GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY (MIS) CHOLECYSTECTOMY

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1 ) C GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY (MIS) CHOLECYSTECTOMY Global Value Dossier: Cholecystectomy 1

2 Prepared by: Jayne Smith-Palmer and Barney Hunt Ossian Health Economics and Communicatio, Bäumleingasse 20, 4051 Basel, Switzerland Phone: Version No. 2.2 Date: April 02, 2016 Global Value Dossier: Cholecystectomy 2

3 Contents 1. Cholecystectomy Overview of procedure Clinical and economic outcomes with versus open Clinical and economic evidence tables References List of Tables Table 1-1 Table 1-2 Table 1-3 Summary of meta-analyses comparing versus open Summary of key clinical studies comparing versus open Summary of key studies comparing economic outcomes of versus open List of Figures Figure 1-1 Percentage of cholecystectomies carried out using laparoscopy in the USA stratified by patient age... 4 Figure 1-2 External view of port locatio for... 5 Figure 1-3 View of the cystic duct and cystic artery entering the gallbladder... 7 Figure 1-4 The dissected gallbladder is placed into an endoscopic retrieval pouch... 8 Figure 1-5 Access port locatio and diameters for alternative techniques... 8 Figure 1-6 LoS for open versus Figure 1-7 Operating time for open versus Figure 1-8 Total hospitalization cost for open versus in US-based studies Global Value Dossier: Cholecystectomy 3

4 Percentage of of cholecystectomies carried out using laparoscopy (%) 1. Cholecystectomy 1.1. Overview of procedure Cholecystectomy is the treatment of choice for patients with symptomatic cholelithiasis (gallstones), chronic cholecystitis (inflammation of the gall bladder), and gall bladder cancer. Whilst coervative management with observation is possible for some patients presenting with non-cancerous gall bladder conditio, this approach is associated with increased pain, increased incidence of gallstone-related complicatio, and almost of half of patients require surgery at a later date, which is associated with greater costs than surgery performed at the time of diagnosis. 1 Gall bladder disease affects 10 15% of adults in industrialized countries and approximately 500,000 cholecystectomies are conducted each year in the USA. 2 Laparoscopic was first performed in Germany in 1985 by Prof. Eric Mühe, with Phillipe Mouret and Francois Dubois, both based in France, performing operatio in 1987 and 1988, respectively. 3 Laparoscopic has rapidly become the gold standard, and now the majority of procedures worldwide and in the USA are carried out using this method (Figure 1-1). 4 For patients whose gallbladder conditio lead to hospitalization, evidence suggests that operation on the day of admission is associated with better outcomes and lower healthcare costs that on subsequent days. 5,6 Figure 1-1 Percentage of cholecystectomies carried out using laparoscopy in the USA stratified by patient age years years years >80 years Year Source: Dua et al Global Value Dossier: Cholecystectomy 4

5 The following paragraphs describe the typical steps generally performed in a, although variatio in surgeo preference and technique may account for differences from this method. An initial small incision is made at the inferior aspect of the umbilicus, and then deepened through the subcutaneous fat to the anterior rectus sheath. For access into the peritoneal cavity, one commonly employed method is the Hasson technique, which allows for entry under direct visualization. A Kocher clamp is used to grasp the reflection of the linea alba onto the umbilicus and elevate it cephalad. A longitudinal incision is then made in the linea alba, allowing for entry into the peritoneal cavity. After ipection, a blunt Hasson trocar is carefully placed into the abdominal cavity under visualization. Carbon dioxide is iufflated to a maximum pressure of 15 mmhg to achieve pneumoperitoneum. The laparoscope is then advanced into the abdominal cavity. Commonly, a 30 laparoscope is used, but a 0 laparoscope may be used, depending on the preference of the surgeon. An incision is made below the xiphoid process, deepened into the subcutaneous fat and a trocar is placed into the abdominal cavity in the direction of the gallbladder. Care is taken to enter to the right of the falciform ligament. The patient is then placed in the reverse Trendelenburg position with the right side up, allowing the small intestine and colon to fall away from the operative field. A grasper is placed through the port below the xiphoid process, and applied to the fundus of the gallbladder. The gallbladder is then elevated cephalad over the dome of the liver to allow the surgeon to make the decision of where to place two further small ports. Port site locatio are chosen, incisio made and trocars are advanced into the abdomen. A grasper is placed through each of the ports. A summary of the port locatio is shown in Figure 1 2. Figure 1-2 External view of port locatio for Global Value Dossier: Cholecystectomy 5

