Original Article

A Randomized Trial Comparing Vaginal and Laparoscopic

Hysterectomy vs Robot-Assisted Hysterectomy
onnerfors, MD, Petur Reynisson, MD, PhD, and Jan Persson, MD, PhD*
Celine L€
From the Department of Obstetrics and Gynecology, Sk
ane University Hospital and Lund University, Lund, Sweden (all authors).

ABSTRACT Study Objective: To investigate the hospital cost and short-term clinical outcome of traditional minimally invasive hyster-
ectomy vs robot-assisted hysterectomy in women primarily not considered candidates for vaginal surgery.
Design: Randomized controlled trial (Canadian Task Force classification I).
Setting: University Hospital in Sweden.
Patients: One hundred twenty-two women with uterine size %16 gestational weeks scheduled to undergo minimally invasive
hysterectomy because of benign disease.
Interventions: Robot-assisted hysterectomy or traditional vaginal or laparoscopic minimally invasive hysterectomy.
Measurements and Main Results: All women underwent surgery as randomized. There were no demographic differences
between the 2 groups. Vaginal hysterectomy was possible in 41% in the traditional minimally invasive group, at a mean hos-
pital cost of $4579 compared with $7059 for traditional laparoscopic hysterectomy. This was reflected in a mean hospital cost
of $993 more per robotic-assisted hysterectomy than for traditional minimally invasive hysterectomy when the robot was a
preexisting investment. This hospital cost increased by $1607 when including investments and cost of maintenance. A per-
protocol subanalysis comparing laparoscopy and robotics demonstrated similar hospital cost when the robot was a preexisting
investment ($7059 vs $7016). Robotic-assisted hysterectomy was associated with less blood loss and fewer postoperative
complications.
Conclusion: A similar hospital cost can be attained for laparoscopy and robotics when the robot is a preexisting investment.
From the perspective of hospital costs, robotic-assisted hysterectomy is not advantageous for treating benign conditions when
a vaginal approach is feasible in a high proportion of patients. Journal of Minimally Invasive Gynecology (2015) 22, 78–86
Ó 2015 AAGL. All rights reserved.
Keywords: Hysterectomy; Laparoscopic hysterectomy; Minimally invasive surgery; Robot-assisted laparoscopy; Vaginal hysterectomy
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The potential benefit of robot-assisted laparoscopic
surgery is enabling a higher proportion of minimally inva-
sive surgical procedures. Despite guidelines supporting
minimally invasive procedures, hysterectomy to treat benign
gynecologic disease is still most commonly performed via
laparotomy [1–9]. Vaginal hysterectomy is primarily
performed in conjunction with surgery to treat prolapse,
Disclosures: Dr. Persson is a proctor in robotic surgery.
Corresponding author: Jan Persson, MD, PhD, Department of Obstetrics and
Gynecology, Sk ane University Hospital, SE-22185 Lund, Sweden.
E-mail: jan.persson@med.lu.se
Submitted June 18, 2014. Accepted for publication July 12, 2014.
Available at www.sciencedirect.com and www.jmig.org
1553-4650/$ - see front matter Ó 2015 AAGL. All rights reserved.
http://dx.doi.org/10.1016/j.jmig.2014.07.010
and the rate in the United States decreased from 22% in
2003 to 19% in 2009–2010, which coincides with the
introduction of robotic-assisted surgery [1–4].
Robot-assisted laparoscopy has been widely adopted to
treat benign gynecologic conditions, although no data have
demonstrated a clinical or economic benefit over other
operative approaches [3,10–17]. Recently, 2 large cohort
studies found similar morbidity profiles as for laparoscopic
hysterectomy, but a substantially increase in cost for
robotic-assisted surgical procedures. However, factors that
might influence the route of hysterectomy chosen, such as
body mass index, uterine weight, and previous abdominal
surgery, were not available [3,15]. A 2012 Cochrane
review identified 2 randomized controlled trials of benign
L€
onnerfors et al. Traditional vs Robotic-Assisted Hysterectomy
gynecologic robotic-assisted hysterectomy and concluded
that robotic surgery was not associated with improved effec-
tiveness or safety [9]. However, both studies were potentially
biased by inclusion of early robot adopters [9,18,19].
The Department of Obstetrics and Gynecology at Sk ane
University Hospital is a tertiary referral unit for both gyne-
cologic oncology and complex benign gynecologic surgery.
Robotic surgery was introduced in October 2005, and to date
.1600 women have undergone robotic-assisted surgery,
with approximately 300 procedures performed each year
[20–22].
Before the implementation of robotic-assisted surgery,
traditional laparoscopy was routinely used for hysterectomy,
and minimally invasive surgery was used to perform 78% of
all hysterectomies to treat benign disease in 2012.
The primary objective of the present study was to inves-
tigate the hospital cost of robotic-assisted hysterectomy
compared with traditional minimally invasive hysterectomy
(vaginal and laparoscopic) performed to treat benign gyne-
cologic disorders in women with uterine size %16 gesta-
