Generalized Robotic Surgery - Northwest Ohio Center for

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Robotic Surgery
Patient Information, Treatment, and Anticipated Recovery Plan
The da Vinci Surgical System by Intuitive Surgical provides patients with an alternative
to both traditional open surgery and conventional laparoscopy. The da Vinci System
enables performance of even the most complex and delicate procedures through very
small incisions with great precision.
For the patient, benefits may include:
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Significantly less pain
Less blood loss
Less scarring
Shorter recovery time
A faster return to normal daily activities
And in many cases, better clinical outcomes
Some benign reasons robotic surgery may be offered include removing uterine fibroids, resecting
endometriosis, and reconnecting scarred fallopian tubes.
da Vinci Robotic Myomectomy is a laparoscopically assisted robotic surgery to treat
uterine fibroids. You may be a candidate for this, uterine-preserving, minimally invasive
procedure . Using the assistance of the most advanced combination of surgical and
robotics technology available – the da Vinci Surgical System – da Vinci Myomectomy
enables Dr. Croak to perform this delicate operation with improved precision and control
– using only a few small incisions.
Another surgical alternative, laparoscopic myomectomy, is also minimally invasive.
However, conventional laparoscopy has inherent technological limitations that limit its
effectiveness for more complex surgical procedures.
In contrast, for many patients, robotic myomectomy, can provide the most effective, least
invasive treatment for uterine fibroids. It is also a uterine-preserving alternative to open
abdominal hysterectomy. Among the potential benefits of robotic myomectomy as
compared to traditional open abdominal surgery are:
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Opportunity for future pregnancy
Significantly less pain
Less blood loss
Fewer complications
Less scarring
A shorter hospital stay
A faster return to normal daily activities
da Vinci Myomectomy is performed through 4 to 5 small minimally invasive abdominal
incisions, to remove fibroids and provide for a precise, comprehensive reconstruction of
the uterine wall, regardless of the size or location of your fibroids. The unique level of
control and precision helps to prevent possible uterine rupture (tearing) during future
pregnancies.
Fibroid removal
Uterine closure
da Vinci Endometriosis Resection enables an operation with enhanced vision, precision,
dexterity and control. da Vinci’s 3D, high-definition vision system allows surgeons to see
key anatomy with immense depth and clarity– critical to removing deep endometrial
tissue implants. da Vinci Endometriosis Resection allows your surgeon to perform a
thorough removal of deeply penetrated or widespread endometrial implants – while
preserving your uterus. Unlike conventional open and laparoscopic surgery, robotic
endometriosis resection offers the added benefit of computer and robotic-assisted
technology, with the goal of minimizing the risk of your endometriosis returning.
Robotic endometriosis resection offers women many potential benefits over traditional
laparoscopy, including:
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Low blood loss
Low conversion rate to open surgery
Low rate of complications
Short hospital stay
Small incisions for minimal scarring
Da Vinci Robotic Tubal Reanastomosis may be an option for those whose have
significant tubal scarring and separation from a prior tubal ligation or less likely from
disease. Advanced #-D vision and microsurgical techniques may also for reanastomosis
with greater success than open techniques with less blood loss and recovery. Ectopic
pregnancy rates have been shown to be higher with robotic tubal reanastomosis.
Other procedures include removal of tubal or ovarian cysts/masses, removal of the
fallopian tubes or ovaries themselves, or dual procedures with a general surgeon to fix
combined gynecologic and colorectal problems.
As with any surgery, these benefits cannot be guaranteed, as surgery is both patient- and
procedure-specific. While using the da Vinci Surgical System is considered safe and
effective, this procedure may not be appropriate for every individual. Always ask about
all treatment options, as well as their risks and benefits.
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. All in-patient surgical procedures are
performed at St. Luke’s Hospital or St. Vincent’s Hospital unless your insurance requires you go
elsewhere. A surgical consent must be signed in the office prior to having your procedure
scheduled.
After surgery, give your self a chance to adjust and recover. Some women feel fine within a
month. Many need a little extra time. Ovarian removal may decrease estrogenization of the
vaginal, leading to vaginal dryness. 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
*Preadmission laboratory tests will be scheduled for you. Report to the out-patient testing
department at St. Luke’s Hospital. Your tests may include blood work, a urinalysis, chest x-ray,
electrocardiogram and a pregnancy test.
*If MRSA positive, please refer to the MRSA protocol below to obtain appropriate preoperative 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
*Obtain a bowel prep kit from your pharmacy, and follow the 24 hour prep instructions. Please
refer to the bowel prep protocols below. Please Follow a Clear Liquid Diet 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. 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 2-4 weeks, meanwhile, do not place anything in the
vagina.
*Resume physical activities slowly; take showers instead of baths for up to 4 weeks
*To avoid constipation eat fruits, vegetables & whole-grain foods. Drink 8 glasses of fluid daily.
*You can drive after 2 days 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 postoperatively, 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 life-threatening 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.
Positive MRSA Screen Protocol (Vancomycin is perioperative antibiotic)
You have tested positive as a carrier of a bacteria called Methicillin resistant staph
aureus. The following steps will decrease the amount of the bacteria present, and help
prevent an infection with surgery.
-Bactroban ointment in both nostrils, twice a day for 10 days before surgery
-Cipro 500 mg by mouth twice daily for 2 days before surgery
-Povidone/Iodine douche 1-3 days before surgery (available at Buderer’s Pharmacy in
Perrysburg)
-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.
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.
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