6 Source: The lateral grasper is applied to the fundus of the gallbladder and used to hold it cephalad over the dome of the liver. The medial grasper is used to retract the infundibulum caudolaterally, moving the cystic duct away from the common bile duct, reducing the risk of damage to the common bile duct. Any adhesio to the omentum or duodenum are lysed using electrocautery. Dissection is carried out around the gallbladder, with particular attention to the triangle Calot until the surgeon can identify the cystic duct and cystic artery entering the (termed the critical view, Global Value Dossier: Cholecystectomy 6

7 Figure 1-3). Clips are then placed on the artery and duct, with division carried out using endoscopic shears. A hook or spatula is used to dissect the gallbladder from the areolar tissue of the liver bed. Any aberrant vessels and ducts that may arise from the liver bed and enter directly into the gallbladder should be clipped and not simply cauterized. Global Value Dossier: Cholecystectomy 7

8 Figure 1-3 View of the cystic duct and cystic artery entering the gallbladder Source: Both graspers are applied to the gallbladder and used to hold it over the right upper quadrant. The laparoscope is traferred to the subxiphoid port, and an endoscopic retrieval pouch is ierted through the umbilical trocar. The gallbladder is placed into the bag, which is then closed (Figure 1-4). The table is returned to the neutral position, and the gallbladder bed irrigated and suction applied to remove debris. The retrieval pouch and itruments are removed, followed by the trocars. Port sites are then closed and sterile dressings applied. Global Value Dossier: Cholecystectomy 8

9 Figure 1-4 The dissected gallbladder is placed into an endoscopic retrieval pouch Source: The procedure can also be carried out using smaller ports, mini-, or using one larger port, single incision (Figure 1-5). A case-matched study has suggested that single incision and multi-incision are associated with similar blood loss, operating time and cost. 7 Single incision and mini have not gained widespread acceptance as these techniques are more challenging to learn and increase operating time. 8 Figure 1-5 Access port locatio and diameters for alternative techniques Source: Baron et al Global Value Dossier: Cholecystectomy 9

10 Guidelines on 2014 United Kingdom National Ititute for Health and Care Excellence (NICE) guidance on gallstone disease: diagnosis and initial management 9 Offer to people diagnosed with symptomatic gallbladder stones Offer day-case for people having it as an elective planned procedure, unless their circumstances or clinical condition make an inpatient stay necessary Offer early (to be carried out within 1 week of diagnosis) to people with acute cholecystitis Recoider for people who have had percutaneous once they are well enough for surgery Guidelines for the Clinical Application of Laparoscopic Biliary Tract Surgery released in 2010 by Society of American Gastrointestinal and Endoscopic Surgeo (SAGES) 10 Laparoscopic has become the standard of care for patients requiring the removal of the gallbladder Indicatio for operatio on the gallbladder and biliary tree include but are not limited to symptomatic cholelithiasis, biliary dyskinesia, acute cholecystitis, and complicatio related to common bile duct stones including pancreatitis with few relative or absolute contraindicatio Relative contra-indicatio for biliary tract surgery are untreated coagulopathy, lack of equipment, lack of surgeon expertise, hostile abdomen, advanced cirrhosis/liver failure, and suspected gallbladder cancer Laparoscopic may be performed safely in patients with cirrhosis and acute cholecystitis, but there are cases in which the open approach may be safer Global Value Dossier: Cholecystectomy 10

