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Quantity of Evidence Base
The evidence base consists of 6 small studies: 1 retrospective comparative study that compared
outcomes of women who underwent robotic-assisted laparoscopic sacrocolpopexy (RALS) (n = 73) and
women who underwent open sacrocolpopexy (n = 105); 2 prospective case series that accessed a total
of 45 patients who underwent RALS; and 3 retrospective case series that accessed a total of 178 patients
who underwent RALS.
Quality of Evidence Base
The evidence base has several limitations. No randomized controlled trials or prospective nonrandomized controlled trials of robotic-assisted laparoscopic sacrocolpopexy (RALS) have been published.
The one comparative study we identified was retrospective, and the study groups had significant
differences in baseline degree of prolapse and number of concomitant procedures. No study compared
RALS to laparoscopic sacrocolpopexy, sacrospinous ligament suspension, or uterosacral ligament
suspension for treatment of vaginal vault prolapse. No study reported comparative data on operating
room setup times, postoperative pain medication use, or return to normal activity. Most of the studies
describe single-center experience and provide data that are not generalizable to a broader population.
Published studies are very small and thus unable to capture rare but serious AEs. Many study patients
had concomitant procedures that confounds interpretation of outcomes data specific to RALS (e.g.,
operative time, blood loss, AEs).
Consistency of Evidence Base
Only one study compared robotic-assisted laparoscopic sacrocolpopexy to open sacrocolpopexy, so
consistency of key outcomes (i.e., operating room setup time, estimated blood loss, need for transfusion,
operative time, postoperative pain medication use, length of stay, return to normal activity) cannot be
measured across studies.
Robotic-assisted laparoscopic sacrocolpopexy for vaginal
vault prolapse
Published: 12/04/2009
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the key outcomes for each technology. Please click on the icon to open the
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Overview
Related Names
Proprietary Names: da Vinci Surgical System; da Vinci S Surgical System; da
Vinci S High Definition (HD) Surgical System; da Vinci Si HD Surgical System; EndoWrist
instrumentation; Intuitive motion
Generic Device Names: remote surgical manipulator; robotic surgical platform; robotic surgical system;
robotic telemanipulator system; surgical robot; telesurgical system
Technology Description
The da Vinci S robotic-assisted surgery system (Intuitive Surgical, Inc., Sunnyvale, CA, USA) includes a
surgeon console, a computerized control system, a patient side cart containing three integrated
instrument arms, and a fourth arm that has a binocular endoscope with a fiberoptic camera. The da Vinci
Si HD Surgical System, the newest system model, features an enhanced three-dimensional (3-D), HD
vision system that provides 10X magnification; an updated user interface; improved ergonomics and
operating room (OR) integration controls; digital zoom; adjusted aspect ratios that provide more viewing
area; a motorized patient cart; and an optional second surgeon console with intercom that can be used
for dual-surgeon procedures or for training during a procedure. One of the da Vinci system arms holds
the laparoscope while the other arms hold various surgical implements. These proprietary laparoscopic
instruments have grasping or cutting end-effectors that attach to the robotic instrument arms. The
surgeon sits at a computer console in the OR and views the operative field that shows the view from a
video camera mounted on one of the robotic arms. While watching the monitor in real time at the
console, the primary surgeon uses master controls to operate the robotic arms. A second surgeon may
assist directly at the operating table several feet away or at the second console.
Open abdominal sacrocolpopexy, which involves using permanent mesh to affix the vaginal vault to the
anterior longitudinal ligament of the sacrum for support of the pelvic floor, is a standard surgical
treatment for apical vaginal vault prolapse. Surgeons can also perform this procedure laparoscopically,
but this approach has not been widely adopted because of the complex suturing and dissection involved.
A trained surgeon may use any of the da Vinci systems to perform robotic-assisted laparoscopic
sacrocolpopexy (RALS). According to Intuitive, the potential benefits of RALS compared to open
sacrocolpopexy for the patient include the following:
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Less pain
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Less blood loss and need for transfusions
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Less risk of infection
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Less scarring (five or six 1/3- to1/2-inch incisions compared to a 6- to 10-inch incision for open
surgery)
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Shorter hospital stay (1 day compared to 3 to 6 days for open surgery)
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Shorter recovery time (1 to 2 weeks compared to 6 weeks for open surgery)
Advantages of laparoscopic robotic-assisted surgery cited by surgeons include magnification in the 3-D
visual field; greater surgical precision and dexterity due to wristed instruments, which have seven
degrees of freedom; improved surgical access in the pelvic cavity; hand-tremor filtration; autonomy; and
ergonomic comfort. Surgeons state that these technical features offer superior visualization, enhanced
depth perception, and better dexterity. Also, some clinical experts feel that robotics may allow a surgeon
to offer a minimally invasive approach to more patients, stating that standard laparoscopic techniques
are more difficult to learn than robotic-assisted techniques and often require a skilled first assistant.
Robotics may also allow a surgeon to offer minimally invasive surgery to patients who are obese or have
significant adhesive disease. According to Intuitive, RALS offers the following specific benefits for the
surgeon: improved access to the pelvis compared to other surgical approaches; easier, more precise
dissections; improved handling of suture and mesh for more accurate graft placement; more precise
suturing for graft attachment; control of the camera and all three operative arms; and a reproducible
approach that is easier than laparoscopic sacrocolpopexy (LS).
Possible disadvantages of RALS are the initial and recurring costs, the initial marked learning curve for
the operative team, and increased system setup time. Initially, RALS may require more intraoperative
time than traditional open surgery. However, intraoperative time typically improves as surgeons gain
experience and OR staff become more familiar with the system, enabling them to set up and execute
changes more quickly.
The procedure begins with the patient lying face up with hips and knees bent and feet in stirrups. As with
any laparoscopic procedure, abdominal insufflation with carbon dioxide is required to see pelvic organs
and perform port placement. Port placement is an important consideration during RALS because the
surgeon must have access to the deep pelvis and the superior-most portion of the sacrum. Typically, the
surgeon creates five small incisions for port placement in a "W" configuration in the patient's abdomen.
Port locations are at or above the umbilicus (endoscope port), in the lower left quadrant, in the lower
right quadrant, between the endoscope port and the lower right quadrant port, and between the
endoscope port and the lower left quadrant port (accessory ports are used for suction). The surgeon may
place additional ports in obese patients for retraction. Placing the patient in the Trendelenburg position
(an inclined position with the patient's head lower than the feet) reduces the likelihood of venous
thrombosis and allows the abdominal viscera to fall away from the pelvis. The surgical team then
attaches each robotic arm into its assigned port, which is called docking. The surgeon then performs the
sacrocolpopexy procedure similarly to the open or laparoscopic approach.
