Robotic Sacralcolpopexy for Pelvic Organ Prolapse
Patient Information, Treatment, and Anticipated Recovery Plan
One or more of the pelvic organs can lose their support and fall out of place. Women with prolapse
may experience pelvic pressure, a sense of a “lump” protruding through the vagina, problems
having a bowel movement, low back pain, and problems having intercourse. Pelvic organ prolapse
may be caused by vaginal childbirth, menopause, chronic coughing or straining, heavy lifting, or
obesity.
Of significance, prolapse often causes problems with urination. Women who may have once
experienced urinary incontinence (a condition common with prolapse) often notice an
“improvement” as their prolapse worsens. This is due to the functional “kinking” of the urethra
caused by the occluding nature of the prolapse. Severe prolapse may not only affect urinary
continence, but also may obstruct the ability to empty the bladder.
In a normal pelvis, the pelvic muscles support the reproductive, urinary, and digestive organs. If
these muscles stretch, weaken, or tear, the pelvic organs fall out of place (prolapse). The prolapse
may mild or severe. It may involve more than one of the three pelvic organ systems mentioned
above. The main types of prolapse are mentioned below:
Once you and your health care provider have decided on pelvic reconstructive surgery, you will
want to understand what needs to be repaired. There are several types of surgery for pelvic organ
prolapse. The goal of each type of surgery is to repair the problem and relieve your symptoms. The
surgery may include one or more repairs, depending on your problem.
The surgeon reaches your pelvic organs through the vagina or the abdomen. An incision may be
made in the vaginal wall. If incisions are made on the abdomen, they can be up and down or across.
The method of surgery may affect your recovery.
Da Vinci Robotic Sacrocolpopexy is a procedure to surgically correct vaginal vault prolapse
where an FDA approved mesh is used to hold the vagina in the correct anatomical position. This
procedure can also be performed following other procedures that may or may not remove the uterus.
For example, robotic sacrocolpopexy may be combined with a supracervical hysterectomy to treat
uterine prolapse to provide long-term support of the vagina. In addition, robotic sacrohysteropexy
may be used to support a prolapsed uterus in a woman who desires to keep her uterus or have more
children.
Sacrocolpopexy has traditionally been performed as an open surgery. A 15-30 cm horizontal
incision is usually made in the lower abdomen in order to manually access the inter-abdominal
organs, including the uterus. This gold standard procedure uses an FDA approved mesh to attach the
vaginal from the inside of the abdomen to the sacral promontory of your tailbone. Long-term
success ranges from 85-97%.
Mesh is suspended from the sacral promontory to the vaginal
Vault to rid the patient of apical prolapse
Robotic sacrocolpopexy uses a state-of-the-art surgical system designed to help your surgeon
perform a minimally invasive surgery through small incisions.
Open
Robotic
Moreover, da Vinci provides with a superior surgical tool for dissection and, as compared to
traditional open or minimally invasive approaches. da Vinci Sacrocolpopexy also allows better
visualization of anatomy, which is especially critical when working around delicate and confined
structures like the bladder. This means that there is a distinct advantage when performing a complex
sacrocolpopexy involving adhesions from prior pelvic surgery.
For most women, da Vinci Sacrocolpopexy offers numerous potential benefits over a traditional
open approach:
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Significantly less pain
Less blood loss and need for transfusions
Less risk of infection
Less scarring
Shorter hospital stay
Shorter recovery time
Quicker return to normal activities
As with any surgery, benefits cannot be guaranteed, as surgery is both patient- and procedurespecific. While sacrocolpopexy by any of the above techniques is considered safe and effective, one
specific surgical route may not be appropriate for each individual. Always ask about all treatment
options, as well as their risks and benefits.
Once the pelvic organ prolapse is repaired, the urethra may no longer be occluded. This may result
in the “unmasking” of the hidden urinary incontinence problem that so often coexists with prolapse.
Urinary incontinence surgery may be needed to help reduce prolapse related urinary leakage.
