [22]. RCT acute cholecystits. Vetrhus M of Same populatio but loger follow-up. Sødeaa et al 1997 [18] Vetrhus et al 2005 [19] Not describ ed Laparos copic/ / covert ed() i cholecy stectom y group 45/15/0 Ad i observa tio rate ad rate of adverse gall stoe related evets Vetrhus et al 2005 [19] 50.5 % radomized to observatio uderwet operatio (media 28 moths). 88.2% radomized to operatio uderwet operatio (media 3 moths). Very few operatios performed after 5 years. 87.1% i cholecystecto my group ad 33.3% i observatio group had udergoe surgery Mea (rage) 14 ( ) years Mea (rage) 14 (13-16) years. 1 patiet each radomized to observatio with acute cholecystitis, commo bile duct stoe ad pacreatitis. I patiets radomized to operatio 1 had a acute pacreatitis caused by ERCP prior to operatio ad 4 ERCP were performed with 1 CBD stoe detected. P for evets /33 patiets i observatio group experieced complicated gall stoe disease (cholecystitis, CBD, ad/or gallstoe pai, the latter beig =1). Overall 13.9%, o for gall stoe disease, equal betwee groups 8/10 deaths, oe caused by gallstoe disease or gallbladd er cacer. 2

3 Author Referece Cholecystect omy / o cholecystecto my Age Type of Exclusios Op tech Outcome measures Follow up Harms Over all death Sødeaa et al Norway 1997 [18] Iclusio Symptomatic gall bladder stoe 59/61 Symptomatic gall bladder stoe ad cholecystitis 31/33 Media (rage) 51 (20-79) ad 57 (26-77) respectiv ely RCT 4 hospitals recruited but oly 2 had substatial patiet recruitmet ad oly these 2 were thus icluded Age < 18 or > 80, pregacy, gagreous gallbladder, suspected CBD stoe, achalculos cholecystitis, patiet preferred symptoms (6.8%), severer or well tolerable symptoms. group 29/2/4 6 /31 patiets i the operatio group experieced complicated gall stoe disease (pai attacks =4). Not describ ed rate 12% of patiets with o cholecystitis ad 13% with a history of cholecystitis radomized to operatio switched to observatio. Correspodig figures for patiets radomized to observatio switchig to operatio were 25 ad 24% respectively years, mea ot give. Not described Not describe d 3

4 Author Referece Cholecystect omy / o cholecystecto my Age Type of Exclusios Op tech Outcome measures Follow up Harms Over all death Vetrhus et al Norway 2005 [19] Vetrhus et al Norway 2003 [21] Søde aa et al 1997 [18] Iclusio /33 Sødea a et al 1997 [18] 31/33 Sødea a et al 1997 [18] Sødeaa et al 1997 [18] Schmidt et al 2011 [16] Sødeaa et al 1997 [18] Sødeaa et al 1997 [18] Not describ ed Not describ ed Pai ad QoL at 6, 12 ad 60 moths. No differece betwee groups. Cumulative risk of cholecystect omy ad gall stoe related complicatio. Sødeaa et al 1997 [18] 13 % radomized to operatio switched to observatio ad 30% radomized to operatio switched to operatio. Media 67 moths Media (rage) 67 (56-98) moths N.A. Cholecystecto my group/observat io group: evets () Admissio for pai 3/4. Acute cholecystitis 1/9. Sødea a et al 1997 [18] Sødea a et al 1997 [18] CBD stoe 1/4. Acute pacreatitis 1/0. (p=0.09). Patiets () with ay of above metioed evets 6/12 (p=0.16). 4