Care Setting
Inpatient, Outpatient
Disease/Condition
Vaginal vault prolapse can occur when damage to the muscles and ligaments in the pelvic floor allows
the pelvic organs to fall or slip out of place. Vaginal prolapse can occur after a hysterectomy as well as
when the uterus is in place. The degree of prolapse can range from mild to severe.
Most physicians use the pelvic organ prolapse quantification (POP-Q) exam to quantify, describe, and
stage pelvic support (Bump et al. 1996). This tool measures nine points at the vagina with respect to the
hymen. The measurement is expressed as a negative number for points above the hymen and a positive
number for points below the hymen. A lettering sequence describes the location of the prolapse, and
numerals 0 through IV describe prolapse severity. Stage IV represents the most severe degree of
prolapse.
Risk factors include prior hysterectomy; number of prior vaginal deliveries; giving birth to a large baby;
large fibroids or tumors; aging and menopause; obesity; chronic coughing, constipation, or straining;
heavy lifting; connective tissue disorders; previous pelvic surgery; spinal cord injury; and Hispanic or
Northern European descent. Symptoms may include a feeling of pressure in the pelvis; pain in the pelvis,
abdomen, or lower back; pain during intercourse; a protrusion of tissue from the vagina; recurrent
urinary tract infections; unusual or excessive vaginal discharge; urinary incontinence; urinary frequency
or urgency; and bowel dysfunction. Clinicians commonly perform a pelvic examination and use pelvic
ultrasound or magnetic resonance imaging to diagnose and assess the severity of prolapse.
Common first-line conservative treatments for women with symptoms of vaginal vault prolapse are
exercises to strengthen the pelvic floor, vaginal support devices (pessaries), and estrogen replacement
therapy. Physicians typically recommend surgical correction only for women with severe symptoms who
have not responded to conservative measures. Common surgical treatment options include sacrospinous
ligament suspension; uterosacral ligament suspension; and sacrocolpopexy (see Effects on Other
Technologies section of this report for more detail on these procedures).
An estimated 75% of patients with vaginal vault prolapse also have a cystocele (bladder prolapse), a
rectocele (rectal prolapse), or an enterocele (small bowel prolapse). Surgical procedures to correct these
defects are commonly performed during the same operative session as sacrocolpopexy. Other
concomitant procedures that are commonly performed during the same operative session include lysis of
adhesions, hysterectomy, and procedures to correct urinary incontinence (i.e., Burch procedure,
midurethral sling procedure, tension-free transvaginal taping).
Prevalence/Incidence Rate
Pelvic organ prolapse is a relatively common disorder in women 50 years of age or older. In the United
States, an estimated 3.3 million women have some degree of pelvic organ prolapse. The incidence of
pelvic organ prolapse is expected to increase to 4.9 million by the year 2050 due to increases in the
aging population and the prevalence of obesity (Lowry 2009). The estimated lifetime risk of undergoing
surgery for prolapse or urinary incontinence is 11% (ACOG, 2007). According to Intuitive Surgical
(manufacturer of the da Vinci robotic systems), more than 120,000 women with vaginal vault or uterine
prolapse receive surgical treatment each year in the United States.
Worldwide, about 34 million women are believed to be affected by pelvic organ prolapse. This statistic is
widely reported in the gray literature, but our searches did not identify the primary source document.
Manufacturers/Suppliers
Intuitive Surgical, Inc. (headquarters in Sunnyvale, CA, USA with European operations in Aubonne,
Switzerland), manufactures and distributes da Vinci Surgical Systems and EndoWrist surgical tools, which
are commercially available in the United States, Canada, Australia, Europe, Japan, and other foreign
markets.
Three systems are available: da Vinci Surgical System, da Vinci S Surgical System, and da Vinci Si HD
Surgical System. All three systems use EndoWrist instrumentation.
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The Si model was introduced in April 2009 with these new features:
Enhanced HD 3-D vision
An updated user interface for setup
Extensibility for digital OR integration
Dual-console capability to support training and collaboration during minimally invasive surgery
All three systems share the following technology:
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3-D HD visualization with up to 10X magnification and an immersive view of the operative field
EndoWrist instrumentation with dexterity and seven-degree range of motion
Proprietary motion technology intended to replicate the experience of open surgery by
preserving natural eye-hand-instrument alignment and intuitive instrument control
EndoWrist instrumentation includes a range of specialized tip designs intended for use for different
clinical applications of the robot: various forceps, needle drivers, scissors, monopolar and bipolar
electrocautery instruments, scalpels, and other specialized instruments. The instruments are available in
5 mm and 8 mm diameters.
Intuitive Surgical no longer markets or supports the ZEUS system, which it had acquired in June 2003
when it bought Computer Motion, Inc. (Goleta, CA, USA).
Regulatory Status
U.S. Food and Drug Administration Clearance
Intuitive Surgical received its first U.S. Food and Drug Administration (FDA) 510(k) marketing clearance
for the da Vinci Surgical System in June 1997 for thoracoscopic and laparoscopic surgical procedures.
Since then, FDA has granted additional clearances related to the systems and instrumentation. In April
2005, the system was cleared for gynecologic laparoscopic surgical procedures. The FDA-approved
product labeling states that "the system is intended to assist in controlling instruments during
laparoscopic surgical procedures and is intended for use by professionals in operating room environments
in accordance with usage instructions."
In December 2006, FDA granted marketing clearance for the da Vinci S Surgical System. The FDAapproved product labeling states that the system is intended to assist in accurately controlling
endoscopic instruments, including endoscopes, scissors, scalpels, ultrasonic shears, and electrocautery
accessories for endoscopic tissue manipulation.
In February 2009, FDA granted marketing clearance for the da Vinci Si Surgical System, a modification of
the da Vinci S Surgical System with the same intended indication.
Clearances Outside the United States
Intuitive Surgical has also received a CE (Conformité Européene) mark for the da Vinci Surgical System
and EndoWrist instruments for use during laparoscopic gynecologic surgery in Europe.
In July 2005, the da Vinci Surgical System received its initial marketing clearance from Health Canada.
The agency has granted subsequent marketing clearances for upgraded systems.
Reported Patient Indications/Contraindications
After conservative treatment has failed, sacrocolpopexy may be indicated to surgically correct vaginal
vault prolapse. Also, surgeons may perform sacrocolpopexy combined with total or supracervical
hysterectomy for uterine prolapse to provide long-term support of the vagina.
Product labeling states that the da Vinci Surgical Systems are indicated for assisting the control of
Intuitive Surgical's endoscopic instruments during gynecologic laparoscopic surgical procedures.