tional weeks after excluding women referred for vaginal
hysterectomy. The secondary objective was to assess short-
term clinical outcome.
Material and Methods
Between January 2010 and June 2013, 125 women
meeting the inclusion criteria were offered participation in
the study (Fig. 1; Table 1). Preoperative evaluation in all
women included medical and surgical history, and clinical
examination including a gynecologic examination and
vaginal ultrasonography. Each woman was assigned an indi-
vidual clinical research file containing all study protocols.
One hundred twenty-two opaque envelopes containing the
assigned surgical method in the proportion of 1:1 were
closed, shuffled, and then numbered. After inclusion,
randomization occurred via telephone during which the en-
velopes were opened in consecutive order at the central
randomization office. The date, clinical research file num-
ber, patient name and social security number, and the as-
signed surgical method were recorded in the central study
log. Before randomization, surgical procedures were sched-
uled to be performed on a day when it was possible to
include all 3 approaches, and after randomization the patient
was assigned a specific surgeon.
All patients were informed of their assignment. The route
of traditional minimally invasive surgery was chosen by the
designated surgeon, with vaginal hysterectomy as the first
choice, followed by laparoscopic hysterectomy. The neces-
sity of concomitant procedures, vaginal access, body mass
index, and the presence of adhesions or endometriosis influ-
enced the choice of surgical approach. Robot-assisted lapa-
roscopic hysterectomy was performed using the da Vinci Si
Surgical System (Intuitive Surgical, Inc., Sunnyvale CA).
All 6 surgeons were consultants experienced in both vaginal
and laparoscopic surgery, and 4 were gynecologic oncolo-
79
gists experienced in robotic-assisted surgery. The case load
of hysterectomy to treat benign disease before commencing
the study was approximately 110 annually, with 31% per-
formed vaginally, 27% laparoscopically, and 15% roboti-
cally. However, most hysterectomies performed at our
institution are to treat malignant disease, with the greatest
proportion performed by the 4 gynecologic oncologists.
The least experienced robotic surgeon had performed 49 ro-
botic hysterectomies before the study, and a total of 231
robotic-assisted procedures by the end of the study, primar-
ily in gynecologic oncology.
All women received oral prophylactic antibiotic therapy
including 200 mg doxycycline (Doxyferm; Nordic Group
BV, Hoofddorp, Holland) and 800 mg metronidazole (Flagyl;
Sanofi-Aventis, Paris, France). All procedures were per-
formed with the patient under general anesthesia. For
robotic-assisted hysterectomy, two or three 8-mm robot tro-
cars and one assistant 5- or 12-mm trocar were used. Laparo-
scopic hysterectomy was performed with the use of 4 ports: a
reusable umbilical port or a 12-mm port (Xcel; Ethicon Endo-
Surgery, Inc., Somerville, NJ) for the optics and 3 assistant
ports, either three 5-mm or two 5-mm plus one 10-mm ports,
in the lower quadrants. Vaginal hysterectomy was performed
in the standard manner. For robot-assisted and total laparo-
scopic hysterectomy the peritoneum of the lateral sidewalls
was opened, the ureters were visualized and lateralized, and
the propria pelvic ligament or infundibulopelvic ligament
and the round ligaments were divided, followed by electro-
coagulation of the uterine arteries and cardinal ligaments.
Then the vagina was incised, and the vaginal cuff was sutured
using polyglactin 910 absorbable sutures (Vicryl; Ethicon) or
V-Loc 180 sutures (Covidien; Mansfield, MA), at surgeon
discretion either robotically, laparoscopically, or vaginally,
with the latter in patients after vaginal coring of the uterus.
During laparoscopic vaginal hysterectomy the procedure
was similar except that the uterine arteries and cardinal liga-
ments were divided vaginally. Postoperative cystoscopy was
not performed.
Total operating room time (from patient entry to depar-
ture from the operating room, including administration of
anesthesia), total operative time (skin to skin including
placement of a catheter, application of a fornix presenter,
docking, and dedocking), intraoperative blood loss, and
complications were recorded. Hemoglobin and C-reactive
protein concentrations and body temperature were noted
on the first postoperative day. All women received similar
pain medication and were given a daily dose of 4500 IE tin-
zaparin (Innohep; LEO Pharma AB, Copenhagen, Denmark)
for 10 days postoperatively. Length of stay and immediate
postoperative complications were recorded. All patients
were advised to contact the department if necessary. A post-
operative visit was planned for 4 months after surgery. To
assess short-term clinical outcome, all adverse events within
this period were included with the exception of uncompli-
cated lower urinary tract infections because this was thought
to be unrelated to the surgical method.
80 Journal of Minimally Invasive Gynecology, Vol 22, No 1, January 2015

