The American College of

Obstetricians and Gynecologists

WOMEN’S HEALTH CARE PHYSICIANS

COMMITTEE OPINION
Number 628 • March 2015
(Reaffirmed 2017)

Committee on Gynecologic Practice

Society of Gynecologic Surgeons
The American Urogynecologic Society endorses this document. This document reflects emerging clinical and scientific advances as
of the date issued and is subject to change. The information should not be construed as dictating an exclusive course of treatment
or procedure to be followed.

Robotic Surgery in Gynecology

ABSTRACT: The field of robotic surgery has developed rapidly, and its use for gynecologic conditions has
grown exponentially. Surgeons should be skilled at abdominal and laparoscopic approaches for a specific procedure
before undertaking robotic approaches. Surgeon training, competency guidelines, and quality metrics should be
developed at the institutional level. Robot-assisted cases should be appropriately selected based on the available
data and expert opinion. As with any surgical procedure, repetition drives competency. Ongoing quality assurance
is essential to ensure appropriate use of the technology and, most importantly, patient safety. Adoption of new
surgical techniques should be driven by what is best for the patient, as determined by evidence-based medicine
rather than external pressures. Well-designed randomized controlled trials or comparably rigorous nonrandomized
prospective trials are needed to determine which patients are likely to benefit from robot-assisted surgery and to
establish the potential risks.

