By Felice J. Freyer; Journal Medical Writer
A costly new device at Miriam Hospital makes tricky surgery easier and may reduce side effects.
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PROVIDENCE – In the operating room at Miriam Hospital, five people surround the patient, draped and unconscious on the table.
But the surgeon who’s performing the operation – Dr. Joseph F. Renzulli II – isn’t among the five.
He’s several feet away, sitting at a console, his shoes on the floor next to him.
Renzulli peers into the machine, operating handles and pedals that direct the surgical instruments poking into the patient’s belly.
This is robot-assisted surgery – and some say it’s the future of surgery. Miriam Hospital is the first hospital in the state to acquire the robot, called the da Vinci Surgical System, which makes it easier to operate in the tighter corners of the human body.
In this case, the tight corner is the pelvis of a 51-year-old man with a cancer-ridden prostate gland, the walnut-sized organ at the base of the bladder that produces seminal fluid.
With instruments inserted through five half-inch incisions, the robot-assisted procedure promises less blood loss, faster recovery, and possibly – though it hasn’t been proven – lower rates of incontinence and impotence, the two most troubling side effects of prostate removal.
Approved for prostate removal in 2001, some 461 da Vinci systems are in use today at North American hospitals. The technology has caught on quickly despite its high cost – Miriam paid $1.7 million for its system – and despite the fact that the jury is still out on whether robot-assisted surgery leads to better long-term outcomes than standard procedures.
Some 920 Rhode Island men (and 219,000 Americans) will get a diagnosis of prostate cancer this year, making it the most common cancer diagnosis, according to American Cancer Society estimates. There is considerable uncertainty about which cases of prostate cancer require treatment (because some tumors can linger harmlessly for years) and whether to treat with surgery or radiation. But for men who choose surgery, three methods are in use.
The conventional approach is open surgery, in which a doctor makes an 8-to-10-inch incision in the abdomen. Patients typically need five to seven days in the hospital and two to three months at home to recover.
Recently, minimally invasive laparoscopic methods have been introduced for prostate surgery. These involve inserting a camera and surgical instruments into tiny incisions in the lower abdomen. Using long, stiff, hand-held instruments, the surgeon watches his work on a video screen. Similar methods have long been used for abdominal surgery, such as gall bladder removal. But because the bones of the pelvis leave little room to maneuver, laparoscopic prostate removal requires extraordinary physical endurance and technical skill, and few medical centers offer it.
Enter the robot. Robot-assisted surgery offers the advantages of laparoscopic surgery – less blood loss, faster recovery – while overcoming the technical challenges. The surgeon, through a binocular lens, watches a three-dimensional, highly magnified image of his work. The instruments have jointed wrists that can swivel more than the normal motion of the human wrist. The system filters out the inevitable tremor in the surgeon’s hand, and converts the surgeon’s movements to smaller, finer movements of the instruments.
“Every limitation of laparoscopic surgery is overcome by the robot,” says Renzulli. “It’s like you’re inside the person’s body.” (One thing that’s missing, however, is the surgeon’s ability to feel what he is doing.)
In the operation Renzulli is performing on the 51-year-old man, he’s especially glad to be able to peer inside. This man’s anatomy poses a particular challenge: his prostate is ensconced under the pubic bone. If this were open surgery, Renzulli says, “this would be a disaster. Think about it. Underneath the bone, you can’t get your head in there.”
Renzulli points out the slender squiggle of the dorsal vein. This vessel must be cut to remove the prostate, and in open surgery it can be the source of massive bleeding. But in robot-assisted surgery the abdomen is pumped full of gas to make room for the instruments to move about, and the pressure from the gas limits the bleeding. Remotely controlling the hooked cautery tool, Renzulli severs the vein, activates another instrument to suction off the little bit of blood that spurts out, and stitches it shut.
Now Renzulli painstakingly separates the netlike membrane of nerves that covers the prostate. It’s like peeling the skin off a grape. He wants to preserve as much of the nerves as possible, because they control urinary continence and erections.
