GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY · 2021. 1. 17. · • Minimally invasive...

GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY

MIS GVD – Hysterectomy 1

GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY (MIS)

Hysterectomy


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. 2.2

Date: March 03, 2020


Contents

1. Hysterectomy .................................................................................................................... 4

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

1.2. Clinical and economic outcomes with open versus minimally invasive hysterectomy .......................................................................................................................... 10

1.1.1. Clinical and economic evidence tables.................................................................... 17

1.3. References ............................................................................................................... 41

List of Tables Table 1-1 Hysterectomy and indications for hysterectomy performed in Germany 2005–2006 ................................................................................................................................ 5

Table 1-2 Summary of meta-analyses comparing laparoscopic versus open hysterectomy .............................................................................................................................. 18

Table 1-3 Summary of key clinical studies comparing open versus laparoscopic hysterectomy .......................................................................................................................... 20

Table 1-4 Summary of key studies comparing economic outcomes of open versus laparoscopic hysterectomy .................................................................................................... 34

List of Figures Figure 1-1 Proportion of abdominal, laparoscopic and vaginal hysterectomies performed in the UK, 2011–2017 ................................................................................................................ 6

Figure 1-2 Laparoscopic hysterectomy .............................................................................. 7

Figure 1-3 LoS for abdominal hysterectomy versus laparoscopic hysterectomy ........... 12

Figure 1-4 Operating time with abdominal hysterectomy versus laparoscopic hysterectomy .......................................................................................................................... 13

Figure 1-5 Estimated blood loss with abdominal hysterectomy versus laparoscopic hysterectomy .......................................................................................................................... 14

Figure 1-6 Total hospital costs for abdominal versus laparoscopic hysterectomy in studies conducted in Europe .................................................................................................. 15

Figure 1-7 Total hospital costs for abdominal versus laparoscopic hysterectomy for studies performed in Australia ................................................................................................ 16

Figure 1-8 Total costs for total abdominal hysterectomy, laparoscopic hysterectomy and vaginal hysterectomy in the United States...................................................................... 17


1. Hysterectomy

1.1. Overview of procedure Hysterectomy is one of the most commonly performed surgical procedures in women. In the US approximately 600,000 hysterectomies are performed annually, with over one-third of women having had the procedure by age 60 years.1 Similarly in Germany in 2006 over 150,000 hysterectomies were performed; where 81% of all hysterectomies were performed for benign indications; but for vaginal hysterectomies this figure was lower at 55%, hysterectomies for malignancy were typically performed via the abdominal approach (Table 1-1).2 The number of procedures performed in other countries are similar at an estimated 100,000 per year in the UK, 60,000 in France and 30,000 per year in Australia.3 Common indications for hysterectomy include endometrial or cervical cancer, ovarian cancer, fibroids, endometriosis, pelvic pain and abnormal vaginal bleeding.

Analysis of trends in terms of the type of hysterectomies performed in the UK showed that over the period 2011–2017 the proportion of laparoscopic hysterectomies increased from 20% to 47% (Figure 1-1).4 Similar increases have been reported in other settings including the US, Taiwan and Australia5,6,7

Hysterectomy is classified as either subtotal (also known as supracervical), total or radical. Subtotal hysterectomy involves the removal of the upper part of the uterus but not the cervix, in total hysterectomy the whole uterus and cervix are removed and in radical hysterectomy the uterus and tissue on either side of the uterus (parametrium), cervix and the top part of the vagina are removed. Radical hysterectomy is typically only performed for cervical malignancy.


Table 1-1 Hysterectomy and indications for hysterectomy performed in Germany 2005–2006

Type of operation

N

Indication for hysterectomy, %

Malignant neoplasm of female

genital organs

Endometrial adenomatous

hyperplasia

Carcinoma in situ of

female genital organs

Neoplasias of

uncertain or

unknown origin

Other malignant

primary tumors

Benign diseases

of female genital organs

Abdominal hysterectomy

120,485 88.7 39.0 22.5 75.0 86.7 31.3

LAVH 17,090 2.3 9.1 6.8 5.8 1.0 6.0

Laparoscopic hysterectomy

14,967 0.7 2.3 1.7 3.8 0.5 5.8

Laparoscopic hysterectomy, conversion to abdominal hysterectomy

1,707 0.2 0.6 0.1 1.4 0.3 0.6

Vaginal hysterectomy, conversion to abdominal hysterectomy

1,616 0.2 0.9 0.6 0.3 0.2 0.6

Vaginal hysterectomy

144,628 5.5 47.4 67.4 11.7 3.6 54.5

Unclear or missing data

4,522 2.3 0.8 1.0 2.1 7.7 1.3

Total 305,015 12.1 1.7 2.1 1.9 0.9 81.4

LAVH, laparoscopically assisted vaginal hysterectomy Source: Stang et al. 20112


Figure 1-1 Proportion of abdominal, laparoscopic and vaginal hysterectomies performed in the UK, 2011–2017

70.067.0

63.058.8

54.950.7

46.5

20.024.0

29.032.9

37.7

42.5

47.2

7.8 7.0 6.4 5.9 4.9 4.2 3.5

1.7 1.9 2.1 2.3 2.5 2.6 2.8

2011 2012 2013 2014 2015 2016 2017

Proc

edur

e, %

Abdominal Laparoscopic Vaginal Failed laparoscopic

Source: Madhvani et al. 20194

Overview of common surgical procedures

Laparoscopic hysterectomy: Laparoscopic hysterectomy is similar to laparoscopically-assisted vaginal hysterectomy in that part of the procedure is performed laparoscopically and part performed vaginally; however, here the ligation of the uterine vessels is performed laparoscopically. For the procedure the patient is placed in the dorsal lithotomy position. A peri-umbilical incision is made and following placement of a trocar and the laparoscope two incisions are made lateral and inferior to the optical trocar within the oblique muscles. An initial inspection of the pelvic region is then made and a uterine manipulator inserted to push the uterus upwards. In the procedure, the utero-ovarian ligaments and fallopian tubes are first identified and dissected, followed by dissection of the left and right round ligament, then the anterior leaf of the broad ligament, followed by the endopelvic fascia and cardinal ligaments, taking care to avoid damaging the bladder. Several alternative methods can be used to dissect the ligaments including for example electrocautery, ultrasonic dissection or radiofrequency vessel sealing. The uterus is then separated from the vagina by cutting along the colpotomy ring and then removed through the vagina, followed by closure of the vaginal cuff laparoscopically and irrigation of the vaginal cuff to check for bleeding.


Figure 1-2 Laparoscopic hysterectomy

Source: Cancer Research UK (available at: http://www.cancerresearchuk.org/about-cancer/type/womb-cancer/treatment/surgery/surgery-to-remove-womb-cancer)

Laparoscopically assisted vaginal hysterectomy: Here part of the procedure is performed laparoscopically and part is performed vaginally; the laparoscopic component does not involve the division of the uterine vessels. This procedure requires an incision to be made in the vagina, through which the uterus is removed.

Total laparoscopic hysterectomy: The entire procedure is performed laparoscopically (including suturing of the vaginal vault), the vaginal component of the procedure is limited to the removal of the uterus.

Vaginal hysterectomy: Vaginal hysterectomy is typically performed for benign indications or carcinoma in situ of the cervix and/or uterus. It is generally considered unsuitable for patients with endometriosis or pelvic pain or for patients with a narrow pubic arch. For the procedure the patient is placed in the dorsal lithotomy position, the cervix is then exposed using a weighted posterior vaginal retractor, two further right-angle retractors are then used to elevate the vaginal wall and expose the cervix. An incision is then made in the vaginal wall and the uterus detached from the bladder, followed by the opening of the posterior peritoneum and dissection of the lower part of the uterus, cutting and ligating the uterine arteries, opening the anterior peritoneum, dissecting the upper part of the uterus, which involves clamping and ligating the round and ovarian ligaments, reconstruction of the pelvic floor and then closing of the vaginal wall.