The manufacturer indicates that contraindications for any minimally invasive surgery would also apply to
robotic-assisted surgery. These conditions include bleeding disorders, adverse prior surgery history, and
cardiopulmonary issues. The potentially longer operative times associated with robotic surgery indicate
that some patients with significant pulmonary disease may not be considered appropriate candidates
because their compromised lung function makes them unable to tolerate the Trendelenburg position that
is used during this surgery for an extended period.
Clinical Practice Guidelines/Other Evidence Reports
Standards/Guidelines
ECRI Institute literature searches did not identify any standards, guidelines, or evidence reports on RALS
for uterine or vaginal vault prolapse. We did identify the following two general guidelines and an
evidence report that discuss sacrocolpopexy for pelvic organ prolapse:
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American College of Obstetricians and Gynecologists. Pelvic Organ Prolapse. 2007. This guideline
describes sacrocolpopexy as a primary procedure for women who experience vaginal vault prolapse
after hysterectomy and as an adjunctive procedure when hysterectomy is performed for uterine
prolapse.
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Royal College of Obstetricians and Gynaecologists. The Management of Post Hysterectomy
Vaginal Vault Prolapse. 2007. This guideline states that "abdominal sacrocolpopexy is an effective
operation for post-hysterectomy vaginal vault prolapse."
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National Institute for Clinical Excellence. Sacrocolpopexy Using Mesh for Vaginal Vault Prolapse
Repair. 2009. This report states that "current evidence on the safety and efficacy of sacrocolpopexy
using mesh for vaginal vault prolapse repair appears adequate to support the use of this procedure.
The procedure should only be carried out by surgeons specializing in the management of pelvic organ
prolapse and female urinary incontinence."
Considerations for Hospitals
Impact on Hospital Operations
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Factors that hospitals should consider before acquiring a robotic surgical system include the following:
Initial acquisition costs
Ongoing maintenance and disposable instrument costs
Staff training and credentialing needs
Impact on physician recruitment
Influence on referral patterns
Impact on OR scheduling
Having sufficient case volume to maintain individual surgeons' proficiency
Competition among clinical service areas to use the robotic system, once acquired (urologists,
gynecologists, general surgeons, pediatric surgeons, and cardiovascular surgeons).
Initially, a hospital purchasing the da Vinci Surgical System may experience an increase in patient
referrals because of patient demand and novelty of the technology in a given geographic area. However,
as more hospitals install robotic systems, the regional growth of programs will ultimately stabilize. To
achieve optimal utilization and cost-effectiveness, hospitals need to focus on coordinating robotic system
use by several disciplines and to consider whether the robotic system confers any clinical advantages
that would offset its costs, given that no extra reimbursement is available for use of the system.
Obtaining a da Vinci Surgical System will initially affect hospital OR and surgery staff schedules due to
potentially longer setup and operative times compared to open surgery and laparoscopic surgery. The
impact may be lessened over time as the operative team gains more experience. Initially,
multidisciplinary use of the system may require that hospitals mediate competing demands of different
surgical teams using the system. Also, if robotic procedures take longer to perform, surgeons may end
up decreasing their overall volume of procedures compared to conventional surgery volumes.
Some hospitals assign access to the system on a rotating schedule, with certain days of the week
allocated for different clinical service areas. If the surgeon does not use the assigned time, the time is
forfeited to another service area. Despite establishing a schedule, consideration is given to surgeons
whose patients have more serious conditions (e.g., cancer) and may need surgery sooner. Some
hospitals elect to purchase a second and even third system to ensure that treatment delays and patient
backlogs do not occur.
Surgeons and OR staff must become proficient with complex setup protocols before surgery and setup
changes needed during surgery. Hospitals that have a dedicated surgical team that trains together on
system setup, sterile draping, and introducing instruments have substantially reduced setup time, and
surgeons report that as their use of the system increases, their intraoperative time, setup time, and
technique improve from baseline.
New surgical residents expect to be trained on a da Vinci Surgical System, and hospitals with surgical
residencies may find that recruitment patterns are changing for surgical residents and surgeons because
of the da Vinci Surgical System.
Physician preference, scheduling, and equipment availability will all have an impact on adoption of RALS.
Surgeons with limited laparoscopic experience may be reluctant to perform RALS because of a need for
additional training and initial longer intraoperative times. Some facilities with a robotic system would not
be able to accommodate their caseload for sacrocolpopexy procedures if all their gynecologic surgeons
wanted to use a da Vinci system. Also, some surgeons wanting to perform RALS may not have access to
a da Vinci system.
Credentialing/Training
Learning Curve
The most commonly debated learning-curve factor is the impact of prior surgical experience, either
laparoscopic or open, on the ability to learn robotic-assisted surgery. Practitioner opinion varies; some
surgeons believe that previous laparoscopic training can shorten the learning curve, and others purport
that it makes learning robotic-assisted surgery more difficult. Practitioners generally seem to agree that
surgeons should be trained in open and laparoscopic procedures before learning how to perform roboticassisted surgery. Further, it is important for OR nursing staff, surgical residents, and practicing surgeons
to undergo hands-on system training and attend medical education programs to develop system
knowledge and skills. Amodeo et al. (2009) determined that the limited availability of robotic systems
has restricted training opportunities.
Training and Usage Requirements
According to the user manuals for the da Vinci Surgical Systems, it is recommended that surgeons attend
da Vinci training provided by the manufacturer. The manufacturer does not provide procedure-specific
training. The manuals further explain that the manufacturer-sponsored training is limited to the use of
the da Vinci Surgical Systems and does not replace medical training and experience required to perform
surgery.
Training Process
Surgical training on a da Vinci Surgical System is a multi-step process. The manufacturer states that the
process includes the following steps:
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Distance learning: an Intuitive online education module that describes system components and
preparation
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On-site training: a four-hour training program for surgeons and nurses conducted by Intuitive
clinical sales representatives
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Off-site training: a one-day training program for surgeons conducted by Intuitive Surgical
training specialists
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Dry run of system preparation and process: rehearsal with the entire surgical team
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Clinical support: system support during initial procedures and/or additional system skill training
or in-services as requested
Intuitive Surgical has approximately 20 training centers in the United States and Europe. Training
centers may have multiple da Vinci Surgical Systems to facilitate training opportunities and staff with
extensive experience to provide training. When a hospital first begins using the da Vinci system clinically,
the surgeon or host hospital may request that an experienced proctor be present during procedures.
Hospital Privileges for Robotic-assisted Surgery
Training does not replace individual hospital credentialing requirements. Although surgical societies may
propose recommendations for surgeons when initiating new surgical techniques, hospitals hold the
responsibility of granting privileges for new procedures. Hospitals vary in their processes of granting
privileges for robotic-assisted surgery, with their primary concerns being patient and staff safety and
compliance with the Joint Commission requirements. Joint Commission privileging standards encourage
facilities to develop systems to evaluate practitioner skill on an ongoing basis and formulate procedures
to monitor practitioners with indeterminate competency or those performing procedures for the first
time. Some hospitals maintain separate credentialing processes for robotic-assisted surgery and standard
laparoscopic surgery, purporting that this approach shortens the learning curve and ensures patient
safety.