But on the left side, where the cancer resides, his main focus is making sure not to leave any cancer behind. This man’s tumor is particularly worrisome because he is young, with many years ahead in which it can grow, and because tests indicated it was an aggressive cancer. (A recent study comparing 50 robotic prostatectomies with 147 laparoscopic ones indicates that the robotic procedure, with its magnification and precision, may improve doctors’ ability to get all the cancer.)
Renzulli says his first priority is cancer control. Second, he strives for continence, and third, to preserve sexual function. He recalls a mentor during his training at Yale observing, “You can’t get an erection in the cemetery.”
A tiny plastic bag, like a snack bag with a long blue drawstring, is brought inside the patient’s abdomen. With a grasping tool, Renzulli maneuvers the detached prostate gland into the bag and pulls the drawstring tight. It will be removed and sent to a pathologist to examine later.
He completes the operation in a little over three hours. It’s June 1, and this was the 71st robotic surgery at the Miriam.
The push to get the da Vinci machine originated with Dr. Henry C. Sax, who became Miriam’s surgeon-in-chief two years ago. He had previously worked at the University of Rochester, which purchased the first da Vinci system in upstate New York and used it to treat hundreds of patients a year.
When Sax came to Rhode Island with the mission of beefing up Miriam’s surgery program, especially minimally invasive surgery, he knew he had to have that machine.
The clincher came in December 2005, when Newsweek published a story about da Vinci surgeries. The featured patient was a Rhode Islander. But he had to go to New York for the procedure. Sax also identified a “pipeline” to Hartford, where 50 to 100 Rhode Islanders had gone for da Vinci prostatectomies.
He wanted people to stay here to get their medical care. Also, he wanted to be able to train – and retain – new surgeons.
“It’s really important for this to be available to help us train the next generation of doctors,” said Sax, who is professor of surgery at the Warren Alpert Medical School of Brown University. “And having it may encourage more to stay here.”
After an arduous review before the Health Department, whose approval is needed for expensive new technologies, Miriam won permission to acquire the robot last fall. The state set strict standards for surgeons’ training and monitoring.
Bill Bradley, 62, of Providence, was the very first da Vinci patient at Miriam, on Nov. 16, 2006. He says he wasn’t worried about the surgeons’ inexperience because his sister-in-law, an oncologist, supported the idea, because he trusted his doctor’s recommendation and because he knew an outside surgeon experienced in robotics would be overseeing the first 10 procedures.
Bradley, a retired schoolteacher who now runs a group home, says he was playing tennis eight days after the surgery. And seven months after the procedure, he has no sign of cancer.
Paul Pecchia, 68, a former Stop & Shop manager who lives in Cranston, had his prostate removed with the da Vinci on March 22, by Dr. Gyan Pareek.
He has two brothers who’d undergone open prostate surgery, 6 and 10 years ago. One lost a lot of blood during surgery and spent five days in intensive care. The other suffered scarring that continues to make it difficult to urinate, requiring a catheter.
In contrast, Paul Pecchia left the hospital after three days. He leaked urine for a couple of days after the catheter was removed and then had no other problems; he says he never even needed a pad. Pecchia volunteered that he’d had no sexual problems either. “If you have to have it done, God forbid,” he says, “I would say that’s the best way to go.”
“The main thing is,” he adds, “the cancer’s gone.”
But despite the glowing testimonials, and all the gee-whiz wonders of the da Vinci machine, do most patients actually fare better with it? Miriam’s advertisements – with the headline, “Love the rest of your life” – emphasize “dramatically” lower risks of incontinence and impotence.
But it will take many years of follow-up to know if that’s true.
“There is no good evidence to suggest that the da Vinci robot produces any better result than standard laparoscopic surgery,” said Dr. Scott MacDougal, chief of surgery at Massachusetts General Hospital in Boston, which has held off on buying a da Vinci robot. Although many studies indicate better results with robot-assisted surgery, MacDougal does not believe those studies were well done.
“To add to the cost of health care through these sorts of mechanisms when it’s not proven to be helpful,” MacDougal said, ” it doesn’t seem like a responsible thing to do.”
MacDougal described da Vinci as “a first step” in the inevitable new world of robotic surgery. “This is an early entry into that area. As technology improves, it will be much more versatile, much less costly.”