Fig. 1
Progression of patients through the study.

Eligible subjects offered

participation
(n =125)
Enrollment

Excluded (n =3)
Declined participation (n =3)

Randomized (n = 122)

Allocated to traditional
minimally invasive
surgery Allocated to robotic
(n = 61) surgery
Allocation

Underwent allocated (n = 61)

intervention (n = 61) Underwent robotic
Vaginal hysterectomy hysterectomy (n = 61)
(n = 25 [41%])
Laparoscopic hysterectomy
(n= 36[59%])

Lost to follow-up Lost to follow-up

Follow-up

(n = 0) (n = 0)
Discontinued intervention Discontinued intervention
(n = 0) (n = 0)
Analysis

Analyzed (n = 61) Analyzed (n = 61)

Excluded from analysis Excluded from analysis
(n = 0) (n = 0)

For estimation of cost-generating factors common to
traditional, minimally invasive, and robotic-assisted hyster-
ectomy we used admittance fee, operating room time, hospi-
tal length of stay, and cost of complications, readmission,
and repeat interventions until 4 months after surgery. The
hospital internal charge is based on the average real cost
for the respective parameter. The per-minute charge for
use of the operating room is based on the previous year’s
mean institutional cost and includes the operating theater,
1 surgeon, 1 assistant, 1 scrub nurse, 1 circulating nurse,
anesthetic staff, cleaning, and basic expendables such as
gowns and gloves. The procedure cost for each approach
was calculated, and included the basic cost and the specific
cost, depending on the surgical approach. The traditional
minimally invasive basic cost comprised the purchase price
of the vaginal and/or laparoscopic equipment including
L€
onnerfors et al. Traditional vs Robotic-Assisted Hysterectomy 81

