GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE …Appendectomy is the second most common general...

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Global GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY (MIS) APPENDECTOMY

Transcript of GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE …Appendectomy is the second most common general...

Global

GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY (MIS)

APPENDECTOMY

Global Value Dossier: Appendectomy 2

Prepared by: Jayne Smith-Palmer

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

Phone: +41 61 271 6214

E-mail: [email protected]

Version No. 2

Date: March 18, 2016

Global Value Dossier: Appendectomy 3

Contents

1. Appendectomy ................................................................................................................... 4

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

1.2. Clinical and economic outcomes with laparoscopic versus open appendectomy... 7

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

1.3. References ............................................................................................................... 26

List of Tables

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

Table 1-2 Summary of key clinical studies comparing laparoscopic versus open appendectomy ..................................................................................................... 17

Table 1-3 Summary of key studies comparing economic outcomes of laparoscopic versus open appendectomy ............................................................................................ 24

List of Figures

Figure 1-1 Proportion of appendectomies performed laparoscopically in the US 2004–2011 .................................................................................................................... 4

Figure 1-2 Laparoscopic appendectomy ............................................................................ 5

Figure 1-3 LoS in open versus laparoscopic appendectomy .............................................. 9

Figure 1-4 Operating time for open versus laparoscopic appendectomy ....................... 10

Figure 1-5 Rates of SSI for open versus laparoscopic appendectomy ............................. 11

Figure 1-6 Return to normal activity for open versus laparoscopic appendectomy ....... 12

Figure 1-7 Total hospitalization cost for open versus laparoscopic appendectomy in US-based studies .................................................................................................... 13

Figure 1-8 Total hospital costs for laparoscopic versus open appendectomy in studies in China ................................................................................................................. 14

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1. Appendectomy

1.1. Overview of procedure

Laparoscopic appendectomy was first performed in Germany by Semm in 1983,1 and it is now one of the most commonly performed laparoscopic surgical procedures and the most common abdominal emergency surgery.

Appendectomy is the second most common general surgical procedure performed in the US2, with approximately 300,000 appendectomies performed each year.3 The use of laparoscopic appendectomy has steadily increased since its introduction, such that in 2011 75% of appendectomies performed in the US were performed laparoscopically (Figure 1-1), representing a 73% increase in use since 2004. The same study showed that the proportion of appendectomies performed has steadily increased across all age groups as well as for both non-perforated and perforated appendicitis.4 However, the authors also noted that age influenced the use of laparoscopy. In 2011, 77% of appendectomies in adults were laparoscopic, but in the elderly this figure was lower at 65%, which was attributed to surgeon concern regarding the use of CO2 pneumoperitoneum in the elderly.

Figure 1-1 Proportion of appendectomies performed laparoscopically in the US 2004–2011

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The following paragraphs describe the typical steps generally performed in a laparoscopic appendectomy, although variations in surgeons’ preference and technique may account for

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differences from this method. In the procedure the patient is placed in a supine position with Trendelenburg with the surgeon positioned on the patients left side (this positioning provides gravity-assisted movement of the small bowel away from the appendiceal/cecal field of vision); a Foley catheter is also useful as this decompresses the bladder, which also improves the viewing field as well as maximizing working space.

The procedure begins with a 2 cm supraumbilical incision above the umbilicus. Subcutaneous tissue is then dissected (typically using electrocautery) through to the linea alba and continuing so as to allow visualization of the whole abdominal cavity; the abdomen is then inflated using carbon dioxide (with an upper limit of intra-abdominal pressure of ~12 mmHg). Two further incisions are then made and 5 mm trocars placed. The first trocar is placed left of the midline approximately 1 cm above the pubic ramus. The second is placed approximately 2 cm above and medial to the left anterior superior iliac spine.