Guidelines on laparoscopic hysterectomy

International Society for Gynecologic Endoscopy (ISGE) evidence-based guidelines for vaginal hysterectomy 2018 8

• Vaginal hysterectomy should be considered as the first choice for benign indications (grade 1B)

• The laparoscopic approach should be considered when vaginal hysterectomy is contraindicated or not technically possible (grade 2B)

Danish Health Authority guidelines on surgical techniques in benign hysterectomy 20179

• Consider vaginal hysterectomy rather than conventional laparoscopic hysterectomy for non-prolapsed uteri when feasible (weak recommendation)

• Robot-assisted laparoscopic hysterectomy should only be preferred over conventional laparoscopic hysterectomy after careful consideration because the beneficial effect is uncertain and because of the longer operating time (weak recommendation)

American College of Obstetricians and Gynecologists (ACOG) committee opinion on the route of hysterectomy for benign disease 201710

• Vaginal hysterectomy is the approach of choice whenever feasible. Evidence demonstrates that is associated with better outcomes when compared with other approaches to hysterectomy

• Laparoscopic hysterectomy is a preferable alternative to open abdominal hysterectomy for those patients in whom a vaginal hysterectomy is not indicated or feasible

• The role of robotic assistance for execution of laparoscopic hysterectomy has not been clearly determined as more data are necessary to determine the most appropriate evidence-based applications for this technology

French College of Obstetrics and Gynecology clinical practice guidelines on hysterectomy for benign disease (2016)11

• In the case of hysterectomy for benign disease, the vaginal or laparoscopic approach should be preferred (grade B). In terms of the prevalence of complications there is no difference between laparoscopic hysterectomy and vaginal hysterectomy. The choice between the two will depend on other parameters such as the surgeons experience, mode of anesthesia, and organizational constraints (length of surgery and medical economic considerations). Data on the robotic approach are insufficient to recommend its use in the case of hysterectomy for benign disease (expert opinion)

• In the case of hysterectomy for benign disease in an obese patient, vaginal or laparoscopic hysterectomy is recommended (grade C)


• Regardless of the surgical approach, increasing experience of the surgeon is associated with decreasing prevalence of complications. It is recommended that hysterectomy be done by a surgeon who performs at least ten hysterectomies a year (grade C)

2011 American Association of Gynecologic Laparoscopists (AAGL) Position Statement: route of hysterectomy to treat benign uterine disease12

• It is the position of the AAGL that most hysterectomies for benign disease should be performed either vaginally or laparoscopically and that continued efforts should be taken to facilitate these approaches

2015 American College of Obstetricians and Gynecologists (ACOG) and Society of Gynecologic Oncology (SGO) practice bulletin endometrial cancer13

• Minimally invasive surgery should be embraced as the standard surgical approach for comprehensive surgical approach for comprehensive surgical staging in women with endometrial cancer (Level A)

• Robotic-assisted laparoscopic stage is a feasible and safe alternative to traditional laparoscopy in women with endometrial cancer (Level B)

• Vaginal hysterectomy may be an appropriate treatment for early-stage endometrioid endometrial cancer in select patients who are at high risk of surgical morbidity (Level C)

2013 European Society for Medical Oncology clinical practice guidelines for diagnosis, treatment and follow-up of endometrial cancer14

• Laparoscopy seems to provide equivalent results in terms of disease-free survival and overall survival compared with laparotomy, with further benefit: shorter hospital stay, less use of pain killers, lower rate of complications and improved quality of life


1.2. Clinical and economic outcomes with open versus minimally invasive hysterectomy

Key findings

Clinical outcomes

• Length of stay: In studies conducted across a broad range of settings laparoscopic hysterectomy was associated with a significantly (p


Economic outcomes

• Total costs: There was some inconsistencies between settings in terms of total costs. In European and Australian studies total costs for laparoscopic hysterectomy were lower than for abdominal hysterectomy; however, in US studies, findings were inconsistent

o European costs: In studies conducted in Europe (Netherlands, Spain and Italy), total hospital costs for laparoscopic hysterectomy were lower than for abdominal hysterectomy; however, statistical significance was not reported (Figure 1-6)35,63,64

o Australian costs: In Australian studies total hospital costs for laparoscopic hysterectomy were consistently lower than for abdominal hysterectomy (Figure 1-7)61,62

o US costs: In one US study, total hospital charges were highest for laparoscopically-assisted vaginal hysterectomy, followed by abdominal hysterectomy; vaginal hysterectomy was associated with the lowest total hospital charges (Figure 1-8).60 In a second US study, laparoscopic hysterectomy was associated with higher intra-operative costs but lower post-operative costs than abdominal hysterectomy.59 In a third study, laparoscopic hysterectomy, laparoscopically-assisted and vaginal hysterectomy were associated with lower total costs than open surgery42

o Canadian costs: In Canada, total inpatient costs were lower with vaginal or laparoscopic hysterectomy relative to open hysterectomy (statistical significance was not reported)48

• Savings due to clinical benefits: The lower total costs reported in European and Australian studies were attributable to lower post-operative hospital costs,61,62,63,64 likely driven by shorter LoS and lower complication rates

Other findings

Impact of SSI: Laparoscopic hysterectomy is associated with a lower incidence of SSI than open hysterectomy.15 SSI is associated with 3–5 fold longer LoS, a 2-fold increase in direct costs and a 3-fold increase in risk for hospital readmission.15 An estimated one-third of post-operative deaths are related in some way to SSI and SSI increases 30-day cost by over USD 5,400 compared with matched patients without SSI16

Risk for SSI: In patients with endometrial cancer undergoing surgery, risk factors for superficial SSI included obesity, American Society of Anesthesiologists (ASA) score >2, anemia, laparotomy16 and longer operating time17

Cost of transfusion: Two studies reported significantly higher transfusion rates with abdominal hysterectomy. The cost of transfusion ranges from USD 522–1,183 per unit of blood18, transfusion also prolongs hospital stay by ≥2 days19

Utilization: In the US there has been a shift towards increased utilization of minimally invasive approaches for hysterectomy (from 2006–2009), which has been accompanied by a decrease in the incidence of intraoperative and postoperative complications and an increase in operative costs, but no increase in overall mean costs20

Influence of setting: In the US, endometrial cancer patients treated at teaching hospitals and high-volume hospitals are more likely to undergo minimally invasive surgery38


Age: The observation that laparoscopic versus open surgery for endometrial cancer is associated with lower mortality and complication rates is consistent across all age groups21

Obesity: Obese patients are more likely to undergo total abdominal hysterectomy and less likely to undergo total vaginal hysterectomy and laparoscopically assisted hysterectomy.22,38 Higher BMI is also associated with longer operating times for total abdominal hysterectomy, total vaginal hysterectomy, laparoscopically-assisted vaginal hysterectomy and total laparoscopic hysterectomy22

Learning curve: High surgeon volume is associated with shorter operating time23 and lower costs.24 Laparoscopic hysterectomy performed by high volume surgeons was associated with a lower risk for perioperative complications,23,25 SSI25 and less blood loss23

Learning curve: In Australia, total hospital costs for laparoscopic hysterectomy were influenced by surgeon volume/experience, such as after a learning curve, the total costs for laparoscopic hysterectomy were significantly lower than for abdominal hysterectomy (Figure 1-7).62 National guidelines for France also advocate that hysterectomy should be performed by surgeons who perform a minimum of ten procedures each year11

Surgeon volume: Laparoscopic hysterectomy performed by high volume surgeons is associated with lower costs than when performed by low and intermediate volume surgeons25

