The idea—and some test cases—of surgery without incisions has recently made headlines in the mainstream media. But are surgeons, their tools and their patients really ready for operations performed entirely through orifices?
Two experts in the field of natural orifice transluminal endoscopic surgery (NOTES) recently debated this question at the American College of Gastroenterology's annual scientific meeting, held in Philadelphia in October.
So far, NOTES procedures have been shown to be safe and effective in animal laboratory studies as well as some humans, said Anthony N. Kalloo, FACP, professor of medicine and chief of gastroenterology and hepatology at Johns Hopkins Hospital in Baltimore.
Liver biopsy during NOTES.
“Several patients have been done, not just in India, but in Europe, even in America. We have preliminary experience that looks good so far,” said Dr. Kalloo, who took the pro side of the debate.
The model example of NOTES is the removal of an appendix through the mouth, performed in India in 2002, noted Dr. Kalloo's debate opponent, Jeffrey L. Ponsky, MD, professor and chair of surgery at Case Western Reserve University in Cleveland.
“Other people have gotten excited about this and said they would like to take other organs out of the peritoneal cavity,” said Dr. Ponsky. In recent U.S. trials, surgeons have removed gallbladders transgastrically and through the vagina.
The NOTES procedures performed to date have all been hybrid procedures, in which both an endoscope and a laparoscope are used. That ensures both safety and a good view of the operation, the experts noted.
But have these trial procedures proven that NOTES should be done more often and should soon have a place in regular practice?
Dr. Kalloo is enthusiastically affirmative about the value of NOTES procedures. “This is how we develop our field. This is how we advance science,” he said.
According to Dr. Kalloo, NOTES has the potential to reduce the pain and risk of complications that current laparoscopy entails. “It [laparoscopic surgery] is a very safe procedure, but there are risks,” he said. “Because you're penetrating the skeletal musculature, it's still going to be painful.”
The absence of scars is another benefit of NOTES. “I think many surgeons and others underestimate the patient's concept about scars. If you give the patient a choice between having a scar versus no scar, they will choose no scar,” said Dr. Kalloo.
A recent patient survey supports his perception of attitudes toward NOTES. A survey of 192 cholecystectomy patients, presented at the Society of American Gastrointestinal Endoscopic Surgeons' annual meeting, found that 56% of patients would choose NOTES over laparoscopic cholecystectomy. “Knowing that NOTES would have less pain and less recovery time but require more skill, 80% said they would still prefer it even with a slightly higher complication rate,” Dr. Kalloo said.
Public opinion is likely to be the biggest impetus for use of NOTES, he predicted. “Our surgeons did not want to do laparoscopy. They did not want to take the gallbladder out, but consumer demand—with expectations of less pain and faster recovery—fueled laparoscopic cholecystectomy.”
Once NOTES is perfected, it will open up the possibility of another patient-pleasing development—the elimination of the operating room. “Laparoscopic surgery must sterilize the abdominal wall. With NOTES, however, your sterile field becomes the GI tract. So if you can sterilize the GI tract and insert sterile equipment, then your need for a sterile operating environment will decrease,” said Dr. Kalloo.
He envisioned a future in which a segment of gastroenterologists will specialize in performing NOTES procedures in their offices, and portable battery-operated NOTES tools will allow rapid treatment of abdominal trauma.
The benefits of NOTES are not yet certain, according to Dr. Ponsky. “Is this operation as good as our traditional operation? Does it achieve the desired results in the correct number of cases? We don't know yet.”
He noted that current laparoscopic procedures may be hard to improve upon. In a laparoscopic appendectomy, “the patient goes home in one hour, taking Darvocet for two days, and [is] back to full activity within a couple of days. They have a one-centimeter incision. We have to match that with NOTES,” he said.
NOTES may in fact cause more complications than traditional surgery because it requires cutting into the stomach, Dr. Ponsky warned, as he showed photos of peritonitis resulting from a NOTES procedure. “If you're going to do an operation in the peritoneal cavity, it's going to have a certain incidence of complications which is not insignificant,” he said. “I could easily puncture your colon trying to get out of the stomach. If I do it once in a hundred, is it worth it?”
The risk of complications is heightened by the fact that the ideal tools for the procedure have not yet been developed. “It's hard to move heavy tissue with tiny, pinching forceps. We need better instrumentation,” Dr. Ponsky said. He predicted that better tools should be available within a few years.
Other limits on the procedure—such as the size and shape of the human body—will not change, however. “If you take out something large and try to remove it through the esophagus, once it gets over about two to three centimeters, it's hard to get it up through the EG [esophagogastric] junction,” he said.
Dr. Ponsky also noted that public acceptance of the idea of NOTES has not been universal. “Some people, some women—rightly so—found it kind of unpleasant to think about a transvaginal operation to take out their gallbladder. Some surgeons published papers saying it was offensive.”
Meeting in the middle
Dr. Ponsky is not among the surgeons who are offended by the concept of NOTES, however. In fact, he has conducted research on the procedure, which both presenters cited in their arguments.
In an animal study of peritoneoscopy, he and other researchers compared the physiologic and inflammatory stress of diagnostic NOTES, diagnostic laparoscopy and diagnostic laparotomy. While the study indicated that NOTES was no more stressful on the body than laparoscopy, the research also raised more questions. Animals that underwent NOTES had persistent increased immunosuppression compared to the other groups.
“It could be a good thing. It could be that these animals feel better,” said Dr. Kalloo.
Or it could be a bad thing. “Maybe it means that if we do this for cancer, the patient may have more disseminated disease than if we did a regular operation,” countered Dr. Ponsky.
This and other unknowns motivate Dr. Ponsky's cautious approach to NOTES. “I'm the first to believe in it and I'm working on it. I think we have to be careful that we don't put our patients at risk by rushing into it too soon,” he said.
On that point, the debaters could agree. “We have to make it safe,” Dr. Kalloo concluded.