Volunteers wanted in obesity study: VBLOC, gastric bypass surgery alternative

Stanford researchers to test alternative to risky surgical procedures

Stanford University is starting a clinical research study on obesity that would give patients an alternative to invasive surgical procedures. The study, called Empower, will evaluate the safety and efficacy of an experimental method, called VBLOC Therapy, that periodically stops the body's neural messages of hunger and fullness from reaching the brain.

Empower is searching for recruits from around the Bay Area. Applicants must be between 18 and 65, with a body mass index between 35 and 45.

A 2001-2004 health and nutrition study by the National Institutes of Health found that about 66 percent of American adults are overweight and nearly one-third are obese.

"About 12 million Americans qualify for the study," said Dr. John Morton, associate professor at Stanford Hospital and Clinics.

"Obesity is now a global medical concern," added Morton, who is leading the study, "and is considered to be one of the leading causes of preventable death, second only to smoking."

Obesity is related to serious health risks such as hypertension, high cholesterol, sleep apnea and osteoarthritis as well as certain types of cancer.

To avoid these health problems, patients often turn to gastric bypass surgery, a major abdominal procedure with high risks and moderate benefits, according to Morton.

"No clinical or medical complications occurred" during international VBLOC trials, said Morton, who added that he has recorded no patient deaths in 1,200 gastric bypass
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operations.

Through the use of implanted electrodes, the VBLOC Therapy blocks the vagus nerve, intermittently stopping the signals of hunger and satisfaction carried from the stomach to the brain.

After a trial VBLOC study conducted outside the United States showed nine participants had excess weight loss of 29.5 percent after nine months, the Food and Drug Administration approved Morton's clinical study.

Participants can expect a comprehensive trial study as they meet with staff during 43 clinical visits that include nutritional and psychological counseling over the course of five years.

To learn more about the study, visit http://www.empowerstudy.com or call 866-978-2562.

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More from 60 Minutes: The gastric bypass effect on diabetes, cancer

It's pretty well known to doctors that the most successful treatment for obesity is surgery, especially the gastric bypass operation. But here's something the medical world is just realizing: that the gastric bypass operation has other even more dramatic effects. It can force type 2 diabetes into almost instant remission and it appears to reduce the risk of cancer.

Surgeons have been performing bariatric, or weight loss operations since the 1950s, but they're much safer than they used to be. They're typically done laparoscopically now, where doctors use tiny surgical tools and video cameras instead of making big, deep incisions.

Despite the increase in obesity, only a small number of people have had the gastric bypass operation. Read more More from 60 Minutes: The gastric bypass effect on diabetes, cancer >>

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60 Minutes segment on gastric bypass surgery effect on diabetes, cancer

60 Minutes reports: Gastric bypass surgery can send diabetes into remission and may reduce risk of other cancers.

It's pretty well known to doctors that the most successful treatment for obesity is surgery, especially the gastric bypass operation. But here's something the medical world is just realizing: that the gastric bypass operation has other even more dramatic effects. It can force type 2 diabetes into almost instant remission and it appears to reduce the risk of cancer.

Surgeons have been performing bariatric, or weight loshttp://www.blogger.com/img/gl.link.gifs operations since the 1950s, but they're much safer than they used to be. They're typically done laparoscopically now, where doctors use tiny surgical tools and video cameras instead of making big, deep incisions.

Despite the increase in obesity, only a small number of people have had the gastric bypass operation. More >>

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Laparoscopic vagatomy: Gastric bypass surgery alternative

Rochester, NY

Thousands of people have weight loss surgery each year. This can mean massive weight loss, but the surgery doesn't come without risks. News 10NBC has the latest on an investigational approach that's helping patients shed pounds a whole lot safer.

Losing weight was never easy for Garth Michaels. “I've felt fat all my life, really,” he said. He topped out at 320 pounds.

“I really was just up against a wall. I was praying daily. I didn't know where to turn,” Garth said. Then, he found Doctor Robert Lustig.

“Everyone in the world seems to think that obesity is just one problem, you know, you eat too much, exercise too little and it couldn't be further from the truth,” Dr. Lustig said.

Lustig says the vagus nerve, which tells the brain when the body's full, plays a big part in obesity.