Table 1 for robotic-assisted and traditional laparoscopy, standard

reusable laparoscopic instruments were used, and the depre-
Inclusion and exclusion criteria ciation cost was estimated to be the same for robotic-assisted
and traditional minimally invasive procedures. Because of
Inclusion criteria Exclusion criteria
their high cost, disposable sealing or cutting instruments or
Need for total hysterectomy Suspicion of or known malignancy morcellators were not used.
to treat benign indication Inasmuch as all procedures were minimally invasive, no
Uterus size %16 Known extensive intra-abdominal differences in societal cost was expected, and therefore
gestational weeks adhesions
was not included.
Uterus/vagina size enabling Contraindication for laparoscopic
For costs charged in Swedish Crowns (SEK) or Euros
vaginal retrieval, allowing surgery
for coring, when necessary
(V), we used the mean currency exchange rate between
No desire for additional Pacemaker or other electrosensitive the US dollar and SEK or V for 2010 to 2012 as estimated
pregnancies implant by Swedish tax authorities (1$ 5 6.4294 SEK or 0.7411 V).
Informed consent Known bleeding disorder The major factor that influences hospital cost at our insti-
Immunosuppression therapy or other tution is the operative time. Existing data on surgical times
known increased risk of infection for robotic-assisted hysterectomy were analyzed (Analyse-
Women referred for vaginal it; Analyse-it Software Ltd, Leeds, UK), found to have
hysterectomy positive skewness, and therefore transformed into natural
Simultaneous need for prolapse logarithms to perform the power analysis. A similar skew-
surgery
ness was supposed for data from traditional minimally inva-
Allergy to metronidazole and/or
sive surgery. We determined that 96 patients were needed to
doxycycline
Inability to understand patient
detect a difference of 30 minutes in operating room time
information between traditional minimally invasive and robotic-
assisted hysterectomy, with 80% power and a significance
level of .05. To compensate for the uncertainty in the distri-
bution of traditional minimally invasive data and the uncer-
annual reinvestment, maintenance, and instrument wear and tainty of the number of hysterectomies available for the
tear, with an estimated depreciation time of 7 years and an vaginal approach, we estimated a need for another 15%. Ac-
annual turnover of 300 procedures. In addition, the tradi- counting for a drop out rate of 10%, a total of 122 women
tional minimally invasive specific cost included the cost of were included in the study.
patient draping, sterilization of all instruments, and cost of Institutional review board approval was obtained.
disposable instruments when applicable, such as a 12-mm The study was registered (www.clinicaltrials.gov
assistant port and a 5-mm suction-irrigation system (Stryker NCT01865929). All included women gave written informed
Endoscopy, San Jose, CA). A non-disposable fornix consent.
presenter was used. Statistical analysis was performed using commercially
The robot basic cost, including investment and mainte- available software (SPSS version 20; IBM Corp., Armonk,
nance, was calculated from the purchase price of the da Vinci NY). For statistical analyses we used the c2 test, the Student
Si system, using a depreciation time of 7 years, the annual t-test, or the Mann-Whitney U test, as appropriate. The
maintenance fee, and an annual turnover of 300 procedures. gaussian distribution of the groups was tested using the
Because the robotic system was purchased for use within gy- Kolmogorov-Smirnov fitness test, and correlation was tested
necologic oncology and for complex benign cases, other using the Pearson correlation. The power analysis was made
benign cases are performed only as excess capacity proce- using an unpaired t-test. All tests were 2-sided, and p ,.05
dures, and thus in a setting such as ours the robot can be was considered significant.
considered a preexisting investment insofar as less compli-
cated procedures. When considering the robot as a preexisting
Results
investment, the robot basic cost was excluded from the robot
procedure cost. The robot specific cost included the cost of pa- One hundred twenty-two women consented to participate
tient draping, sterilization of all instruments including robotic in the study, were enrolled and randomized, and underwent
instruments, ports and optics, robot draping (3- or 4-arm kit), surgery (Fig. 1). There were no demographic differences
cost of the actual number of robotic instruments, and dispos- between groups (Table 2). Uterine myomas (44%) and
able instruments used. A modified non-disposable trocar (Ter- abnormal bleeding (31%) were the most common indica-
namian Endotip; Karl Storz GmbH & Co KG, Tuttlingen, tions for surgery.
Germany) hosted the optics. The mean operating room time was 145 minutes for tradi-
The electrocoagulation devices used were the bipolar for- tional minimally invasive hysterectomy (103 minutes for
ceps and monopolar scissors for traditional laparoscopy and vaginal hysterectomy and 174 minutes for laparoscopic hy-
their robotic counterparts for robotic-assisted surgery. Both sterectomy), compared with 147 minutes for robotic-assisted
82 Journal of Minimally Invasive Gynecology, Vol 22, No 1, January 2015