5 Author Referece Cholecystect omy / o cholecystecto my Age Type of Exclusios Op tech Outcome measures Follow up Harms Over all death Vetrhus et al 2002 [22] Iclusio /69 Schmidt et al 2011 [16] RCT Same populatio as Schmidt M a radomized) but shorter follow-up I.e. the same populatio as Sødeaa et al 1997 [18] but here is also a third hospital icluded. Schmidt et al 2011 [16] Laparos copic/ / covert ed() i cholecy stectom y group 45/15/0 Ad i observa tio group 29/2/4 Schmidt et al 2011 [16] Same outcome measures but with a shorter follow-up. 88 % radomized to operatio ad 51% radomized to observatio uderwet operatio. Media (rage) 67 (56-91) moths. Major complicatios (i.e. itra - abdomial ifectio, bile leakage, woud ifectio, dehiscece) () 3 i cholecystecto my, 5 i observatio group. 0/0 related to cholecyst ectomy or gall bladder stoe. No data for total mortality. Vetrhus et al Norway 2004 [20] Vetrhus et al 2002 [22] 68/69 Vetrhus et al 2002 [22] Vetrhus et al 2002 [22] Vetrhus et al 2002 [22] Laparos copic/ / covert ed() i cholecy stectom y group 45/15/0 Ad i observa tio group 29/2/4 Pai ad QoL at 6, 12 ad 60 moths. No differece see over betwee groups. Patiet with high iitial pai radomized to observatio were more likely to udergo operatio. Vetrhus et al 2002 [22] Vetrhus et al 2002 [22] N.A. Vetrhus et al 2002 [22] 5

6 Table 14.2 a: Early vs delayed surgery for acute cholecystectomy systematic reviews ad RTCs. Author Referece Cao et al 2015 [24] early/ late Mea age (years) Type of 795/ Systematic review 15 RTCs Exclusio Def early/ late - Early with 24 to 96 hours Op tech Not give Outcome measures Total hospital stay (days mea) 4.1/7.3 p>0.001 Days off work 14.75/23.50 p<0.07 Follow up Harms Total complicatios RR 0.66 (95% CI, 0.42; 1.03) Bile duct leak RR 0.79 (95% CI, 0.27; 2.34) Postoperative woud ifectio RR 0.57 ()%% CI, 0.35; 0.93) Over all death partly same studies as Gusura my 2013 Icludes Gutt 2013 ad Gul 2013 Studies icluded i Cao et al. (above) Mortality RR 1.03 (95% CI, 0.05; 20.50) Gurusamy et al 2013 * [23] search util July / years i differet studies Systematic review (6 studies) Various Operatig (miutes) MD (95% CI -3.07; 0.64) (6 trials) Total hospital stay (days) MD (95% CI -5.22; -3.03) (4 trials) 19.7/22.1% RR 0.89; (95% CI 0.63; 1.25) (6 trials). Complicatio s total 6.5/5.0 % RR 1.29; (95% CI 0.61;2.72) (5 trials) Bile duct ijuries 0.4/0.9% OR 0.49; (95% CI /0 / high Retur to work based o 36 patiets i oe trial 6

7 Author Referece Gul et al * 2013 Idia [26] early/ late Mea age (years) 30/30 40 (SD 8)/ 38 (SD 10) Type of RCT 1 hospital Exclusio Jaudice, choledoch o-lithiasis, pacreatiti s, maligac y, previous upper abdomial surgery Def early/ late <72 hours/ 6-12 weeks Op tech Laparo scopic Outcome measures Retur to work (days) MD -11,.0 95% CI -19.6; - 2.4) (1 trial) Op (mi) 99/81 p<0.05 Blood loss 173/101 (ml) p<0.05 Hospital stay 4.8/10.1 (days) sig Follow up Harms to 4.72) (5 trials) 3/4 s ot give Fever 2/1 Peumoia 2/1 Bile leakage 1/0 Itraabdomi al collect 0/1 Woud ifectio 1/1 All s Over all death ot give / high Gutt et al * 2013* Germay/ Sloveia [25] / (SD16)/ 57 (SD17) RCT Idividual 35 cetres ASA 4-5 Septic chock Peroratio Abscess Pregac y <24 hours after hospital admissio / 7-45 days Laparo scopic Morbidity withi 75 days 11.8/34.4% Hospital stay 5.4/10.0 p<0.01 Total hospital costs 2 919/4 262 p< /33 p= days All adverse evets 58 (= 43) / 179 (=127) Serious adverse evets = 28/85 1/1 s High Post op hospitalisatio 4.7/4.9 p=0.57 Morbidity score o day /1.12 p<