Two atraumatic graspers are then inserted through the two 5 mm trocars, the right colon identified and the taeniae coli followed down to the base of the cecum and appendix. The tip of the appendix is then grasped, after which the mesoappendix, which contains the appendiceal artery, is divided and transected (e.g. using a harmonic scalpel). A stapler is then placed through the umbilical port and placed at the base of the appendix/cecum, the stapler is then closer, and the transection line and appendiceal stump staple line inspected for any bleeding (which can be dealt with either endoscopic clips or sutures). A specimen retrieval bag is then inserted through the umbilical port, the appendix placed inside and the bag sealed ready for removal following irrigation and suction of the area. All instruments are then removed and the ports sutured.

Hemodynamic instability is an absolute contraindication for laparoscopic appendectomy; relative contraindications include severe abdominal distention, generalized peritonitis, severe pulmonary disease and extreme obesity.

Figure 1-2 Laparoscopic appendectomy

Excision of appendix during laparoscopic appendectomy and removal through the port using the ligating loop around the base of the appendix. Source: http://www.laparoscopyhospital.com/lap_app.htm

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Guidelines on the use of laparoscopic appendectomy

Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) guidelines for laparoscopic appendectomy5

Laparoscopic appendectomy is a safe and effective method for the treatment of uncomplicated appendicitis and may be used as an alternative to standard open appendectomy (level I, grade A)

Laparoscopic appendectomy may be performed safety in patients with perforated appendicitis (level II, grade B), and is possibly the preferred approach (level III, grade C)

Laparoscopic approach for fertile women with presumed appendicitis should be the preferred method of treatment (level 1, grade A)

In elderly patients laparoscopic approach may be the preferred method of treatment (level II, grade B)

Laparoscopic appendectomy may be safely performed in pediatric patients. For specific recommendations, reference may be made to the IPEG guidelines

Laparoscopic appendectomy may be performed safely in pregnant patients with suspicion of appendicitis (level II, grade B)

Laparoscopic appendectomy is safe and effective in obese patients (level II, grade B) and may be the preferred approach (level III, grade C)

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1.2. Clinical and economic outcomes with laparoscopic versus open appendectomy

Key findings

Clinical outcomes

Length of Stay (LoS): LoS was consistently significantly shorter with laparoscopic appendectomy than with open appendectomy (Figure 1-3)3,15,16,17,18,19,20,23,24,26,27,29,30,31,32,35,36,38,39

Operating time: Operating time for laparoscopic appendectomy was consistently longer than for open appendectomy, with several studies showing that laparoscopic appendectomy was associated with significantly longer operating time (Figure 1-4)2,25,27,29,30,32,33,36,38

Surgical Site Infections (SSI): Rates of SSI were consistently lower with laparoscopic appendectomy than with open appendectomy, with SSI rates being significantly lower in several studies (Figure 1-5) 17,19,24,26,38,40

Incision size: The size of incision (and scar) with laparoscopic appendectomy is significantly smaller than with open appendectomy35

Abdominal abscess: a higher proportion of patients undergoing laparoscopic appendectomy experienced abdominal abscess compared with those undergoing open appendectomy20,21,23,28,36,39

Return to work: Patients undergoing laparoscopic appendectomy were able to return to work earlier than those undergoing open appendectomy27,30, in one study return to work was significantly earlier with laparoscopic appendectomy30

Return to normal activities: Patients who underwent laparoscopic appendectomy were able to return to normal activities significantly sooner than patients who underwent open appendectomy (Figure 1-6) 23,24,29,32,33

Post-operative pain scores: Post-operative pain scores were consistently lower with laparoscopic appendectomy than with open appendectomy,22,30,32,35 achieving statistical significance in two studies30,35

Analgesic use: Laparoscopic appendectomy was associated with significantly lower levels of post-operative analgesic use compared with open appendectomy24,29,30,32,33,35,36

Re-admission rates: 30-day readmission rates were significantly lower for patients undergoing laparoscopic appendectomy than for those undergoing open appendectomy16,17,19

Economic outcomes

Total hospital costs: the findings of cost studies were inconsistent and varied notably between settings

o United States: In US-based cost studies laparoscopic appendectomy was consistently associated with lower total costs than open appendectomy17,20,27 , with this difference achieving statistical significance in one study (Figure 1-7)20