11 1.2. Clinical and economic outcomes with versus open Key findings Clinical outcomes Length of stay: Laparoscopic was coistently associated with reduced length of stay, with this difference achieving statistical significance in several studies including a meta-analysis of 10 randomized, controlled trials, and analyses in the US, Taiwan (three studies), Columbia, Spain, Italy, China, Norway, Finland (two studies) Korea, Sweden, and Egypt. 4,11,12,13,14,15,16,17,18,19,20,21,22,23,24, In two studies in India and the United States was associated with a non-statistically significant reduction in length of stay 25,26 Operating time: Results around operating time were incoistent (Figure 1-7), several studies reported no significant difference between open and, 16,17,18,21,22,24,25 four reported significantly longer operating time for 15,19,20,23 and one study reported a significantly shorter operating time with a approach 13 Mortality: Only two studies assessed mortality (one meta-analysis and one retrospective analysis in the USA) but both found that patients undergoing surgery were at lower risk of mortality 4,27 Complicatio: Statistically significant reductio in cardiac, respiratory, surgical, or post-operative complicatio were reported across a range of studies 4,13,15,16,18,20,27 and several studies reported no statistically significant differences in gall bladder perforation, bile duct injury, post-operative ileus, infectious, intra-operative, or minor complicatio 11,20 pain: One meta-analysis reported a reduced risk for post-operative pain with 11, and three individual studies, including one prospective study reported a significantly lower level of pain medication use with versus open 13,21,23 Blood loss: Only one study reported blood loss, with a statistically significant reduction with surgery reported 18 Return to normal activities: Studies assessing time to return to work, time to return to normal activity, sick leave, or convalescence time all found that a statistically significant reduction was associated with 11,15,19,20,23 Economic outcomes Total hospital costs: In the majority of cost studies, surgery was associated with statistically significant reductio in total hospital costs o o Asia: Two studies in Taiwan carried out between 1996 and 2007 identified that was associated cost savings that were increasing over time 12,13 United States: A large retrospective study in the US identified cost savings with surgery across all patient age groups (Figure 1-8), but a smaller study showed that whilst inpatient costs were lower with surgery, other costs (such as pharmacy costs, operating room costs) and total costs did not show a statistically significant difference Global Value Dossier: Cholecystectomy 11

12 between the two methods of 4,26 o South America: Reduced hospital costs were also identified in Columbia 15 o India: One study found that was associated with a statistically significant increase in total costs 25 Savings due to clinical benefits: The lower total hospital costs associated with were driven by significantly shorter length of stay 4,12,15,26 and significantly lower complication rates 4,15 Other findings Morbidity: A meta-analysis reported a statistically significant reduction in morbidity with surgery, but two studies found non-statistically significant reductio 22,27 Lung function: Measures of lung function in the post-operative period (from 6 hours to 6 days) showed statistically significant improvements with 17,21,28,29 Global Value Dossier: Cholecystectomy 12

13 Hsu 2010 Shi 2010 Fajardo 2011 Keus 2009 Lujan 1998 Volpino 1998 Srivastava 2001 Ji 2005 Trondsen 1993 Kiviluoto 1998 Agarwal 2015 Hendolin 2000 Boo 2007 Huang 1996 Berggren 1994 Hamad 2010 Anderson 1991 Length of stay, days Figure 1-6 Length of stay for open versus 23.6 Open Laparoscopic * 13.5 * 4.5 * * *** * ** *** ** ** ** 2.8 ** ** *** *p; **p; ***p<0.001;, not significant Global Value Dossier: Cholecystectomy 13

14 Fajardo 2011 Keus 2009 Lujan 1998 Volpino 1998 Srivastava 2001 Ji 2005 Trondsen 1993 Kiviluoto 1998 Agarwal 2015 Hendolin 2000 Boo 2007 Huang 1996 Berggren 1994 Hamad 2010 Operating time, minutes Figure 1-7 Operating time for open versus Open Laparoscopic * *** *** ** 100 ** *** ** *p; **p; ***p<0.001;, not significant Global Value Dossier: Cholecystectomy 14

15 Total cost, USD Figure 1-8 Total hospitalization cost for open versus in US-based studies 26,342 Open Laparoscopic 24,060 19,651 *** 15,030 15,723 *** 12,451 *** 10,425 *** 8,858 5,017 4,070 Dua years Dua years Dua years Dua years Anderson 1991 *p; **p; ***p<0.001;, not significant Clinical and economic evidence tables A summary of clinical evidence on compared with open surgery from published meta-analyses and published studies is shown in Table 1-1 and Table 1-2, respectively. A summary of economic evidence from published cost studies is shown in Table 1-3. In the following tables outcomes where p are underlined. Global Value Dossier: Cholecystectomy 15