8 Table 14.2 b: Early vs delayed surgery for acute cholecystectomy Retrospective comparative register. Author Referece de Mestral et al 2014 Caada [27] early/ late / Mea age (years) 53 (SD18)/ 56 (SD 17) Type of Retrospective comparative register 154 hospitals i Otario Exclusio Severe cholecystiti s, Biliary maligacy Def early/ late 7days/ media 8 weeks (IQR 4-12 weeks) Op tech Laparoscopic Ope 922 Outcome measures Post op hospital stay (days) hospital stay MD -1.9 (95% CI -2.1: -1.7) Follow up 1 220/719 >6 moths Harms Major bile duct ijury = 38/ %/0.53 % RR 0.53 (95% CI 0.31; 0.90) Over all death at 30 days 0.46%/ 0.64% RR=0.73, (95% KI: 0.47; 1.15) 8

9 Table 14.3: Laparoscopic vs cholecystectomy for cholecystitis. Author Coccolii et al 2015 Italy ad Irelad [32] Number ad geder laparoscopic/ = 677/697 Geder ot stated. Media age (years) laparosc opic/ope Not give Systematic review metaaalysis 4 RCT ad 6 observatioal (4 retropective ad 2 prospective) Radomisatio Idicatio for surgery Assessmet ad follow-up Results laparoscopic/ Postoperative legth of stay (1 RCT, 1 observatioal MD (95% CI, ; -0.43) Harms: Complicatios/ Mortality laparoscopic/ LC vs OC Complicatios 4 RCTs LC 27/154 OC 43/156 OR 0.54 (95% CI, 0.31; 0.94) Surgery (mi) laparosc opic/ MD -90 (95% CI, ; 16.31). Not etirely cosequet reportig of the differet parameters. Errors i umberig of tables 4 RCT + 5 observatioal studies OR 0.46 (95% CI, 0.34, 0.61) Icludes all the above RTCs Bile leakage 1 RCT, 3 observatioal studies OR 1,26 (95% CI, 0.34; 4.62) Mortality 4 observatioal studies OR 0.20 (95% CI, 0.04; 0.89) 9

10 Author Studies icluded i Coccolii et al Number ad geder laparoscopic/ Media age (years) laparosc opic/ope Radomisatio Idicatio for surgery Assessmet ad follow-up Results laparoscopic/ Harms: Complicatios/ Mortality laparoscopic/ Surgery (mi) laparosc opic/ (above) Boo et al 2007 Korea [28] May to Decem ber 2004 = 33 18/15 9 wome 9 me/ 9 wome 6 me LC 53±16 OC 63±13 (P=0.06 2) RCT (Computer radomiztio) Acute cholecystiti s Preoperati veday 1, day 3 postoperati ve. a/ LC causes less surgical trauma ad immuosuppre ssio tha OC. b/ Hospital stay (days) 3.7±1.2/6.3±2.7 Complicatios LC 0/15 OC 2/18 o sigificat differece o mortality 73.2±24/ 90.2±23 s + Catea et al 2013 Italy/ [29] Johasso et al.2005 [30] 2 years = 164 Apr Mar ot icluded, 11 refused, 9 requested LC Geder ot give 35/35 (16 wome, 19 me/ 19 wome, 16 me) >18 Media ot give 53 (23-84)/ 56 (31-80) s RCT (Radomized computer to evelopes) RCT (Double blid. Sealed evelopes stratified for age ad sex Idividually) Acute cholecystiti s Early (<72 hours) Acute cholecystiti s Symptom s >6hr + lab. Preoperati ve Peroperati ve Discharge, 7days 1 moth 6 moths Preoperati ve durig hospital stay ad postop (4 w) rate LC 9.7% (7/72) Outcome of LC ot differet from OC i AC. Legth of stay i hospital (days) 5.1/5.4 : 8/35 Sick leave s Pai score at discharge s Complicatios: OC 25/72 LC 24/72 (s) 1 bile leakage from the cystic duct i LC group. o mortality Complicatios LC 2/35 OC 3/35 s o bile leakage 109/98 s 90 (30-155)/ 80 (50-170) (P=0.04) /Low poor data descriptio? Radomizatio. Process 2/3 gagree or empyema., Questios regardig statistics. Biased? 10