Table 2
Demographic data

Procedure
Variable Traditional minimally invasive hysterectomy Robotic-assisted hysterectomy p Value
Age, yr, median (range) 46 (29–69) 47 (27–65) .89
Body mass index, median (range) 24.9 (17.6–42) 24.9 (17–39.2) .86
Median parity, No. (range) 2 (0–5) 2 (0–6)
No vaginal deliveries, % 21 23 .85
Previous abdominal surgery, % 56 54 .76
Previous cesarean delivery, % 18 23 .44

hysterectomy. This being the major factor influencing hospital
cost led to a mean hospital cost per patient of $993 less for
traditional minimally invasive hysterectomy as a whole
compared with robotic-assisted hysterectomy when consid-
ering the robot as a preexisting investment (Tables 3 and 4).
This difference increased by $1607 if the robot basic cost
was included.
Intention-to-treat analysis was influenced by the surpris-
ingly high number of women who were candidates for
vaginal hysterectomy, and a per-protocol analysis of laparo-
scopic vs robotic-assisted hysterectomy was performed.
When considering the robot as a preexisting investment,
the hospital cost was similar for robotic-assisted and laparo-
scopic hysterectomy ($7016 vs $7059; p 5 .85), which was
also found when comparing the robotic group in whom
vaginal hysterectomy was not considered feasible by the as-
signed surgeon (n 5 38) with the 36 women who underwent
a traditional laparoscopic approach ($7154 vs $7059;
p 5 .72) (Table 4).
Perioperative data are given in Table 5. Two conversions
from laparoscopy to laparotomy occurred in the traditional
minimally invasive group, one because of a large uterus

Table 3
Mean hospital cost (US$) per patient

Procedure
Traditional minimally
invasive hysterectomy Robotic-assisted hysterectomy
Excluding Robot Including Robot
basic cost basic cost
Cost Units Mean cost Units per Mean cost Mean cost
Variable per unit per patient per patient patient per patient per patient
Patients, No. (%) 61 (50) 61 (50)
Admittance feea $671 1.12 $752 1.05 $705 $705
Traditional minimally invasive basic cost $317 1 $317
Traditional minimally invasive specific cost $377 1 $377
Robot basic cost $1607 0 (1) 0 $1607
Robot specific costb $1876 1 $1876 $1876
Cost of conversion to laparotomy $309 0.03 $10
Mean operating room time, minc 26 145 $3763 147 $3815 $3815
Postoperative stay, dayd $549 1.42 $778 1.12 $615 $615
Blood transfusion $150 0.03 $5
Vaginal procedure basic cost at repeat $104 0.07 $7 0.02 $2 $2
operation
Vaginal procedure specific cost at repeat $212 0.07 $14 0.02 $3 $3
operation
Total cost, mean (SD) $6023 ($1881) $7016 ($1018) $8623 ($1018)
p Value ,.001 ,.001 ,.001
a
Including readmission fee.
b
Mean number of robotic instruments used, 2.8.
c
Including operating room time at repeat operation.
d
Including stay at readmission.
 L€
onnerfors et al.
Traditional vs Robotic-Assisted Hysterectomy
Table 4
Mean hospital cost (US$) per patient according to surgical approach

