GLOBAL VALUE DOSSIER FOR MINIMALLY ... - medtronic.com · Global Value Dossier: Cholecystectomy 5 The following paragraphs describe the typical steps generally performed in a laparoscopic

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Global Value Dossier: Cholecystectomy 1

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GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY (MIS)

CHOLECYSTECTOMY


Prepared by: Jayne Smith-Palmer and Barney Hunt

Ossian Health Economics and Communications, Bäumleingasse 20, 4051 Basel, Switzerland

Phone: +41 61 271 6214

E-mail: [email protected]

Version No. 2.2

Date: April 02, 2016


Contents

1. Cholecystectomy ............................................................................................................... 4

1.1. Overview of procedure .............................................................................................. 4

1.2. Clinical and economic outcomes with laparoscopic versus open cholecystectomy . .................................................................................................................................. 10

1.1.1. Clinical and economic evidence tables ............................................................ 14

1.3. References ............................................................................................................... 23

List of Tables

Table 1-1 Summary of meta-analyses comparing laparoscopic versus open cholecystectomy ................................................................................................. 15

Table 1-2 Summary of key clinical studies comparing laparoscopic versus open cholecystectomy ................................................................................................. 16

Table 1-3 Summary of key studies comparing economic outcomes of laparoscopic versus open cholecystectomy ........................................................................................ 21

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 locations for laparoscopic cholecystectomy .................. 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 locations and diameters for alternative laparoscopic cholecystectomy techniques ............................................................................ 8

Figure 1-6 LoS for open versus laparoscopic cholecystectomy ...................................... 12

Figure 1-7 Operating time for open versus laparoscopic cholecystectomy ................... 13

Figure 1-8 Total hospitalization cost for open versus laparoscopic cholecystectomy in US-based studies ............................................................................................. 14


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 conservative management with observation is possible for some patients presenting with non-cancerous gall bladder conditions, this approach is associated with increased pain, increased incidence of gallstone-related complications, 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 cholecystectomy was first performed in Germany in 1985 by Prof. Eric Mühe, with Phillipe Mouret and Francois Dubois, both based in France, performing operations in 1987 and 1988, respectively.3 Laparoscopic cholecystectomy 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 conditions 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

83.584.4 83.8

84.7 8586.3

88.7 89.2

73.274.2 74.7 74.4 75.0 75.6

78.6 78.9

65.366.9

68.3 67.969.5

69.8

72.373.3

59.7

62.364.2 64.2

67.1 67.7

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1999 2000 2001 2002 2003 2004 2005 2006

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18-49 years 50-64 years 65-79 years >80 years

Source: Dua et al. 20144


The following paragraphs describe the typical steps generally performed in a laparoscopic cholecystectomy, although variations in surgeons’ 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 inspection, a blunt Hasson trocar is carefully placed into the abdominal cavity under visualization. Carbon dioxide is insufflated 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 locations are chosen, incisions made and trocars are advanced into the abdomen. A grasper is placed through each of the ports. A summary of the port locations is shown in Figure 1 2.

Figure 1-2 External view of port locations for laparoscopic cholecystectomy


Source: http://emedicine.medscape.com/article/1582292-technique#c2

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 adhesions 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,


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.


Figure 1-3 View of the cystic duct and cystic artery entering the gallbladder


Both graspers are applied to the gallbladder and used to hold it over the right upper quadrant. The laparoscope is transferred to the subxiphoid port, and an endoscopic retrieval pouch is inserted 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 instruments are removed, followed by the trocars. Port sites are then closed and sterile dressings applied.


Figure 1-4 The dissected gallbladder is placed into an endoscopic retrieval pouch


The procedure can also be carried out using smaller ports, mini-laparoscopic cholecystectomy, or using one larger port, single incision laparoscopic cholecystectomy (Figure 1-5). A case-matched study has suggested that single incision laparoscopic cholecystectomy and multi-incision laparoscopic cholecystectomy are associated with similar blood loss, operating time and cost.7 Single incision laparoscopic and mini-laparoscopic cholecystectomy have not gained widespread acceptance as these techniques are more challenging to learn and increase operating time.8

Figure 1-5 Access port locations and diameters for alternative laparoscopic cholecystectomy techniques

Source: Baron et al. 20158


Guidelines on laparoscopic cholecystectomy

2014 United Kingdom National Institute for Health and Care Excellence (NICE) guidance on gallstone disease: diagnosis and initial management9

Offer laparoscopic cholecystectomy to people diagnosed with symptomatic gallbladder stones

