No scars: New TOGA obesity surgery goes through mouth

Chicago, IL

Doctors are testing a new kind of obesity surgery without any cuts through the abdomen, snaking a tube as thick as a garden hose down the throat to snap staples into the stomach. The experimental, scar-free procedure creates a narrow passage that slows the food as it moves from the upper stomach into the lower stomach, helping patients feel full more quickly and eat less.

Doctors say preliminary results from about 200 U.S. patients and 100 in Europe look promising.

After about 18 months, obese European patients have lost an average of about 45 percent of their body weight, said Dr. Gregg Nishi, a surgeon at Cedars-Sinai Medical Center in Los Angeles. He discussed the European and U.S. studies during a Chicago conference this week for digestive disease specialists.

The procedure is only being done in the studies, which recently ended enrollment. Makers of the device used in the operation plan to seek federal approval if the research continues to go as planned.

While the two studies are still under way and only brief details are being released, Nishi said results so far are slightly better than typical results from with conventional stomach stapling.

Risks include perforating the esophagus, as Nishi said happened to a patient at another center, but otherwise, he said, there have been no major complications.

Some study patients have lost weight after unknowingly undergoing fake procedures — sedation and the tube, but no stapling. Results comparing them with the real thing aren't yet available.

Liliana Gomez, an administrative coordinator at Cedars-Sinai, was among the first Americans to have the scarless obesity surgery last year, as a test case for the U.S. study. She had planned on more invasive conventional surgery until learning that doctors at her hospital were studying the scarless stapling technique.

"When I found out it was going to be oral, through your mouth, I was like, 'Wow, that's kind of different,'" she said.

Since her operation in August, Gomez has lost about 40 pounds and dropped from size 22 to size 16.

The 35-year-old mother of three has a long way to go — she's still obese according to body mass index standards. But Gomez says she has cut her meal portions by more than half and still feels full, and is optimistic she'll continue to lose weight.

The new method is part of a medical movement to perform surgery through body openings such as the nose, mouth and vagina instead of making cuts. The idea is to reduce chances of infection and pain, and speed recovery. With no scars, there are cosmetic advantages, too.

Gomez had considered a gastric bypass operation, a more complex kind of stomach stapling, but worried about risks from that surgery. It reduces the stomach to the size of a golf ball and reroutes the digestive tract.

Whether done through one large abdominal incision or several tiny ones, gastric bypass is far more invasive and increases chances for malnutrition because it repositions how the stomach attaches to the intestines to restrict calorie absorption.

Another popular weight-loss surgery option involves putting an adjustable band around the top part of the stomach to create a small pouch.

The experimental method Gomez had is the oral version of a different kind of stomach surgery, which reduces the size of the stomach with staples but doesn't reroute the digestive system.

Surgery is generally considered a last-resort treatment for obesity, which affects more than 15 million Americans. Still, demand is high. More than 200,000 Americans are expected to have conventional forms of obesity surgery this year, according to the American Society for Metabolic & Bariatric Surgery.

Dr. Scott Shikora, the society's president, called the oral procedure exciting and innovative, but said, "It is too early for us to say this is going to be a breakthrough."

Shikora said many U.S. obesity surgeons prefer the rerouting surgery or flexible bands, and that it remains to be seen whether the oral method has the same drawbacks as more outmoded stapling procedures.

The U.S. study is taking place at 10 centers. Patients will be followed for at least one year, with final results expected in 2010. They are randomly selected to undergo either the operation or a sham procedure.

Nishi said of 25 patients enrolled at his hospital, 17 got the real treatment, with no complications.

"I'm very impressed with it," Nishi said. So far, it looks like "a viable alternative," he said.

Satiety Inc., a California company that created the medical devices used in the technique, is paying for the research. Nishi said he has no financial ties to the company.

At Washington University School of Medicine in St. Louis, where the first U.S. procedure was done last summer, about 30 patients have undergone the treatment. Side effects have been minimal, including sore throats, nausea and some abdominal pain lasting less than a week, said Dr. J. Christopher Eagon. He said weight loss results from his center aren't yet available.

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Gastroplasty: New bariatric procedure for shrinking the stomach

Miami, FL

Until now shrinking the stomach for weight loss was done through lengthy and risky surgery, but a new procedure can do it in under an hour with no cutting.

When 30-year-old Belinda Guevara's weight peaked at 217 pounds she decided to take action.

"I've heard about gastric bypass," she said. "I've also heard about the gastric banding and I'm really not the type of person that would submit myself to that kind of surgery."

Instead, Guevara opted for a new experimental weight loss procedure that shrinks stomach size without surgery.