Novel Training Methods
In April 2009, the Chamberlain Group (Barrington, MA, USA) announced the development of a uterine
robotic surgery trainer that is an anatomically accurate, full-scale model of the uterus and vaginal canal
with corresponding elasticity. Surgeons can use the model to practice skills, such as suturing and
incising. Also, the newly marketed da Vinci Si System has an option for two surgeon consoles connected
with specialized hardware and software for teaching and mentoring surgeons.
For more detailed information on training, see the Emerging Technology Evidence Report on
training/learning curve for robotic-assisted surgery.
Competing and Complementary Technologies
Effect on Other Technologies
RALS competes with other surgical methods of performing sacrocolpopexy, including open
sacrocolpopexy and LS. Open sacrocolpopexy is the standard approach to treat vaginal vault prolapse,
and it requires a 6- to 10-inch incision, a 3- to 6- day hospital stay, and 6-week recovery. Total LS for
vaginal vault prolapse has not been widely adopted because of the complex suturing and dissection
involved. Patients will likely prefer a minimally invasive approach, and RALS may allow more women to
be treated laparoscopically.
Some surgeons have begun to perform sacrocolpopexy through a single umbilical port. Laparoendoscopic
single-site surgery was developed as an extension of standard laparoscopic surgery. The current singleport systems use articulating, flexible, nonrobotic instruments, which a surgeon inserts through a single
3/4-inch incision. The aim of this procedure is to minimize discomfort, shorten recovery, and improve
cosmesis.
RALS may also compete with other surgical treatment options of treating vaginal vault prolapse,
including sacrospinous ligament suspension and uterosacral ligament suspension. These procedures can
be performed vaginally or laparoscopically and are intended to reverse the prolapse. Sacrospinous
ligament suspension involves suturing the vagina to one of the sacrospinous ligaments. Uterosacral
ligament suspension involves attaching the apex of the vagina to the uterosacral ligaments close to their
origin at the sacrum.
RALS performed with the da Vinci system may ultimately compete with the ViKY robotic system
(Endocontrol Medical; La Tronche, France) that a surgeon can use to perform colpopexy through a single
umbilical port. Patients will likely find single-port surgery attractive, since this procedure is less invasive
than multiple-port RALS. Also, the ViKY robotic system is expected to cost about $170,000, considerably
less than existing robotic systems used to perform gynecologic procedures.
Diffusion Status
Phase of Diffusion
Early Diffusion
According to the manufacturer, as of June 2009, approximately 1,200 da Vinci Surgical Systems have
been placed in clinical centers worldwide, including 916 in the United States, 221 in Europe, and 105 in
other parts of the world. Robotic-assisted surgery is offered at over 950 hospitals. More than 200
facilities own 2 or more da Vinci Systems. According to the manufacturer's Web site surgeon locator tool,
300 gynecologic surgeons in the United States have performed at least 20 cases and have chosen to
have their name listed on the manufacturer's Web site. Also, Intuitive has announced that approximately
300 hospitals worldwide offer RALS to patients with vaginal vault prolapse. In 2008, surgeons performed
about 2,600 RALSs.
Ongoing Clinical Trials
ECRI Institute searches identified the following three ongoing trials of RALS:
Cleveland Clinic (Cleveland, OH, USA) is enrolling an estimated 64 women with vaginal prolapse
in a randomized controlled trial (RCT) that compares conventional LS and RALS. The study's primary
outcome is total operative time. Time taken for the suturing component of the procedure will also be
measured. Secondary outcome measures include complications, costs, length of hospital stay, and
quality of life. Researchers are collecting data between September 2006 and November 2009.
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Kantonsspital Aaru (Aaru, Switzerland) is enrolling an estimated 30 women with vaginal wall
prolapse in a prospective case-series study to evaluate outcomes after RALS. The study's primary
outcome is operative time. Secondary outcome measures are complications, quality of life, and costs.
Researchers are collecting data between April 2009 and April 2011.
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University of California (Irvine, Ca, USA) is enrolling an estimated 10 women with vaginal
prolapse in a prospective case-series study to evaluate whether RALS is a feasible and safe method for
apical repair of vaginal prolapse. The study's primary outcomes are operative time, blood loss,
complication rates, length of hospital stay, and cure. The secondary outcome is quality of life.
Researchers are collecting data between May 2007 and June 2011. This study is ongoing but not
recruiting participants.
Cost and Reimbursement
Costs
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Costs include purchase of capital equipment (i.e., surgical system, reusable instruments, accessories),
disposables (limited-use and disposable instruments and accessories, draping, sterilization trays), and
service contracts. ECRI Institute's PricePaid database (July 2009) lists the following average (nationally)
quoted prices for these models:
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da Vinci S HD Surgical System: $1.6 million
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da Vinci Si HD System: $1.73 million
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da Vinci Si HD with dual console: $2.2 million
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Upgrade to the da Vinci S HD Surgical System for hospitals that currently have the da Vinci S
Surgical System: $120,000
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Upgrade to the da Vinci Si HD Surgical System for hospitals that currently have the da Vinci S
HD Surgical System: $600,000
The surgical instruments (i.e., scissors, forceps/pick-ups, needle drivers, electrocautery) can be used in
up to 10 surgical procedures before replacement is necessary. The average instrument cost per
procedure is approximately $1,990.
Annual maintenance costs (i.e., service agreement costs) are approximately $150,000 per year for the
da Vinci S HD and the da Vinci Si HD Systems and about $175,000 for the da Vinci Si HD with the dual
console.
The da Vinci Surgical Systems have an estimated useful life of five years. Individual components last an
estimated four to seven years.
Reimbursement
Coverage
Some payers consider a robotic system to simply be a surgical tool that does not merit any difference in
payment rate. Others have specific noncoverage policies for robotic-assisted surgery (i.e., they will not
reimburse for a robotic-assisted procedure).
The U.S. Centers for Medicare & Medicaid Services (CMS) has no national coverage determination for
RALM. Coverage is left to the discretion of local Medicare carriers.
ECRI Institute's searches of 10 representative third-party payers identified 3 policies (i.e., CIGNA
HealthCare, Humana, United Healthcare) addressing robotic-assisted surgery in general. The other
payers do not mention or address robotic-assisted surgery.
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CIGNA's policy states that the insurer will not provide additional reimbursement for procedures
completed with robotic assistance.
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Humana's policy states that members may be eligible for coverage of robotic-assisted
procedures if the devices used are consistent with the FDA-approved indications.
