Questions and Answers about Robotic Prostatectomy Using the da Vinci Surgical System
Answers to Clinical Questions
1. What is the prostate?
The prostate gland, a key part of the male reproductive system, is linked closely with the urinary system. It is a small gland that secretes much of the liquid portion of semen, the milky fluid that transports sperm through the penis during ejaculation. The prostate is located just beneath the bladder, where urine is stored, and in front of the rectum. It encircles a section of the urethra.
2. What is prostate cancer?
Cancer of the prostate, the male reproductive gland located below the bladder & in front of the rectum. Early prostate cancer usually causes no symptoms and is found by a PSA test and/or DRE. Some advanced prostate cancers can slow or weaken your urinary stream or make you need to urinate more often.
3. What is Prostatectomy?
Surgery to remove the prostate in order to treat and prevent the reoccurrence of prostate cancer. A secondary goal of prostatectomy is early return of urinary continence. Where applicable, a third goal is early return of sexual potency.
4. What is Minimally Invasive Surgery (MIS)?
Minimally invasive surgery (also known as MIS, minimal access, keyhole surgery, laparoscopic, or endoscopic surgery) is intended to eliminate the most physically and emotionally traumatic elements of conventional open surgery, including pain and lengthy recovery. Advances in MIS allow surgeons access to affected tissues and organs through very small incisions.MIS is surgery typically performed through small incisions, or operating ports, rather than large incisions, resulting in potentially shorter recovery times, fewer complications, reduced hospitalization costs and reduced trauma to the patient.
5. Why do we need a new way to do minimally invasive surgery?
Despite the widespread use of minimally invasive or laparoscopic surgery in today's hospitals, adoption of laparoscopic techniques, for the most part, has been limited to a few routine procedures. This is due mostly to the limited capabilities of traditional laparoscopic technology, including standard video and rigid instruments, which surgeons must rely on to operate through small incisions.
In traditional open surgery, the physician makes a long incision and then widens it to access the anatomy. In traditional minimally invasive surgery which is widely used for routine procedures -- the surgeon operates using rigid, hand-operated instruments, which are passed through small incisions and views the anatomy on a standard video monitor. Neither this laparoscopic instrumentation nor the video monitor can provide the surgeon with the excellent visualization needed to perform complex surgery like valve repair or nerve-sparing prostatectomy.
6. What are the benefits of da Vinci Surgery compared with traditional methods of surgery?
Some of the major benefits experienced by surgeons using the da Vinci Surgical System over traditional approaches have been greater surgical precision, increased range of motion, improved dexterity, enhanced visualization and improved access. Benefits experienced by patients may include a shorter hospital stay, less pain, less risk of infection, less blood loss, fewer transfusions, less scarring, faster recovery and a quicker return to normal daily activities. None of these benefits can be guaranteed, as surgery is necessarily both patient- and procedure-specific.
7. What is robot-assisted or robotic surgery?
Surgery performed using the assistance of robotic technologies. Existing systems like da Vinci are designed to provide surgeons with enhanced capabilities rather than designed to operate on their own.
8. Where is the da Vinci Surgical System being used now?
Currently, the da Vinci Surgical System is being used in hundreds of locations worldwide, in major centers in the United States, Austria, Belgium, Canada, Denmark, France, Germany, Italy, India, Japan, the Netherlands, Romania, Saudi Arabia, Singapore, Sweden, Switzerland, United Kingdom, Australia and Turkey.
9. Has the da Vinci Surgical System been cleared by the FDA?
The U.S. Food and Drug Administration (FDA) has cleared the da Vinci Surgical System for a wide range of procedures. Please see the FDA Clearance page for specific clearances and representative uses.
10. Is da Vinci Surgery covered by insurance?
da Vinci Surgery is categorized as robot-assisted minimally invasive surgery, so any insurance that covers minimally invasive surgery generally covers da Vinci Surgery. This is true for widely held insurance plans like Medicare. It is important to note that your coverage will depend on your plan and benefits package.
11. Will the da Vinci Surgical System make the surgeon unnecessary?
On the contrary, the da Vinci System enables surgeons to be more precise, advancing their technique and enhancing their capability in performing complex minimally invasive surgery. The System replicates the surgeon's movements in real time. It cannot be programmed, nor can it make decisions on its own to move in any way or perform any type of surgical maneuver without the surgeon's input.
12. Is a surgeon using the da Vinci Surgical System operating in "virtual reality"?
Although seated at a console a few feet away from the patient, the surgeon views an actual image of the surgical field while operating in real-time, through tiny incisions, using miniaturized, wristed instruments. At no time does the surgeon see a virtual image or program/command the system to perform any maneuver on its own/outside of the surgeon's direct, real-time control.
13. Is this telesurgery?
Can you operate over long distances? The da Vinci Surgical System can theoretically be used to operate over long distances. This capability, however, is not the primary focus of the company and thus is not available with the current da Vinci Surgical System.
14. While using the da Vinci Surgical System, can the surgeon feel anything inside the patient's chest or abdomen?
The system relays some force feedback sensations from the operative field back to the surgeon throughout the procedure. This force feedback provides a substitute for tactile sensation and is augmented by the enhanced vision provided by the high-resolution 3D view.