Tissue trauma: Abdominal hysterectomy is associated with more tissue trauma than vaginal hysterectomy and total laparoscopic hysterectomy, as evidenced by significantly higher levels of markers including IL-6 and creatine phosphokinase26

Opioid use: Patients undergoing laparoscopic or vaginal hysterectomy had lower levels of opioid pain relief use relative to patients who underwent abdominal hysterectomy in the 2-week period following the procedure27

Figure 1-3 LoS for abdominal hysterectomy versus laparoscopic hysterectomy

3.7

5.0

6.4

16.0

3.8

6.3

3.03.4

3.0 3.0 3.0

4.2

1.62.0

3.5

9.0

1.6

3.1

2.0 2.3

1.0 1.0 1.0

2.1

Warren2009

Doganay2011

Chalermcho-ckchareonkit

2012

Park2013

Scalici2015

Tinelli2014

Wright2012

Pelligrino2017

Packiam2016

Casarin2018

Linkov2017

Suisted2017

Leng

th o

f sta

y, d

ays

Abdominal Laparoscopic

NR

* * *

* * *

* * *

* *

NR*

NR

* * * * * * NR* * *

*p


Figure 1-4 Operating time with abdominal hysterectomy versus laparoscopic hysterectomy

125

140

264

109

148143

4955

116110

105

139 140

103

130

185

280

119

192

166

9286

105

131 127

154164

127

Doganay2011


2012

Park2013

Riberio2003

Scalici2015

Tinelli2014

Kumar2014

Garry2004

Pellegrino2017

Packiam2016

Wallace2016

Casarin2018

Linkov2017

Suisted2017

Ope

rati

ng ti

me,

min

s


NR

* * *

ns

ns

* * *

ns

* * *NR

NR

* * * NR

* * *NR

* * *

*p


Figure 1-5 Estimated blood loss with abdominal hysterectomy versus laparoscopic hysterectomy

300

761

500

125

200

165

517

200

303 300

65

320

81

153

Doganay2011


2012

Park2013

Tinelli2014

Kumar2014

Pellegrino2017

Suisted2017

Esti

mat

ed b

lood

loss

, mL


ns

* * * * *

* *

* *

NR

* * *

*p


Figure 1-6 Total hospital costs for abdominal versus laparoscopic hysterectomy in studies conducted in Europe

2505

4681

2846

2348

4594

2053

Bijen2011

Netherlands

Coronado2012Spain

Pellegrino2017Italy

Tota

l cos

t, E

UR

Abdominal hysterectomy

Laparoscopic hysterectomy

NR

NR

NR

*p


Figure 1-7 Total hospital costs for abdominal versus laparoscopic hysterectomy for studies performed in Australia

15,870

9,0098,647

12,124

7,842

6,797

Graves2013

Rhou2013

Rhou2013

After learning curveonly

Tota

l cos

ts, A

UD

Abdominal hysterectomy Laparoscopic hysterectomy

NR

ns

* * *

*p


Figure 1-8 Total costs for total abdominal hysterectomy, laparoscopic hysterectomy and vaginal hysterectomy in the United States

10,935

17,631

24,198

10,809

16,361

14,167

13,049

Cohen2017

Fader2016

Fitch2016

Tota

l cos

t, U

SD

Total abdominal hysterectomy Laparoscopic Vaginal

* * *

* * *

* * *

*p

Global Value Dossier: Hysterectomy

18

Table 1-2 Summary of meta-analyses comparing laparoscopic versus open hysterectomy

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

Nieboer et al. 2009 28 34 RCTs, n=4,495 patients

Vaginal hysterectomy versus abdominal hysterectomy and laparoscopic hysterectomy

Vaginal hysterectomy versus abdominal hysterectomy Return to normal activities, days Estimated blood loss, mL Transfusion Length of stay, days Laparoscopic hysterectomy versus abdominal hysterectomy Return to normal activities, days Operating time, mins Estimated blood loss, mL Transfusion Wound/abdominal wall infection LoS, days

−9.47 (−12.57, −6.37)a −11.93 (−70.70, 46.84)a 1.31 (0.46, 3.72) −1.07 (−1.22, −0.92)a −13.63 (−15.42, −11.84)a 0.27 (−23.39, 23.93)a −45.26 (−72.68, −17.85)a 0.78 (0.51, 1.19) 0.31 (0.12, 0.77) −2.01 (−2.17, −1.86)a


19

Table 1-2 Summary of meta-analyses comparing laparoscopic versus open hysterectomy

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

Wang et al. 2018 30 9 RCTs, n=2,263 patients

Abdominal hysterectomy versus laparoscopic hysterectomy versus laparoscopically-assisted vaginal hysterectomy for endometrial cancer (only comparison of abdominal versus laparoscopic presented)

Peri-operative Operating time, mins Bowel injury Post-operative Wound infection

18.80 (5.10, 32.49) 0.94 (0.40, 2.21) 0.52 (0.13, 1.79)

0.002 0.615 0.015

Walsh et al. 200931 3 RCTs, n=201 patients

Total abdominal hysterectomy versus laparoscopic hysterectomy for benign disease

Peri-operative Operating time, mins Estimated blood loss, mL Peri-operative complications Post-operative LoS, days Major complications Minor complications Blood transfusion

22 (5, 39)a −183 (−346, −21)a 0.19 (0.07, 0.50) −2.5 (−5.1, 0.01)a 1.35 (0.32, 5.73) 0.12 (0.04, 0.35) 0.27 (0.05, 2.55)

0.01 0.03 0.0008 0.05 0.68 0.0001 0.31

For odds ratios values below 1.00 favor laparoscopic/vaginal hysterectomy, values above 1.00 favor abdominal hysterectomy aWeighted mean difference, positive values favor abdominal hysterectomy, negative values favor laparoscopic/vaginal hysterectomy CI, confidence interval; LoS, length of stay; OR, odds ratio; RCT, randomized controlled trial


20

Table 1-3 Summary of key clinical studies comparing open versus laparoscopic hysterectomy

Study Setting Study details Procedure (year performed)

Summary of clinical findings

Endpoint Open MIS P value vs open

Garry et al. 200432 and Sculpher et al. 200433

United Kingdom and South Africa

2 parallel multicenter RCTs, n=1,346 Abdominal trial, n=292 abdominal hysterectomy, n=584 laparoscopic Vaginal trial; n=168 vaginal hysterectomy, n=336 laparoscopic

Laparoscopic versus abdominal hysterectomy and laparoscopic versus vaginal hysterectomy for non-malignant conditions (1996–2000)

Abdominal trial Mean operating time, mins Major bleeding Vaginal trial Mean operating time, mins Major bleeding

Abdominal 55.2 2.4%

Laparoscopic 85.9 4.6% Laparoscopic 76.5 5.1%

Vaginal 46.6 2.9%

NR NR NR NR

Baker et al. 201334 Multinational Post-hoc analysis of the LACE RCT data, n=353 total abdominal hysterectomy; n=407 total laparoscopic hysterectomy

Total abdominal hysterectomy versus total laparoscopic hysterectomy for stage I endometrial cancer (2005–2010)

Post-operative Mean (SD) pain score Week 1 Week 4 Month 3 Month 6

Abdominal 2.48 (2.13) 0.89 (1.5) 0.54 (1.26) 0.45 (1.27)

Laparoscopic 1.62 (2.01) 0.63 (1.34) 0.48 (1.39) 0.27 (0.98)


21





Pellegrino et al. 201735

Italy Prospective single center study, n=130 laparoscopic hysterectomy, n=74 open hysterectomy, n=64 robotic hysterectomy (data not presented for robotic hysterectomy)

Open versus laparoscopic hysterectomy for benign conditions (2014–2015)

Peri-operative Mean (SD) operating time, mins Mean (SD) blood loss, mL Post-operative Mean (SD) LoS, days

Open 116 (25) 165 (248) 3.4 (0.8)