Bulking
agent
A transurethral bulking agent injects material into the urethra and helps to close the urethra
during activities that cause urine leakage. An incontinence sling is placed vaginally under the
urethra to recreate a hammock of support that kinks the urethra closed during activities that
cause urine leakage. A retropubic urethropexy uses an abdominal incision to resuspend the
bladder neck to ligaments adjacent to the back of the pubic bone.
If prolapse or incontinence is severe or recurrent, biologic or synthetic material may need to be used
for the repair. If necessary, this will be discussed before surgery.
All in-patient surgical procedures are performed at St. Luke’s Hospital or St. Vincent Medical
Center unless your insurance requires you go elsewhere. A surgical consent must be signed in the
office prior to having your procedure scheduled.
You will have an intravenous line to provide fluids, and a urinary catheter to drain your bladder. Drains
may be present to help drain fluid from your incision. Medication to relieve pain and nausea will be
available throughout your hospital stay.
You may stay in hospital for 1 night or longer. Or, you may go home the same day. The length of
stay depends on the nature of your surgery. You will have an intravenous line to provide fluids.
Medication to relieve pain and nausea will be available throughout your hospital stay.
It may be hard for you to urinate for a few days or weeks. Sometimes, up to 40% of women cannot
urinate efficiently after surgery due to swelling or anesthesia. This may last a few hours to a few
weeks.
You may be required to use a catheter in your bladder to help it drain. One kind of catheter, called a
Foley catheter, may be placed into the bladder through the urethra. This is usually reserved for
large pelvic reconstructive surgeries and delayed recovery. Most patients learn how to use a
catheter intermittently to empty their bladder. This is called self intermittent catheterization. It is
an easy technique to learn and helps to the threat of urine infection. A third kind of catheter is
called a suprapubic catheter (SPC). This catheter is place through a small incision in the
abdomen. A SPC is good for elderly patients who may not be able to insert a catheter or who are
obese. Other tubes may help drain fluid from your incision.
After surgery, give yourself a chance to adjust and recover. Some women feel fine within a month. Many
need a little extra time. Sexual response may change after sacrocolpopexy. There are no definitive studies
saying sacrocolpopexy decreases orgasmic potential. If pain and bleeding have been a problem, you may
feel better and have more energy as your body heals. Once you have fully recovered, you can focus on
enjoying your life.
Before Surgery
* For surgery scheduled at St. Luke’s Hospital or St. Vincent Medical Center, pre-admission
testing will be scheduled for you. Your tests may include blood work, a urinalysis, chest x-ray,
electrocardiogram and pregnancy test.
* If MRSA positive, please refer to the MRSA protocol below to obtain appropriate pre-operative
therapies to use before your surgery.
* The anesthesiologist will talk with you at the time of your testing regarding the specific type of
anesthesia that will be administered. Inform the anesthesiologist if you wear dentures, or have a
family history of anesthetic complications. He/she or one of the personnel in the out-patient
testing will tell you what time to report to the out-patient admitting office the day of your
scheduled surgery.
* Do not bring jewelry or valuables with you to the hospital.
* Stopping smoking before surgery if strongly encouraged.
One Day Prior to Surgery
* Please refer to the bowel prep protocols attached. Please Follow a Clear Liquid Diet
beginning at 4:00 PM the day before surgery. You may have Jello, broth, coffee, popsicles,
tea, soda, Kool-Aid and juices (except orange). ABSOLUTELY NO FOOD, LIQUID OR
MEDICATION SHOULD BE TAKEN BY MOUTH AFTER MIDNIGHT OF THE DAY
PRIOR TO SURGERY UNLESS DIRECTED. Please let Dr. Croak and the anesthesiologist
know if you take any medicines daily, or have a chronic illness.
After Surgery
* Robotic surgery may be outpatient
* For robotic procedures requiring an overnight stay, the length of your hospital stay can vary, but
is typically is 1-3 days. Please understand that with healthcare reform, Medicare and many
private insurers will now only allow a one night in the hospital for most robotic procedures.
* Perform breathing exercises every hour while awake in the hospital to keep lungs clear of excess
fluid; walking with assistance later in the day of surgery can help prevent blood clot formation
* Normal activities can be resumed in 4 weeks in most cases.