Offer day-case laparoscopic cholecystectomy for people having it as an elective planned procedure, unless their circumstances or clinical condition make an inpatient stay necessary

Offer early laparoscopic cholecystectomy (to be carried out within 1 week of diagnosis) to people with acute cholecystitis

Reconsider laparoscopic cholecystectomy for people who have had percutaneous cholecystectomy 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 Surgeons (SAGES)10

Laparoscopic cholecystectomy has become the standard of care for patients requiring the removal of the gallbladder

Indications for laparoscopic operations on the gallbladder and biliary tree include but are not limited to symptomatic cholelithiasis, biliary dyskinesia, acute cholecystitis, and complications related to common bile duct stones including pancreatitis with few relative or absolute contraindications

Relative contra-indications for laparoscopic biliary tract surgery are untreated coagulopathy, lack of equipment, lack of surgeon expertise, hostile abdomen, advanced cirrhosis/liver failure, and suspected gallbladder cancer

Laparoscopic cholecystectomy may be performed safely in patients with cirrhosis and acute cholecystitis, but there are cases in which the open approach may be safer


1.2. Clinical and economic outcomes with laparoscopic versus open cholecystectomy

Key findings

Clinical outcomes

Length of stay: Laparoscopic cholecystectomy was consistently 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 laparoscopic cholecystectomy was associated with a non-statistically significant reduction in length of stay25,26

Operating time: Results around operating time were inconsistent (Figure 1-7), several studies reported no significant difference between open and laparoscopic cholecystectomy,16,17,18,21,22,24,25 four reported significantly longer operating time for laparoscopic cholecystectomy15,19,20,23 and one study reported a significantly shorter operating time with a laparoscopic approach13

Mortality: Only two studies assessed mortality (one meta-analysis and one retrospective analysis in the USA) but both found that patients undergoing laparoscopic surgery were at lower risk of mortality4,27

Complications: Statistically significant reductions in cardiac, respiratory, surgical, or post-operative complications were reported across a range of studies4,13,15,16,18,20,27 and several studies reported no statistically significant differences in gall bladder perforation, bile duct injury, post-operative ileus, infectious, intra-operative, or minor complications11,20

Post-operative pain: One meta-analysis reported a reduced risk for post-operative pain with laparoscopic cholecystectomy11, and three individual studies, including one prospective study reported a significantly lower level of pain medication use with laparoscopic versus open cholecystectomy13,21,23

Blood loss: Only one study reported blood loss, with a statistically significant reduction with laparoscopic surgery reported18

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 laparoscopic cholecystectomy11,15,19,20,23

Economic outcomes

Total hospital costs: In the majority of cost studies, laparoscopic surgery was associated with statistically significant reductions in total hospital costs

o Asia: Two studies in Taiwan carried out between 1996 and 2007 identified that laparoscopic cholecystectomy was associated cost savings that were increasing over time12,13

o United States: A large retrospective study in the US identified cost savings with laparoscopic surgery across all patient age groups (Figure 1-8), but a smaller study showed that whilst inpatient costs were lower with laparoscopic surgery, other costs (such as pharmacy costs, operating room costs) and total costs did not show a statistically significant difference


between the two methods of cholecystectomy4,26

o South America: Reduced hospital costs were also identified in Columbia15

o India: One study found that laparoscopic cholecystectomy was associated with a statistically significant increase in total costs25

Savings due to clinical benefits: The lower total hospital costs associated with laparoscopic cholecystectomy were driven by significantly shorter length of stay4,12,15,26 and significantly lower complication rates4,15

Other findings

Morbidity: A meta-analysis reported a statistically significant reduction in morbidity with laparoscopic surgery, but two studies found non-statistically significant reductions22,27

Lung function: Measures of lung function in the post-operative period (from 6 hours to 6 days) showed statistically significant improvements with laparoscopic cholecystectomy17,21,28,29


Figure 1-6 Length of stay for open versus laparoscopic cholecystectomy

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Figure 1-7 Operating time for open versus laparoscopic cholecystectomy

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Figure 1-8 Total hospitalization cost for open versus laparoscopic cholecystectomy in US-based studies

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1.1.1. Clinical and economic evidence tables

A summary of clinical evidence on laparoscopic cholecystectomy 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<0.05 are underlined.