11 Author Number ad geder laparoscopic/ Media age (years) laparosc opic/ope Radomisatio Idicatio for surgery Not more tha 6 days. Assessmet ad follow-up Pai score at discharge, Sick Leave, Results laparoscopic/ Legth of stay i hospital (days) 2 (1-10)/2 (1-8) p=0.011 Harms: Complicatios/ Mortality laparoscopic/ No mortality Surgery (mi) laparosc opic/ High coversio rate. Kiviluoto et al 1998 Filad [31] Ja 95- Aug 96 = 32/31 Geder ot stated (28-82)/58. 9 (25-88) RCT (Blided, Sealed evelopes.) Acute cholecystiti s Cosecuti ve >24 hours pai + lab 1-2 moths Legth of stay i hospital LC 4 (2-5) OC 6 (5-8) (p=0.006) Sick leave (days) 13.9/30.9 (p=<.0001) Complicatios LC 1/32 OC 13/31 No mortality (±49.9)/ 99.8 (±39.7) s High MD = mea differece; OR = odds ratio; RTC = radomized cotrolled trial Postoperative complicatios Major 0/32/7/31(p= ) Mior 1/32/6/31 (p=0.0530) 11

12 Table 14.4: Laparoscopic ad cholecystectomy for cholecystitis harms, observatioal studies. Author ad Geder Media age (years) (rage) desig Aim Idicatio for surgery Assessmet ad Followup Bile duct ijuries Other complicatio s Mortality Adamse et al 1997 Demark [35] =7 654 Geder ot stated. Not stated Register. All laparoscopic cholecystect omies Assess bile duct ijury after LC icidece, types treatmet Symptomatic gallstoe ad complicatios Elective ad acute laparoscopic cholecystecto my. Preoperative Peroperative 30 days follow-up. 57 (0.74%) 84% occurred before coversio to OC. Icidece BDI was ot reduced durig the. 18% i those with bile duct ijury - Lackig coverage rate ad overall mortality. Pessaux et al 2001 Frace [37] Jauary Decemb er 1999 =139 LC =50 OC =89 LC 30 wome 20 me. OC 51 wome, 38 me >75 Observatio al Prospective iclusio of patiets >75 with acute cholecystitis Determie the feasibility ad the efficacy of LC for AC i patiets >75year ad compare with OC. Acute cholecystitis All preoperative, ad postoperative data were collected prospectively o stadardized forms. 2.1% of LC had bile leakage without BDI. Noe Postoperative complicatios, woud ifectio, subhepatic collectio, retaied CBD stoes, cardiogeic pulmoary oedema, arrhythmia, real failure, uriary ifectio would haematoma, septic shock 4/139 (all after OC) Selectio bias? Log waitig s. 12

13 Author ad Geder Media age (years) (rage) desig Aim Idicatio for surgery Assessmet ad Followup Bile duct ijuries Other complicatio s Mortality take together. Strömberg et al 2015 [36] = wome me < ; > Data missig 2 All cholecystect omies Register Crossmatched with Natioal patiet register. Report the icidece of ad risk factors for symptomatic veous thromboemb olism after cholecystect omy. All cholecystect omies. Peroperative Postoperativ e 30 day follow-up. LC 9/50 (18%) OC 19/89 (21.3%) - Veous thromboemb olism i 154 (0.25%). Deep veous thrombosis i 36 (0.06%) Pulmoary embolus i 25 (0.04%). Not stated High Stadardize d icidece rate for deep veous thrombosis 22.2 (95% CI, 13.1; 31.3) Stadardize d icidece rate for pulmoary embolus 5.6 (95% CI, 2.3; 8.9) 13