15. Why is it called the da Vinci® Surgical System?
The product is called "da Vinci" in part because Leonardo da Vinci invented the first robot. He also used unparalleled anatomical accuracy and three-dimensional details to bring his masterpieces to life. The da Vinci Surgical System similarly provides physicians with such enhanced detail and precision that the System can simulate an open surgical environment while allowing operation through tiny incisions.
Answers to Questions Concerning the Limited Guarantee
1. What is the limited guarantee?
Saint Luke’s Hospital of Bethlehem, Pennsylvania d/b/a St. Luke’s Hospital & Health Network (St. Luke’s), St. Luke’s Center for Urology (SLCU) and Northgate Urology Associates (NUA) have agreed not to bill eligible patients or their insurance companies (if applicable) for any charges associated with a robotic prostatectomy performed at St. Luke’s, if:
- St. Luke’s or urologists practicing through SLCU or NUA fail to follow a specific Robotic Prostatectomy Care Plan; or
- an eligible patient experiences any of three specific undesired outcomes during a robotic prostatectomy.
In addition, St. Luke’s, SLCU and NUA have agreed not to bill eligible patients or their insurance companies (if applicable) for charges associated with readmission to St. Luke’s within thirty (30) days of the procedure as a direct result of an adverse outcome caused solely by a participating urologist’s technical portion of a robotic prostatectomy performed at St. Luke’s.
2. Why are St. Luke’s, SLCU and NUA offering the limited guarantee?
The care plan is designed to improve patient outcomes, and the limited guarantee is intended to demonstrate the desire of St. Luke’s, SLCU and NUA to follow certain practices and procedures in furtherance of improved patient outcomes. However, St. Luke’s, SLCU and NUA cannot guarantee specific outcomes for patients. For example, the three undesired outcomes are atypical, but they may occur from time to time. In addition, any failure to follow the care plan or the occurrence of an undesired outcome or a readmission is not intended to constitute an acknowledgement of fault or wrongdoing by St. Luke’s, SLCU, NUA or the participating urologists.
3. What is the Robotic Prostatectomy Care Plan?
St. Luke’s, SLCU and NUA have developed and implemented at St. Luke’s a multi-faceted Robotic Prostatectomy Care Plan intended to direct the pre-operative and inpatient process for eligible patients who undergo prostate removal through robotic prostatectomy at St. Luke’s.
4. Will the plan still be followed if an otherwise eligible patient does not want to participate in the guarantee?
Yes. We expect that the plan will be followed by the urologists practicing through SLCU and NUA and St. Luke’s staff for every patient who undergoes prostate removal through robotic prostatectomy at St. Luke’s.
5. What are the three specific undesired outcomes?
The three undesired outcomes are: (a) rectal injury requiring fecal diversion and/or additional procedures related to rectal injury; (b) ureteral injury; and (c) prolonged anastamotic leak requiring retention of foley catheter by a patient for more than thirty (30) days following the date the patient undergoes the procedure.
6. Why did we choose these outcomes?
We believe that these should typically be preventable when a robotic prostatectomy is performed by a qualified surgeon.
7. If an otherwise eligible patient is readmitted following a robotic prostatectomy, will the patient and his insurance company (if applicable) be charged by the urologists and St. Luke’s?
It depends. St. Luke’s, SLCU and NUA have agreed not to bill eligible patients or their insurance companies (if applicable) for charges associated with any readmission to St. Luke’s within thirty (30) days of the procedure as a direct result of an adverse outcome caused solely by a participating urologist’s technical portion of a robotic prostatectomy performed at St. Luke’s. In other words, the limited guarantee will apply to readmissions at St. Luke’s if a participating urologist’s technical portion of the surgery causes an adverse outcome. This includes things within the direct control of the urologists during the technical portion of the surgery, but it excludes many other risks generally associated with surgery. However, this does not include a readmission caused by an adverse outcome if the adverse outcome is not caused solely by a participating urologist’s technical portion of the surgery.
8. What are some examples of adverse outcomes not caused solely by a participating urologist’s technical portion of a robotic prostatectomy?
If an eligible patient suffers a heart attack, stroke or pulmonary embolism (blockage of the pulmonary artery) during or following the procedure, the adverse outcome would not be caused solely by a surgeon’s technical portion of a robotic prostatectomy and thus the adverse outcome resulting in the readmission would not be covered by the limited guarantee. The adverse events listed in the prior sentence are only examples and are not intended to include all adverse events not caused solely by an urologist’s technical portion of a robotic prostatectomy.
9. Who is eligible for this limited guarantee?
The limited guarantee applies only to patients (a) of SLCU and NUA; (b) who undergo prostate removal through robotic prostatectomy at St. Luke’s; (c) who sign a patient acknowledgment; and (d) with respect to patients who experience a readmission to St. Luke’s within thirty (30) days of the surgery as a direct result of an adverse outcome caused solely by a participating urologist’s technical portion of the surgery at St. Luke’s, who are readmitted to St. Luke’s for treatment.