16 Table 1-1 Summary of meta-analyses comparing versus open Authors Details Procedures Outcome OR (95% CI) P value Antoniou et al RCTs, 11 observational trials, n=101,559 Laparoscopic versus open in patients aged 65 years or older Castro et al RCTs, n=2,043 Laparoscopic versus minilaparotomy for treatment of cholelithiasis LoS, length of stay; RCT, randomized controlled trial Odds ratios less than 1 favor a Mean difference, negative values indicate a reduced value with b Risk difference, negative values indicate a reduced risk with Mortality Morbidity Cardiac complicatio Respiratory complicatio Operating time, minutes Surgical conversion Gall bladder perforation Bile duct injury Surgical site infection pain ileus Infectious complicatio LoS, days Surgical re-intervention Time to return to work, days 0.24 (0.17, 0.35) 0.44 (0.33, 0.59) 0.55 (0.38, 0.80) 0.55 (0.51, 0.60) (12.20, 18.81) a 0.03 ( 0.06, 0.00) b 0.00 ( 0.05, 0.05) b 0.00 ( 0.01, 0.01) b 0.01 ( 0.03, 0.01) b 0.18 ( 0.23, 0.13) b 0.01 ( 0.01, 0.06) b 0.03 ( 0.04, 0.01) b 0.82 ( 0.94, 0.71) a 0.01 ( 0.02, 0.01) b 0.49 (0.04, 0.93) a < < < < < < < Global Value Dossier: Cholecystectomy 16

17 Table 1-2 Summary of key clinical studies comparing versus open Study Setting Study details Procedure (year Summary of clinical findings performed) Endpoint Open Laparoscopic P value Dua et al. United States Hsu et al Shi et al Fajardo et al Taiwan Taiwan Columbia Retrospective crosssectional study of patients undergoing (N=358,091) Analysis of claims from the Bureau of National Health Iurance in Taiwan, n=80,335, n=32,535 open Analysis of claims from the Bureau of National Health Iurance in Taiwan, n=43,321, n=2,698 open Cost-effectiveness analysis based on a sample of 376 ( ) ( ) ( ) Surgical complicatio, % 80 years years year years Mean (SD) LoS, days 80 years years years years Mortality, % 80 years years years years Mean (SD) LoS, days Period 1 ( ) Period 2 ( ) Period 3 ( ) Mean (SD) LoS, days Period 1 ( ) Period 2 ( ) Period 3 ( ) Mean (SD) operating time, minutes Complicatio, % (10.1) 10.3 (0.3) 8.1 (9.6) 6.2 (7.9) (7.6) 13.1 (7.2) 12.4 (6.9) 14.8 (7.6) 13.7 (7.0) 13.1 (7.0) 68 (25) (6.5) 5.0 (5.7) 3.8 (4.8) 3.1 (3.4) (3.5) 4.6 (2.7) 4.5 (2.6) 6.6 (3.7) 5.3 (2.9) 4.9 (2.7) 90 (41) Global Value Dossier: Cholecystectomy 17

18 Table 1-2 Summary of key clinical studies comparing versus open Study Setting Study details Procedure (year Summary of clinical findings performed) Endpoint Open Laparoscopic P value patients (May 2005 to June 2006), n=220 Mean (SD) LoS, days 2.2 (2.2) 1.6 (1.5) 0.003, n=156 open Mean (SD) time to return to normal activity, 33 (16) days 10 (11) <0.001 Lujan et al Volpino et al Mimica et al Spain Italy Croatia Prospective, randomized analysis of patients aged > 65 years for symptomatic cholelithiasis, n=133, n=131 open Prospective, randomized analysis of patients undergoing elective, n=58, n=60 open Prospective, randomized controlled trial of patients undergoing, n=50, ( ) ( ) (year performed not presented) Mean (range) operating time, minutes Mean (range) LoS, days complicatio, % Mean (SD) operating time, minutes Mean (SD) blood ph Mean (SD) PaCO2, kpa Mean (SD) PaO2, kpa Mean (SD) LoS, days Mean (SD) FVC day 1, ml Mean (SD) FVC day 2, ml Mean (SD) FVC day 3, ml Mean (SD) FEV1 day 1, ml Mean (SD) FEV1 day 2, ml Mean (SD) FEV1 day 3, ml FEF75 85% day 1, ml (SD) FEF75 85% day 2, ml (SD) FEF75 85% day 3, ml (SD) Mean (SD) FVC 6 hours, L Mean (SD) FVC 24 hours, L Mean (SD) FVC 72 hours, L Mean (SD) FVC 144 hours, L Mean (SD) FEV1 6 hours, L 71 (49, 115) 9.9 (5, 33) (25) 7.44 (0.05) 4.1 (0.6) 18.1 (6.2) 7.8 (3.1) 1,435 (668) 1,503 (388) 2,139 (758) 1,251 (542) 1,202 (409) 1,726 (635) 553 (440) 403 (218) 587 (348) 1.9 (0.7) 2.5 (0.5) 2.8 (0.8) 2.9 (0.8) 1.6 (0.4) 75 (20, 180) 3.7 (1, 27) (22) 7.38 (0.05) 4.9 (0.8) 19.6 (4.9) 4.6 (2.9) 1,755 (719) 2,068 (997) 2,334 (878) 1,455 (652) 1,580 (773) 1,868 (758) 622 (412) 769 (535) 694 (376) 2.3 (0.7) 2.9 (0.7) 3.4 (0.8) 3.6 (0.9) 1.6 (0.5) > > >0.05 >0.05 >0.05 >0.05 > >0.05 Global Value Dossier: Cholecystectomy 18