Procedure
Traditional Minally invasive hysterectomy Robotic-assisted hysterectomya
Robotic patients not suitable
Vaginal hysterectomy Laparoscopic hysterectomy All robotic patients candidates for vaginal surgery
Units per Mean cost Units per Mean cost Units per Mean cost Units per Mean cost
Variable $/Unit patient per patient patient per patient patient per patient patient per patient
Patients, No. (%) 25 (20) 36 (30) 61 (50) 38
Admittance feeb $671 1.12 $752 1.11 $746 1.05 $705 1.05 $705
Vaginal approach basic cost $104 1.08 $112 0.92 $96
Vaginal approach specific cost $212 1.08 $229 0.92 $195
Laparoscopic basic cost $375 0.04 $15 1 $375
Laparoscopic specific cost $309 0.04 $12 1 $309
Robot specific costc $1876 1 $1876 1 $1876
Cost of conversion to laparotomy $309 0.06 $17
Mean operating room time, mind $26 103 $2678 174 $4537 147 $3815 152 $3952
Postoperative stay, daye $549 1.4 $769 1.4 $784 1.12 $615 1.13 $621
Blood transfusion $150 0.08 $12
Total cost, mean (SD) $4579 ($1654) $7059 ($1260) $7016 ($1018) $7154 ($1015)
p Value, traditional vs robotic ,.001 .85
a
Excluding robot basic cost.
b
Including readmission fee.
c
Mean number of robotic instruments used, was 2.8.
d
Including operating room time at repeat operation.
e
Including stay at readmission.

83
84 Journal of Minimally Invasive Gynecology, Vol 22, No 1, January 2015

Table 5
Perioperative dataa

Procedure
Traditional minimally
Variable Vaginal Laparoscopic invasive Robotic p Valueb
Patients 25 36 61 (50) 61 (50)
Conversion to laparotomy 0 2 (5.6) 2 (3.3) 0 .50
Intraoperative bleeding, mL 50 (0–350) 100 (10–600) 100 (0–600) 50 (0–400) .001
Intraoperative complications 0 1 (2.8) 1 (1.6) 1 (1.6) 1.0
Operative time, min 59 (29–118) 104 (54–223) 86 (29–223) 76 (43–210) .54
Operating room time, min 91 (59–154) 163 (116–286) 148 (59–286) 140 (98–280) .59
Uuterine weight, g 152 (30–433) 163 (31–694) 154 (30–694) 180 (54–1114) .53
Concomitant procedures 4 (19) 27 (75) 31 (51) 36 (59) .47
Inpatient time, day 1.4 (0.87) 1.4 (0.6) 1.4 (0.81) 1.1 (0.52) .09
Postoperative complications 5 (20) 7 (19.4) 12 (19.7) 4 (6.6) .01
Vaginal cuff hematoma 5 (20) 6 (16.7) 11 (18) 2 (3.3) .02
Vaginal cuff dehiscence 0 1 (2.8) 1 (1.6) 1 (1.6) 1.0
Port infection 0 0 0 1 (1.6) 1.0
Repeat operation 2 (8) 2 (5.6) 4 (6.6) 1 (1.6) .21
Readmission 3 (12) 4 (11) 7 (11.5) 3 (4.9) .32
Change in hemoglobin concentration, g/L 15 (1–27) 18 (3–34) 16 (1–34) 8 (0–24) .004
Postoperative temperature,  C 37 (36–37.5) 36.7 (35.6–37.7) 36.7 (35.6–37.7) 36.9 (36.0–38.0) .23
Postoperative C-reactive protein 15 (4.6–69) 12 (0.6–34) 13 (0.6–69) 12 (1.4–90) .72
concentration, mg/L
a
Unless otherwise indicated, values are given as No. (%), median (SD), or median (range).
b
Traditional minimally invasive vs robotic approach.