14 Author ad Geder Media age (years) (rage) desig Aim Idicatio for surgery Assessmet ad Followup Bile duct ijuries Other complicatio s Mortality Harboe et al 2011 Demark, [34] Jauar y Jue patiets 73% wome 49 (4-101) Register Assess the of LC ad OC i Demark Gallstoe ad complicatio s rate Legth of hospital stay Additioal procedures 0,2 % BDI 5,6 % additioal. procedures LC ad OC together rate LC 7.6% Recostructi ve 54/ (0.27%). Does ot differ LC ad OC completely Readmissio Törqvist et al [33] 2015 Rystedt et al [9] % wome % wome 51 (38-63) i those without BDI 62 (3-99) Register (GallRiks) Register (GallRiks) All BDI All, 18.2 % cholecystitis Severe BDI (Haover scale C or higher All, 43.7 % ucomplicat ed gallstoe disease 30 day mortality Register (GallRiks) Patiet records i those registered with BDI 747 (1.5%) o mortality 174 (0.3%) 6/ (0.01%) BD = bile duct; BDI = bile duct ijury; GallRiks = atioal register for cholecystectomies ad ERCP; LC = 0 laparoscopic cholecystectomy; OC = cholecystectomy High High 14

15 Table 14.5: Ecoomic evaluatios comparig surgery (cholecystectomy) with observatio/coservative maagemet. Author Referece Brazzelli et al [41] 2014 UK de Mestral et al [42] 2016 Caada desig Populatio Settig Perspective Model-based CUA Time horizo 5 years Populatio from 2 RCTs o adults with first episode of symptomatic ucomplicated gallstoe disease, suitable for cholecystectomy Secodary care NICE Health ad Persoal Social Services perspective Model-based CUA Time horizo 5 years Register data. Adults with acute cholecystit without previous symptomatic gallstoe disease, admitted to ED March 2004-April 2011 ( patiets). Prsity score matched Hospital Itervetio vs cotrol Base case model estimates for female aged 51 years I: Surgery C: Coservative maagemet (surgery if symptoms persist) Three arms: 1: Early surgery (withi 7 days of symptoms) 2: Delayed surgery 3: Watchful waitig (urget surgery if recurret symptoms) Icremetal cost All costs reported i GBP year 2011/2012 I: C: Differece: All costs reported i CAD year : : Differece: 370 Icremetal effect Effects reported i QALYs I: C: Differece: Effects reported i QALYs 1: : 3.99 Differece: ICER per QALY Coservative maagemet most probable cost-effective at a willigess to pay per QALY below Watchful waitig domiated by Early surgery (less cost ad more QALYs) Sesitivity aalyses (threshold ad probabilistic) cofirm domiace of Early surgery ad trasferability* Further iformatio Commets High High trasferability to Further iformatio i [16,17] Results very sesitive to probability of surgery ad to QoL of patiets with persistet symptoms i coservative maagemet High High trasferability to Further iformatio i [11,27] Results sesitive to QoL post surgery table 14.6 for the secod arm results Sadzé et al [10] 2013 Third party payer perspective (Otario Miistry of Health ad Log Term Care) Register-based descriptive Swedish Natioal Patiet Register data. Patiets with gallbladder disease (o previous admissio for biliary diagosis for 2 years) admitted to hospital Four patiet groups: 1: Surgery at admissio 2: Elective surgery withi 2 years No costs reported Resource cosumptio reported as mea days of hospital stay, icludig idex admissio Not reported Not reported assessed as observatioal ; medium risk of bias 41 % of patiets foud i group 4. No surgery withi 2 years 15

16 Jauary 1988-December 2006 ( admissios) Hospital No costs reported 3: Emergecy surgery withi 2 years 4. No surgery (cholecystectomy) withi 2 years ad 2-year admissios for biliary diagoses 1: : : : 8.05 table 14.6 for the secod patiet group results Differece: 4 vs 1: 0.48 days * is a combied assessmet of the of the from a cliical as well as a ecoomic perspective CUA = Cost-utility aalysis; GBP = British poud; QoL = -of-life; ED = emergecy departmet; CAD = Caadia dollars 16