19 Table 1-2 Summary of key clinical studies comparing versus open Study Setting Study details Procedure (year Summary of clinical findings performed) Endpoint Open Laparoscopic P value n=50 open Mean (SD) FEV1 24 hours, L Mean (SD) FVC 72 hours, L Mean (SD)FVC 144 hours, L Mean (SD) PaO2 6 hours, kpa Mean (SD) PaO2 24 hours, kpa 1.5 (0.6) 1.6 (0.8) 2.4 (0.7) 9.5 (2.7) 9.7 (1.6) 2.0 (0.8) 2.4 (1.0) 3.0 (0.8) 11.8 (0.3) 11.5 (1.5) Srivastava et al Ji et al Trondsen et al Kiviluoto et al Hendolin et al India China Norway Finland Finland Prospective randomized trial of patients with gallstones, n=59, n=40 minilaparotomy Retrospective analysis of patients with cirrhotic portal hyperteion, n=38, n=42 open Prospective, randomized study of patients when underwent elective, n=35, n=35 open Prospective, randomized study of patients for acute cholecystitis, n=32, n=31 open Prospective, randomized study of Minilaparotomy versus ( ) (year performed not presented) ( ) ( ) Mean (95% CI) operating time, minutes Mean (95% CI) LoS, days Mean (SD) operating time, minutes Mean (SD) blood loss, ml Mean (SD) LoS, days Mean (SD) time to resume diet, hours complicatio rate, % 57 (52, 63) 1.6 (1.2, 2.0) 61 (17.5) 113 (24) 7.5 (3.5) 44.2 (10.5) 30.0 Median (range) operating time, minutes 50 (15, 115) Median (range) LoS, days 4 (2, 22) Median (range) sick leave (employees), days 34 (20, 48) Median (range) convalescence (unemployed or retired) 49 (10, 247) Mean (SD) operating time, minutes Minor complicatio, % Major complicatio, % Median (IQR) LoS, days Mean (SD) sick leave, days 100 (40) (5, 8) 30.1 (5.3) 54 (49, 60) 1.2 (0.9, 1.6) 63 (15.2) 76 (18) 4.6 (2.4) 18.3 (6.5) (52, 180) 2 (1, 9) 11 (4, 267) 8 (3, 40) 108 (50) (2, 5) 13.9 (6.6) Median (range) operating time, minutes, 90 (60, 150) 90 (45, 160) NR Global Value Dossier: Cholecystectomy 19