and the other because of a last-minute change to an inexpe-
rienced assistant. There was no difference in uterine weight
(p 5 .53), median operating room time (p 5 .59), and me-
dian operative time (p 5 .54) between the traditional mini-
mally invasive and robotic-assisted groups. Operative time
was significantly related to uterine weight in both groups
(p ,.01). The patients operated on per surgeon ranged
from 3 to 50, with 3 surgeons (JP, PR, CB) performing
85% of the procedures; all 3 surgeons performed hysterec-
tomies via all routes. Intraoperative complications were
rare, with 1 accidental cystotomy occurring in each group;
contributing factors were adhesions after previous cesarean
section deliveries. Both lesions were repaired intraopera-
tively with no need for conversion. Median blood loss was
lower in the robotic-assisted group, 50 mL vs 100 mL; p
,.05). No patient received an intraoperative blood transfu-
sion. One patient in the traditional minimally invasive group
received a postoperative blood transfusion because of occult
bleeding. This patient had an extended hospital stay; howev-
er, no further intervention was needed.
There were fewer complications in the robotic-assisted
group (p 5 .01) (Table 5). Postoperatively, no patients expe-
rienced thrombosis or a gastrointestinal, cardiac, or pulmo-
nary complication. A vaginal cuff hematoma developed in
more women in the traditional minimally invasive group
(11 of 61 [18%]); 3 of these patients (27%) underwent sec-
ondary surgery. The remaining 7 patients and the 2 in the
robotic-assisted group with vaginal cuff hematomas were
managed conservatively.
Vaginal cuff dehiscence developed in 1 woman in each
group, and a secondary cuff-closure procedure was per-
formed vaginally. In addition, 3 women in the traditional
minimally invasive group underwent a repeat operation vagi-
nally to evacuate a vaginal cuff hematoma. An additional 3
women in the traditional minimally invasive group and 2
in the robot-assisted group were readmitted because of
symptoms associated with vaginal cuff hematomas or infec-
tion. Uncomplicated lower tract urinary infection was noted
in 4 women in each group but was not included as a postop-
erative complication because it was not thought to be related
to the surgical method. No further complications were
observed at the 4-month follow-up.
Discussion
A paradigm shift from traditional minimally invasive hys-
terectomy to robotic-assisted hysterectomy in women with
benign disease and uterine size %16 gestational weeks
will lead to substantially increased hospital costs, primarily
because of the lower cost of vaginal hysterectomy. In the
present study, vaginal hysterectomy was possible in 41% pa-
tients, even after excluding women referred to undergo the
vaginal approach. A better short-term clinical outcome
was observed after robotic-assisted hysterectomy; however,
L€
onnerfors et al. Traditional vs Robotic-Assisted Hysterectomy
although the complication rate was low in all subgroups, it is
debatable whether this can motivate the higher cost. Howev-
er, per-protocol analysis indicates that laparoscopic and
robotic-assisted hysterectomy can be performed at similar
hospital cost because of higher robot capacity that entails
excluding the cost of investment and maintenance, i.e., the
basic cost of the robot. This cost differs among institutions,
depending on the number of procedures performed; howev-
er, the difference becomes less pronounced when 300 to 400
procedures or more are performed annually and the cost for
instruments and disposables accounts for most of the cost of
the procedure.
The power analysis of this randomized trial was based on
an expected operating room time of 30 minutes less in the ro-
botic group. Even though women referred for vaginal
hysterectomy were excluded before randomization, a sur-
prisingly high rate of women in the traditional minimally
invasive group were suitable candidates for vaginal hyster-
ectomy. The mean operating room time for vaginal hy-
sterectomy was 71 minutes less than for laparoscopic
hysterectomy, and aggregating the 2 approaches led to no dif-
ference in operating room time between robotic-assisted and
traditional minimally invasive surgery. Consequently, this
unanticipated difference in expected and observed mean
operating room time in the traditional minimally invasive
group was reflected in higher hospital cost for robotic sur-
gery. However, a per-protocol analysis comparing laparo-
scopic and robotic-assisted hysterectomy resulted in a
similar mean hospital cost. This was primarily due to the sub-
stantially shorter operating room time observed with robotic-
assisted procedures, which counteracted the increased cost of
robotic draping, instruments, and sterilization.
Despite the high rate of vaginal hysterectomy, our find-
ings differ from those of 2 previous randomized studies
that compared hysterectomy via laparoscopy vs robotic-