* Sexual intercourse may be resumed in 4-6 weeks, meanwhile, do not place anything in the
vagina.
* Resume physical activities slowly; take showers instead of baths for 4 weeks
* To avoid constipation eat fruits, vegetables & whole-grain foods. Drink 8 glasses of fluid daily.
* You can drive after 1-2 weeks if you feel up to it, have discontinued narcotic pain meds, and can
press on the brake quickly without pain
* Do not lift more than 15 lbs until after your 4-week appointment; when you can return to work
depends on your responsibilities
* You will be seen in the office at 1 & 4 weeks post-operatively, and as needed
* Please call the office with any questions or concerns at 419.893.7134
* Notify your Dr. if you notice fever or chills, heavy vaginal bleeding or foul vaginal
discharge, redness, bleeding or discharge at the incision site, pain or swelling in your legs,
shortness of breath or chest pain, severe abdominal or pelvic pain
POSITION ON ROBOTIC SURGERY
With the commencement of class action litigation in regards to robotic surgery, this document is
being provided to inform you as a patient on FDA approval of robotic surgery for gynecologic
indications. Most of this document is based on the Women’s Health and Education Center Practice
Bulletin and Clinical Management Guidelines for healthcare providers, published November 23,
2009. Dr. Croak agrees and complies fully with these guidelines. He was one of the first
gynecologic surgeons to learn robotic surgery and has successfully completed over 300 procedures
with less than 1% complication rates for bladder/bowel/vascular injury, abdominal conversion,
reoperation, or fistula. Dr. Croak is involved on the local and national level in establishing robotic
safety guidelines and standards for the teaching and credentialing of residents, fellows, and
surgeons.
Audience: Patients considering or have received a robotic surgery for a gynecologic indication
Device: The da Vinci Robot by Intuitive Surgical, Inc., Sunnyvale, CA
Background: In 2005, U.S. Food and Drug Administration approved use of the daVinci robot for
gynecologic surgery as a modification of the laparoscopic approach. The surgeon, seated at an
ergonomically designed video console with an "immersive" 3-D display, initiates the digital
instructions through robotic arms to control sophisticated hand grips that control modified
laparoscopic instruments with seven degrees of freedom, giving the surgeon significantly improved
dexterity. The advent of this technology has made it possible to perform the traditional
gynecological procedures through a laparoscopic technique that allows for ease of maneuvering,
thus combining the benefits of a minimally invasive surgical procedure with reduced patient
morbidity, a shorter recovery period, and a shorter hospital stay. The use of robotics in gynecologic
surgery is increasing in the United States. In gynecology the expansion is reflected in literature
reports on robotic applications in general gynecology, urogynecology/pelvic reconstructive surgery,
gynecologic oncology, and reproductive endocrinology.
Advantages: Robotic surgery offers three advantages over laparoscopy: a three-dimensional vision system,
wristed instrumentation, and ergonomic positioning for the surgeon while performing surgical procedures.
Conventional laparoscopic surgery has a steep learning curve for physicians because it has two-dimensional
imaging and involves mastering counter-intuitive hand movements. The enhanced visualization gives the
gynecologic surgeon an improved ability to identify tissue planes, blood vessels, and nerves while
performing the surgical procedure. The "wristed" instrumentation affords greater dexterity and provides
seven degrees of freedom, similar to the human hand With robotic surgery, the surgeon sits comfortably at
the surgical console and manipulates the hand controls and foot pedals while in an ergonomic position which
reduces fatigue and discomfort during surgery.
Minimally invasive hysterectomy approaches (vaginal and laparoscopic) are underused in the United States.
Will robot surgery substantially improve outcomes over vaginal or conventional laparoscopic routes?
Currently, of hysterectomies done for the top seven non-cancer diagnoses in the United States, approximately
66.1% are abdominal, 21.8% are performed vaginally, and only 11.8% are performed laparoscopically. The
best comparative review of 200 robotic versus laparoscopic hysterectomies shows no differences in patient
characteristics, but does show intraoperative conversion to laparotomy was two-fold higher with
laparoscopy. The mean blood loss was also significantly reduced in the robotic group. The incidence of
adverse events was similar in the two groups.