20 Table 1-2 Summary of key clinical studies comparing versus open Study Setting Study details Procedure (year Summary of clinical findings performed) Endpoint Open Laparoscopic P value patients requiring for cholelithiasis, n=25,, n=22 open ( ) 175 (60, 450) 219 (80, 660) NR Boo et al Huang et al Berggren et al Korea Taiwan Sweden Prospective study in patients with acute cholecystitis, n=18, n=15 open Prospective, randomized study in patients aged over 70 years, n=15, n=12 open Prospective, randomized study of patients with stones in the gall bladder, n=15, n=12 open (2004) ( ) (1991) Median (range) time in recovery room, minutes Median (range) LoS, days Median (range) convalescence time, days Median (range) oxycodone received on ward, mg Mean (SD) FVC one day, L Mean (SD) FEV1 one day, L Mean (SD) PEF one day, L/min Mean (SD) PaO2 one day, kpa Mean (SD) PaCO2 one day, kpa Mean (SD) operating time, minutes Mean (SD) LoS, days Mean (SD) operating time, minutes Complicatio (n) Mean (SD) LoS, days Mean (SD) post-operative analgesic requirements, number of doses Mean (SD) operating time, minutes Mean (SD) anesthesia time, minutes Mean (SD) LoS, days Mean (SD) sick leave, days Median (IQR) opiate coumption 0 12 hours, mg Median (IQR) opiate coumption hours, mg 4 (2, 19) 29 (7, 34) 24 (0, 60) 1.7 (0.7) 1.5 (9.6) 196 (92) 9.1 (1.4) 5.2 (0.5) 90 (23) 6.3 (13) 176 (26) (0.8) 2.0 (0.7) 69 (11.2) 114 (19.4) 2.8 (0.8) 24.0 (4.4) 125 (50, 275) 200 (150, 250) 2 (1, 15) 14 (7, 17) 12 (0, 50) 2.6 (0.7) 2.3 (0.7) 314 (101) 10.3 (1.3) 5.0 (0.4) 73 (24) 3.7 (1.2) 93 (25) (1.7) 0.5 (0.5) 87 (24.3) 145 (23.5) 1.8 (0.6) 11.7 (4.1) 150 (113, 250) 125 (62, 175) <0.001 <0.001 NR Global Value Dossier: Cholecystectomy 20

21 Table 1-2 Summary of key clinical studies comparing versus open Study Setting Study details Procedure (year Summary of clinical findings performed) Endpoint Open Laparoscopic P value Hamad et al. Egypt Prospective, randomized study of patients with liver cirrhosis, n=15, n=15 open (year performed not presented) Mean (range) operating time, minutes Mean (SD) LoS, days Mean (SD) change in Child-Pugh score 49 (30, 70) 4.5 (1.2) (0.64) 57 (40, 115) 2.1 (2.3) (0.92) Anderson et al Frazee et al United States United States Comparison of hospital charges for patients for uncomplicated gallstones, n=13, n=11 open Prospective study evaluating postoperative pulmonary function in patients, n=20 n=16 open ( ) (1990) Mean (SE) operating room time, minutes Mean (SE) anesthesia time, minutes Mean (SE) LoS, days Fraction of baseline pulmonary function FVC (%) FEV1 (%) FEV25 75% (%) 602 (31) 217 (11.5) 4.1 (1.6) 735 (24) 244 (5.0) 1.0 (0.41) FEV1, forced expiratory volume in 1 second; FEV25 75%, forced expiratory volume at 25 75%; FEF75 85%, forced expiratory volume at 75 85%; FVC forced vital capacity; IQR, inter-quartile range; LoS, length of stay; Pa, partial pressure; PEF, peak expiratory flow rate; SD, standard deviation; SE, standard error; : not significant; NR: Not Reported Global Value Dossier: Cholecystectomy 21

22 Table 1-3 Summary of key studies comparing economic outcomes of versus open Study Setting Study details Procedures Currency Cost (Cost Outcome Open Laparoscopic P value year) Dua et al United States USD (2005) Hsu et al Shi et al Fajardo et al Srivastava et al Taiwan Taiwan Columbia India Retrospective cross-sectional study (N=358,091) Analysis of claims from the Bureau of National Health Iurance between , n=80,335, n=32,535 open Analysis of claims from the Bureau of National Health Iurance between , n=43,321, n=2,698 open Costeffectiveness analysis based on 376 patients (May 2005 to June 2006), n=220, n=156 open A prospective randomized trial of patients with Minilaparotomy versus TWD (2004) USD (2007) USD (cost year not given) INR (cost year not given) Mean (SD) total inpatient care cost 80 years years years years Mean (SD) total hospital charge Period 1 ( ) Period 2 ( ) Period 3 ( ) Mean (SD) total surgical cost Period 1 ( ) Period 2 ( ) Period 3 ( ) 26,342 (27,611) 24,060 (30,200) 19,651 (27,588) 15,723 (21,811) 2,506 (1,421) 2,568 (1,494) 2,729 (1,603) 2,733 1,468) 2,861 (1,540) 3,184 (1,721) 15,030 (15,100) 12,451 (13,723) 10,425 (11,369) 8,858 (8,051) 1,707 (433) 1,611 (366) 1,588 (411) 1,801 (479) 1,720 (456) 1,593 (488) Mean total cost 1, Not stated Mean total cost 5,126 6,555 Global Value Dossier: Cholecystectomy 22