assisted surgery, which found similar clinical outcome but
longer operative time with robotic surgery [18,19]. We
believe this discrepancy reflects the fact that the robot,
contrary to the above-mentioned studies, was well imple-
mented at our institution before onset of our study. This is
supported by recent studies that suggest a longer learning
curve for robotics than initially reported [23–25].
All 6 participating surgeons were highly experienced, and
no difference in operative time was observed between
surgeons, hence enabling evaluation of the potential of the
techniques rather than comparing individual surgeon skills.
The low overall rate of intraoperative complications,
1.6%, was probably influenced by surgeon experience, as
suggested by other authors [26,27]. This is further
supported by Boggess et al [28], who reported a rate of
2.1% in 152 patients undergoing robotic-assisted hysterec-
tomy, primarily to treat complex benign indications, in
which most were performed by 1 highly experienced sur-
geon. Rosero et al [3] recently reported a rate of 4.67% for
robotic-assisted hysterectomy and 5.33% for laparoscopic
hysterectomy when investigating all hysterectomies per-
85
formed to treat benign disease in the United States in
2009–2010. The overall low rates of intraoperative compli-
cations and conversions and an acceptable rate of postoper-
ative complications support the overall feasibility of
minimally invasive surgery. This is further illustrated by
recent reports of decreasing rates of abdominal hysterec-
tomy and an increased use of minimally invasive surgery
overall after the introduction of robotic-assisted surgery
[3,15,16].
In the present study, because of the associated cost of
disposable instruments, their use was kept at a minimum,
which may not reflect the situation at other institutions.
Expensive single-use sealing and cutting instruments are
frequently used in traditional laparoscopy, as reported by
Paraiso et al [18], whereas these instruments are rarely
needed in robotic-assisted surgery. Hence, we may have
underestimated the instrument cost for traditional laparos-
copy in general. Whether this increased cost would be some-
what counteracted by shorter operative time, better
hemostasis, and decreased incidence of vaginal cuff hema-
tomas remains unknown.
Major strengths of the present study are that it was per-
formed at an institution with well-implemented programs
within both traditional minimally invasive and robotic-
assisted surgery, and procedures were performed only by
highly experienced surgeons. Additional strengths are
good methods of allocation concealment, preventing an
imbalance in the baseline prognostic value by excluding pa-
tients with factors believed to be strongly related to outcome,
and using an intention-to-treat analysis. In addition, no pro-
tocol violations occurred, and no patients were lost to
follow-up.
The surprisingly high rate of vaginal hysterectomies led
to the study being underpowered for comparing traditional
laparoscopy with robotic-assisted hysterectomy, which is
an unexpected weakness. An additional weakness is that
although a trend was observed toward fewer conversions,
repeat operations, and readmissions with robotic surgery,
the study was not powered to detect differences in infrequent
adverse advents.
Ascertainment bias due to lack of blinding is unavoidable
in a setting such as ours. However, blinding the adminis-
tering clinician to the treatment allocation is impossible
for all surgical trials, and at our hospital the patient must spe-
cifically either consent to the suggested surgical approach or
be able to decline the procedure. The primary factor deter-
mining hospital cost is operative time, which is expected
to be independent of whether the study was blinded.
When used for gynecologic cancer surgery, given a high
annual caseload and an experienced team, the robot can be
economically viable [14,29,30]. To date, no other studies
have found a clinical or economical benefit for robotics in
comparison with traditional laparoscopic procedures for
benign indications [3,15,16,18,19]. A per-protocol analysis
of our results showed a similar hospital cost for laparoscopic
and robotic-assisted hysterectomy to treat benign disease
86
when the latter is performed because of excess robot avail-
ability. This might indicate that robotic surgery can be
economically feasible for treatment of complex benign cases
such as severe endometriosis, intra-abdominal adhesions,
high body mass index, or a large uterus. A randomized study
addressing these issues is ongoing at our institution.
Acknowledgments
We would like to thank Christer Borgfeldt, MD, PhD, Pia
Teleman, MD, PhD, and Thomas Bossmar, MD, PhD,
Department of Obstetrics and Gynecology, Sk ane University
Hospital and Lund University, Lund, Sweden for their
contribution as participating surgeons.
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