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United Healthcare's policy states that using robotic surgical systems does not provide any
additional health benefits to patients, and the insurer does not provide coverage for robotic-assisted
surgery as a separate service.
Coding
The American Medical Association (AMA) has not assigned Current Procedural Terminology (CPT) codes
to describe RALS. However, AMA has assigned a CPT code to describe laparoscopic colpopexy with
suspension of vaginal apex. This code is typically used for billing RALS.
AMA, in collaboration with the American Urological Association, the American College of Obstetricians and
Gynecologists, and the American Association of Gynecologic Laparoscopists, concluded that currently
available Level I laparoscopic CPT codes adequately describe the physician's work value for procedures
completed with or without robotic assistance.
CMS has issued a temporary Healthcare Common Procedure Coding System (HCPCS) code (S2900) to
describe surgical techniques requiring use of a robotic surgical system. S codes are used by the Blue
Cross Blue Shield Association and the Health Insurance Association of America to report drugs and
services for which there are no national permanent Level II HCPCS codes. This code is listed separately
in addition to the primary surgical procedure. S codes are not payable by Medicare and are carrier-priced
at the discretion of the local private payer.
Payment
Payers generally cover and reimburse RALS at the same rate as standard LS. The national 2009 Hospital
Outpatient Prospective Payment System payment for this procedure is $2,502, and the 2009 Medicare
Physician Fee Schedule payment rate for the CPT code that may be used to report LS is $930.
LS typically may involve an overnight stay in the hospital. Payment for inpatient services that are
provided during a particular admission depend on the diagnosis-related group (DRG) assignment.
Developed by CMS as part of the prospective payment system, DRGs represent services that are
expected to have similar hospital resource use. Hospitals receive a predetermined lump sum for each
Medicare discharge, regardless of cost. DRG assignments are contingent on the patient's geographic
location, principal diagnosis, age, comorbid conditions, primary and secondary procedures performed,
and complications.
Two DRGs are possible for LS for uterine or vaginal vault prolapse:
DRG 742 (uterine and adnexa procedures for nonmalignancy with complications/comorbidity)
has a 2009 Medicare national average payment of $7,274 (average length of stay [LOS] 4.5 days).
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DRG 743 (uterine and adnexa procedures for nonmalignancy without complications/comorbidity)
has a 2009 Medicare national average payment of $4,570 (average LOS 2.3 days).
Cost Effectiveness & Considerations
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Currently, because no extra reimbursement is associated with robotic surgery, a hospital's direct
intraoperative costs of RALS may be higher than those associated with LS alone or open procedures to
treat prolapse. However, the postoperative LOS after RALS is typically shorter than that for LS or open
sacrocolpopexy. LOS differences may diminish the cost gap between the procedures. As surgeons gain
more experience, robotic techniques evolve over the next several years, and surgical residents train from
the outset on robotic systems, direct procedural costs—especially operative time—are expected to
decrease.
Even so, hospitals need to consider the impact of the longer RALS procedures on OR scheduling, patient
throughput, and revenue stream. Hospitals' costs may be offset if RALS definitively proves to significantly
shorten hospital stays, lower morbidity, and decrease recuperation time compared to LS and open
sacrocolpopexy.
With regard to societal costs, if patients recover more quickly and return to work faster after RALS, then
cost-benefits may accrue with respect to improved productivity and quality of life compared to recovery
from open procedures.
The robotic systems can also be used in some urology, cardiology, and pediatric surgeries, as well as
some general surgery applications. Thus, hospitals' utilization of the technology can be optimized by
expanding clinical applications if surgical teams in each of these clinical service lines are sufficiently
trained.
ECRI Institute searches identified one small, retrospective study that compared the short-term hospital
charges and costs for open sacrocolpopexy, LS, and RALS (Patel et al. 2009) from the hospital cost
perspective. The study reported on 15 patients who underwent prolapse repair at the Hartford Hospital
(Hartford, CT, USA) between 2002 and 2007. The patients were comparable in terms of age, body mass
index (BMI), gravidity, parity, number of vaginal deliveries, number of cesarean sections, stage of
prolapse, and number of previous prolapse surgeries. Five patients were in each of the three study
groups (i.e., open sacrocolpopexy, LS, RALS). The study authors estimated hospital charges (i.e.,
supplies, surgeries, radiological tests, laboratory tests, nursing services, pharmacy charges, roomingrelated services) and total costs (i.e., patient care, supplies used during surgery, anesthesia, OR time,
housekeeping, security, office supplies, maintenance). Mean estimated hospital charges for RALS were
significantly higher than those for LS ($24,161 and $19,309, respectively; p = 0.02; calculated by ECRI
Institute) or open sacrocolpopexy ($24,161 and $13,150, respectively; p < 0.001; calculated by ECRI
Institute). Mean estimated total costs for RALS were significantly higher than those for open
sacrocolpopexy ($12,526 and $6,817, respectively; p = 0.003; calculated by ECRI Institute). However,
the difference in estimated mean costs between RALS and LS was not significant ($12,526 and $11,094,
respectively; p = 0.64; calculated by ECRI Institute).
Procedure Charges
See the Cost Effectiveness section of this report for data on procedure charges reported by one study.
Evidence/Outcomes
Search Methods
We searched four bibliographic databases, including MEDLINE, EMBASE, the Cochrane Library, and
PubMed, to identify clinical trials and other information published between 1996 and 2009. Mechanisms
used to retrieve additional relevant information included review of bibliographies/reference lists from
peer reviewed and gray literature. The major search terms and concepts searched included the following:
robotics, sacrocolpopexy, sacropexy, colpopexy, colposcopy, uterine prolapse, vaginal prolapse,
descensus, procidentia, and pelvic organ prolapse. Of the citations reviewed, we retrieved and reviewed
full text of a total of 11 articles. Of those, six met our study inclusion criteria for at least one of the key
questions for this report and were included in our analysis. Click here to view the complete Search
Strategy for this report.
Evidence Base
We searched for clinical studies to address the following key questions:
1. How does RALS compare to open sacrocolpopexy, LS, sacrospinous ligament suspension, and
uterosacral ligament suspension as measured by the following key outcomes: OR setup time,
estimated blood loss, need for transfusion, operative time, postoperative pain medication use,
LOS, and return to normal activity?
2. How do AE rates for RALS compare to AE rates for open sacrocolpopexy, LS, sacrospinous
ligament suspension, and uterosacral ligament suspension for vaginal vault prolapse?
3. What are the reported occurrences of AEs associated with RALS for vaginal vault prolapse
(i.e., injury to the gastrointestinal system; injury to the genitourinary system; injury to pelvic
viscera, nerves, and major blood vessels; presacral bleeding; mesh infection and/or erosion;
conversion to an alternate surgical procedure; infection; recurrent vaginal vault prolapse; and
port-site hernia)?
