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? What if I choke on it?’ ” said Pagliuca, 45, who lives outside Chicago.
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 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 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..”
David Cronin, an associate professor of surgery at the Medical College of Wisconsin, is especially concerned that non-surgeons will start doing the operations.
Proponents argue that they are well aware of the pitfalls and have taken steps to prevent them. Two key medical specialties joined to try to ensure 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 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 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 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.
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.
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?” 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 there is no regulatory body equivalent to the Food and Drug Administration that can stop a procedure from proliferating too quickly.
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.”
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.
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