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o China: In contrast, in cost studies from China, total costs were higher for laparoscopic appendectomy19,23, with the difference achieving statistical significance in one study (Figure 1-8)19

o Europe: In an Italian study, there was no significant difference in total costs between laparoscopic and open appendectomy31

Savings due to clinical benefits: Evidence from US-based studies showed that the lower costs associated with laparoscopic appendectomy were driven by significantly shorter LoS17,20,27 and lower rates of complications17

Cost of SSI: In a Chinese study SSI was associated with significantly higher total hospitalization costs (CNY 9,090 versus CNY 5,787; p<0.001)19

Other findings:

SSI: SSI following appendectomy is associated with a significantly higher risk for in-hospital death (p=0.014), and significantly longer length of hospital day (11.9 versus 6.1 days; p<0.001, significantly higher rates of 30-day readmission (p<0.001)19

Risk for SSI: Significant risk factors for SSI in appendectomy include open (versus laparoscopic) procedure, BMI >30 kg/m2, diabetes and perforated (versus unperforated) appendicitis19

Single incision laparoscopic appendectomy: There is no significant difference between single and multiport laparoscopic appendectomy in terms of operating time, LoS, morbidity or wound infection rates6

Patient characteristics: In an analysis of elderly patients with appendicitis those undergoing laparoscopic appendectomy were significantly younger, more likely to be white and had lower Charlson co-morbidity scores than those undergoing open appendectomy15

Temporal trends: In a comparison of pre-2000 versus post-2000 studies, operating time for laparoscopic appendectomy was 15.14 minutes longer (p<0.001) than open appendectomy, but this decreased to 8.67 minutes longer than open surgery (p=0.04) in post-2000 studies.11

Obesity: Obese patients represent a challenging patient group due to difficulties with venous access, airway and ventilation issues and access during surgery. However, there are no significant differences between obese and non-obese patients undergoing appendectomy in terms of wound infection, intra-abdominal abscess or conversions to open surgery13

Learning curve: Operating time for laparoscopic appendectomy has been shown to decrease with increasing surgeon experience7,8,9

Venous thromboembolism: Laparoscopic appendectomy is associated with a significantly lower incidence of venous thromboembolism in comparison with open appendectomy10

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Figure 1-3 LoS in open versus laparoscopic appendectomy

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Figure 1-4 Operating time for open versus laparoscopic appendectomy

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Figure 1-5 Rates of SSI for open versus laparoscopic appendectomy

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Figure 1-6 Return to normal activity for open versus laparoscopic appendectomy

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Figure 1-7 Total hospitalization cost for open versus laparoscopic appendectomy in US-based studies

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Figure 1-8 Total hospital costs for laparoscopic versus open appendectomy in studies in China

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1.1.1. Clinical and economic evidence tables

A summary of clinical evidence on laparoscopic versus open appendectomy 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.

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Table 1-1 Summary of meta-analyses comparing laparoscopic versus open appendectomy Authors Details Procedures Outcome OR (95% CI) P value

Li et al. 201011 44 RCTs, n=5,292 patients

Open versus laparoscopic appendectomy

Peri-operative Operating time, minutes Intraoperative bleeding, mL Post-operative LoS, days Return to normal activity, days Post-operative pain, VAS score Wound infection Intra-abdominal abscess

12.35 (7.99, 16.72)a 1.56 (0.54, 4.48) −0.60 (−0.85, −0.36)a −4.52 (−5.95, −3.10)a −070 (−1.22, −0.19)a 0.45 (0.34, 0.59) 0.91 (0.57, 1.47)

<0.00001 0.41 <0.00001 <0.00001 <0.00001 <0.00001 0.71

Sauerland et al. 201012 67 studies Open versus laparoscopic appendectomy in adults or adolescents (separate analysis in children, not presented here)

Peri-operative Operating time, minutes Post-operative Wound infection Intra-abdominal abscess Pain intensity Day 1, VAS LoS, days Return to normal activities, days Return to work Mean costs