Recommendations benefits associated with the robotic technique com-

pared with alternative approaches and other thera-
• Well-designed randomized controlled trials (RCTs)
peutic options.
or comparably rigorous nonrandomized prospective
trials are needed to determine which patients are • Surgeons should describe their experience with
likely to benefit from robot-assisted surgery and to robotic-assisted surgery or any new technology when
establish the potential risks. counseling patients regarding these procedures.
• Robot-assisted cases should be appropriately selected • Surgeons should be skilled at abdominal and lapa-
based on the available data and expert opinion. As roscopic approaches for a specific procedure before
with any surgical procedure, repetition drives com- undertaking robotic approaches.
petency. In addition to the didactic and hands-on • Surgeon training, competency guidelines, and qual-
training necessary for any new technology, ongoing ity metrics should be developed at the institutional
quality assurance is essential to ensure appropriate level.
use of the technology and, most importantly, patient • Reporting of adverse events is currently voluntary and
safety. unstandardized, and the true rate of complications is
• Adoption of new surgical techniques should be driven not known. The American College of Obstetricians
by what is best for the patient, as determined by evi- and Gynecologists (the College) and the Society of
dence-based medicine rather than external pressures. Gynecologic Surgeons (SGS) recommend the devel-
• As with any procedure, adequate informed consent opment of a registry of robot-assisted gynecologic
should be obtained from patients before surgery. In procedures and the use of the Manufacturer and User
the case of robotic procedures, this includes a dis- Facility Device Experience Database to report adverse
cussion of the indications for surgery and risks and events.
Background used with the robotic arms. The console provides three-
The field of robotic surgery has developed rapidly, and its dimensional imaging with improved depth perception,
use for gynecologic conditions has grown exponentially and the surgeon has autonomous control of the camera
(1, 2). Initially developed for battlefield medicine, robot- and instruments. Finally, the robotic arm, with its wristed
assisted surgery was approved by the U.S. Food and Drug joint and six degrees of freedom, allows for greater dexter-
Administration in 1999 for urologic and cardiac proce- ity than unassisted surgery and decreases normal hand
dures and in 2005 for gynecologic surgery. Today, robot tremors.
technology is applied widely in gynecology for hyster- Summary of Current Evidence
ectomy, sacrocolpopexy, myomectomy, adnexal surgery,
The rapid adoption of robotic technology for gynecologic
and malignancy staging (3).
surgery is not supported by high-quality patient outcomes,
Robot-assisted surgery currently is performed at
safety, or cost data. A wide array of liter-ature exists, but
more than 2,025 academic and community hospital
sites nationwide, with growth in excess of 25% annually most studies are retrospective, observational, and non-
(4). Growth in hospital ownership of robotic systems comparative. Four RCTs compared robot-assisted surgery
parallels the increase in the volume of robotic-assisted for benign gynecologic disease with laparoscopy, and
procedures (5). Beyond physician preference, patient none showed any benefit from using the robotic approach
fascination with technology, industry pressure, and mar- (9–12). These and other studies show that robot-assisted
keting efforts of hospitals and physicians have fueled gynecologic surgery can be performed safely in centers
the popularity of robot-assisted surgery. Hospitals and with experienced surgeons and that this minimally inva-
physicians actively advertise and promote robotic sur- sive approach could be considered for procedures that
gery programs, often with unsubstantiated claims of might otherwise require laparotomy. For gynecologic
improved outcomes and patient safety (6, 7). The pur- oncology surgery, there are no data from RCTs. Well-
pose of this Committee Opinion, developed by the designed RCTs or comparably rigorous nonrandomized
College and SGS, is to provide background information prospective trials are needed to determine which patients
on robot-assisted surgery for gynecologic conditions, are likely to benefit from robot-assisted surgery and
review the literature on this topic, and offer practice to establish the potential risks. Adoption of new surgi-
recommendations. cal techniques should be driven by what is best for the
patient, as determined by evidence-based medicine rather
Overview of Technology than external pressures. As with any procedure, adequate
The current robotic surgical system consists of four com- informed consent should be obtained from patients before
ponents: 1) a console where the surgeon sits, views the surgery. In the case of robotic procedures, this includes
screen, and controls the robotic instruments and camera a discussion of the indications for surgery and risks and
via finger graspers and foot pedals; 2) a robotic cart with benefits associated with the robotic technique compared
three or four interactive arms that hold instruments with alternative approaches and other therapeutic options.
through trocars attached to the patient; 3) a camera and
vision system that allow for a three-dimensional image Benign Hysterectomy
of the pelvis using image synchronizers and illumina- Hysterectomy is the second most common surgical pro-
tors; and 4) wristed instruments with computer inter- cedure in the United States, with approximately 433,000
faces that translate the mechanical movements of the inpatient hysterectomies performed annually (13).
surgeon’s hands into computer algorithms that direct the Although more than 50% of hysterectomies are per-
instruments’ movements within the patient (8). During formed abdominally, there is an increasing trend towards
robotic surgery, the primary surgeon sits unscrubbed at minimally invasive approaches (13–15). In 2010, 30.5% of
the console, away from the operating room table and at benign hysterectomies were performed laparoscopically
some distance from the patient, using finger graspers to compared with only 14% in 2005 (13, 14). The increase
control the instruments. Foot pedals and a clutch are used has been even steeper for robotic-assisted hysterectomy,
for camera control, activation of energy sources, focusing, with 0.5% of all hysterectomies performed robotically in
and switching the robotic arm. Four to five trocars are 2007 compared with 9.5% in 2010 (13).
used, including one through which a 12-mm or 8-mm
Despite this rapid increase, data on outcomes and
three-dimensional endoscope is placed. Instruments are
costs are limited. Two of the four RCTs compared
passed through three to four ports, three of which can
robot-assisted and laparoscopic hysterectomy (9, 11). In
be controlled by the robotic arms. One additional arm,
not controlled by the robot, may be placed as an “assis- these two trials, comprising 148 patients, operative times
tant” port. Assistant surgical team members pass robotic were significantly longer for robot-assisted hysterectomy
instruments and sutures through these ports for use by (29 minutes and 77 minutes mean difference, respectively).
the primary surgeon. These ports also provide suction, However, no differences in blood loss, length of stay, type
irrigation, and countertraction. Instruments for sutur- or number of complications, postoperative pain levels,
ing, clamping, endosurgery, and tissue manipulation are analgesic use, or recovery time were found.

