By Rob Stein
Washington Post Staff Writer
Sunday, September 21, 2008
When Albert Pagliuca got gallstones, his surgeon offered to remove his gallbladder with a new operation designed to hurt less, get him back to work more quickly and leave no visible scars. But there was one catch: Doctors would pull the organ out through his mouth.
"I kept thinking, 'What if it gets stuck in my windpipe?' " said Pagliuca, 45, who lives outside Chicago. " 'What if I choke on it?' "
After doctors guaranteed that would not happen, he agreed, becoming one of several dozen Americans who have undergone experimental procedures that could take minimally invasive surgery to a new level -- operations that do not cut the skin open. Instead, surgeons enter the body through a "natural orifice."
"It's potentially a very big deal," said Nathaniel J. Soper, who chairs the surgery department at Northwestern University. "This could be the endpoint in innovation, going from big incisions to little incisions to no incisions at all, which is the Holy Grail when things have to be removed from the body."
Many surgeons are enthusiastic about the possibilities, but some question the need for the new procedures when safe, only slightly invasive alternatives exist. And they fear that doctors will rush ahead before they have perfected their techniques and made sure that the benefits are worth the risks.
"That's exactly what's going to happen," said Ira J. Kodner, a surgery professor and a bioethicist at Washington University School of Medicine in St. Louis. "Those who haven't been trained are going to go out and do it. They are going to take a weekend course and start offering it. It's going to happen. I guarantee it."
David Cronin, an associate professor of surgery at the Medical College of Wisconsin, is especially concerned that non-surgeons will start doing the operations. He said: "Not every idea is a good idea. I've been following this one with clenched teeth."
Proponents argue that they are well aware of the pitfalls and have taken steps to prevent them. Two key medical specialties joined together to try to ensure that the operations are carefully studied before becoming widespread, in the hope of avoiding the kinds of complications caused by laparoscopic surgeries in the early 1990s.
"It's very promising," said David W. Rattner, chief of general and gastrointestinal surgery at Massachusetts General Hospital. "But patient safety is paramount. This needs to be developed in a responsible and careful manner. I think we're proceeding very well so far."
The approach, called NOTES -- for natural orifice transluminal endoscopic surgery -- seeks to move beyond arthroscopic and laparoscopic techniques, which for many procedures replaced large incisions with several small ones, shortening hospital stays and recovery time, reducing pain and risks, and leaving much smaller scars.
More recently, surgeons realized they could enter the body through natural openings with flexible endoscopes, which are routinely used for diagnostic purposes such as colon cancer screening. After experimenting for years on pigs and human cadavers, a team in India announced in 2005 the first successful procedure in humans.
"At first people said, 'Are you crazy? That's ridiculous,' " said Anthony Kalloo, a professor of medicine and the chief of gastroenterology at Johns Hopkins University who pioneered the new techniques in the laboratory. "But this has really started to take off."
Surgeons have now performed the procedures on more than 400 patients worldwide, mostly in South America and India. Doctors in Europe are experimenting with them, and a handful of surgeons began trying the approach in the United States in the past year.
The technique has been used mostly to remove gallbladders through the mouth or the vagina. But a few patients have had appendectomies, and doctors are experimenting with stomach surgery for obesity and other conditions.
"For centuries, we thought to do any surgery in the abdomen we needed to create this big hole, do what you need to do and close that big hole," said Mark A. Talamini, who chairs the surgery department at the University of California at San Diego. His colleague Santiago Horgan has performed about 29 NOTES operations in the United States and Argentina. "This is a totally different way of thinking about operating," Talamini said.
To remove a gallbladder or an appendix through the mouth, surgeons give patients general anesthesia and slide an endoscope down the throat and into the stomach. They inflate the abdominal area to make it easier to see and sterilize the stomach. In addition to a camera that transmits images, the endoscope is equipped with a variety of small instruments, including a tiny scalpel that cuts a hole in the stomach wall, allowing the surgeon to snake the endoscope to the organ needing removal. Other instruments enable the surgeon to move the organ, cauterize bleeding blood vessels, suture and clip the internal incisions and pull out the organ.