10.24 (5.51, 14.97)a

0.43 (0.34, 0.54) 1.87 (1.19, 2.93) −0.82 (−1.14, −0.49)a −1.13 (−1.51, −0.74)a −5.17 (−6.83, −3.50)a −1.60 (−5.22, 2.02)a 4.55 (3.27, 5.82)a

NR NR NR NR NR NR NR NR

Dasari et al. 201513 1 RCT and 7 retrospective cohort studies, n=3,701

Open versus laparoscopic appendectomy in obese patients

Peri-operative Duration of surgery, minutes Post-operative Mortality Overall complications Wound infection Intra-abdominal abscess LoS, days

−13.96 (−15.44, −12.49)a 0.19 (0.12, 0.30)b 0.49 (0.47, 0.51)b 0.27 (0.21, 0.35)b 0.38 (0.33, 0.43)b 2.03 (1.86, 2.19)a

<0.00001 <0.00001 <0.0001 <0.00001 <0.00001 <0.00001

Markar et al. 201114 6 studies (n=1,122 laparoscopic, n=1,187 open appendectomies)

Open versus laparoscopic appendectomy in obese patients

Peri-operative Operating time, minutes Post-operative LoS, days Post-operative complications Intra-abdominal complications Wound complications

1.54 (−0.67, 3.74)a

−1.26 (−2.36, −0.16)a 0.49 (0.38, 0.64) 1.04 (0.60, 1.80) 0.37 (0.19, 0.72)

0.17 0.02 <0.0001 0.88 0.004

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bMean difference or weighted mean difference aRR, risk ratio, values below 1.00 favor laparoscopic surgery For ORs values below 1.00 favor laparoscopic surgery

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

performed) Summary of clinical findings Endpoint Open Laparoscopic P value

Ward et al. 201415

United States Retrospective cross-sectional database analysis in elderly (≥65 years) patients, n=170,276 open, n=87,209 laparoscopic

Open versus laparoscopic appendectomy (1998–2009)

Post-operative Mean (SE) LoS, days Mortality

7.86 (0.06) 2.8%

4 (0.04) 0.9%

<0.001 <0.001

Wang et al. 201316

Taiwan Retrospective database analysis, n=22,068 laparoscopic, n=43,271 open

Laparoscopic versus open appendectomy for acute appendicitis (2007–2009)

Post-operative Mean (SD) LoS, days 30 day readmission rate

5.33 (5.12) 1.92%

4.01 (2.90) 0.66%

<0.001 <0.001

Nguyen et al. 200417

United States Multicenter retrospective database analysis, n=41,085 open, n=19,151 laparoscopic

Open versus laparoscopic appendectomy for acute and perforated appendicitis (1999–2003)

Post-operative Mean (SD) LoS, days Overall complications Wound infection 30-day readmission

3.42 (3.39) 9.6% 1.8% 1.3%

2.49 (2.46) 6.1% 0.8% 1.0%

<0.01 <0.01 <0.01 <0.01

Guller et al. 200418

United States Retrospective database analysis, n=7,618 laparoscopic, n=36,139

Open versus laparoscopic appendectomy (excluding patients with appendicolithiasis and appendicopathia oxyurica) (1997)

Post-operative Mean LoS, days In hospital mortality Routine discharge Infections

3.8 0.3% 95.1% 1.9%

2.6 0.05% 98.4% 0.8%

<0.0001 0.002 <0.0001 <0.0001

Xiao et al. 201519

China Retrospective multicenter analysis, n=3,422 laparoscopic; n=12,841 open

Open versus laparoscopic appendectomy for acute appendicitis (2010–2013)

Peri-operative Mean (SD) operating time, minutes Post-operative In hospital mortality Overall SSI Incisional SSI Organ/space SSI Mean (SD), LoS, days 30-day post-discharge re-admission