2 Committee Opinion No. 628

 A large cohort study analyzed 264,758 women who However, adoption of the laparoscopic approach has
underwent hysterectomy for benign gynecologic disor- been limited by a steep learning curve. Robot-assisted
ders at 441 hospitals across the United States from 2007 sacrocolpopexy is believed to facilitate this technically
to 2010 (16). Compared with conventional laparoscopy, difficult procedure and allow more surgeons to offer a
robot-assisted hysterectomy was associated with a sig- minimally invasive approach. However, in the two RCTs
nificantly lower risk of hospitalization longer than 2 days that compared robot-assisted sacrocolpopexy with lapa-
(24.9% versus 19.6%, although the study did not provide roscopic sacrocolpopexy, operating time, postoperative
data regarding overall average length of stay) but a signifi- pain, and cost were found to be significantly greater in
cantly higher total cost ($2,189 more per case). No other the robot-assisted group (10, 12). Both groups had simi-
differences in rates of transfusion, overall in-hospital lar anatomical and functional outcomes 6 months to
complications, or discharges to nursing facilities were 1 year after surgery, though the robotic experience of
found. Another large cohort study that used the 2009 the surgeons was low at the start of the study, which may
and 2010 Nationwide Inpatient Sample found hospital have affected the results. A retrospective cohort study
costs to be $2,489 higher for robot-assisted hysterecto- that compared robot-assisted sacrocolpopexy with the
mies compared with laparoscopic hysterectomies (15). abdominal approach found longer operating times but
Transfusions were decreased and postoperative pneumo- shorter lengths of stay and less blood loss with the robot-
nia was increased in the robot-assisted group. assisted group (27). Overall, the current literature is too
The remainder of the current literature consists scant to adequately indicate which minimally invasive
of single-institution studies of low-to-moderate quality approach should be recommended. Further comparative
that compare robotic hysterectomy with abdominal and studies that assess long-term anatomical and functional
laparoscopic approaches (17–23). These studies show no outcomes and patient safety and that identify subgroups
significant difference in mean operating time or periop- of patients who would benefit from a robotic approach are
erative morbidity compared with traditional laparoscopic warranted.
procedures. However, compared with laparotomy, robot-
assisted approaches had less blood loss, lower complica- Myomectomy
tion rates, and shorter hospital stays (18, 19). Uterine leiomyomas are the most common pelvic mass
Concern has arisen that vaginal cuff dehiscence may in women and myomectomy often is selected to relieve
be more likely with robotic-assisted hysterectomy. The myoma-related symptoms in women who desire con-
overall incidence of vaginal cuff dehiscence after any tinued fertility or who decline hysterectomy (28–32).
hysterectomy is 0.14–4.1%; however, a recent large cohort Although laparoscopic myomectomy techniques have
study suggested that transvaginal closure of the cuff was been shown to decrease postoperative morbidity and
associated with a threefold and ninefold reduction in allow faster recovery (33, 34), most myomectomies are
the risk of dehiscence compared with laparoscopic and completed via laparotomy (35). The robotic system may
robotic closure, respectively (24, 25). help overcome limitations, such as unfavorable myoma
Overall, the current literature shows conflicting location (36) or patient obesity (37).
evidence and is of poor quality. Based on RCTs and two Despite the purported benefits of robot assistance,
large cohort studies, robot-assisted hysterectomy appears data are limited to observational studies of varying quality
to have similar morbidity profiles to laparoscopic pro- and power. Although shown to have significantly shorter
cedures but results in significantly higher costs. Further postoperative recovery times than abdominal myomec-
comparative studies that assess long-term outcomes and tomy, robot-assisted laparoscopic myomectomies have
patient safety and identify subgroups of patients who longer operative times and significantly higher costs
would benefit from a robotic approach are warranted. than abdominal and laparoscopic approaches (38–45).
Reporting of adverse events is currently voluntary and Overall, there was no difference in blood loss, length of
unstandardized, and the true rate of complications is not stay, and complication profiles for robot-assisted lapa-
known. The College and SGS recommend the develop- roscopic myomectomy compared with either abdominal
ment of a registry of robot-assisted gynecologic proce- or laparoscopic procedures. Furthermore, the current
dures and the use of the Manufacturer and User Facility literature is insufficient to comment on postprocedure
Device Experience Database to report adverse events. conception rates or pregnancy outcomes. Comparative
Additionally, based on its well-documented advantages effectiveness studies are needed to better evaluate out-
and lower complication rates, the College continues to comes, safety, and cost of robot-assisted myomectomy.
recommend vaginal hysterectomy as the approach of
choice for benign disease whenever feasible (26). Gynecologic Malignancies
Robot-assisted surgery has been increasingly used for
Sacrocolpopexy early-stage endometrial cancer. Although randomized
Sacrocolpopexy is widely used for the management of prospective trials currently do not exist for the robotic-
apical vaginal vault prolapse. Traditionally, it has been assisted surgical management of endometrial cancer,
performed with an abdominal or laparoscopic approach. there are 13 retrospective trials comparing robot-assisted