17 Table 14.6: Ecoomic evaluatios comparig early acute surgery (cholecystectomy) with delayed elective surgery (cholecystectomy). Author Referece Gutt et al [25] 2013 Germay ad Sloveia desig Populatio Settig Perspective RCT-based CA Follow-up 75 days Adult patiets with symptoms of acute cholecystitis ad possibility of laparascopic surgery withi 24 hours of admissio 618 patiets from 35 cetres Itervetio vs cotrol I: Immediate surgery, mea day of surgery 0.6 days C: Coservative treatmet ad delayed elective surgery, mea day of surgery 25.1 days Icremetal cost All costs reported i EUR year 2010 I: C: Mea total hospital days: I: 5.4 (95 % CI: ) Icremetal effect ICER ad trasferability* Further iformatio Commets - - Moderate Moderate trasferability to 75-day morbidity score statistically sigificat lower i Immediate group Hospital Hospital perspective C: (95 % CI: ) Johasso et al [43] 2003 RCT-based, resource cosumptio Patiets aged <91 years with diagosis acute cholecystitis 145 patiets Hospital No costs reported I: Laparoscopic surgery withi 7 days of symptom oset C: Coservative treatmet ad delayed elective surgery 6-8 weeks later Total hospital days, media: I: 5 C: Moderate Moderate trasferability to 26 % of patiets i Delayed group required emergecy surgery Wilso et al [45] 2010 UK Model-based CUA Time horizo 1 year Patiets with acute cholecystitis. May evet probabilities from Gurusamy et al, 2010 [51] Hospital I: Early surgery C: Delayed surgery All costs reported i GBP year 2006 Per 1000 patiets: I: C: Effects reported i QALYs Per 1000 patiets: I: C: Delayed surgery domiated by Early surgery (less cost ad more QALYs) Early surgery has a 70 % probability of beig cost-effective agaist Delayed at a willigess High High trasferability to Patiet groups ot clearly described 17

18 NICE healthcare perspective Differece: Differece: to pay per QALY, ad decreased to a 62 % probability at a willigess to pay Joher et al [44] 2013 Caada Model-based CUA Time horizo 1 year Patiets with acute cholecystitis. Most evet probabilities from Gurusamy et al, 2010 [51] Hospital Healthcare perspective I: Early surgery C: Delayed elective surgery as defied i [51] All costs reported i CAD year 2009 I: C: Differece: Effects reported i QALYs I: C: Differece: Delayed surgery domiated by Early surgery (less cost ad more QALYs) Moderate Moderate trasferability to Few sesitivity aalyses reported de Mestral et al [42] 2016 Caada Model-based CUA Time horizo 5 years Register data. Adults without previous symptomatic gallstoe disease, admitted to ED March 2004-April 2011 ( patiets) Prsity score matched. Hospital Three arms: 1: Early surgery (withi 7 days of symptoms) 2: Delayed surgery (elective 8-12 weeks later) 3: Watchful waitig All costs reported i CAD year : : Differece: Effects reported i QALYs 1: : 4.18 Differece: Delayed surgery domiated by Early surgery (less cost ad more QALYs) Sesitivity aalyses (threshold ad probabilistic) cofirm domiace of Early surgery High High trasferability to Further iformatio i [11,27] table 14.5 for the third arm results Third party payer perspective (Otario Miistry of Health ad Log Term Care) Sadzé et al [10] 2013 Register-based descriptive Swedish Natioal Patiet Register data. Patiets with gallbladder disease (o previous admissio for biliary diagosis for 2 years) admitted to hospital Jauary 1988-December 2006 ( admissios) Four patiet groups: 1: Surgery at admissio 2: Elective surgery withi 2 years No costs reported Resource cosumptio reported as mea days of hospital stay, icludig idex admissio ad 2-year Not reported Not reported assessed as observatioal ; medium risk of bias table 14.5 for the fourth patiet group results 18

19 Hospital No costs reported 3: Emergecy surgery withi 2 years 4. No surgery (cholecystectomy) withi 2 years admissios for biliary diagoss 1: : : : 8.05 Differece: 2 vs 1: 0.98 days * is a combied assessmet of the of the from a cliical as well as a ecoomic perspective CA = Cost aalysis; EUR = Euros; CI = cofidece iterval; CUA = Cost-utility aalysis; CAD = Caadia dollars; GBP = British pouds; ED = emergecy departmet 19