So far, most surgeons are making at least one external incision in the abdomen, usually in the bellybutton, to insert a laparoscope to help them see where they are working and sometimes assist with other aspects of the procedure, such as lifting the organ. But at least one group has started removing gallbladders through the vagina without any external incisions, and the goal is to refine the techniques and instruments to operate entirely internally.
All of the 40 or so reported U.S. procedures have been done under guidelines established by NOSCAR, the Natural Orifice Surgery Consortium for Assessment and Research. The consortium was created by the American Society for Gastrointestinal Endoscopy and the Society of American Gastrointestinal and Endoscopic Surgeons to try to develop the technique safely.
The guidelines call for all operations to be conducted under the close watch of an independent panel of experts to make sure, among other things, that they are done as safely as possible and that patients understand that they are experimental. The group has also established a registry to gather data on safety and effectiveness.
Still, some question whether the potential risks are warranted. One of the biggest fears is that the incision in the stomach wall might leak, which could cause life-threatening infections.
"You have to ask: Does the science at this point justify doing this? What is the risk-benefit ratio?" Kodner said. "For the most part, the benefit is there's no visible hole on a person's body. The risk is you may perforate an organ and cause a patient a really serious complication just to avoid a cosmetic scar. Is it worth it?"
While praising NOSCAR for trying to develop the technique carefully, Kodner and others note that there is no regulatory body equivalent to the Food and Drug Administration that can stop a procedure from proliferating too quickly, especially if patients start clamoring for it.
"What's going to control it from expanding before it's ready for prime time?" Kodner asked. "How do you control it once the box is open? That's what's happened with every other surgical innovation. Once it hits the media, everyone wants it. That's the shady side."
Cronin also worries that non-surgeons may start performing the procedures.
"If NOTES is being done by a gastroenterologist who does endoscopies, they may know what the anatomy looks like in a textbook, but they are very unsophisticated and unknowledgeable about what complications to expect from surgery and how to treat them because they are not surgeons," he said.
But no major complications have been reported so far, and the procedures appear to cause less pain and speed recovery, several surgeons said. Most patients spend a night in the hospital just to be safe but could probably go home the same day. Some need nothing more than over-the-counter painkillers. They return to work in less than a week -- with virtually no visible scars.
"I am so happy this was available to me," said Pagliuca, who after his surgery last summer had a mild sore throat, which went away quickly, and stomach pain for a few days that felt like he had done too many sit-ups. "It was so easy, and I don't have a scar I have to look at every day to remind me of something I don't want to have to think about. It's fantastic."
Awilda Sanchez, 31, of New York, went home the same day she had her gallbladder removed through her vagina in March, after doctors assured her the procedure would not affect her sex life or her ability to have children. She said: "I think everybody should get this. Now when it's bikini time, I won't have to worry about a scar. I think it's great."
But not everyone has been thrilled.
After having her gallbladder removed through her mouth last November, Colleen Caddell, 53, of Hillsboro, Ore., experienced several days of throat pain so intense she could barely swallow and a week of vomiting.
"I had terrible problems," she said. "It was excruciating. It was not at all what I was expecting."
Caddell's doctor said that she had preexisting throat problems and sensitivity to pain medications that probably contributed to her complications, and that none of his other patients had any problems.
Several experts predicted that the procedures could be widely available in two to five years, but they acknowledged that much more work needs to be done first. The operations take much longer than laparoscopic procedures. Better instruments need to be developed to reduce the time and the need for outside incisions.
"There's been a kind of frenzy of activity with a lot of new start-up companies to design instrumentation," said Lee Swanstrom, director of minimally invasive surgery at Legacy Health System in Portland, Ore.
In addition, careful studies need to be done to compare the procedures directly with existing operations to prove that NOTES is equally safe and offers clear advantages.
"If it proves to be risky, which I don't think it will be, or of limited benefit, then we'll stop doing it," said Marc Bessler, director of laparoscopic surgery at New York-Presbyterian Hospital at Columbia. "So far it doesn't seem to be risky, the patients definitely have a cosmetic benefit, recovery seems to be better, and they seem to have less pain. If we can get to recovery-free, pain-free and scar-free surgery, that would be a revolution."