GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE …Appendectomy is the second most common general...
Transcript of GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE …Appendectomy is the second most common general...
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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Source: Masoomi et al. 20144
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
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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
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
1.3. References
1 Semm K. Endoscopic appendectomy. Endoscopy. 1983 Mar;15(2):59-64 (PMID: 6221925)
2 Katkhouda N, Mason RJ, Towfigh S, Gevorgyan A, Essani R. Laparoscopic versus open appendectomy: a prospective randomized double-blind study. Ann Surg. 2005 Sep;242(3):439-48 (PMID: 16135930)
3 Azaro EM, Amaral PC, Ettinger JE, Souza EL, Fortes MF, Alcântara RS, Regis AB, Sousa MM, Fogagnoli WG, do Carmo VM, Galvão TD, Stagliorio EP, Santana PA Jr, Fahel E. Laparoscopic versus open appendicectomy: a comparative study. JSLS. 1999 Oct-Dec;3(4):279-83 (PMID: 10694074)
4 Masoomi H, Nguyen NT, Dolich MO, Mills S, Carmichael JC, Stamos MJ. Laparoscopic appendectomy trends and outcomes in the United States: data from the Nationwide Inpatient Sample (NIS), 2004-2011. Am Surg. 2014 Oct;80(10):1074-7 (PMID: 25264663)
5 Society of American Gastrointestinal and Endoscopic Surgeons. Guidelines for Laparoscopic Appendectomy. Available at: http://www.sages.org/publications/guidelines/guidelines-for-laparoscopic-appendectomy/ [Last accessed November 18, 2015]
6 Raakow J, Liesaus HG, Neuhaus P, Raakow R. Single-incision versus multiport laparoscopic appendectomy: a case-matched comparative analysis. Surg Endosc. 2015 Jun;29(6):1530-6 (PMID: 25294525)
7 Ali A, Moser MA. Recent experience with laparoscopic appendectomy in a Canadian teaching centre. Can J Surg. 2008 Feb;51(1):51-5 (PMID: 18248706)
8 Lin YY, Shabbir A, So JB. Laparoscopic appendectomy by residents: evaluating outcomes and learning curve. Surg Endosc. 2010 Jan;24(1):125-30 (PMID: 19760332)
9 Jaffer U, Cameron AE. Laparoscopic appendectomy: a junior trainee's learning curve. JSLS. 2008 Jul-Sep;12(3):288-91 (PMID: 18765054)
10 Nguyen NT, Hinojosa MW, Fayad C, Varela E, Konyalian V, Stamos MJ, Wilson SE. Laparoscopic surgery is associated with a lower incidence of venous thromboembolism compared with open surgery. Ann Surg. 2007 Dec;246(6):1021-7 (PMID: 18043105)
11 Li X, Zhang J, Sang L, Zhang W, Chu Z, Li X, Liu Y. Laparoscopic versus conventional appendectomy--a meta-analysis of randomized controlled trials. BMC Gastroenterol. 2010 Nov 3;10:129 (PMID: 21047410)
12 Sauerland S, Jaschinski T, Neugebauer EA. Laparoscopic versus open surgery for suspected appendicitis. Cochrane Database Syst Rev. 2010 Oct 6;(10):CD001546 (PMID: 20927725)
13 Dasari BV, Baker J, Markar S, Gardiner K. Laparoscopic appendicectomy in obese is associated with improvements in clinical outcome: systematic review. Int J Surg. 2015 Jan;13:250-6 (PMID: 25498498)
14 Markar SR, Venkat-Raman V, Ho A, Karthikesalingam A, Kinross J, Evans J, Bloom I. Laparoscopic versus open appendicectomy in obese patients. Int J Surg. 2011;9(6):451-5 (PMID: 21820087)
15 Ward NT, Ramamoorthy SL, Chang DC, Parsons JK. Laparoscopic appendectomy is safer than open appendectomy in an elderly population. JSLS. 2014 Jul-Sep;18(3). pii: e2014.00322 (PMID: 25392668)
Global Value Dossier: Appendectomy 27
16 Wang CC, Tu CC, Wang PC, Lin HC, Wei PL. Outcome comparison between laparoscopic and open appendectomy: evidence from a nationwide population-based study. PLoS One. 2013 Jul 12;8(7):e68662 (PMID: 23874710)
17 Nguyen NT, Zainabadi K, Mavandadi S, Paya M, Stevens CM, Root J, Wilson SE. Trends in utilization and outcomes of laparoscopic versus open appendectomy. Am J Surg. 2004 Dec;188(6):813-20 (PMID: 15619505)
18 Guller U, Hervey S, Purves H, Muhlbaier LH, Peterson ED, Eubanks S, Pietrobon R. Laparoscopic versus open appendectomy: outcomes comparison based on a large administrative database. Ann Surg. 2004 Jan;239(1):43-52 (PMID: 14685099)
19 Xiao Y, Shi G, Zhang J, Cao JG, Liu LJ, Chen TH, Li ZZ, Wang H, Zhang H, Lin ZF, Lu JH, Yang T. Surgical site infection after laparoscopic and open appendectomy: a multicenter large consecutive cohort study. Surg Endosc. 2015 Jun;29(6):1384-93 (PMID: 25303904)