Laparoscopic 105 (27) 81 (73) 2.3 (0.5)

NR NR NR

Packiam et al. 201636 United States

Retrospective analysis of n=28,408 abdominal hysterectomy, n=51,293 minimally invasive hysterectomy (including laparoscopic, vaginal and robot-assisted)

Abdominal hysterectomy versus minimally invasive (including laparoscopic, vaginal and robot-assisted) (2005–2013)

Peri-operative Median (IQR) operating time, mins Post-operative Overall complications Wound complications Transfusion Median (IQR) LoS, days Reoperation Readmission Death

Abdominal 110 (80–155) 14.8% 4.7% 7.4% 3 (2–3) 1.9% 5.0% 0.17%

MIS 131 (94–180) 6.6% 2.1% 1.9% 1 (1–1) 1.4% 3.2% 0.04%


22





Cohen et al. 201737 United States

Cross sectional analysis, n=8,433 vaginal hysterectomy, n=49,902 laparoscopic hysterectomy

Laparoscopic versus vaginal hysterectomy for any indication (2011)

Post-operative Mean (95% CI) LoS, days

Laparoscopic 0.65 (0.65–0.66)

Vaginal 0.79 (0.78–0.81)

NR

Fader et al. 201638 United States

Retrospective database analysis, n=21,717, n=10,843 MIS for hysterectomy

Open hysterectomy versus MIS (vaginal, laparoscopic or robot-assisted) hysterectomy for early stage endometrial cancer (2007–2011)

Peri-operative Surgical complication Post-operative SSI Wound/fascial dehiscence Major blood loss LoS >2 days Death

Open 15% 1.5% 0.7% 8% 79% 0.5%

MIS 8.0% 0.3% 0.1% 3.5% 18% 0.1%

NR NR NR NR NR NR


23





Wallace et al. 201639 United States

Retrospective database analysis, n=17,764 total abdominal hysterectomy, n=22,217 laparoscopic and n=11,078 vaginal hysterectomy

Total abdominal versus laparoscopic and vaginal hysterectomy for benign and malignant indications (2008–2012)

Peri-operative Median (IQR) operating time, benign, mins Median (IQR) operating time, malignant (uterine), mins Median (IQR) operating time, malignant, (cervical), mins Post-operative Benign indications Wound complications Blood transfusion Any complication Readmission Return to OR Death Malignant indications Wound complications Blood transfusion Any complication Readmission Return to OR Death

Open 105 (77–146) 143 (103–194) 177 (124–252) TAH 4.1% 5.7% 12.1% 2.2% 1.0% 0.33% 8.2% 18.9% 29.4% 5.5% 1.7% 0.84%

Laparoscopic 127 (95–174) 172 (127–229) 210 (134–189) Laparoscopic 2.1% 1.3% 6.2% 2.0% 1.0% 0.20% 2.2% 2.0% 7.2% 3.2% 0.90% 0.14%

Vaginal 94 (65–135) Vaginal 1.7% 1.7% 7.0% 1.4% 0.86% 0.07% 3.2% 3.2% 9.7% 3.8% 1.1% 0.54%

NR NR NR NR NR NR NR NR NR NR NR NR


24





Warren et al. 200940 United States

Retrospective database analysis, n=8754 open abdominal hysterectomy, n=3,520 laparoscopic hysterectomy, n=3,130 vaginal hysterectomy

Open abdominal versus laparoscopic and vaginal hysterectomy (2005–2006)

Post-operative Any infection Mean (SD) LoS, days

Abdominal 18% 3.66 (1.83)

Laparoscopic 15% 1.56 (1.48)

Vaginal 14% 2.21 (1.50)

Laparoscopic


25





Fitch et al. 201642 United States

Retrospective database analysis, n=6,060 inpatient open, n=10,175 outpatient laparoscopic, n=3,415 outpatient laparoscopically-assisted, n=2,276 outpatient vaginal

Inpatient open versus outpatient MIS (2012–2013)

Post-operative 30-day readmission

Open 0.31%

Laparoscopic 0.21%

LAVH 0.22%

Vaginal 0.25%

0.01b

Leiserowitz et al. 200943

United States

Retrospective database analysis, n=978 laparoscopically-assisted vaginal hysterectomy; n=11,765 total abdominal hysterectomy

Laparoscopically assisted vaginal hysterectomy versus total abdominal hysterectomy for endometrial cancer (1997–2001)

Post-operative


26





Harris et al. 201644 United States

Retrospective cohort study in n=3,385 abdominal hysterectomy, n=7,759 laparoscopic hysterectomy, n=3,272 vaginal hysterectomy

In patients undergoing hysterectomy for benign indications (2013–2015; only 2015 data presented)

Post-operative Major complications Hospital readmission Reoperation

Abdominal 10.2% 6.1% 3.4%

Laparoscopic 3.4% 3.7% 2.0%

Vaginal 3.1% 3.6% 2.3%

NR NR NR

Hanwright et al. 201345

United States

Retrospective database analysis, n=4,4107 laparoscopically assisted vaginal hysterectomy (LAVH) and n=2,083 total laparoscopic hysterectomy

Laparoscopically assisted vaginal hysterectomy versus total laparoscopic hysterectomy for any indication (2006–2010)

Perioperative Mean (SD) Length of surgery, hours Post-operative Overall complications Wound complications Medical complications Reoperation Mean (SD) LoS, days

LAVH 2.20 (1.14) 7.0% 2.2% 5.4% 1.3% 1.36 (1.61)

TLH 2.66 (1.25) 6.3% 1.8% 4.9% 1.7% 1.18 (1.35)

LAVH vs. TLH


27





Doganay et al. 201146

Turkey Retrospective single center chart review, n=4,398 abdominal hysterectomy, n=1,944 vaginal hysterectomy, n=138 total laparoscopic hysterectomy

Open abdominal versus total laparoscopic and vaginal hysterectomy for benign indications (2001–2009)

Peri-operative Major complications Minor complications Median (range) operating time, mins Median (range) blood loss, mL Post-operative Median (range) LoS, days

Abdominal 3.6% 2.7% 125 (35–240) 300 (80–1,800) 5 (3–40)

TLH 2.8% 0.7% 130 (70–260) 200 (50–650) 2 (1–15)

Vaginal 2.7% 1.4% 95 (30–108) 250 (50–800) 2 (5–20)

TLH NR NR NR


28





Gale et al. 2016 48 Canada Retrospective single center analysis, n=1,760 laparotomy, n=1,972 laparoscopic hysterectomy, n=605 vaginal hysterectomy

Laparotomy versus laparoscopic and vaginal hysterectomy for benign disease (2005–2012)

Post-operative ED visit Readmission Transfusion Return to OR Admission to ICU

10.6% 3.2% 2.4% 1.1% 0.1%

Laparoscopic 12.9% 3.5% 1.0% 1.0% 0.3%

Vaginal 10.1% 3.4% 1.3% 0.9% 0.1%

Laparoscopic ns ns ns ns ns

Vaginal ns ns ns ns ns

Wright et al. 201249 United States

Retrospective database analysis, n=1,610 abdominal hysterectomy, n=217 laparoscopic hysterectomy, n=67 robotic hysterectomy (not presented)

Abdominal versus laparoscopic versus robotic (not presented) radical hysterectomy for cervical cancer (2006–2010)

Peri-operative Intraoperative complication Post-operative Any complication Surgical site complications Medical complications Transfusion Re-operation Median LoS, days LoS >3 days Non-routine discharge Mortality

Abdominal 5.8% 15.8% 3.4% 8.8% 15.0% 0.4% 3 44.3% 1.3% 1.3%

Laparoscopic 5.1% 9.2% 3.2% 3.2% 5.1% 0 2 11.1% 0.9% 0

NR NR NR NR NR NR NR NR NR NR


29





Scalici et al. 201550 United States

Retrospective database analysis, n=1,269 exploratory laparotomy, n=807 minimally invasive surgery