45 (23) 0.08% 6.7% 4.2% 3.0% 6.7 (3.3) 2.8%

48 (29) 0.09% 4.5% 1.9% 3.0% 5.4 (2.5) 2.2%

0.137 1.00 <0.001 <0.001 0.995 <0.001 0.031

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

performed) Summary of clinical findings Endpoint Open Laparoscopic P value

Fullum et al. 201020

United States Retrospective database analysis, n=2,228 open, n=5,304 laparoscopic

Open versus laparoscopic appendectomy (2005–2006)

Post-operative Post-op minor bleed Post-op major bleed Intra-abdominal abscess Wound infection LoS, days

7% 2% 38% 1% 3.91

6% 1% 44% 1% 3.27

ns <0.05 <0.05 ns <0.05

Katkhouda et al. 20052

United States RCT, n=134 open, n=123 laparoscopic (n=113 laparoscopic included in analysis)

Laparoscopic versus open (McBurney’s incision) appendectomy (year not stated)

Peri-operative Median operating time, (IQR) Post-operative Overall complication rate Wound infection rates Median (IQR) LoS, days Median (IQR) pain distress (VAS) Pre-op Day 1 2 week

60 (45, 75) 17.1% 6.7% 3 (2, 4) 92 (70,100) 58 (37, 83) 6 (0, 24)

80 (60, 105) 18.5% 6.2% 2 (2, 4) 90 (54, 100) 64 (23,85) 5 (0, 10)

0.000 1.00 1.00 0.66 NR NR NR

Azaro et al. 19993

Brazil Non-randomized prospective study, n=164 open, n=332 videolaparoscopic (n=18 conversions)

Open (McBurney’s or para-rectal incision) versus videolaparoscopic appendectomy for acute appendicitis (1992–1998)

Peri-operative Mean operating time, minutes Post-operative Mean time to first flatus, days Post-operative complications Mean LoS, days

59 1.4 18.3% 5

84.4 1.3 6.9% 3.9

0.079 0.78 NR 0.006

Kehagias et al. 200821

Greece Prospective study in consecutive patients, n=165 open, n=128 laparoscopic

Open versus laparoscopic appendectomy for acute appendicitis (2006–2008)

Peri-operative Mean operating time, minutes Post-operative Uncomplicated disease Wound infection Morbidity Complicated disease Wound infection Intra-abdominal abscess

47 (20) 0.8% 0.8% 12.8% 2.1%

44 (24) 0% 1.1% 5.3% 5.3%

0.31 0.01 0.5 0.03 0.002

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

performed) Summary of clinical findings Endpoint Open Laparoscopic P value

Cipe et al. 201422

Turkey Single center prospective study, n=120 open, n=121 laparoscopic

Open versus laparoscopic appendectomy (2012)

Post-operative Mean (SD) pain score at 24 hours, VAS Mean (SD) LoS, hours Mean (range) return to normal activities, days Wound infection

3.4 (1.3) 29.9 (23.0) 6 (3–16) 5%

2.9 (1.1) 26.7 (24.6) 5 (2–13) 1.7%

0.057 0.072 0.325 NR

Wei et al. 201023

China Prospective RCT, n=108 open, n=112 laparoscopic

Open (McBurney’s incision) versus laparoscopic appendectomy for acute appendicitis (2006–2007)

Peri-operative Mean (SD) operating time, minutes Post-operative Mean (SD) LoS, days Mean (SD) days until normal activity Mean (SD) days until work Wound infection Abdominal abscess

29 (16) 7.2 (1.7) 13.7 (5.8) 27.7 (4.9) 13% 8.3%

30 (15) 4.1 (1.5) 9.1 (4.2) 21.2 (3.5) 0% 1.8%

ns <0.05 <0.05 <0.05 NR NR

Utpal 200524

India Prospective non-randomized study, n=100 laparoscopic, n=179 open

Laparoscopic versus open appendectomy for acute appendicitis (year not stated)

Peri-operative Median operating time, minutes Post-operative Overall complication rate Wound/port infection Incisional/port site hernia Median LoS, days Median time to full activity, days Median parenteral analgesia, days Median oral analgesia, days