In regards to gynecologic cancer surgery, one study found the highest lymph node yields with the robotic
approach. When looking at fibroid removal (myomectomy) comparing robotic to open myomectomy, the
robotic group had longer operative times were reported in the robotic group, but decreased blood loss and
shorter length of stay. Although pregnancy rates after myomectomy managed robotically are similar to those
after open laparotomy, a major worry continues to be the risk of uterine rupture. These factors and the
associated learning curve may contribute to the fact that abdominal myomectomy remains the standard
approach. Robotic tubal reanastomosis results are promising as a result of the advanced vision along with
microsurgical precision of robotic. One study compared robotic to open tubal anastomosis in women with
tubal ligation desiring reversal, and found robotic tubal anastomosis was associated with longer operative
time but shorter hospital length of stay and faster return to normal activities of daily living. Pregnancy rates
were comparable between groups, yet the robotic group had a higher number of ectopic pregnancies. Robotic
sacrocolpopexy for pelvic organ prolapse demonstrated similar short-term vaginal vault support compared
with abdominal sacrocolpopexy, with less blood loss and shorter length of stay in studies. Operative time
was longer but decreases as the learning curve for this new procedure improves. There were similar
outcomes between the two groups in terms of perioperative complications, but this is limited by the low
incidence of these complications. Long-term data are needed to assess the durability of this newer minimally
invasive approach to prolapse repair. Robotic vesicovaginal and ureterovaginal fistula repair has been
reported through small reports. In a valid series, no significant intraoperative or postoperative complications
were observed
Disadvantages: The main disadvantages of robotic surgery across applications are the cost ($ 1.65 million
with maintenance costs of $ 149,000 per year), the large size of the robot console, limited availability within
some health systems, lack of tactile feedback, and the need to train residents, attending surgeons and
operating room personnel on proper use. There is evidence that with experience, operative time can become
shorter.
Vaginal cuff dehiscence with small bowel evisceration after hysterectomy is a rare event that may be
occurring more frequently with the advent of robotic laparoscopic hysterectomies. A review of all
hysterectomies performed at the Mayo Clinic in Scottsdale, Arizona, showed that of the 15% were performed
robotically, the vaginal cuff dehiscence rate was 2.87%.
Lawsuits: Recently, class action litigation has commenced regarding da Vinci robotic surgery. These
lawsuits contend that many physicians are not adequately trained or proctored on robotic surgery, which may
increase the risk of patient complications and injuries. Although some research suggests surgeons may
require usually 50 and up to 200 robotic cases per procedure for proficiency, minimal and insufficient
training is currently available for physicians. Research has suggested that while a surgeon is learning the new
techniques of robotic surgery, many patients will experience more inferior outcomes than with an
experienced surgeon. Although training is critical, the problem with this argument is that historically,
even those experienced surgeons had to go through a learning curve to master new and valuable
medical technologies.
In addition, the lawsuits allege robotic design defects that may be responsible for serious and potentially lifethreatening injuries. The contention is the energy used with the da Vinci system may pass outside the
surgical field as a result insulation defects in the instruments, without awareness of the surgeon, which may
cause injuries to surrounding body parts. Likewise, cuts, tears and burns may be suffered by nearby arteries
or internal organs, which often go undetected for some time after surgery, and may result in severe
complications days later, which require additional surgery and may cause permanent injury or death. The
lawsuits claim that safer designs were available, including other methods to cut, burn and cauterize tissue,
which could reduce complications. The criticism with this argument is that there is a risk of these types
of injuries no matter what route the surgery is performed. Many studies now show that the purported
complication risks or robotic surgery are no greater or less than that of abdominal or laparoscopic
surgery.
It is recommended that health care providers should:
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Obtain specialized training for robotic surgery, and be aware of the risks of robotic surgery.
Be vigilant for potential adverse events of robotic surgery, especially complications
associated with the tools used in robotic surgery, especially bowel, bladder and blood vessel
perforations, or electrical energy injuries.