Exploratory laparotomy versus minimally invasive surgery for hysterectomy for endometrial cancer (2006–2010)

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

Open 148 (68) 3.8 (2.1) 31.3%

MIS 192 (84) 1.6 (1.2) 12.0%


30





Chalermchockchareonkit et al. 2012 52

Thailand Retrospective chart review, n=115 laparoscopic hysterectomy, n=388 abdominal hysterectomy

Abdominal versus laparoscopic hysterectomy for severe pelvic endometriosis (2002–2007)

Peri-operative Conversion Mean (SD) surgical time, mins Estimated blood loss, mL Blood loss ≥500 mL Blood loss ≥1,000 mL Blood transfusion Post-operative Mean (SD) LoS, days Complications Post-operative fever Organ injuries Bladder injury Ureteric injury Bowel injury

Abdominal ― 140 (52) 761 (633) 59% 26% 31% 6.4 (3.0) 49% 28% 5% 0.5% 0.8% 4%

Laparoscopic 4.3% 185 (49) 303 (255) 20% 4% 7% 3.5 (1.1) 18% 10% 0.9% 0.9% 0 0


31





Suisted et al. 201753 New Zealand Single center analysis prospective data collection for n=120 total laparoscopic hysterectomy, n=120 abdominal hysterectomy, n=120 vaginal hysterectomy

Abdominal versus total laparoscopic versus vaginal hysterectomy for benign disease or early malignancy (2012–2015)

Peri-operative Mean (SD) operating time, mins Mean (SD) estimated blood loss, mL Post-operative Mean (SD) LoS, hours Any major complication Re-operation Wound infection Readmission Transfusion

Open 103 (33) 517 (672) 102 (37) 6.6% 3.3% 5% 7.5% 5.8%

TLH 127 (45) 153 (116) 51 (21) 2.5% 0.8% 3.3% 3.3% 0%

Vaginal 93 (27) 245 (207) 75 (31) 6.6% 3.3% 3.3% 2.5% 0%

TLH


32





Park et al. 201355 South Korea Retrospective single center analysis, n=115 laparoscopic radical hysterectomy; n=188 open radical hysterectomy

Laparoscopic versus open radical hysterectomy for stage IB2 and IIA2 cervical cancer (1997–2011)

Peri-operative Median (range) operating time, mins Median (range) blood loss, mL Transfusion required Intraoperative complication Post-operative Post-operative complication Median (range) LoS, days

Open (radical) 264 (110–505) 500 (50–2,000) 44.7% 2.1% 13.8% 16 (4–69)

Laparoscopic 280 (145–580) 300 (50–2,000) 46.9% 4.3% 6.1% 9 (5–33)

0.080 0.003 0.708 0.269 0.036 0.001

Tinelli et al. 201456 Italy Multicenter analysis in obese patients, n=45 laparoscopic, n=30 laparotomic hysterectomy

Laparoscopic versus laparotomy for hysterectomy in obese women with endometrial cancer (2004–2013)

Peri-operative Mean (SD) blood loss, mL Mean (SD) operating time, mins Post-operative Mean (SD) LoS, days Post-discharge Cancer recurrence

Open 125 (32) 143 (25) 6.3 (1.1) 6.6%

Laparoscopic 65 (15) 166 (21) 3.1 (0.4) 8.8%


33





Riberio et al. 200357 Brazil RCT, n=20 total abdominal hysterectomy, n=20 vaginal hysterectomy, n=20 laparoscopic hysterectomy

Total abdominal hysterectomy versus vaginal hysterectomy versus laparoscopic hysterectomy

Peri-operative Mean operating time, mins

TAH 109

Laparoscopic 119

Vaginal 78

Laparoscopic ns

Vaginal


34

Table 1-4 Summary of key studies comparing economic outcomes of open versus laparoscopic hysterectomy

Study Setting Study details Procedures Currency (Cost year)

Cost

Outcome Open MIS P value

Pellegrino et al. 201735

Italy Prospective single center study, n=130 laparoscopic hysterectomy, n=74 open hysterectomy, n=64 robotic hysterectomy (data not presented for robotic hysterectomy)

Open versus laparoscopic hysterectomy for benign conditions (2014–2015)

EUR (2014–2015)

Costs Mean total cost Mean cost hospital stay Mean cost operating room staff

2,846 1,740 935

Laparoscopic 2,053 1,120 775

NR NR NR

Cohen et al. 201737

United States Cross sectional analysis, n=7,625 vaginal hysterectomy, n=44,624 laparoscopic hysterectomy

Laparoscopic versus vaginal hysterectomy for any indication (2011)

USD (year not stated)

Costs Mean (95% CI) total charges

Laparoscopic 24,198 (24,017–24,381)

Vaginal 14,167 (13,912–14,427)


35



Cost


laparoscopic hysterectomy, n=3,130 vaginal hysterectomy

Mean (SD) outpatient cost (adjusted)

NA

9,426 (339)

7,627 (304)

NR

NR

Fader et al. 201638

United States Retrospective database analysis, n=21,717, n=10,843 MIS for hysterectomy

Open hysterectomy versus MIS (vaginal, laparoscopic or robot-assisted) hysterectomy for early stage endometrial cancer (2007–2011)


Costs Overall mean costs without complication Adjusted additional cost associated with complications

10,935 7,444

Laparoscopic 10,809 7,358


36



Cost


Mannschreck et al. 201658

United States Retrospective cohort study in n=7,388 (propensity matched) patients with open or minimally invasive hysterectomy

Open hysterectomy versus minimally invasive (vaginal, laparoscopic or robot-assisted) in patients with non-metastatic endometrial cancer (propensity score matched analysis) (2012–2013)


Costs Mean (95% CI) overall cost Mean (95% CI) cost without complications Mean (95% CI) cost with complications

14,712 (14,434–14,989) 12,269 (12,013–12,525) 20,617 (20,009–21,225)

13,469 (13,217–13,722)

12,301 (12,067–12,536)

20,795 (20,089–21,501)


37



Cost


n=217 laparoscopic hysterectomy, n=67 robotic hysterectomy (not presented)

hysterectomy for cervical cancer (2006–2010)

Barnett et al. 201059

United States Cost comparison of robotic, versus laparoscopic versus open hysterectomy using decision analytic model

Robotic versus laparoscopic versus open hysterectomy (robotic not presented here)

USD (2008) Costs Preoperative holding cost Intraoperative Anesthesia professional fee Surgeon professional fee Operating room time Operating room fees Anesthesia set up Operating room set up Disposable instruments Post-operative Post-operative anesthesia care unit Room, board, transfusions and pharmacy Recovery Lost wages and caregiver

95 923 1,186 1,600 341 1,381 198 404 4,044 4,405

95

1,385

1,351 2,326

341

1,085 1,138

216

704

2,677

NR

NR

NR NR

NR NR NR

NR

NR

NR

Lenihan et al. 200460

United States Combined retrospective cohort study, of

Total abdominal hysterectomy versus total vaginal

USD Costs Total hospital charges Time to return to normal

13,089 5.7

LAVH 15,186 3.17

TVH 10,146 5.25


38



Cost


total abdominal hysterectomy, total vaginal hysterectomy and laparoscopically assisted vaginal hysterectomy

hysterectomy and laparoscopically assisted vaginal hysterectomy (2001–2003)

activity, weeks Time to return to work, weeks Family time off, days

5.93 4.63

3.8 2.38

5.0 3.8

NR NR

Sculpher et al. 200433

United Kingdom

Cost-effectiveness analysis based on two parallel trial, one comparing laparoscopic versus vaginal hysterectomy and laparoscopic versus abdominal hysterectomy