23 Table 1-3 Summary of key studies comparing economic outcomes of versus open Study Setting Study details Procedures Currency Cost (Cost Outcome Open Laparoscopic P value year) gallstones, n=59, n=40 minilaparotomy Anderson et al US USD (1990) 1,335 (138) 1,048 (74) 353 (40) 1,388 (163) Comparison of hospital charges for uncomplicated gallstones, n=13, n=11 open Mean (SE) patient cost Mean (SE) operating costs Mean (SE) pharmacy costs Mean (SE) supplies cost Mean (SE) Laboratory costs Mean (SE) total costs 691 (87) 943 (100) 241 (57) 5,017 (497) EUR, Euros; INR, Indian rupees; SD, standard deviation; SE, standard error; TWD, new Taiwan dollars; USD, United States dollars 531 (55) 1,147 (123) 128 (25) 4,070 (297) Global Value Dossier: Cholecystectomy 23

24 1.3. References 1 Brazzelli M, Cruickshank M, Kilonzo M, Ahmed I, Stewart F, McNamee P, Elders A, Fraser C, Avenell A, Ramsay C. Systematic review of the clinical and cost effectiveness of versus observation/coervative management for uncomplicated symptomatic gallstones or cholecystitis. Surg Endosc Mar;29(3): (PMID: ) 2 Schirmer BD, Winters KL, Edlich RF. Cholelithiasis and cholecystitis. J Long Term Eff Med Implants. 2005;15(3): (PMID: ) 3 Reynolds W. The first. JSLS Jan-Mar;5(1): (PMID: ) 4 Dua A, Aziz A, Desai SS, McMaster J, Kuy S. National Trends in the Adoption of Laparoscopic Cholecystectomy over 7 Years in the United States and Impact of Laparoscopic Approaches Stratified by Age. Minim Invasive Surg. 2014;2014: (PMID: ) 5 Zafar SN, Obirieze A, Adesibikan B, Cornwell EE, Fullum TM, Tran DD. Optimal time for early for acute cholecystitis. JAMA Surg Feb;150(2): (PMID: ) 6 Schwartz DA, Shah AA, Zogg CK, Nicholas LH, Velopulos CG, Efron DT, Schneider EB, Haider AH. Operative delay to : Racking up the cost of health care. J Trauma Acute Care Surg Jul;79(1): (PMID: ) 7 Beck C, Eakin J, Dettorre R, Renton D. Analysis of perioperative factors and cost comparison of single-incision and traditional multi-incision. Surg Endosc Jan;27(1): (PMID: ) 8 Baron TH, Grimm IS, Swatrom LL. Interventional Approaches to Gallbladder Disease. N Engl J Med Jul 23;373(4): (PMID: ) 9 National Ititute for Health and Care Excellence. Gallstone disease: diagnosis and initial management NICE guidelines [CG188]. Available at [Last accessed 17 November, 2015] 10 Society of American Gastrointestinal and Endoscopic Surgeo (SAGES). SAGES guidelines for the clinical application of biliary tract surgery. Los Angeles (CA): Society of American Gastrointestinal and Endoscopic Surgeo (SAGES); Available at [Last accessed 17 November, 2015] 11 Castro PM, Akerman D, Munhoz CB, Sacramento ID, Mazzurana M, Alvarez GA. Laparoscopic versus minilaparotomy in cholelithiasis: systematic review and meta-analysis. Arq Bras Cir Dig Apr-Jun;27(2): (PMID: ) 12 Hsu CE, Lee KT, Chang CS, Chiu HC, Chao FT, Shi HY. Cholecystectomy prevalence and treatment cost: an 8-year study in Taiwan. Surg Endosc Dec;24(12): (PMID: ) 13 Huang SM1, Wu CW, Lui WY, P'eng FK. A prospective randomised study of v. open in aged patients with cholecystolithiasis. S Afr J Surg Nov;34(4): (PMID: ) Global Value Dossier: Cholecystectomy 24