The ideal study of this technology would be a prospective RCT that compares the outcomes of a group of
patients undergoing RALS to a similar group of patients undergoing open sacrocolpopexy, LS,
sacrospinous ligament suspension, and uterosacral ligament suspension for treatment of vaginal vault
prolapse. Performing an RCT of this nature may be difficult since patients who are eligible for LS or RALS
may be reluctant to be randomly assigned to other more invasive procedures, and the patient
populations eligible for these procedures may differ.
ECRI Institute applied the following study-selection criteria to identify appropriate studies that could
provide reliable (i.e., unbiased) data to address the key questions:

Study must have been published in English.

Study was reported as a full-length article. We excluded abstracts and meeting presentations
because they do not give complete results and sufficient detail about methodology to assess the risk
of bias and to evaluate study quality, and final results may differ from preliminary results.

To avoid double counting of patient outcomes, if more than one article has been published to
describe the same study, the article must be the latest published report or have the most complete
report of an outcome.

Study must have included 10 or more patients per treatment group.

Study must have reported at least one of the outcomes of interest for one or more of the key
questions: setup time, estimated blood loss, need for transfusion, operative time, postoperative pain
medication use, LOS, return to normal activity, or AEs. Mixed populations with combined outcomes
will only be considered if outcomes data are reported separately or the large majority (> 85%) of
patients underwent RALS.

To answer Key Questions 1 and 2, the study had to be a controlled trial that compared outcomes
for a group that underwent RALS to outcomes for a group that underwent open sacrocolpopexy, LS,
sacrospinous ligament suspension, or uterosacral ligament suspension for treatment of vaginal vault
prolapse.

To answer Key Question 3, the study had to assess RALS and report on AEs.
ECRI Institute searches identified one retrospective comparative study that met our inclusion criteria for
Key Questions 1 and 2 (Geller et al. 2008; n = 178) and five case series studies (Elliott et al. 2006, n =
30; Daneshgari et al. 2007, n = 15; Shariati et al. 2008, n = 77; Akl et al. 2009, n = 80; Kramer et al.
2009, n = 21) that met our inclusion criteria for Key Question 3. See study details below.
Comparative Studies
Geller et al. (2008) performed a retrospective cohort study that compared the outcomes of 73 women
who underwent RALS between March 2006 and March 2008 at the University of North Carolina (UNC)
HealthCare System (Chapel Hill, NC, USA) or Duke University (Durham, NC, USA) and those of 105
women who underwent open sacrocolpopexy at UNC between January 2004 and March 2008. Study
patients had a diagnosis of vaginal vault prolapse and were not excluded for previous prolapse surgery or
concomitant prolapse or incontinence surgery. The patient groups were similar in terms of mean age,
race, mean BMI, and the need for concurrent incontinence surgery. However, the RALS group had
significantly more severe prolapse preoperatively than the open sacrocolpopexy group as measured by
the POP-Q tool: C (prolapse at the most distal edge of the cervix or vaginal cuff scar [+3 RALS, +1 open;
p = 0.002]); Ba (prolapse at the most distal position of the remaining upper anterior vaginal wall -3 cm
to + total vaginal length [+4 RALS, +3 open; p < 0.001]); and Bp (prolapse at the most distal position
of the remaining upper posterior vaginal wall -3 cm to + total vaginal length [+2.5 RALS, 0 open; p =
0.005]). Significantly more patients in the RALS group underwent concomitant hysterectomy than in the
open sacrocolpopexy group (47.9% RALS, 29.5% open; p = 0.02). Also, significantly fewer RALS
patients underwent concurrent prolapse repair than the open sacrocolpopexy group (5.5% RALS, 65.7%
open; p < 0.001).
The same surgeon performed all the RALS procedures. Attending surgeons at UNC (number unspecified)
performed the open sacrocolpopexy procedures. Outcomes reported were improvement on POP-Q,
estimated blood loss, need for transfusion, operative time, length of hospital stay, and complications.
Case Series
The case series we identified on RALS were prospective (Elliott et al. 2006; Daneshgari et al. 2007) or
retrospective (Shariati et al. 2008; Akl et al. 2009; Kramer et al. 2009) reports of single-center
experiences. Study patients had moderate to severe vaginal vault prolapse, and about half of them had a
concurrent anti-incontinence procedure and/or a cystocele/rectocele repair during the same operative
session. For details on these studies, see Table 1.
The limitations of the evidence base include the following:
No RCTs or prospective non-randomized controlled trials assessing this technology for this
indication have been published. The only comparative study we identified was retrospective, and the
study groups had significant differences in baseline characteristics (i.e., degree of prolapse,
concomitant procedures performed). No study compared RALS to LS, sacrospinous ligament
suspension, or uterosacral ligament suspension for treatment of vaginal vault prolapse.

No controlled study reported data on OR setup times, postoperative pain medication use, or
return to normal activity.

Most of the studies describe single-center experience, and data are not generalizable to a
broader population.

Published studies were small and were likely underpowered to detect significant differences
between groups. The small study sizes also made them unlikely to capture rare but potentially serious
AEs.

Many study patients had concomitant procedures that confound interpretation of outcomes RALS
data (e.g., operative time, blood loss, AEs).
Reported Outcomes/Adverse Events

The outcomes of interest for this technology are OR setup time, estimated blood loss, need for
transfusion, operative time, postoperative pain medication use, LOS, return to normal activity, and AEs
(i.e., injury to the gastrointestinal system; injury to the genitourinary system; injury to pelvic viscera,
nerves, and major blood vessels; presacral bleeding; mesh infection and/or erosion; conversion to an
alternate surgical procedure; infection; recurrent vaginal vault prolapse; and port-site hernia).
One study (Geller et al. 2008) compared outcomes for RALS (n = 73) and open sacrocolpopexy (n =
105) and reported on mean improvement in POP-Q score, mean estimated blood loss, operative time,
and LOS. The study reported that the RALS group had slightly more improvement in C-point
measurement (prolapse at the most distal edge of the cervix or vaginal cuff scar) than the open
sacrocolpopexy group (-9 RALS, -8 open; p = 0.008). There were no significant differences between
groups on all other point measurements. The study also reported significantly less blood loss in the RALS
group compared to the open sacrocolpopexy group (103 mL RALS, 255mL open; p < 0.001), but the
difference in mean number of transfusions required by patients in each group was not statistically
significant. With regard to operative times, the study reported a significantly longer mean operative time
in the RALS group than in the open sacrocolpopexy group (328 minutes RALS, 225 minutes open; p <
0.001). With regard to LOS, the study reported a significantly shorter LOS in the RALS group than in the
open sacrocolpopexy group (1.3 days RALS, 2.7 open; p < 0.001).