Committee Opinion No. 628 3

hysterectomy with either conventional laparoscopic Other Gynecologic Procedures
(46–54) or abdominal hysterectomy (47, 51, 53, 55–59). Patients scheduled for gynecologic procedures of short
In the SGS systematic review, eight studies that duration and low complexity are unlikely to benefit from
compared robotic-assisted surgery with laparoscopy for robotic-assisted surgery. The College and SGS suggest
endometrial cancer were assessed in a total of 1,218 that there is no advantage, and that there are possible
patients (60). Length of stay was significantly reduced disadvantages, to performing the following procedures
among the robotic-assisted cohort. There was a trend with robotic assistance compared with other minimally
toward reduced operating times, but the finding was not invasive approaches:
consistent among the studies. In most studies, estimated
blood loss was significantly less with robotic surgery. The • Tubal ligation
number of lymph nodes retrieved did not differ between • Simple ovarian cystectomy
groups. Additionally, some studies showed more rapid • Surgical management of ectopic pregnancy
postsurgical recovery with robot-assisted surgery.
• Prophylactic bilateral salpingo-oophorectomy
In eight studies that compared robot-assisted sur-
gery with abdominal surgery (642 patients had robotic Learning Curve
surgery and 835 patients had abdominal surgery), it was
consistently reported that women who had robotic sur- For the surgeon, robot-assisted surgery addresses com-
gery had less estimated blood loss and shorter hospital mon problems of conventional laparoscopic surgery.
stays (47, 51, 53, 55–59). Operating room time was longer Fatigue and muscle strain are minimized because the
for the robotic-assisted cohort in most of the studies, and surgeon sits ergonomically at a console separate from the
there appear to be no significant differences between the patient. Some claim that the combination of improved
two modalities in relation to the total number of lymph imaging and instrument control allows for a faster sur-
nodes retrieved. gical learning curve compared with conventional lapa-
Cost comparisons of robotic and traditional open roscopy, which includes two-dimensional imaging and
techniques have been reported by two groups (47, 61). counterintuitive hand movements (1). Thus, robotics may
When the total direct and indirect costs were compared, permit less experienced laparoscopic surgeons to perform
robot-assisted surgery was found to have advantages over minimally invasive procedures that previously would
open surgery ($8,212.00 versus $12,943.60, P=.001) in have required laparotomy. Although the use of robot-
large part because of shorter lengths of stay with mini- assisted technology is believed to shorten the learning
mally invasive surgery. curve of complex minimally invasive procedures, this has
Although there are no RCTs that compare robotic not been substantiated.
approaches for endometrial cancer with laparoscopic or The number of cases required for proficiency is not
open abdominal approaches, there is a body of retrospec- clear. One retrospective study evaluated robotic learn-
tive literature that suggests a decrease in perioperative ing curves based on time for completion of the index
morbidity and improvement in surgical variables with gynecologic procedures. Investigators reported that times
the use of robotic approaches. As with benign gyne- plateaued after 50 cases (67). A retrospective review from
cologic procedures, prospective comparative trials are a single surgeon performing 100 robotic hysterectomies
needed to better define outcomes and identify patients found that improvement in surgical times and complica-
with endometrial cancer who would benefit from robotic tion rates peaked at 20 cases (47). A further small decrease
surgery. in operative times was noted after each subsequent quin-
Robot-assisted surgery is increasingly used for treat- tile (20 cases). It is unclear if skill acquisition is prolonged
ment of cervical cancer, but outcome data are limited to with more complex gynecologic cases. Factors that affect
retrospective reviews. One study that compared robot- this learning curve include abdominal or laparoscopic
assisted hysterectomy with laparoscopic radical hysterec- experience with procedures being performed, prior lapa-
tomy found no advantages to the robotic approach (62). roscopic skills of the surgeon, and the experience of the
The only area of significance was in a reduced estimate robotic surgical team. Training of the surgical team is
of blood loss among the robotic cohort (115.5 cc ver- essential and has been reported to decrease operative
sus 171 cc, P<.001). Additional studies are necessary to time and complication rates (67, 68). One simulator study
help validate whether robot-assisted and laparoscopic found that robot implementation hastened skill acquisi-
radical hysterectomy have similar outcomes. In six trials tion for certain tasks in surgeons with less experience but
that compared robot-assisted radical hysterectomy with not in experienced surgeons (69). Robot-assisted cases
abdominal radical hysterectomy, robot-assisted surgery should be appropriately selected based on the available
had reduced lengths of stay, less blood loss, and higher data and expert opinion. As with any surgical procedure,
total number of lymph nodes retrieved (55, 62–66). There repetition drives competency. Ongoing quality assurance
were inconsistent data on which modality had shorter is essential to ensure appropriate use of the technology
operating times. Data on long-term survival for the vari- and, most importantly, patient safety. Adoption of new
ous approaches are not currently available. surgical techniques should be driven by what is best for

