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: 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: 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: 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: 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: 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 May have regular diet up until 4:00 PM day before surgery At 4:00 PM, begin a clear liquids diet AND take one (1) Ducolax laxative tablet 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.