10. Which surgeons are offering this guarantee?
The surgeons who currently offer this limited guarantee are: Eric Mayer, M.D., Jarrod E. Rosenthal, M.D., Frank J. Tamarkin, M.D. and Joseph B. Lennert, MD.
11. What happens if an otherwise eligible patient is readmitted to a different hospital other than St. Luke’s?
If an otherwise eligible patient is admitted to a hospital other than St. Luke’s as a direct result of an adverse outcome caused solely by a participating urologist’s technical portion of a robotic prostatectomy performed at St. Luke’s, the patient is not eligible to participate in the limited guarantee.
12. What does an eligible patient need to sign to participate in the limited guarantee?
In order to be eligible for the limited guarantee, a patient must execute prior to the robotic prostatectomy a patient acknowledgement in the form delivered by the patient’s participating urologist. The patient acknowledgement includes a verification by the patient that certain portions of the Robotic Prostatectomy Care Plan have been performed, such as a discussion between the physician and the patient of prostate cancer treatment options. The patient must also agree to follow his pre- and post-surgical instructions.
13. Does the guarantee cover all services related to the surgery?
Certain third parties other than St. Luke’s and the urologists participating in the limited guarantee, including certain affiliates of St. Luke’s, may provide services in connection with a robotic prostatectomy performed at St. Luke’s, the treatment of an undesired outcome or treatment provided during a readmission. For example, an anesthesiologist may provide and bill for professional services performed in connection with a robotic prostatectomy, a colorectal surgeon may attempt to correct a rectal injury or a cardiologist may provide consultative services during a patient’s recovery at St. Luke’s. The limited guarantee is not intended to, and does not, preclude these professionals from billing a patient or his insurance company for services provided, including such professionals employed or engaged by St. Luke’s or its affiliates.
14. How does a patient make a request not to be billed under the guarantee?
If an eligible patient believes that he or his insurance company (if applicable) should not be billed for a robotic prostatectomy or a readmission, the patient must deliver written notice to the appropriate practice within ninety (90) days following the date of the procedure at the following address:
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SLCU Patients
St. Luke's Center for Urology
1521 8th Avenue, Suite 201
Bethlehem, Pennsylvania 18018
Attn: Practice Administrator
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NUA Patients
Northgate Urology Associates
5325 Northgate Drive, Suite 203
Bethlehem Medical Arts Bldg.
Bethlehem, PA 18017
Attn: Practice Administrator
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A patient must provide a detailed written description of the reasons why he or his insurance company (if applicable) should not be billed. If requested by the performing urologist, the patient must submit to one (1) or more physical examinations by a physician employed or engaged by the applicable practice so that the patient’s urologist may adequately evaluate the patient and determine whether the limited guarantee applies.
15. Can the guarantee terms change?
Yes. The terms of the limited guarantee may change from time to time. Patients should revisit the Terms and Conditions prior to undergoing a procedure. The latest terms and conditions and the Robotic Prostatectomy Care Plan posted on this website (http://www.mystlukesonline.com/guarantee) at least five (5) days prior to the date of a procedure will apply to a patient.
16. What if there is a dispute?
In the event of a dispute concerning an alleged failure to follow the care plan, an alleged occurrence of an undesired outcome or an alleged readmission arising under the limited guarantee, the dispute will be submitted to a panel consisting of John J. Lukaszczyk, M.D., Mark E. Schadt, M.D., and Marc Granson, M.D., who serves as the Chief of Surgery at St. Luke’s. The panel will consider in its sole discretion, information it deems relevant in making a determination, which decision will be final. If requested by the panel, the patient must meet with members of the panel, so that the panel may review the patient’s assertions. The patient may be required to answer questions from the panel. If requested by the panel, the patient must undergo a physical examination by all or select members of the panel. The panel may review the patient’s medical records, including any physical examination conducted by the applicable practice. In the event of a disagreement among members of the panel, a decision by a majority of the members of the panel will control.
17. Can a person use the terms of the guarantee in a medical malpractice claim against St. Luke’s, SLCU, NUA and/or the participating urologists?
No. A failure to follow the care plan, the occurrence of an undesired outcome or a readmission covered by the limited guarantee is not an acknowledgement of fault or wrongdoing by St. Luke’s, SLCU, NUA or the participating urologists and cannot be considered an admission of liability by St. Luke’s, SLCU, NUA or the participating urologists. The limited guarantee cannot be used as evidence in any legal proceeding alleging professional negligence or misconduct. In fact, the standards set forth in the limited guarantee may be a higher standard than the applicable standard of care required by law.
THESE FREQUENTLY ASKED QUESTIONS ARE INTENDED TO ASSIST YOU IN YOUR INTERPRETATION OF THE TERMS AND CONDITIONS APPLICABLE TO THE LIMITED GUARANTEE. HOWEVER, YOU SHOULD READ THE TERMS AND CONDITIONS CAREFULLY. IN THE EVENT OF A DISPUTE BETWEEN THESE FREQUENTLY ASKED QUESTIONS AND THE TERMS AND CONDITIONS, THE TERMS AND CONDITIONS SHALL CONTROL.