But MacDougal acknowledged that Mass. General may be losing some prospective patients to hospitals that have the robot. Many patients read about the da Vinci online and decide they want it. Da Vinci’s manufacturer, Intuitive Surgical, estimates that by the end of this year, more than half of all prostatectomies will be done with a da Vinci machine – up from 15 percent in 2004.
Renzulli acknowledges that the studies done so far involved individual surgeons reporting on their own results, not the gold standard for clinical research. But he says the surgeons are reporting similar findings.
Renzulli is especially impressed by what he has read and experienced regarding incontinence.
“You really see the difference when you talk to patients,” Renzulli said. “Our patients are coming back – they’re dry much quicker than they were with open surgery.”
As for preserving potency, that’s harder to measure. Half of all men over 50 already have some erectile dysfunction before the surgery, Renzulli said. Discerning whether the surgery made matters worse can be subjective.
But, says Renzulli, “If they have no preoperative erectile dysfunction, three out of four guys get that potency back in a year.”
“I think this thing is worth it,” said Pareek, the other Miriam urologist trained in using the da Vinci machine. “When you’re operating deep down in the pelvis, it’s very difficult.”
Sandra L. Coletta, Miriam’s chief operating officer, acknowledged that at $1.7 million, the da Vinci machine required a big upfront investment, which Miriam was able to pay without borrowing. The time needed for training and the slower, more carefully monitored procedures in the beginning also cost money. Additionally, disposable surgical equipment costs $1,500 to $2,000 per procedure, according to the manufacturer.
But because patients spend less time in the hospital, the overall cost is comparable to that of open surgery, Coletta said. Shorter stays also open up beds for new patients.
The robot also attracts more patients. In 2006, Miriam surgeons did about 50 prostate removals. Since November, when the machine came on line, the hospital has done more than 70.
Among those patients, Renzulli and Pareek said, there were few complications. No one needed a blood transfusion. One patient had surgical adhesions from a previous operation, forcing doctors to switch to an open procedure. No other patients had complications during surgery, and postoperative complications were few and not unusual.
One patient died, however. Megan Martin, hospital spokeswoman, said the man died in the days after the procedure from a common complication of any surgery and that a Health Department investigation did not find anything that the hospital should have done differently.
One aspect of that investigation is still under way, as the state Board of Medical Licensure and Discipline examines the conduct of the physicians involved. Dr. Robert S. Crausman, the board’s chief administrative officer, said he cannot comment on any incomplete investigation. But he added: “The medical board was very impressed with the quality of work being done [in the da Vinci surgery program] and the efforts they’ve put into bringing this technology to the state.”
So far, Miriam has been using the robot exclusively for prostate removal. But surgeons hope to soon employ it for kidney and bladder cancer, and also have state approval to use it for cardiac and gastrointestinal procedures.
As for the man in the surgery that Renzulli performed on June 1, everything seemed to have gone smoothly. Renzulli said a few days afterward that the man had stayed in the hospital for two nights and seemed to be recovering well. The pathologist was still examining his tissue, so the status of his cancer wasn’t yet known.
As with so many things in medicine, only time will tell.
[email protected] / (401) 277-7397
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ROBOTIC SURGERY
Advantages:
Superior 3-dimensional vision
Magnification of surgical field
Greater dexterity, precision and control of instruments
Filtration of physiological tremors
DISADVANTAGES
Costs of system, instruments, disposable supplies
Increased time in learning, connecting and maintaining equipment
Additional operative time
Lack of tactile feedback
Source: “The Advantages and Disadvantages of Robot-Assisted Surgery,” prepared for the R.I. Department of Health by Harvey Zimmerman.
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Dr. Joseph Renzulli demonstrates the da Vinci robot, used to remove cancerous prostate glands. Most da Vinci patients spend less time in the hospital than traditional prostate cancer patients.
The Providence Journal / Steve Szydlowski
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As Dr. Joseph F. Renzulli II works at the robotic surgery console in the background, Dr. Harry Iannotti, center, monitors the procedure during the operation at Miriam Hospital on June 1.
The Providence Journal / Mary Murphy
(c) 2007 Providence Journal. Provided by ProQuest Information and Learning. All rights Reserved.
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