25 31.8% 14% 9.5% 5 14 5 7

30 15% 4% 2% 3 3 1 1

<0.05 <0.0001 <0.001 ns <0.0001 <0.0001 <0.0001 <0.0001

Swank et al. 201125

Netherlands Retrospective single center study, n=545 open, n=210 laparoscopic

Open versus laparoscopic appendectomy for appendicitis (1995–2005)

Peri-operative Mean operating time, minutes Post-operative Abdominal abscess

59 1.5%

71 6.2%

0.000 0.001

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

performed) Summary of clinical findings Endpoint Open Laparoscopic P value

Wound infection/abscess 30-day mortality

2.6% 0.2%

1.4% 0.0%

0.259 0.722

Agresta et al. 200326

Italy Retrospective case-control study, n=322 laparoscopic, n=233 open

Open versus laparoscopic appendectomy for appendicitis (1993–2000)

Peri-operative Major intra-operative complications Post-operative Mean (SD) LoS, days Wound infection

0 5 (3.4) 6.6%

0.3% 4.4 (1.2) 0

ns 0.01 <0.01

Martin et al. 199527

United States Prospective RCT, n=88 open, n=81 laparoscopic

Open versus laparoscopic appendectomy for acute appendicitis (year not stated)

Peri-operative Mean operating time, minutes Post-operative Mean LoS, days Mean days to normal activity Mean days to work

82 4.3 12.8 23.6

102 2.2 12.2 23.3

0.0002 0.0007 0.92 0.99

Khan et al. 200728

United Kingdom

Prospective study, n=80 laparoscopic, n=54 open

Open versus laparoscopic appendectomy (year not stated)

Peri-operative Median (range) operating time Post-operative Wound infection Intraabdominal abscess

41 (30, 95) 9.3% 1.9%

51 (35, 100) 1.3% 1.3%

NR NR NR

Razak Shaikh et al. 200929

Pakistan Prospective comparative study, n=52 open, n=48 laparoscopic

Open versus laparoscopic appendectomy for acute appendicitis (2003–2006)

Peri-operative Mean operating time, minutes Post-operative Parenteral analgesics (doses) Oral analgesics (doses) LoS, days Return to normal activities, days Wound infection Intra-abdominal abscess

32 (13) 1.5 (0.6) 3.0 (1.5) 3.4 (1.0) 19.1 (3.1) 13.7% 1.9%

55 (15) 1.0 (0.5) 2.5 (0.8) 1.4 (0.7) 12.6 (3.3) 6.3% 4.2%

<0.001 0.001 0.05 <0.001 <0.001 0.32 ns

Rashid et al. 201330

India Prospective RCT, n=50 open, n=50 laparoscopic

Laparoscopic interval appendectomy versus open interval appendectomy for

Peri-operative Mean (SD) operating time, minutes Post-operative Mean (SD) pain score on Day 1;

34 (8) 6.01 (0.12)

58 (10)

<0.0001

Global Value Dossier: Appendectomy

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

performed) Summary of clinical findings Endpoint Open Laparoscopic P value

appendicular phlegmon (year not stated)

VAS Mean (SD) doses IV pain medication Mean (SD) doses oral pain medication Mean (SD) duration of ileus, hours Mean (SD) LoS, days Mean (SD) return to work, days

7.24 (1.15) 4.04 (0.95) 22.4 (3.5) 3.1 (0.89) 9.64 (2.08)

5.14 (0.13) 3.12 (0.69) 2.8 (0.83) 11.8 (2.9) 1.06 (0.24) 3.6 (1.03)

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

Minutolo et al. 201431

Italy Retrospective analysis, n=139 laparoscopic, n=91 open

Open (McBurney’s incision) versus laparoscopic appendectomy for acute appendicitis (without pre-operative bowel perforation) (2008–2012)

Peri-operative Conversion Mean operating time, minutes Post-operative Mean LoS, days Mean duration of post-op ileus, days Post-op complication rate Wound infection, n Intra-abdominal abscess, n