Global Value Dossier: Cholecystectomy

16

Table 1-1 Summary of meta-analyses comparing laparoscopic versus open cholecystectomy

Authors Details Procedures Outcome OR (95% CI) P value

Antoniou et al. 201427 2 RCTs, 11 observational trials, n=101,559

Laparoscopic versus open cholecystectomy in patients aged 65 years or older

Post-operative Mortality Morbidity Cardiac complications Respiratory complications

0.24 (0.17, 0.35) 0.44 (0.33, 0.59) 0.55 (0.38, 0.80) 0.55 (0.51, 0.60)

<0.00001 <0.00001 <0.00001 <0.00001

Castro et al. 201411 10 RCTs, n=2,043 Laparoscopic versus minilaparotomy for treatment of cholelithiasis

Peri-operative Operating time, minutes Surgical conversion Gall bladder perforation Bile duct injury Post-operative Surgical site infection Post-operative pain Post-operative ileus Infectious complications LoS, days Surgical re-intervention Time to return to work, days

15.51 (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

<0.00001 0.06 0.98 1.00 0.52 <0.00001 0.22 0.002 <0.00001 0.27 0.03

LoS, length of stay; RCT, randomized controlled trial Odds ratios less than 1 favor laparoscopic cholecystectomy aMean difference, negative values indicate a reduced value with laparoscopic cholecystectomy bRisk difference, negative values indicate a reduced risk with laparoscopic cholecystectomy


17

Table 1-2 Summary of key clinical studies comparing laparoscopic versus open cholecystectomy Study Setting Study details Procedure (year

performed) Summary of clinical findings Endpoint Open Laparoscopic P value

Dua et al. 20144

United States Retrospective cross-sectional study of patients undergoing cholecystectomy (N=358,091)

Open versus laparoscopic cholecystectomy (1999–2006)

Peri-operative Surgical complications, % ≥80 years 65–79 years 45–64 year 18–44 years Post-operative Mean (SD) LoS, days ≥80 years 65–79 years 45–64 years 18–44 years Mortality, % ≥80 years 65–79 years 45–64 years 18–44 years

61.1 50.0 37.2 25.3 11.9 (10.1) 10.3 (0.3) 8.1 (9.6) 6.2 (7.9) 8.3 4.0 1.6 0.5

37.2 26.3 16.4 10.3 6.8 (6.5) 5.0 (5.7) 3.8 (4.8) 3.1 (3.4) 2.3 0.9 0.30 0.10

<0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001 <0.0001

Hsu et al. 201012

Taiwan Analysis of claims from the Bureau of National Health Insurance in Taiwan, n=80,335 laparoscopic, n=32,535 open


Post-operative Mean (SD) LoS, days Period 1 (1996–1998) Period 2 (1999–2001) Period 3 (2002–2004)

13.8 (7.6) 13.1 (7.2) 12.4 (6.9)

5.9 (3.5) 4.6 (2.7) 4.5 (2.6)

<0.05 <0.05 <0.05

Shi et al. 201013

Taiwan Analysis of claims from the Bureau of National Health Insurance in Taiwan, n=43,321 laparoscopic, n=2,698 open


Post-operative Mean (SD) LoS, days Period 1 (1996–1999) Period 2 (2000–2003) Period 3 (2004–2007)

14.8 (7.6) 13.7 (7.0) 13.1 (7.0)

6.6 (3.7) 5.3 (2.9) 4.9 (2.7)

<0.05 <0.05 <0.05

Fajardo et al. 201115

Columbia Cost-effectiveness analysis based on a sample of 376

Open versus laparoscopic cholecystectomy

Peri-operative Mean (SD) operating time, minutes Complications, %

68 (25) 13.5

90 (41) 6.4

0.001 0.020


18



patients (May 2005 to June 2006), n=220 laparoscopic, n=156 open

Post-operative Mean (SD) LoS, days Mean (SD) time to return to normal activity, days

2.2 (2.2) 33 (16)

1.6 (1.5) 10 (11)

0.003 <0.001

Lujan et al. 199816

Spain Prospective, randomized analysis of patients aged > 65 years for symptomatic cholelithiasis, n=133 laparoscopic, n=131 open


Peri-operative Mean (range) operating time, minutes Post-operative Mean (range) LoS, days Post-operative complications, %

71 (49, 115) 9.9 (5, 33) 23.6

75 (20, 180) 3.7 (1, 27) 13.5

ns <0.05 <0.05

Volpino et al. 199817

Italy Prospective, randomized analysis of patients undergoing elective cholecystectomy, n=58 laparoscopic, n=60 open


Peri-operative Mean (SD) operating time, minutes Mean (SD) blood pH Mean (SD) PaCO2, kPa Mean (SD) PaO2, kPa Post-operative 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)

81 (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)

87 (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)