Inform patients of the risks, benefits, and alternatives of robotic surgery and that
complications associated with robotic surgery may require additional surgery that may or
may not correct the complication.
Inform patients about the potential for serious complications and their effect on quality of
life, including pain during sexual intercourse, scarring, and vaginal cuff dehiscence.
In addition, patients should:
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Recognize that in most cases, robotic surgery is a safe and effective surgical method.
Choose robotic surgery only after weighing the risks and benefits of surgery versus all other
surgical and non-surgical alternatives.
Compare the benefits and risks of non-surgical options, non-robotic surgery, and the likely
success of these alternatives compared to surgery via other routes.
Ask if robotic surgery will be used and inquire about information about the robot.
Ensure that you understand the postoperative risks and complications of robotic surgery as
well as limited long-term outcomes data.
Taken from www.fda.gov Medical Devices Safety Alerts & Notices (07/13/2011)
Information on Surgical Mesh for Pelvic Organ Prolapse and Stress Urinary Incontinence: FDA wants to inform
you about the complications that can occur when surgical mesh is used to treat Pelvic Organ Prolapse (POP) and Stress
Urinary Incontinence (SUI), and provide you with questions to ask your surgeon before having these procedures. This is
part of our commitment to keep healthcare professionals and the public informed about the medical products we
regulate.
FDA has received reports of complications associated with the placement of mesh through an incision made in the wall of
the vagina. Although rare, these complications can have serious consequences. The reports have not been linked to a
single brand or model of mesh.
The most frequent complications included erosion through the vagina, infection, pain, urinary problems and recurrence of
the prolapse and/or incontinence.
In some cases, erosion of the mesh and scarring of the vagina led to discomfort and pain, including pain during sexual
intercourse. Some patients needed additional surgery to remove the mesh that had eroded into the vagina. Other
complications included injuries to nearby organs such as the bowel and bladder, or blood vessels.
Background: A pelvic organ prolapse (POP) occurs when a pelvic organ, such as your bladder, drops (“prolapses”)
from its normal position and pushes against the walls of your vagina. This can happen if the muscles that hold your pelvic
organs in place become weak or stretched from childbirth or surgery. More than one pelvic organ can drop at the same
time. Organs that can be involved in a pelvic organ prolapse include the bladder, the uterus, the bowel and the rectum.
Pelvic organ prolapse can cause pain or problems with bowel and bladder functions or interfere with sexual activity.
Stress urinary incontinence (SUI) is a type of incontinence caused by leakage of urine during moments of physical stress.
Talking to your doctor: Before having an operation for POP or SUI, be sure to let your surgeon know if you’ve had a
past reaction to mesh materials such as polypropylene. Questions you should ask the surgeon before you agree to
surgery in which mesh will be used:
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What are the pros and cons of using surgical mesh in my particular case? Can my repair be successfully
performed without using mesh?
If a mesh is to be used, what’s been your experience with implanting this particular product? What experience
have your other patients had with this product?
What’s been your experience in dealing with the complications that might occur?
What can I expect to feel after surgery and for how long?
Are there any specific side effects I should let you know about after the surgery?
What if the mesh doesn’t correct my problem?
If I have a complication related to the mesh, can the mesh be removed and what could the consequences be?
If a mesh is to be used, is there patient information that comes with the product, and can I have a copy?
Reporting complications to the FDA: In order to help FDA learn more about possible problems with surgical mesh, it
is important that both physicians and patients report complications that may be associated with this product.
You can report any problems to the FDA's MedWatch Adverse Event Reporting program either online, by mail or FAX.
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Online : MedWatch Online Voluntary Reporting Form (3500)5
Mail : use postage-paid FDA form 3500 available at: MedWatch Forms6
Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
FAX: 1-800-FDA-0178
Related Links
FDA Public Health Notification: Serious Complications Associated with Transvaginal Placement of Surgical Mesh in Repair of
Pelvic Organ Prolapse and Stress Urinary Incontinence
MRSA SCREEN PROTOCOL
(For patients with a positive result only)
IF you have tested positive for Methicillin Resistant Staph Aureus (MRSA), the
following protocol will be used to decrease the amount of bacteria present and help
prevent an infection with surgery.