― 49.3 3.87 1.4 13.2% 0 1

1.4% 52.2 2.75 1.2 2.9% 5 2

0.476 0.011 0.024 0.006 0.009 0.563

Hart et al. 199632

Canada Single center prospective randomized trial, n=44 laparoscopic, n=37 open

Open versus laparoscopic appendectomy for acute appendicitis (1993–1994)

Peri-operative Mean (SD) operating time, minutes Post-operative Mean (SD) LoS, days Mean (SD) number of pain killer injections Mean (SD) pain score at Day 7 Mean (SD) time to full recovery, days

45 (12.9) 3.03 (1.24) 5.58 (3.36) 2.59 (2.07) 16.2 (12.9)

73.8 (23.2) 3.23 (5.55) 4.05 (6.39) 2.53 (2.59) 9.0 (8.4)

<0.001 <0.001 <0.001 >0.55 <0.001

Frazee et al. 199433

United States Prospective RCT, n=37 open, n=38 laparoscopic

Open versus laparoscopic appendectomy (1992–1993)

Peri-operative Mean (range) operating time, minutes Post-operative

65 (20–210)

87 (45–150)

<0.001

Global Value Dossier: Appendectomy

22

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

performed) Summary of clinical findings Endpoint Open Laparoscopic P value

Mean LoS, days Mean parental analgesic use, days Mean oral analgesic use, days Mean return to full activities, days

2.8 2.0 8.0 25

2.0 1.2 5.4 14

ns <0.02 <0.02 <0.001

Thomson et al. 201534

South Africa RCT, n=32 open, n=31 laparoscopic

Laparoscopic versus open surgery for complicated appendicitis (2011–2012)

Peri-operative Mean (SD) operating time Post-operative Wound sepsis, n Mean LoS, days

58 (35) 9 4.5

76 (49) 2 5.0

ns 0.03 0.26

Gundavda et al. 201235

India Prospective trial, n=30 open, n=30 laparoscopic

Open versus laparoscopic appendectomy (year not stated)

Peri-operative Mean post-operative pain, Day 1 (VAS) Mean post-operative pain, Day 7 Mean no analgesic injections Wound complications Mean scar size, cm Mean LoS, days Mean sick leave, days

4.26 1.23 5.9 16.7% 6.1 3.4 8.2

3.73 1.07 4 6.7% 2.1 2.2 6.5

<0.05 <0.05 <0.05 <0.001 <0.001 <0.05 <0.05

Lee et al. 201136

Korea Retrospective study, n=372 open, n=46 laparoscopic

Open versus laparoscopic appendectomy (2010)

Peri-operative Mean (SD) operating time, minutes Post-operative Mean (SD) no analgesics Mean (SD) LoS, days Wound infection Intra-abdominal abscess

46 (18) 2.0 (2.3) 4.6 (2.6) 4.0% 1.1%

72 (26) 1.9 (1.1) 3.6 (1.6) 6.5% 4.4%

0.0004 <0.0001 0.0002 NR NR

Peiser et al. 200237

Israel Retrospective single center study, n=100 open, n=94 laparoscopic

Open versus laparoscopic appendectomy (1995)

Peri-operative Mean operating time minutes Post-operative Mean LoS, days

62 2.7

57 2.5

0.075 ns

Global Value Dossier: Appendectomy

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

performed) Summary of clinical findings Endpoint Open Laparoscopic P value

Intraoperative complications Postoperative complications

0 9.3%

2.3% 5.7%

ns ns

Yong et al. 200638

China Retrospective analysis, n=82 laparoscopic, n=119 open

Routine open versus laparoscopic appendectomy for suspected appendicitis (2002–2003)

Peri-operative Median (range) operating time, minutes Post-operative Median (range) LoS, days Wound infection Intra-abdominal abscess

60 (25–260) 4.0 (1-47) 5.0% 0%

80 (40–196) 3.0 (1-47) 4.9% 4.9%

<0.005 0.037 0.861 0.021

Lim et al. 201139

Korea Retrospective analysis, n=38 laparoscopic, n=22 open

Open versus laparoscopic appendectomy for complicated appendicitis (2009–2011)