No comparative data were available on OR setup times, postoperative pain medication use, or return to
normal activity.
Adverse Events
Our searches found one comparative study and five case series that reported on AEs. The studies were
small, and they may be underpowered to detect clinically important AEs. Most AEs occurred
intraoperatively or within the first month postsurgery; in a few cases, AEs occurred several months
postsurgery (e.g., recurrent vaginal vault prolapse). In the controlled study, overall AE rates were similar
between groups; however, incidence of one particular AE was different between groups. The RALS group
had a significantly higher incidence of postoperative fever than the open sacrocolpopexy group (3 cases
RALS, 0 cases open; p = 0.04). For details on specific AEs reported in the included studies, see Table 2.
Summary
ECRI Institute Conclusions
This report focuses on using da Vinci Surgical Systems (Intuitive Surgical, Inc., Sunnyvale, CA, USA) to
perform robotic-assisted laparoscopic sacrocolpopexy (RALS) to treat uterine and vaginal vault prolapse.
The potential patient benefits of RALS compared to open sacrocolpopexy include less pain, less blood
loss, fewer adverse events (AEs), less scarring (five or six 1/3- to 1/2-inch incisions compared to a 6- to
10-inch incision for open surgery), a shorter hospital stay (1 day compared to 3 to 6 days for open
surgery), and a faster recovery (1 to 2 weeks compared to 6 weeks for open surgery).
Surgeons who perform sacrocolpopexy assert that robotic assistance offers superior visualization,
enhanced depth perception, autonomy, and ergonomic comfort. Robotics may allow a surgeon to offer a
minimally invasive approach to more patients. According to Intuitive, RALS offers the following specific
benefits for the surgeon: improved access to the pelvis compared to other surgical approaches; easier,
more precise dissections; improved handling of suture and mesh for more accurate graft placement;
more precise suturing for graft attachment; control of the camera and all three operative arms; and a
reproducible approach that is easier than laparoscopic sacrocolpopexy (LS).
Possible disadvantages of RALS include the initial and recurring costs, the marked learning curve for the
operative team, and increased system setup time.
Our findings for the key questions are as follows:
1. How does RALS compare to open sacrocolpopexy, LS, sacrospinous ligament suspension, and
uterosacral ligament suspension as measured by the following key outcomes: operating room
(OR) setup time, estimated blood loss, need for transfusion, operative time, postoperative
pain medication use, length of stay, and return to normal activity?
Compared to open sacrocolpopexy, data from one comparative study suggest that RALS
results in about half the blood loss (though it is not clear that this is a clinically significant
difference), a significantly longer mean operative time by 103 minutes, and a significantly
shorter length of stay by 1.4 days. No controlled study reported comparative data on OR
setup times, postoperative pain medication use, or return to normal activity.
No data were available that compared RALS to LS, sacrospinous ligament suspension, or
uterosacral ligament suspension for treatment of vaginal vault prolapse.
2.
How do AE rates for RALS compare to AE rates for open sacrocolpopexy, LS, sacrospinous
ligament suspension, and uterosacral ligament suspension for treatment of vaginal vault
prolapse?
The one small comparative study that met our selection criteria reported similar overall AE
rates for open surgery and RALS, but a higher incidence of postoperative fever in the RALS
group (3 cases RALS, 0 cases open; p = 0.04). This study may be underpowered, however, to
detect clinically important AEs.
No AE data were available that compared RALS to LS, sacrospinous ligament suspension, or
uterosacral ligament suspension for treatment of vaginal vault prolapse.
3.
What are the reported occurrences of AEs associated with RALS for treatment of vaginal vault
prolapse (i.e., injury to the gastrointestinal system; injury to the genitourinary system; injury
to pelvic viscera, nerves, and major blood vessels; presacral bleeding; mesh infection and/or
erosion; conversion to an alternate surgical procedure; infection; recurrent vaginal vault
prolapse; and port-site hernia)?
AE rates varied widely among the studies reporting them. Reported rates of conversion to
open surgery were 0% to 20% in the five studies reporting it. The AE reported most often
was mesh infection and/or erosion rate (6.3% to 9.1% in the three studies reporting on it).
The infection rate ranged from 0% to 6.7% in the three studies that reported this
complication. The rate of recurrent vaginal vault prolapse ranged from 1.3% to 4.8% in the
three studies that reported it. The rate of injury to the genitourinary system ranged from
1.4% to 5.2% in the three studies that reported it. Rates of injury to the gastrointestinal
system ranged from 0% to 1.3% in the three studies that reported it. The rate of injury to
pelvic viscera, nerves, and major blood vessels was 6.7% in the one study that reported this
complication. The rate of presacral bleeding was 1.3% in the one study that reported this
complication. Port-site hernia was not reported as a complication that occurred in any of the
included studies.
The direct cost of acquiring a da Vinci system ranges from about $1.7 million to $2.2 million (cost varies
by model). Ongoing maintenance is $150,000 to $175,000 per year. The direct cost of surgical
instruments required for each procedure is about $2,000. Hospitals planning to use these systems can
also expect to incur costs related to surgeon training and equipment upgrades. Because the cost of the
robotic system is not reimbursed separately, the direct intraoperative cost of RALS is higher than the
costs associated with other surgical approaches. However, the postoperative care costs after RALS may
be lower than those of open surgery because of a shorter length of stay. As surgeons gain more
experience and robotic techniques evolve over the next several years, direct procedural costs-especially
operative time-are expected to decrease.
Before acquiring a robotic surgical system, hospitals should also consider the impact it will have on OR
scheduling due to the increased system setup time and competition among clinical service areas (i.e.,
urologists, gynecologists, general surgeons, pediatric surgeons, cardiovascular surgeons) to use the
robotic system. Having a sufficient case volume to maintain individual surgeons' proficiency is critical to
consider.
According to the manufacturer, about 300 hospitals worldwide offer RALS to patients with uterine vault
prolapse. In 2008, surgeons performed approximately 2,600 RALSs using a da Vinci Surgical System.
References
Selected Sources
EndoControl. [Web site]. Dover (DE): EndoControl, Inc.; 2009 [accessed 2009 Dec 2]. [various].
Available: http://www.endocontrol-medical.com.
Advincula AP, Wang K. Evolving role and current state of robotics in minimally invasive gynecologic
surgery. J Minim Invasive Gynecol 2009 May-Jun;16(3):291-301.
Akl MN, Long JB, Giles DL, Cornella JL, Pettit PD, Chen AH, Magtibay PM. Robotic-assisted
sacrocolpopexy: technique and learning curve. Surg Endosc 2009 Oct;23(10):2390-4.
Amodeo A, Linares Quevedo A, Joseph JV, Belgrano E, Patel HR. Robotic laparoscopic surgery: cost and
training. Minerva Urol Nefrol 2009 Jun;61(2):121-8.
