Image: Connie Harris
David Ahntholz  /  for msnbc.com
Connie Harris, 60, of Carlsbad, Calif., says she was up and around within days of undergoing unusual natural orifice surgery.
Image: JoNel Aleccia
By JoNel Aleccia Health writer
msnbc.com
updated 8/18/2010 9:00:57 AM ET 2010-08-18T13:00:57

A California woman who says she’s has been dieting for 50 years believes she’s finally found the solution to her weight-loss woes: A doctor removed most of her stomach — through her mouth.

Connie Harris, 60, of Carlsbad, this month became the first patient in the U.S. to undergo a sleeve gastrectomy, a surgery that eliminates 80 percent of the stomach, using a new technique that removes organs and tissues not in the traditional way, but through natural bodily openings.

“I was expecting the worst, at least a sore throat, but my mouth was just dry,” Harris told msnbc.com while recuperating from home. “I’m feeling good.”

While weight loss was her main goal, Harris said she was happy to join about 150 other patients across the country who have had the unusual operations known as NOTES — natural orifice translumenal endoscopic surgery — aimed at reducing scarring, pain, infection and recovery time. In fact, it’s the main reason she chose her surgeon, Dr. Santiago Horgan, director of minimally invasive surgery at the University of California, San Diego Medical Center.

“This guy has done gallbladders out of your mouth, an appendix out of your mouth, and this very operation vaginally,” said Harris. “He pulls things out of everywhere and he has some serious skills.”

Orifice operations now more common
Once regarded as “highly experimental,” NOTES operations are now becoming more common, at least in the few centers that specialize. Harris and other patients who undergo the procedures agree to part be part of clinical trials to test the operations’ safety and effectiveness.

Horgan has performed two-thirds of the NOTES surgeries in the U.S., becoming a pioneer in a fledging field that began here with surgeries in animals, mostly pigs, in 2004.

On the other side of the country, Dr. Marc Bessler, a surgeon at Columbia Presbyterian Hospital in New York, performed the first U.S. NOTES procedure on a human in 2007 by removing a woman’s gallbladder through her vagina.

Since then, the field has expanded, albeit slowly. Put simply: “It’s surgical procedures through different ports,” said Dr. Michael Kochman, co-chairman of the research committee for NOSCAR, the Natural Orifice Surgery Consortium for Assessment and Research. NOTES and NOSCAR are trademarked terms.

The idea is to use a direct route to reach the organ, tumor or other tissue, make a small incision and then remove it through the same pathway. To remove a gallbladder through the mouth, for instance, a doctor would insert a tube down the esophagus, make a cut in the stomach or digestive tract, and then retract the organ and seal the wound. Other sites such as the vagina, rectum, urethra or bladder are also used.

Deciding the best way to remove an organ or tissue depends on the situation, Horgan said.

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“From the gallbladder to the vagina, you have a straight shot,” he said. “I think the gastric sleeve surgery is better through the mouth.”

Less pain, faster recovery
The surgeries allow patients to avoid large external scars and reduce the pain and recovery time of surgery, he said. Patients in traditional operations can take six weeks to resume normal activities; with NOTES procedures they can be back to work in a week, Horgan said.

NOTES surgeries improve on laparoscopy by using no external incisions at all, experts said. In the meantime, some operations are done as hybrid procedures that use laparoscopy in conjunction with natural orifice removal.

Getting back to normal quickly was important to Harris, a retired real estate broker who says she was about 70 pounds overweight before the surgery. After yo-yo dieting since she was a teenager, she was willing to put the $21,000 bill on her credit card and go for it.

“The big thing was, I don’t have an incision in my stomach and I didn’t have to have my muscles cut,” she said. “Six days after the surgery, I went to the follow-up appointment and then we went to the mall.”

So far, NOTES operations have been tightly controlled and supervised, Horgan and Kochman stressed. Only about a dozen sites across the U.S. perform them, even though they’ve been widely done internationally. Clinical trials in humans comparing NOTES gallbladder surgeries with ordinary laparoscopic surgeries have begun, with the first of about 180 patients enrolled.

Early studies indicate that NOTES procedures cause less pain in patients and little infection or complications, said Dr. Daniel Scott, associate professor and director of the Southwestern Center for Minimally Invasive Surgery at the University of Texas Southwestern Medical Center in Dallas.

More studies are needed, however, to confirm safety and efficacy, he added. In addition, expansion has been hampered by the slow development and approval of equipment specifically designed for NOTES surgeries. Traditional endoscopic devices work fine, but can be too flexible and not versatile enough for the trickiest surgeries.

Perhaps hundreds of devices specifically designed for NOTES surgeries are in the works, but none has yet received approval from the Food and Drug Administration, Kochman noted. 

In addition, doctors have to make sure to perfect techniques for sealing internal wounds to ensure that they are routinely secure and safe.

Idea still shocks many patients
But an even bigger hurdle may be the ick factor. For some patients, the notion of extracting an organ from their mouth or elsewhere is still shocking.

“Many times, when I tell a patient, ‘I want to operate through your vagina,’ they say ‘NO!’” Horgan said.

Gradually, though, some patients are getting used to the idea, and even asking for it. Horgan said he’s had people from as far away as Chicago want to come to San Diego after researching the operation on the internet. In the future, patients may be able to have kidneys, spleens and parts of the colon removed using NOTES procedures.

Right now, the only way to schedule a NOTES surgery is to go through a hospital where the procedure has been vetted by an institutional review board and a patient can join a clinical trial. But as many as 15 sites across the U.S. are ramping up to perform NOTES surgeries as soon as equipment, research and demand allows.

Experts say the caution around NOTES procedures mirror the concerns about laparoscopy when it was first introduced. But as far as patients like Connie Harris are concerned, it’s the way to go.

“When I tell people, they are just, you know, very surprised,” she said. “I can’t wait to get a copy of the video. It’s cool.”

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