It's done by going in through the mouth and down the esophagus.

"We are not removing anatomy were just making the tunnel a little thinner," Dr. Joe Greer said. "This is completely reversible. This is a procedure that takes up to 45 minutes to perform and patients go home within half an hour to an hour after the procedure."

Mercy Hospital in Miami is one of three centers in the U.S. that studies whether vertical gastroplasty is safe and effective.

Dr. Roberto Fogel of Mercy Hospital came up with this procedure in Venezuela.

Using a device that's FDA-approved to treat reflux, he stitches together parts of the stomach to make it smaller.

The procedure has been found to reduce levels of the hormone that controls hunger.

"So you have a little pouch that actually drips the food in one by one," Greer said. "You eat smaller amounts, you're not as hungry and so you lose weight."

Fogel said there have been no serious complications so far.

"We had in Venezuela maybe six or seven patients from the almost 400 with a small bleeding but a bleeding that was controlled in the moment," Fogel said.

Fogel provided before and after photos showing some impressive results.

The procedure costs $8,900 and insurance companies will not cover it because it's considered investigational.

Candidates for the study are people with a body mass index or BMI between 28 and 40, needing to lose less than a hundred pounds and have no chronic health conditions.

"Morbidly obese patients still should go for gastric bypass surgery," Greer said.

Two days after her gastroplasty, Guevara said she felt great and has noticed a big difference in her appetite.

"I'm not hungry, which is great because you don't have the urge and you don't have the sensation to just eat," she said. "It's incredible because you would never think that you would feel full having soup and having a small amount of soup. I'm already full."

Guevara said her goal is to lose 60 pounds.

Her doctors said most of that should be gone in six months.

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First transoral gastroplasty bariatric procedure performed in St. Louis

St. Louis, MO

A Granite City, Illinois woman has become the first patient in the country to undergo a new obesity procedure that can restrict the size of the stomach without an incision.

Inserting instruments through Carrie Williamson's mouth and down her throat, doctors at Barnes-Jewish Hospital on Wednesday created a small pouch in her stomach that will make her feel full after eating only a small amount of food.

The procedure was performed as part of the TOGA (transoral gastroplasty) Pivotal Trial, a multicenter national study that is evaluating the investigational, nonsurgical procedure.

"This is a shift in the way we approach the surgical treatment of obesity," said Dr. J. Christopher Eagon, a Washington University bariatric surgeon. "If this technique provides results close to those achieved with more traditional surgery, it may be an option for people who need to lose a great deal of weight but don't want to have surgery."

In the TOGA procedure, doctors insert a set of flexible stapling devices through the mouth and into the stomach. Then, watching through a scope, they use the staplers to create a restrictive pouch to help limit food intake. In the traditional surgery, surgeons work through incisions in the abdomen.

Between February 2006 and July 2007, 47 patients who were an average of 120 pounds overweight had the TOGA procedure in a pilot study at medical centers in Mexico and Belgium. After a year, they had lost an average of 40 percent of their excess weight.

"That's not as great a loss as we see with gastric bypass surgery, which is still the gold standard for weight-loss procedures," said Dr. Sreenivasa Jonnalagadda, the co-principal investigator at Washington University.

"The key benefits ... are quicker recovery period, shortened hospital stay, decreased risk of complications and an incision-free procedure. And if the restrictive pouch becomes bigger over time, as has been the experience with some obesity surgery patients, it may be possible in the future to further decrease the size of pouch with this new generation of devices."

Williamson's procedure was done under general anesthesia and required an overnight stay at Barnes-Jewish Hospital for observation. Eventually, Eagon and Jonnalagadda expect it could be done on an outpatient basis under sedation, depending on the results of the study.

The current study will involve at least 275 patients at centers across the country. Washington University will enroll at least 27 volunteers. Those eligible must be 18 to 60 years old, at least 100 pounds overweight and have no history of heart attack, stroke, chest pain or severe reflux disease. Lighter patients may be considered if they have type 2 diabetes or high blood pressure.

Because she was the first, Williamson knew she was getting the actual treatment, but during the study, one of every three volunteers will receive only anesthesia and an examination of the stomach, not the procedure itself.

However, these "control" patients will be offered the TOGA procedure after 12 months if it proves effective. Doctors will evaluate weight loss along with related health problems such as diabetes, cholesterol and blood pressure.

"In patients undergoing gastric bypass surgery, it's common to see blood lipids and blood glucose levels normalize in the days after surgery, even before they lose any weight," Eagon said. "We may see similar benefits from this procedure, but we need to test that hypothesis."

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