Barsoom R, Sinert R. Uterine prolapse. [database online]. New York (NY): WebMD; 2009 Jun 12
[accessed 2009 Jun 12]. [10 p]. Available: http://emedicine.medscape.com/article/797295-overview.
Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The
standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet
Gynecol 1996 Jul;175(1):10-7.
Daneshgari F, Kefer JC, Moore C, Kaouk J. Robotic abdominal sacrocolpopexy/sacrouteropexy repair of
advanced female pelvic organ prolaspe (POP): utilizing POP-quantification-based staging and outcomes.
BJU Int 2007 Oct;100(4):875-9.
Elliott DS, Krambeck AE, Chow GK. Long-term results of robotic assisted laparoscopic sacrocolpopexy for
the treatment of high grade vaginal vault prolapse. J Urol 2006 Aug;176(2):655-9.
Frick AC, Falcone T. Robotics in gynecologic surgery. Minerva Ginecol 2009 Jun;61(3):187-99.
Ganatra AM, Rozet F, Sanchez-Salas R, Barret E, Galiano M, Cathelineau X, Vallancien G. The current
status of laparoscopic sacrocolpopexy: a review. Eur Urol 2009 May;55(5):1089-105.
Geller EJ, Siddiqui NY, Wu JM, Visco AG. Short-term outcomes of robotic sacrocolpopexy compared with
abdominal sacrocolpopexy. Obstet Gynecol 2008 Dec;112(6):1201-6.
Holloway RW, Patel SD, Ahmad S. Robotic surgery in gynecology. Scand J Surg 2009;98(2):96-109.
Intuitive Surgical, Inc. da Vinci Sacrocolpopexy: surgery for uterine or vaginal vault prolapse. [internet].
Sunnyvale (CA): Intuitive Surgical, Inc.; 2009 [accessed 2009 Oct 7]. [3 p]. Available:
http://www.davincisurgery.com/gynecology/gynecology-procedures/sacrocolpopexy.html.
Kramer BA, Whelan CM, Powell TM, Schwartz BF. Robot-assisted laparoscopic sacrocolpopexy as
management for pelvic organ prolapse. J Endourol 2009 Apr;23(4):655-8.
Lazarou G, Grigorescu B. Pelvic organ prolapse. [database online]. New York (NY): WebMD; 2008 Sep 05
[accessed 2008 Sep 5]. [17 p]. Available: http://emedicine.medscape.com/article/276259-overview.
Lowry F. Pelvic floor disorders will affect one third of all American women by 2050. In: Medscape medical
news [internet]. New York (NY): WebMD; 2009 Oct 15 [accessed 2009 Oct 16]. [2 p]. Available:
http://www.medscape.com/viewarticle/710562_print.
Patel M, O'Sullivan D, Tulikangas PK. A comparison of costs for abdominal, laparoscopic, and robot-
assisted sacral colpopexy. Int Urogynecol J Pelvic Floor Dysfunct 2009 Feb;20(2):223-8.
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Related ECRI Institute Reports
TARGET [database online]. Plymouth Meeting (PA): ECRI Institute; 2009 Oct 30. Laparoscopic roboticassisted hysterectomy for benign conditions. Available: http://www.ecri.org.
TARGET [database online]. Plymouth Meeting (PA): ECRI Institute; 2009 Sep 4. Laparoscopic roboticassisted hysterectomy and lymphadenectomy for early-stage cervical cancer. Available:
http://www.ecri.org.
TARGET [database online]. Plymouth Meeting (PA): ECRI Instititue; 2009 Aug 21. Laparoscopic roboticassisted hysterectomy and lymphadenectomy for endometrial cancer. Available: http://www.ecri.org.
TARGET [database online]. Plymouth Meeting (PA): ECRI Institute; 2009 Dec. Robotic-assisted
laparoscopic myomectomy for uterine fibroids. Available: http://www.ecri.org.
TARGET [database online]. Plymouth Meeting (PA): ECRI Institute; 2008 Apr 24. Training/learning curve
for robotic-assisted surgery (overview). Available: http://www.ecri.org.
Standards and Guidelines
American College of Obstetricians and Gynecologists (ACOG). Pelvic organ prolapse. Washington (DC):
American College of Obstetricians and Gynecologists (ACOG); 2007 Sep. 13 p. (ACOG practice bulletin;
no. 85).
Royal College of Obstetricians and Gynaecologists (RCOG). The management of post hysterectomy
vaginal vault prolapse. London (UK): Royal College of Obstetricians and Gynaecologists (RCOG); 2007
Oct. 13 p. (Green-top guideline; no. 46).
Evidence Reports
NICE. Sacrocolpopexy using mesh for vaginal vault prolapse repair. London (UK): National Institute for
Clinical Excellence (NICE); 2009 Jan. 2 p. (Interventional procedure guidance; no. 283).
Classifications
Technology Class
Device, Procedure
Clinical Category
Treatment--Therapeutic
Clinical Specialty
Gynecology, Surgery, Women's Health Services
UMDNS
Telemanipulation Systems, Surgical, Minimally Invasive [18-600] Laparoscopes, Surgical [20-485];
Mesh, Polymeric [12-510]
MeSH
Robotics; Laparoscopy; Surgical Procedures, Minimally Invasive; Surgery, Computer-Assisted;
Laparoscopes; Gynecologic Surgical Procedures; Surgical Mesh; Colposcopy; Pelvic Organ Prolapse
ICD9
Unspecified prolapse of vaginal walls [618.00]; Other computer assisted surgery [00.39]; Laparoscopy
[54.21]; Laparoscopic robotic assisted procedure [17.42]
FDA SPN
SYSTEM,SURGICAL,COMPUTER CONTROLLED INSTRUMENT [NAY]; LAPAROSCOPE, GYNECOLOGIC (AND
ACCESSORIES) [HET]; MESH, SURGICAL [FTM]
HCPCS
SURGICAL TECHNIQUES REQUIRING USE OF ROBOTIC SURGICAL SYSTEM (LIST SEPARATELY IN
ADDITION TO CODE FOR PRIMARY PROCEDURE) [S2900]
SNOMED CT
Sacrocolpopexy [176716008]; Vaginal vault prolapsed [237113009]; Laparoscopic procedure
[73632009]; Hospital robot [66222000]; Robotic arm [82830000]; Laparoscope [86174004]; Abdomen
endoscopy [108191006]; Colposcopy [392003006]
Publication History
ECRI Institute's technology assessment publications include a detailed publication history that enables
you to track the evolution of each report from its initial publication through the current version available
on our website. Reports published before 08/01/2008 may not include this feature.
Date
Action
Comments
12/4/2009Published
Initial publication
972
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