>0.05 0.006 0.0012 0.05 0.0005 >0.05 0.02 >0.05 >0.05 >0.05 >0.05 >0.05 0.01 >0.05

Mimica et al. 200028

Croatia Prospective, randomized controlled trial of patients undergoing cholecystectomy, n=50 laparoscopic,

Open versus laparoscopic cholecystectomy (year performed not presented)

Post-operative 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

1.9 (0.7) 2.5 (0.5) 2.8 (0.8) 2.9 (0.8) 1.6 (0.4)

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 ns


19



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)

<0.05 <0.05 <0.05 <0.05 <0.05

Srivastava et al. 200125

India Prospective randomized trial of patients with gallstones, n=59 laparoscopic, n=40 minilaparotomy

Minilaparotomy versus laparoscopic cholecystectomy (1995–1997)

Peri-operative Mean (95% CI) operating time, minutes Post-operative Mean (95% CI) LoS, days

57 (52, 63) 1.6 (1.2, 2.0)

54 (49, 60) 1.2 (0.9, 1.6)

0.233 0.06

Ji et al. 200518

China Retrospective analysis of patients with cirrhotic portal hypertension, n=38 laparoscopic, n=42 open


Peri-operative Mean (SD) operating time, minutes Mean (SD) blood loss, mL Post-operative Mean (SD) LoS, days Mean (SD) time to resume diet, hours Post-operative complications rate, %

61 (17.5) 113 (24) 7.5 (3.5) 44.2 (10.5) 30.0

63 (15.2) 76 (18) 4.6 (2.4) 18.3 (6.5) 13.2

ns <0.01 <0.05 <0.01 <0.01

Trondsen et al. 199319

Norway Prospective, randomized study of patients when underwent elective cholecystectomy, n=35 laparoscopic, n=35 open


Peri-operative Median (range) operating time, minutes Post-operative Median (range) LoS, days Median (range) sick leave (employees), days Median (range) convalescence (unemployed or retired)

50 (15, 115) 4 (2, 22) 34 (20, 48) 49 (10, 247)

100 (52, 180) 2 (1, 9) 11 (4, 267) 8 (3, 40)

<0.01 <0.01 <0.01 <0.01

Kiviluoto et al. 199820

Finland Prospective, randomized study of patients for acute cholecystitis, n=32 laparoscopic, n=31 open


Peri-operative Mean (SD) operating time, minutes Minor complications, % Major complications, % Post-operative Median (IQR) LoS, days Mean (SD) sick leave, days

100 (40) 19 23 6 (5, 8) 30.1 (5.3)

108 (50) 3 0 4 (2, 5) 13.9 (6.6)

0.490 0.0530 0.0048 0.0063 <0.0001

Hendolin et al. 200021

Finland Prospective, randomized study of

Open versus laparoscopic

Peri-operative Median (range) operating time, minutes,

90 (60, 150)

90 (45, 160)

NR


20



patients requiring cholecystectomy for cholelithiasis, n=25 laparoscopic,, n=22 open

cholecystectomy (1993–1996)

Post-operative 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

175 (60, 450) 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)

219 (80, 660) 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)

NR <0.01 <0.01 <0.05 <0.01 <0.001 <0.001 <0.01 NR

Boo et al 200722

Korea Prospective study in patients with acute cholecystitis, n=18 laparoscopic, n=15 open

Open versus laparoscopic cholecystectomy (2004)

Peri-operative Mean (SD) operating time, minutes Post-operative Mean (SD) LoS, days

90 (23) 6.3 (13)

73 (24) 3.7 (1.2)

0.271 0.010

Huang et al. 199613

Taiwan Prospective, randomized study in patients aged over 70 years, n=15 laparoscopic, n=12 open


Peri-operative Mean (SD) operating time, minutes Complications (n) Post-operative Mean (SD) LoS, days Mean (SD) post-operative analgesic requirements, number of doses

176 (26) 3 7.9 (0.8) 2.0 (0.7)

93 (25) 0 3.9 (1.7) 0.5 (0.5)

0.00001 0.0075 0.00001 0.00001

Berggren et al. 199423

Sweden Prospective, randomized study of patients with stones in the gall bladder, n=15 laparoscopic, n=12 open


Peri-operative Mean (SD) operating time, minutes Mean (SD) anesthesia time, minutes Post-operative Mean (SD) LoS, days Mean (SD) sick leave, days Median (IQR) opiate consumption 0–12 hours, mg Median (IQR) opiate consumption 13–24 hours, mg

69 (11.2) 114 (19.4) 2.8 (0.8) 24.0 (4.4) 125 (50, 275) 200 (150, 250)