4 Committee Opinion No. 628

the patient, as determined by evidence-based medicine with robotic-assisted surgery or any new technology
rather than external pressures. when counseling patients regarding these proce-
dures.
Credentialing, Privileging, and Training
• Residents in obstetric and gynecologic programs
Credentialing and privileging are conducted by health approved by the Accreditation Council for Graduate
care institutions, whereas boards, such as the American Medical Education are becoming trained in new
Board of Obstetrics and Gynecology, provide certification minimally invasive technologies, with some residency
after completion of resident training. Medical specialty programs instituting robotic training. The Council
organizations, other educational institutions, and the on Resident Education in Obstetrics and Gynecology
health care industry do not have the authority to certify, is developing criteria for training in robot-assisted
credential, or privilege but may educate physicians and surgery. Although robot-assisted surgery is not a
document their completion of training. specific part of the newly adopted Milestones in
Although obstetric and gynecologic residencies are obstetric and gynecologic residency training (http://
increasingly including training in robotic procedures, acgme.org/acgmeweb/Portals/0/PDFs/Milestones/
many practitioners receive privileges to perform robotic ObstetricsandGynecologyMilestones.pdf), individ-
procedures as a new skill. Robot-assisted surgery utilizes ual programs and specific residents may well receive
new technology for commonly indicated procedures. training compatible with that outlined previously for
The College and SGS recommend that credentialing and the practicing physician. Training also is available at
privileging for robotic procedures be based on the follow- the fellowship level. Whether a graduate has appro-
ing general criteria: priate training in these areas will be validated by the
• The practitioner must have completed a didactic residency or fellowship training program director.
educational program. These programs may have Residency and fellowship programs serve an impor-
been a part of residency or fellowship training and tant role by ensuring their graduates maintain a balanced
may be offered and accredited by such organizations experience and that the introduction of robotic technol-
as the College, SGS, the American Association of ogy does not limit graduates’ competence in perform-
Gynecologic Laparoscopists, the Society of Gyneco- ing vaginal, laparoscopic, or abdominal hysterectomies.
logic Oncology, and the American Urogynecologic Surgeons should be skilled at abdominal and laparoscopic
Society. approaches for a specific procedure before undertak-
• Individuals must have hands-on training using the ing robotic approaches. Surgeon training, competency
new technology. When possible, this should first be guidelines, and quality metrics should be developed at
provided in a laboratory setting using animal sub- the institutional level.
jects or human cadavers. As simulation capabilities
continue to improve, simulation centers will be able References
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