Post-operative LoS (SD), days Overall complications SSI Intra-abdominal abscess

5.8 (2.9) 27.3% 13.6% 0%

4.4 (2.3) 15.8% 0% 5.3%

0.045 0.0327 NR NR

Baek et al. 201140

Korea Retrospective study in elderly (>60 years) patients, n=30 laparoscopic, open =47

Open versus laparoscopic appendectomy for appendicitis in elderly patients (2007–2012)

Peri-operative Mean (SD) operating time Post-operative Mean (SD) LoS, days Mean (SD) analgesic use (time) Wound infection Intraabdominal abscess

65 (26) 9.0 (5.8) 1.2 (1.4) 19% 2%

63 (31) 7.4 (3.1) 0.8 (1.1) 3% 0

ns ns ns 0.044 ns

LoS, length of stay; NR, not reported; ns, not significant; SD, standard deviation; SSI, surgical site infection; VAS visual analog scale

Global Value Dossier: Appendectomy

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

(Cost year) Cost Outcome Open Laparoscopic P value

Minutolo et al. 201431

Italy Retrospective analysis, n=139 laparoscopic, n=91 open

Open (McBurney’s incision) versus laparoscopic appendectomy for acute appendicitis (without pre-operative bowel perforation) (2008–2012)

EUR (year not stated)

Mean total cost 2,337 2,282 0.812

Xiao et al. 201519

China Retrospective multicenter analysis, n=3,422 laparoscopic; n=12,841 open

Open versus laparoscopic appendectomy for acute appendicitis (2010–2013)

CNY (year not stated)

Mean (SD) total hospitalization costs

5,532 (2,828) 7,852 (2,880) <0.001

Wei et al. 201023

China Prospective RCT, n=108 open, n=112 laparoscopic

Open (McBurney’s incision) versus laparoscopic appendectomy for acute appendicitis (2006–2007)

CNY (year not stated)

Mean (SD) billed charges

5,310 (575) 5,720 (116) ns

Wang et al. 201316

Taiwan Retrospective database analysis, n=22,068 laparoscopic, n=43,271 open

Laparoscopic versus open appendectomy for acute appendicitis (2007–2009)

TWD (2007) Mean (SD) cost per discharge

38,509 (48,941) 40,554 (23,306) <0.001

Utpal 200524

India Prospective non-randomized study, n=100 laparoscopic, n=179 open

Laparoscopic versus open appendectomy for acute appendicitis

INR (year not stated)

Median operating cost

923 925 ns

Nguyen et al. 200417

United States

Retrospective database analysis, n=41,085 open, n=19,151 laparoscopic

Open versus laparoscopic appendectomy for acute and perforated appendicitis (1999–2003)

USD (year not stated)

Mean (SD) cost 6,260 (6,530) 6,242 (3,935) ns

Martin et al. 199527

United States

Prospective RCT, n=88 open, n=81 laparoscopic

Open versus laparoscopic appendectomy for acute appendicitis (year not stated)

USD (year not stated)

Total cost, all patients Acute appendicitis Perforated Normal

7,227 5,277 13,670 5,515

6,077 6,189 7,465 5,088

0.164 0.074 0.05 0.51

Global Value Dossier: Appendectomy

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

(Cost year) Cost Outcome Open Laparoscopic P value

Lee et al. 201136

Korea Retrospective study, n=372 open, n=46 laparoscopic

Open versus laparoscopic appendectomy (2010)

KRW (year not stated)

Mean (SD) total hospital cost

2,408,117 (734,440)

3,153,567 (652,940)

0.3363

Fullum et al. 201020

United States

Retrospective database analysis, n=2,228 open, n=5,304 laparoscopic

Open versus laparoscopic appendectomy (2005–2006)

USD (year not stated)

Total cost 14,032 11,298 <0.05

Global Value Dossier: Appendectomy 26

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