87 (24.3) 145 (23.5) 1.8 (0.6) 11.7 (4.1) 150 (113, 250) 125 (62, 175)

<0.01 <0.01 <0.01 <0.01 0.93 0.04


21



Hamad et al. 201024

Egypt Prospective, randomized study of patients with liver cirrhosis, n=15 laparoscopic, n=15 open


Peri-operative Mean (range) operating time, minutes Post-operative Mean (SD) LoS, days Mean (SD) change in Child-Pugh score

49 (30, 70) 4.5 (1.2) +0.14 (0.64)

57 (40, 115) 2.1 (2.3) +0.53 (0.92)

0.15 0.0013 ns

Anderson et al. 199126

United States Comparison of hospital charges for patients for uncomplicated gallstones, n=13 laparoscopic, n=11 open


Peri-operative Mean (SE) operating room time, minutes Mean (SE) anesthesia time, minutes Post-operative Mean (SE) LoS, days

602 (31) 217 (11.5) 4.1 (1.6)

735 (24) 244 (5.0) 1.0 (0.41)

0.003 0.03 0.001

Frazee et al. 199129

United States Prospective study evaluating postoperative pulmonary function in patients, n=20 laparoscopic n=16 open


Post-operative Fraction of baseline pulmonary function FVC (%) FEV1 (%) FEV25–75% (%)

54 52 53

73 72 81

0.002 0.006 0.07

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; ns: not significant; NR: Not Reported


22

Table 1-3 Summary of key studies comparing economic outcomes of laparoscopic versus open cholecystectomy Study Setting Study details Procedures Currency

(Cost year)

Cost Outcome Open Laparoscopic P value

Dua et al. 20144

United States

Retrospective cross-sectional study (N=358,091)


USD (2005)

Mean (SD) total inpatient care cost ≥80 years 65–79 years 45–64 years 18–44 years

26,342 (27,611) 24,060 (30,200) 19,651 (27,588) 15,723 (21,811)

15,030 (15,100) 12,451 (13,723) 10,425 (11,369) 8,858 (8,051)

<0.0001 <0.0001 <0.0001 <0.0001

Hsu et al. 201012

Taiwan Analysis of claims from the Bureau of National Health Insurance between 1996–2004, n=80,335 laparoscopic, n=32,535 open


TWD (2004)

Mean (SD) total hospital charge Period 1 (1996–1998) Period 2 (1999–2001) Period 3 (2002–2004)

2,506 (1,421) 2,568 (1,494) 2,729 (1,603)

1,707 (433) 1,611 (366) 1,588 (411)

<0.05 <0.05 <0.05

Shi et al. 201013

Taiwan Analysis of claims from the Bureau of National Health Insurance between 1996–2007, n=43,321 laparoscopic, n=2,698 open


USD (2007)

Mean (SD) total surgical cost Period 1 (1996–1999) Period 2 (2000–2003) Period 3 (2004–2007)

2,733 1,468) 2,861 (1,540) 3,184 (1,721)

1,801 (479) 1,720 (456) 1,593 (488)

<0.05 <0.05 <0.05

Fajardo et al. 201115

Columbia Cost-effectiveness analysis based on 376 patients (May 2005 to June 2006), n=220 laparoscopic, n=156 open


USD (cost year not given)

Mean total cost 1,048 995 Not stated

Srivastava et al. 200125

India A prospective randomized trial of patients with

Minilaparotomy versus laparoscopic

INR (cost year not given)

Mean total cost 5,126 6,555 <0.05


23

Table 1-3 Summary of key studies comparing economic outcomes of laparoscopic versus open cholecystectomy Study Setting Study details Procedures Currency

(Cost year)

Cost Outcome Open Laparoscopic P value

gallstones, n=59 laparoscopic, n=40 minilaparotomy

cholecystectomy

Anderson et al. 199126

US Comparison of hospital charges for uncomplicated gallstones, n=13 laparoscopic, n=11 open


USD (1990)

Mean (SE) patient cost Mean (SE) operating costs Mean (SE) pharmacy costs Mean (SE) supplies cost Mean (SE) Laboratory costs Mean (SE) total costs

1,335 (138) 1,048 (74) 691 (87) 943 (100) 241 (57) 5,017 (497)

353 (40) 1,388 (163) 531 (55) 1,147 (123) 128 (25) 4,070 (297)

0.001 0.087 0.122 0.223 0.067 0.10

EUR, Euros; INR, Indian rupees; SD, standard deviation; SE, standard error; TWD, new Taiwan dollars; USD, United States dollars


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