Laparoscopic versus vaginal hysterectomy and laparoscopic versus abdominal hysterectomy for benign indications

GBP (1999–2000)

Vaginal trial Mean theatre cost Hospital “hotel” cost Other post-operative cost Follow-up cost at 6 weeks Follow-up cost at 4 months Follow-up cost at 1 year Total cost Abdominal trial Mean theatre cost Hospital “hotel” cost Other post-operative cost Follow-up cost at 6 weeks Follow-up cost at 4 months Follow-up cost at 1 year Total cost

453 692 13 128 88 146 1,520

Vaginal 396 591 18 89 47 112 1,253

Laparoscopic 807 589 14 144 37 64 1,654 788 548 21 193 39 115 1,706

NR NR NR NR NR NR NR NR NR NR NR NR NR NR


39



Cost


Graves et al. 201361

Australia Cost-effectiveness modeling study using RCT data

Total abdominal hysterectomy versus total laparoscopic hysterectomy

AUD (2011) Costs Surgery costs Total costs

6,755 15,870

7,265

12,124

NR

Rhou et al. 201362

Australia Retrospective review of direct costs in a tertiary hospital in a matched cohort

Total laparoscopic hysterectomy versus fast track open hysterectomy

AUD (year not stated)

Costs Intraoperative costs Post-operative cost Total cost Total cost after learning curve

2,776 6,233 9,009 8,647

3,877 3,965 7,842 6,797

0.001 0.001 0.068 0.001

Bijen et al. 201163

The Netherlands

Cost-effectiveness analysis based on RCT, n=185 laparoscopic, n=94 open

Total laparoscopic hysterectomy versus total abdominal hysterectomy for early stage endometrial cancer

EUR (2008) Costs Operative procedure Hospital stay Additional homecare

372 (169) 2,133 (1,175) 1,072 (1,508)

1,173 (345)

1,175 (995)

1,105 (1,928)

NR NR NR


40



Cost


Coronado et al. 201264

Spain Single center study of costs and outcomes, n=84 laparoscopic, n= 192 open and n=71 robotic (not presented here)

Robotic versus laparoscopy versus laparotomy surgery including hysterectomy for endometrial cancer (robotic not presented) (2003–2011)

EUR (year not stated)

Costs Mean (SD) surgical cost Mean (SD) hospitalization cost Mean (SD) total cost

1,145 (206) 4,384.5 (2,932.9) 4,680.7 (1,860.3)

2,334.5 (334.1)

2,694.3 (2,547.5)

4,594.3 (1,447.8)

NR NR NR

aIncludes procedure and 30-day readmission costs LAVH, laparoscopically-assisted vaginal hysterectomy; MIS; minimally invasive surgery; NR, not reported; RCT, randomized controlled trial; SD, standard deviation; TVH, total vaginal hysterectomy

Global Value Dossier: Hysterectomy 41

1.3. References

1 Whiteman MK, Hillis SD, Jamieson DJ, Morrow B, Podgornik MN, Brett KM, Marchbanks PA. Inpatient hysterectomy surveillance in the United States, 2000-2004. Am J Obstet Gynecol. 2008 Jan;198(1):34.e1-7 (PMID: 17981254) 2 Stang A, Merrill RM, Kuss O. Hysterectomy in Germany: a DRG-based nationwide analysis, 2005-2006. Dtsch Arztebl Int. 2011 Jul;108(30):508-14 (PMID: 21904583)

3 Garry R. Health economics of hysterectomy. Best Pract Res Clin Obstet Gynaecol. 2005 Jun;19(3):451-65 (PMID: 15985258)

4 Madhvani K, Curnow T, Carpenter T. Route of hysterectomy: a retrospective, cohort study in English NHS Hospitals from 2011 to 2017. BJOG. 2019 May;126(6):795-802 (PMID:

30461181) 5 Lee J, Jennings K, Borahay MA, Rodriguez AM, Kilic GS, Snyder RR, Patel PR. Trends in the national distribution of laparoscopic hysterectomies from 2003 to 2010. J Minim Invasive Gynecol. 2014 Jul-Aug;21(4):656-61 (PMID: 24462854)

6 Huang CC, Lo TS, Huang YT, Long CY, Law KS, Wu MP. Surgical Trends and Time Frame Comparison of Surgical Types of Hysterectomy: A Nationwide, Population-based 15-year Study. J Minim Invasive Gynecol. 2019 Mar 28. pii: S1553-4650(19)30141-4 (PMID: 30928611)

7 Cure N, Robson SJ. Changes in Hysterectomy Route and Adnexal Removal for Benign Disease in Australia 2001-2015: A National Population-Based Study. Minim Invasive Surg. 2018 May 31;2018:5828071 (PMID: 29955395)

8 Chrysostomou A, Djokovic D, Edridge W, van Herendael BJ. Evidence-based guidelines for vaginal hysterectomy of the International Society for Gynecologic Endoscopy (ISGE). Eur J Obstet Gynecol Reprod Biol. 2018 Dec;231:262-267 (PMID: 30447552) 9 Sloth SB, Schroll JB, Settnes A, Gimbel H, Rudnicki M, Topsoee MF, Joergensen A, Nortvig H, Moeller C. Systematic review of the limited evidence for different surgical techniques at benign hysterectomy: A clinical guideline initiated by the Danish Health Authority. Eur J Obstet Gynecol Reprod Biol. 2017 Sep;216:169-177 (PMID:28779691) 10 Committee on Gynecologic Practice. Committee Opinion No 701: Choosing the Route of Hysterectomy for Benign Disease. Obstet Gynecol. 2017 Jun;129(6):e155-e159 (PMID: 28538495) 11 Deffieux X, Rochambeau Bd, Chene G, Gauthier T, Huet S, Lamblin G, Agostini A, Marcelli M, Golfier F. Hysterectomy for benign disease: clinical practice guidelines from the French College of Obstetrics and Gynecology. Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:83-91 (PMID: 27196085)

12 AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):1-3 (PMID: 21059487) 13 Practice Bulletin No. 149: Endometrial cancer. Obstet Gynecol. 2015 Apr;125(4):1006-26 (PMID: 25798986)

http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+17981254http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+21904583http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+15985258https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A++30461181https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A++30461181http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+24462854https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+30928611https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+30928611https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+29955395https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+30447552https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+28779691https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+28538495https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+28538495https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+27196085http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+21059487http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+25798986


14 Colombo N, Preti E, Landoni F, Carinelli S, Colombo A, Marini C, Sessa C; ESMO Guidelines Working Group. Endometrial cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi33-8 (PMID: 24078661) 15 Roy S, Patkar A, Daskiran M, Levine R, Hinoul P, Nigam S. Clinical and economic burden of surgical site infection in hysterectomy. Surg Infect (Larchmt). 2014 Jun;15(3):266-73 (PMID: 24801549) 16 Bakkum-Gamez JN, Dowdy SC, Borah BJ, Haas LR, Mariani A, Martin JR, Weaver AL, McGree ME, Cliby WA, Podratz KC. Predictors and costs of surgical site infections in patients with endometrial cancer. Gynecol Oncol. 2013 Jul;130(1):100-6 (PMID: 23558053) 17 Tuomi T, Pasanen A, Leminen A, Bützow R, Loukovaara M. Incidence of and risk factors for surgical site infections in women undergoing hysterectomy for endometrial carcinoma. Acta Obstet Gynecol Scand. 2016 Apr;95(4):480-5 (PMID: 26661044) 18 Shander A, Hofmann A, Ozawa S, Theusinger OM, Gombotz H, Spahn DR. Activity-based costs of blood transfusions in surgical patients at four hospitals. Transfusion. 2010 Apr;50(4):753-65 (PMID: 20003061) 19 Hill SR, Carless PA, Henry DA, Carson JL, Hebert PC, McClelland DB, Henderson KM. Transfusion thresholds and other strategies for guiding allogeneic red blood cell transfusion. Cochrane Database Syst Rev. 2002;(2):CD002042. Review. Update in: Cochrane Database Syst Rev. 2010;(10):CD002042 (PMID: 12076437) 20 Jonsdottir GM, Jorgensen S, Cohen SL, Wright KN, Shah NT, Chavan N, Einarsson JI. Increasing minimally invasive hysterectomy: effect on cost and complications. Obstet Gynecol. 2011 May;117(5):1142-9 (PMID: 21508754) 21 Mahdi H, Lockhart D, Maurer KA. Impact of age on 30-day mortality and morbidity in patients undergoing surgery for endometrial cancer. Gynecol Oncol. 2015 Apr;137(1):106-11 (PMID: 25640765)