20 Fullum TM, Ladapo JA, Borah BJ, Gunnarsson CL. Comparison of the clinical and economic outcomes between open and minimally invasive appendectomy and colectomy: evidence from a large commercial payer database. Surg Endosc. 2010 Apr;24(4):845-53 (PMID: 19730950)
21 Kehagias I, Karamanakos SN, Panagiotopoulos S, Panagopoulos K, Kalfarentzos F. Laparoscopic versus open appendectomy: which way to go? World J Gastroenterol. 2008 Aug 21;14(31):4909-14 (PMID: 18756599)
22 Cipe G, Idiz O, Hasbahceci M, Bozkurt S, Kadioglu H, Coskun H, Karatepe O, Muslumanoglu M; -. Laparoscopic versus open appendectomy: where are we now? Chirurgia (Bucur). 2014 Jul-Aug;109(4):518-22 (PMID: 25149616)
23 Wei HB, Huang JL, Zheng ZH, Wei B, Zheng F, Qiu WS, Guo WP, Chen TF, Wang TB. Laparoscopic versus open appendectomy: a prospective randomized comparison. Surg Endosc. 2010 Feb;24(2):266-9 (PMID: 19517167)
24 Utpal D. Laparoscopic versus open appendectomy in West Bengal, India. Chin J Dig Dis. 2005;6(4):165-9 (PMID: 16246224)
25 Swank HA, Eshuis EJ, van Berge Henegouwen MI, Bemelman WA. Short- and long-term results of open versus laparoscopic appendectomy. World J Surg. 2011 Jun;35(6):1221-6 (PMID: 21472367)
26 Agresta F, De Simone P, Michelet I, Bedin N. Laparoscopic appendectomy: why it should be done. JSLS. 2003 Oct-Dec;7(4):347-52 (PMID: 14626402)
27 Martin LC, Puente I, Sosa JL, Bassin A, Breslaw R, McKenney MG, Ginzburg E, Sleeman D. Open versus laparoscopic appendectomy. A prospective randomized comparison. Ann Surg. 1995 Sep;222(3):256-61 (PMID: 7677456)
28 Khan MN, Fayyad T, Cecil TD, Moran BJ. Laparoscopic versus open appendectomy: the risk of postoperative infectious complications. JSLS. 2007 Jul-Sep;11(3):363-7 (PMID: 17931520)
29 Shaikh AR, Sangrasi AK, Shaikh GA. Clinical outcomes of laparoscopic versus open appendectomy. JSLS. 2009 Oct-Dec;13(4):574-80 (PMID: 20202400)
30 Rashid A, Nazir S, Kakroo SM, Chalkoo MA, Razvi SA, Wani AA. Laparoscopic interval appendectomy versus open interval appendectomy: a prospective randomized controlled trial. Surg Laparosc Endosc Percutan Tech. 2013 Feb;23(1):93-6 (PMID: 23386160)
31 Minutolo V, Licciardello A, Di Stefano B, Arena M, Arena G, Antonacci V. Outcomes and cost analysis of laparoscopic versus open appendectomy for treatment of acute
Global Value Dossier: Appendectomy 28
appendicitis: 4-years experience in a district hospital. BMC Surg. 2014 Mar 19;14:14 (PMID: 24646120)
32 Hart R, Rajgopal C, Plewes A, Sweeney J, Davies W, Gray D, Taylor B. Laparoscopic versus open appendectomy: a prospective randomized trial of 81 patients. Can J Surg. 1996 Dec;39(6):457-62 (PMID: 8956810)
33 Frazee RC, Roberts JW, Symmonds RE, Snyder SK, Hendricks JC, Smith RW, Custer MD 3rd, Harrison JB. A prospective randomized trial comparing open versus laparoscopic appendectomy. Ann Surg. 1994 Jun;219(6):725-8 (PMID: 8203983)
34 Thomson JE, Kruger D, Jann-Kruger C, Kiss A, Omoshoro-Jones JA, Luvhengo T, Brand M. Laparoscopic versus open surgery for complicated appendicitis: a randomized controlled trial to prove safety. Surg Endosc. 2015 Jul;29(7):2027-32 (PMID: 25318368)
35 Gundavda MK, Bhandarwar AH. Comparative study of laparoscopic versus open appendicectomy. Indian J Med Sci. 2012 May-Jun;66(5-6):99-115 (PMID: 23806983)
36 Lee HJ, Park YH, Kim JI, Choi PW, Park JH, Heo TG, Lee MS, Kim CN, Chang SH. Comparison of clinical outcomes and hospital cost between open appendectomy and laparoscopic appendectomy. J Korean Surg Soc. 2011 Nov;81(5):321-5 (PMID: 22148124)
37 Peiser JG, Greenberg D. Laparoscopic versus open appendectomy: results of a retrospective comparison in an Israeli hospital. Isr Med Assoc J. 2002 Feb;4(2):91-4 (PMID: 11875999)
38 Yong JL, Law WL, Lo CY, Lam CM. A comparative study of routine laparoscopic versus open appendectomy. JSLS. 2006 Apr-Jun;10(2):188-92 (PMID: 16882418)
39 Lim SG, Ahn EJ, Kim SY, Chung IY, Park JM, Park SH, Choi KW. A Clinical Comparison of Laparoscopic versus Open Appendectomy for Complicated Appendicitis. J Korean Soc Coloproctol. 2011 Dec;27(6):293-7 (PMID: 22259744)
40 Baek HN, Jung YH, Hwang YH. Laparoscopic versus open appendectomy for appendicitis in elderly patients. J Korean Soc Coloproctol. 2011 Oct;27(5):241-5 (PMID: 22102974)
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