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Bactroban ointment in both nostrils, twice a day for 10 days before surgery
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Cipro 500 mg by mouth twice daily for 2 days before surgery
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Povidone/Iodine douche 1-3 days before surgery (available at Buderer’s Pharmacy in
Perrysburg)
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Chlorhexadine (or similar) shampoo/wash the day before surgery (available at Buderer’s
Pharmacy in Perrysburg)
PRE-SURGERY BOWEL PREP INSTRUCTIONS
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May have regular diet up until 4:00 PM day before surgery
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At 4:00 PM, begin a clear liquids diet AND take one (1) Ducolax laxative tablet
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At 6:00 PM, use one (1) Fleets enemas according to instructions
Examples of Clear Liquids: Water, clear fruit juices (apple or white grape), chicken/beef bouillon
cubes, jello (NO RED OR PURPLE), popsicles ( NO RED OR PURPLE), Gatorade (Light color
only), clear soft drinks (7-UP, Sprite, Vernors), coffee/tea without cream (sugar is Ok). No milk,
milk products, or orange juice.
*** ABSOLUTELY NOTHING BY MOUTH AFTER MIDNIGHT ***
STOP Plavix/Aspirin, Aspirin by-products 1 week prior to your surgery.
STOP Coumadin 5 days prior to your surgery.
PLEASE CONSULT the physician who ordered the Plavix and Coumadin before you stop taking.
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NEWER ANTICOAGULANTS (I.E. PRADAXA, EFFIENT) MAY REQUIRE A LONGER
DISCONTINUANCE RATE PRIOR TO SURGERY DUE TO HEAVY BLEEDING RISK
PELVIC RECONSTRUCTIVE SURGERY AND DISABILITY
Pelvic prolapse is a condition that may be caused by vaginal childbirth, menopause, chronic coughing or
straining, heavy lifting, or obesity. It is a condition that often takes many years to present itself as a
condition of moderate to severe bother, thus patients with prolapse may choose to delay a visit until their
problem is severe. A delay in seeking help often has caused extreme and permanent pelvic floor dysfunction
from their prolapse including but not limited to urinary of fecal incontinence, pain, weak tissue, and poor
neurological function.
Many women with chronic health problems including but not limited to obesity, diabetes, smoking, joint
replacements, and prior pelvic surgery are prone to prolapse. In addition, women with jobs requiring heavy
labor, lifting, or standing for long periods tend to get prolapse. By the time many patient seek help for their
prolapse problem, they may experience more severe symptoms requiring more complex surgery that involves
longer surgical recuperation.
The fact of the matter is that Dr. Croak will try his BEST to repair a prolapse, but sometimes the
patient’s conditions and poor pelvic health will not allow for the most optimal healing. Recurrent
prolapse is always possible and is more likely to occur in patients with the problems mentioned above.
To help prevent recurrent prolapse after a surgery, Dr. Croak may give recommendations including but not
limited to limiting heavy lifting, maintaining regular bowel function, optimizing weight loss and exercise,
and improving overall pelvic floor health.
It is impossible for Dr. Croak to control what people do in their daily lives or for him to list the
hundreds of activities that people may do that cause strain to the pelvic floor. Just as a person with
common sense would not cross a busy intersection into oncoming traffic, a postoperative patient should not
do activities that strain a repair such as skydiving, waterskiing, or dead-lifting.
THESE ARE NOT RESTRICTIONS – THEY ARE RECOMMENDATIONS.
The reason Dr. Croak does not give out restrictions is because many patients are employed by
companies that will not allow their employees back to work with a restriction in place. This is their way
to escape responsibility towards protecting their employee’s health after a pelvic surgery. If an employed
patient is put in the position of jeopardizing their repair, they should ask for assistance in performing that
particular job or be switched to another position.
Dr. Croak understands that a patient must return to work to make a living, but he does not have the means or
staff to place restrictions on patients or pursue lengthily disability claims.