22 Mikhail E, Miladinovic B, Velanovich V, Finan MA, Hart S, Imudia AN. Association between obesity and the trends of routes of hysterectomy performed for benign indications. Obstet Gynecol. 2015 Apr;125(4):912-8 (PMID: 25751208) 23 Vree FE, Cohen SL, Chavan N, Einarsson JI. The impact of surgeon volume on perioperative outcomes in hysterectomy. JSLS. 2014 Apr-Jun;18(2):174-81 (PMID: 24960479) 24 Shepherd JP, Carter-Brooks CM, Kantartzis KL, Lee T, Bonidie MJ. The Impact of Individual Surgeon Volume on Hysterectomy Costs. JSLS. 2017 Jan-Mar;21(1). pii: e2016.00112 (PMID: 28400697) 25 Wallenstein MR, Ananth CV, Kim JH, Burke WM, Hershman DL, Lewin SN, Neugut AI, Lu YS, Herzog TJ, Wright JD. Effect of surgical volume on outcomes for laparoscopic hysterectomy for benign indications. Obstet Gynecol. 2012 Apr;119(4):709-16 (PMID: 22433333) 26 Oksuzoglu A, Seckin B, Turkcapar AF, Ozcan S, Gungor T. Comparison of tissue trauma after abdominal, vaginal and total laparoscopic hysterectomy. Ginekol Pol. 2015 Apr;86(4):268-73 (PMID: 26117985)

27 As-Sanie S, Till SR, Mowers EL, Lim CS, Skinner BD, Fritsch L, Tsodikov A, Dalton VK, Clauw DJ, Brummett CM. Opioid Prescribing Patterns, Patient Use, and Postoperative Pain

http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+24078661http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+24801549http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+24801549http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+23558053https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+26661044http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+20003061http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+12076437http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+21508754http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+25640765http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+25751208http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+24960479http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+24960479https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+28400697http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+22433333http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+22433333http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+26117985


After Hysterectomy for Benign Indications. Obstet Gynecol. 2017 Dec;130(6):1261-1268 (PMID: 29112660)

28 Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677 (PMID: 19588344)

29 Wang HL, Ren YF, Yang J, Qin RY, Zhai KH. Total laparoscopic hysterectomy versus total abdominal hysterectomy for endometrial cancer: a meta-analysis. Asian Pac J Cancer Prev. 2013;14(4):2515-9 (PMID: 23725166)

30 Wang YR, Lu HF, Huo HC, Qu CP, Sun GX, Shao SQ. A network meta-analysis of comparison of operative time and complications of laparoscopy, laparotomy, and laparoscopic-assisted vaginal hysterectomy for endometrial carcinoma. Medicine (Baltimore). 2018 Apr;97(17):e0474 (PMID: 29703003) 31 Walsh CA, Walsh SR, Tang TY, Slack M. Total abdominal hysterectomy versus total laparoscopic hysterectomy for benign disease: a meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2009 May;144(1):3-7 (PMID: 19324491) 32 Garry R, Fountain J, Mason S, Hawe J, Napp V, Abbott J, Clayton R, Phillips G, Whittaker M, Lilford R, Bridgman S, Brown J. The eVALuate study: two parallel randomised trials, one comparing laparoscopic with abdominal hysterectomy, the other comparing laparoscopic with vaginal hysterectomy. BMJ. 2004 Jan 17;328(7432):129 (PMID: 14711749) 33 Sculpher M, Manca A, Abbott J, Fountain J, Mason S, Garry R. Cost effectiveness analysis of laparoscopic hysterectomy compared with standard hysterectomy: results from a randomised trial. BMJ. 2004 Jan 17;328(7432):134 (PMID: 14711748) 34 Baker J, Janda M, Belavy D, Obermair A. Differences in Epidural and Analgesic Use in Patients with Apparent Stage I Endometrial Cancer Treated by Open versus Laparoscopic Surgery: Results from the Randomised LACE Trial. Minim Invasive Surg. 2013;2013:764329 (PMID: 23956855) 35 Pellegrino A, Damiani GR, Fachechi G, Corso S, Pirovano C, Trio C, Villa M, Turoli D, Youssef A. Cost analysis of minimally invasive hysterectomy vs open approach performed by a single surgeon in an Italian center. J Robot Surg. 2017 Jun;11(2):115-121 (PMID: 27460843)

36 Packiam VT, Cohen AJ, Pariser JJ, Nottingham CU, Faris SF, Bales GT. The Impact of Minimally Invasive Surgery on Major Iatrogenic Ureteral Injury and Subsequent Ureteral Repair During Hysterectomy: A National Analysis of Risk Factors and Outcomes. Urology. 2016 Dec;98:183-188 (PMID: 27392649) 37 Cohen SL, Ajao MO, Clark NV, Vitonis AF, Einarsson JI. Outpatient Hysterectomy Volume in the United States. Obstet Gynecol. 2017 Jul;130(1):130-137. (PMID: 28594764)

38 Fader AN, Weise RM, Sinno AK, Tanner EJ 3rd, Borah BJ, Moriarty JP, Bristow RE, Makary MA, Pronovost PJ, Hutfless S, Dowdy SC. Utilization of Minimally Invasive Surgery in Endometrial Cancer Care: A Quality and Cost Disparity. Obstet Gynecol. 2016 Jan;127(1):91-100. (PMID: 26646127)

39 Wallace SK, Fazzari MJ, Chen H, Cliby WA, Chalas E. Outcomes and Postoperative Complications After Hysterectomies Performed for Benign Compared With Malignant Indications. Obstet Gynecol. 2016 Sep;128(3):467-75 (PMID: 27500339)

https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+29112660http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+19588344http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+23725166https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+29703003http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+19324491http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+14711749http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+14711748http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+23956855https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+27460843https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+27460843https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+27392649https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+28594764https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+26646127https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+27500339


40 Warren L, Ladapo JA, Borah BJ, Gunnarsson CL. Open abdominal versus laparoscopic and vaginal hysterectomy: analysis of a large United States payer measuring quality and cost of care. J Minim Invasive Gynecol. 2009 Sep-Oct;16(5):581-8 (PMID: 19835801) 41 Casarin J, Multinu F, Ubl DS, Dowdy SC, Cliby WA, Glaser GE, Butler KA, Ghezzi F, Habermann EB, Mariani A. Adoption of Minimally Invasive Surgery and Decrease in Surgical Morbidity for Endometrial Cancer Treatment in the United States. Obstet Gynecol. 2018 Feb;131(2):304-311 (PMID: 29324598) 42 Fitch K, Huh W, Bochner A. Open vs. Minimally Invasive Hysterectomy: Commercially Insured Costs and Readmissions. Manag Care. 2016 Aug;25(8):40-47 (PubMed PMID: 28121585)

