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June 4, 2009

Non-Invasive Stomach-Stapling Technique Looks Promising

By inserting a garden hose-sized tube through the esophagus, surgeons are experimenting with a new kind of stomach-stapling procedure that does not involve cutting open the abdomen. 

As with the older version of this drastic surgery intended to help people experience fullness with less food, the experimental, scar-free procedure works by narrowing the passage that slows the food as it moves from the upper stomach into the lower stomach.

Physicians have said that the preliminary results from studies on some 200 U.S. patients and 100 in Europe look promising.

European patients reported having lost an average of 45 percent of their body weight within 18 months after the surgery, said Dr. Gregg Nishi, a surgeon at Cedars-Sinai Medical Center in Los Angeles.

Nishi shared the results of the European and U.S. studies this week at a conference in Chicago for digestive disease specialists.

Currently, the experimental operation is only being performed in closely monitored studies and is not yet available to the public.  However, the producers of the device used in the minimally invasive procedure intend to apply for federal approval if the experimental trials continue to prove successful.

Though both the European and Americans studies are still ongoing, Dr. Nishi commented that the results so far indicate an even higher success rate than that usually seen with conventional methods of stomach stapling.

Potential risks may include perforating the esophagus, which Nishi mentioned had happened to one patient.  Otherwise, the procedure appears to be quite safe and no major side effects have yet been observed.

One of the first U.S. patients to take part in the study was Liliana Gomez, an administrative coordinator at Cedars-Sinai. Gomez said she had originally planned on having the more invasive stomach-stapling operation until she heard that doctors at her own hospital were conducting studies on the scarless stapling procedure.

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

Gomez said she has lost 40 pounds and dropped three clothing sizes since undergoing the operation in August.

The 35-year-old Los Angeles resident is still technically classified as obese according to medical standards and says that she knows that she's got a long way to go before she reaches a healthy body weight. Gomez says that since the surgery, she has managed to reduce her meal portions by more than half and expresses optimism that she'll continue to shed pounds.

The new stapling technique is part of a broader trend in the medical community aimed at reducing invasiveness of surgeries by entering the body through orifices like the nose, mouth and vagina instead of making incisions. The goal is to reduce the incidence of post-surgical infections and shorten the necessary recovery period, not to mention the aesthetic benefits of scarless operations.

Gomez said that she had previously contemplated having a gastric bypass operation, a significantly more complicated variety of stomach stapling that also involves rerouting the digestive tract.  Gastric bypass often requires multiple incisions, and patients run the risk of developing malnutrition as the surgery alters the way the intestines absorb calories.

The experimental procedure performed on Gomez is more or less the oral-entry version of a relatively simple kind of stomach surgery involving a reduction of the size of the stomach without a restructuring of the digestive tract.

According to the American Society for Metabolic & Bariatric Surgery, over 200,000 Americans are expected to undergo some form of obesity surgery in 2009.  While still considered an option of last resort for treating obesity, the practice is becoming increasingly more accepted, both in the medical community and in the population at large.  In recent years, demand for such surgeries has been rising steadily.

Dr. Scott Shikora, president of ASMBS, expressed optimism about the success of the experimental new oral procedure, but also warned that "[i]t is too early for us to say this is going to be a breakthrough."

Shikora explained that many U.S. surgeons still prefer the rerouting surgery or flexible bands, and that it is still too early to tell whether the new method will have the same drawbacks as conventional stapling techniques.

The U.S. version of the study is being conducted at 10 different health centers. After the procedure, patients are monitored closely for at least one year. Final results of the study are expected to be released sometime in 2010.

Regarding the initial results of the study, Nishi said that he was "very impressed with it," and that the procedure may well turn out to be a "viable alternative" to the more invasive techniques currently in practice.

Satiety Inc., the California-based company responsible for the development of the device used in the new procedure, is sponsoring the study.

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