25 14 Shi HY, Lee KT, Uen YH, Chiu CC, Lee HH. Changing approaches to in elderly patients: a 10-year retrospective study in Taiwan. World J Surg Dec;34(12): (PMID: ) 15 Fajardo R, Valenzuela JI, Olaya SC, Quintero G, Carrasquilla G, Pinzón CE, López C, Ramírez JC. Cost-effectiveness of versus open Biomedica Oct-Dec;31(4): (PMID: ) 16 Lujan JA, Sanchez-Bueno F, Parrilla P, Robles R, Torralba JA, Gonzalez-Costea R. Laparoscopic vs. open in patients aged 65 and older. Surg Laparosc Endosc Jun;8(3): (PMID: ) 17 Volpino P, Cangemi V, D'Andrea N, Cangemi B, Piat G. Hemodynamic and pulmonary changes during and after. A comparison with traditional surgery. Surg Endosc Feb;12(2): (PMID: ) 18 Ji W, Li LT, Wang ZM, Quan ZF, Chen XR, Li JS. A randomized controlled trial of versus open in patients with cirrhotic portal hyperteion. World J Gastroenterol Apr 28;11(16): (PMID: ) 19 Trondsen E, Reiertsen O, Andersen OK, Kjaersgaard P. Laparoscopic and open. A prospective, randomized study. Eur J Surg Apr;159(4): (PMID: ) 20 Kiviluoto T, Sirén J, Luukkonen P, Kivilaakso E. Randomised trial of versus open for acute and gangrenous cholecystitis. Lancet Jan 31;351(9099): (PMID: ) 21 Hendolin HI, Pääkönen ME, Alhava EM, Tarvainen R, Kemppinen T, Lahtinen P. Laparoscopic or open : a prospective randomised trial to compare postoperative pain, pulmonary function, and stress respoe. Eur J Surg May;166(5): (PMID: ) 22 Boo YJ, Kim WB, Kim J, Song TJ, Choi SY, Kim YC, Suh SO. Systemic immune respoe after open versus in acute cholecystitis: a prospective randomized study. Scand J Clin Lab Invest. 2007;67(2): (PMID: ) 23 Berggren U, Gordh T, Grama D, Haglund U, Rastad J, Arvidsson D. Laparoscopic versus open : hospitalization, sick leave, analgesia and trauma respoes. Br J Surg Sep;81(9): (PMID: ) 24 Hamad MA, Thabet M, Badawy A, Mourad F, Abdel-Salam M, Abdel-Rahman Mel-T, Hafez MZ, Sherif T. Laparoscopic versus open in patients with liver cirrhosis: a prospective, randomized study. J Laparoendosc Adv Surg Tech A Jun;20(5): (PMID: ) 25 Srivastava A, Srinivas G, Misra MC, Pandav CS, Seenu V, Goyal A. Cost-effectiveness analysis of versus minilaparotomy for gallstone disease. A randomized trial. Int J Technol Assess Health Care Fall;17(4): (PMID: ) 26 Anderson RE, Hunter JG. Laparoscopic is less expeive than open. Surg Laparosc Endosc Jun;1(2):82-4. (PMID: ) 27 Antoniou SA, Antoniou GA, Koch OO, Pointner R, Granderath FA. Meta-analysis of vs open in elderly patients. World J Gastroenterol Dec 14;20(46): (PMID: ) Global Value Dossier: Cholecystectomy 25

26 28 Mimica Z, Biocić M, Bacić A, Banović I, Tocilj J, Radonić V, Ilić N, Petricević A. Laparoscopic and laparotomic : a randomized trial comparing postoperative respiratory function. Respiration. 2000;67(2): (PMID: ) 29 Frazee RC1, Roberts JW, Okeson GC, Symmonds RE, Snyder SK, Hendricks JC, Smith RW.. A comparison of postoperative pulmonary function. Ann Surg Jun;213(6): (PMID: ) 2016 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 04/2016 US Global Value Dossier: Cholecystectomy 26