43 Leiserowitz GS, Xing G, Parikh-Patel A, Cress R, Abidi A, Rodriguez AO, Dalrymple JL. Laparoscopic versus abdominal hysterectomy for endometrial cancer: comparison of patient outcomes. Int J Gynecol Cancer. 2009 Nov;19(8):1370-6 (PMID: 20009892) 44 Harris JA, Swenson CW, Uppal S, Kamdar N, Mahnert N, As-Sanie S, Morgan DM. Practice patterns and postoperative complications before and after US Food and Drug Administration safety communication on power morcellation. Am J Obstet Gynecol. 2016 Jan;214(1):98.e1-98.e13 (PMID: 26314519)

45 Hanwright PJ, Mioton LM, Thomassee MS, Bilimoria KY, Van Arsdale J, Brill E, Kim JY. Risk profiles and outcomes of total laparoscopic hysterectomy compared with laparoscopically assisted vaginal hysterectomy. Obstet Gynecol. 2013 Apr;121(4):781-7 (PMID: 23635678) 46 Doğanay M, Yildiz Y, Tonguc E, Var T, Karayalcin R, Eryılmaz OG, Aksakal O. Abdominal, vaginal and total laparoscopic hysterectomy: perioperative morbidity. Arch Gynecol Obstet. 2011 Aug;284(2):385-9 (PMID: 20844884) 47 Wright JD, Burke WM, Tergas AI, Hou JY, Huang Y, Hu JC, Hillyer GC, Ananth CV, Neugut AI, Hershman DL. Comparative Effectiveness of Minimally Invasive Hysterectomy for Endometrial Cancer. J Clin Oncol. 2016 Apr 1;34(10):1087-96 (PMID: 26834057) 48 Gale J, Cameron C, Chen I, Guo Y, Singh SS. Increasing Minimally Invasive Hysterectomy: A Canadian Academic Health Centre Experience. J Obstet Gynaecol Can. 2016 Feb;38(2):141-6 (PMID: 27032738)

49 Wright JD, Herzog TJ, Neugut AI, Burke WM, Lu YS, Lewin SN, Hershman DL. Comparative effectiveness of minimally invasive and abdominal radical hysterectomy for cervical cancer. Gynecol Oncol. 2012 Oct;127(1):11-7 (PMID: 22735788) 50 Scalici J, Laughlin BB, Finan MA, Wang B, Rocconi RP. The trend towards minimally invasive surgery (MIS) for endometrial cancer: an ACS-NSQIP evaluation of surgical outcomes. Gynecol Oncol. 2015 Mar;136(3):512-5 (PMID: 25462206) 51 Linkov F, Sanei-Moghaddam A, Edwards RP, Lounder PJ, Ismail N, Goughnour SL, Kang C, Mansuria SM, Comerci JT. Implementation of Hysterectomy Pathway: Impact on Complications. Womens Health Issues. 2017 Jul - Aug;27(4):493-498 (PMID: 28347618) 52 Chalermchockchareonkit A, Tekasakul P, Chaisilwattana P, Sirimai K, Wahab N. Laparoscopic hysterectomy versus abdominal hysterectomy for severe pelvic endometriosis. Int J Gynaecol Obstet. 2012 Feb;116(2):109-11 (PMID: 22093496) 53 Suisted P, Chittenden B. Perioperative outcomes of total laparoscopic hysterectomy at a regional hospital in New Zealand. Aust N Z J Obstet Gynaecol. 2017 Feb;57(1):81-86 (PMID: 28251631)

http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+19835801https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+29324598https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+28121585https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+28121585http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+20009892https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+26314519http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+23635678http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+20844884https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+26834057https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+27032738http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+22735788http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+25462206https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+28347618http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+22093496https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+28251631https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+28251631


54 Kumar A, Pearl M. Mini-laparotomy versus laparoscopy for gynecologic conditions. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):109-14 (PMID: 23911561) 55 Park JY, Kim DY, Kim JH, Kim YM, Kim YT, Nam JH. Laparoscopic versus open radical hysterectomy in patients with stage IB2 and IIA2 cervical cancer. J Surg Oncol. 2013 Jul;108(1):63-9 (PMID: 23737035)

56 Tinelli R, Litta P, Meir Y, Surico D, Leo L, Fusco A, Angioni S, Cicinelli E. Advantages of laparoscopy versus laparotomy in extremely obese women (BMI>35) with early-stage endometrial cancer: a multicenter study. Anticancer Res. 2014 May;34(5):2497-502 (PMID: 24778066) 57 Ribeiro SC, Ribeiro RM, Santos NC, Pinotti JA. A randomized study of total abdominal, vaginal and laparoscopic hysterectomy. Int J Gynaecol Obstet. 2003 Oct;83(1):37-43 (PMID: 14511870) 58 Mannschreck D, Matsuno RK, Moriarty JP, Borah BJ, Dowdy SC, Tanner EJ 3rd, Makary MA, Stone RL, Levinson KL, Temkin SM, Fader AN. Disparities in Surgical Care Among Women With Endometrial Cancer. Obstet Gynecol. 2016 Sep;128(3):526-34 (PMID: 27500330)

59 Barnett JC, Judd JP, Wu JM, Scales CD Jr, Myers ER, Havrilesky LJ. Cost comparison among robotic, laparoscopic, and open hysterectomy for endometrial cancer. Obstet Gynecol. 2010 Sep;116(3):685-93 (PMID: 14711748) 60 Lenihan JP Jr, Kovanda C, Cammarano C. Comparison of laparoscopic-assisted vaginal hysterectomy with traditional hysterectomy for cost-effectiveness to employers. Am J Obstet Gynecol. 2004 Jun;190(6):1714-20 (PMID: 15284779) 61 Graves N, Janda M, Merollini K, Gebski V, Obermair A; LACE trial committee. The cost-effectiveness of total laparoscopic hysterectomy compared to total abdominal hysterectomy for the treatment of early stage endometrial cancer. BMJ Open. 2013 Apr 18;3(4) (PMID: 23604345) 62 Rhou YJ, Pather S, Loadsman JA, Campbell N, Philp S, Carter J. Direct hospital costs of total laparoscopic hysterectomy compared with fast-track open hysterectomy at a tertiary hospital: a retrospective case-controlled study. Aust N Z J Obstet Gynaecol. 2013 May 2. doi: 10.1111/ajo.12093. [Epub ahead of print] (PMID: 23634987) 63 Bijen CB, Vermeulen KM, Mourits MJ, Arts HJ, Ter Brugge HG, van der Sijde R, Wijma J, Bongers MY, van der Zee AG, de Bock GH. Cost effectiveness of laparoscopy versus laparotomy in early stage endometrial cancer: a randomized trial. Gynecol Oncol. 2011 Apr;121(1):76-82 (PMID: 21215439) 64 Coronado PJ, Herraiz MA, Magrina JF, Fasero M, Vidart JA. Comparison of perioperative outcomes and cost of robotic-assisted laparoscopy, laparoscopy and laparotomy for endometrial cancer. Eur J Obstet Gynecol Reprod Biol. 2012 Dec;165(2):289-94 (PMID: 22819573)

©2020 Medtronic. All rights reserved. Medtronic, Medtronic logo and Further, Together are trademarks of Medtronic. All other brands are trademarks of a Medtronic company. 3/2020 US160331(2)

http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+23911561http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+23737035http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+24778066http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+24778066http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+14511870http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+14511870https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+27500330https://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+27500330http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+14711748http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+15284779http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+23604345http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+23634987http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+21215439http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+22819573http://www.ncbi.nlm.nih.gov/pubmed/?term=PMID%3A+22819573

1. Hysterectomy1.1. Overview of procedure1.2. Clinical and economic outcomes with open versus minimally invasive hysterectomy1.1.1. Clinical and economic evidence tables

1.3. References

GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY · 2021. 1. 17. · • Minimally invasive...

Documents

Transcript of GLOBAL VALUE DOSSIER FOR MINIMALLY INVASIVE SURGERY · 2021. 1. 17. · • Minimally invasive...