“Every single thing the vagus nerve does is designed to get energy into your fat cells,” Dr. Lustig said.

He's testing an easy-on-the patient surgery called a laparoscopic vagotomy where he actually cuts the vagus nerve.

“The severe hunger that many obese patients report seems to be just completely obviated. It goes away completely,” said Dr. Lustig.

An early study shows the 20-minute procedure led to an average 18 percent excess weight lost. More >>

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VBLOC: Gastric bypass surgery alternative

New York, NY

There may be new hope for people struggling with obesity.

It's called VBLOC therapy and it works by stopping the impulse to overeat by blocking the vagal nerves. Those nerves communicate feelings of hunger and fullness from the brain to the stomach.

With the new approach, doctors insert a VBLOC device just beneath the skin. It's a receiver. Electrodes are hooked up to the vagal nerves. And the patient wears a belt that transmits electronic impulses to confuse or block the nerves' signals. The desired result - pangs of hunger are reduced, and patients eat less.

A nationwide trial of VBLOC therapy is under way.

The treatment is considered less invasive than bariatric surgeries, which usually involve shrinking the stomach by wrapping a tight band around it - a so-called lap-band - or bypassing large sections of the stomach altogether and going directly to the rest of the digestive tract - commonly referred to as gastric bypass surgery.

On "The Early Show" Friday, Dr. Scott Shikora, chief of bariatric surgery at Tufts University Medical Center in Boston and one of the current study's principal investigators, showed a VBLOC device, explained how it works, and outlined the new therapy's possible benefits.

And Jeff Collins, who had the device implanted in Los Angeles in December, said he's lost 20 pounds and now weighs 285. "I would recommend it to anybody who's (trying) to lose weight."

"The risk with the other two gastric bypass procedures right now is too high, especially with people my age," Collins said.

"With gastric bypass," Shikora pointed out to CBS News, "we're dividing the stomach and bowel, and it's fraught with potential risks, such as infection. With the VBLOC, we're not dividing the stomach, we're simply attaching electrodes to two very prominent nerves."

But, he cauutioned, "Remember: This is research. We don't know yet how this device will perform, how consistent it will be long-term. It could prove to be a better alternative for some. Also, gastric bypass has a 40-year track record. We know it works."

Shikora says it takes 45 minutes to an hour to implant the device and patients can often go home the same day. More >>

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Sleeve gastrectomy: Gastric bypass surgery alternative

Miami, FL

Gastric bypass surgery has been a life-saving procedure for many morbidly-obese people. During the preparation for that surgery, a patient's stomach may have to be stapled. Now, doctors at UCLA Medical Center say the stomach stapling alone may be very effective to help the patient lose weight.

The procedure is called a "sleeve gastrectomy." It involves trimming down the stomach over a special calibrating tube to 1/3 or ¼ the current size. The surgery is typically reserved for those patients considered to be morbidly obese.

UCLA doctors say the new procedure is still major surgery and the more research is needed, but believe it could become more common than a gastric bypass.

Candidates for most of the new bariatric surgeries must be at least 100 pounds overweight and have medical problems like diabetes, arthritis, or high blood pressure.

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Stanford in study on vagal nerve blocking, gastric bypass surgery alternative

San Francisco, CA

Stanford researchers are participating in a national study to test a new weight-loss therapy that blocks the nerves that tell people when they're hungry and control how the body stores fat.

The treatment is considered a less invasive alternative to bariatric surgeries, which typically involve shrinking the stomach by wrapping a tight band around it or bypassing large sections of it and going straight to the rest of the digestive tract.

In the new treatment, which has been tested overseas, a device inserted just beneath the skin emits electronic impulses that confuse signals sent on the vagal nerves from the brain to the stomach. In early studies, the impulses made people feel full and satisfied when they'd otherwise be hungry.

"It starts in the brain, and works down to the stomach. We're not cutting or sewing or rerouting the anatomy here," said Dr. John Morton, a bariatric surgeon leading the study at Stanford. "It has a lot of potential to help patients lose weight."

The treatment is called VBLOC therapy, for vagal blocking. Stanford is one of 13 sites around the country participating in the study, being funded by medical device company EnteroMedics. Researchers hope to sign up 250 to 300 volunteers, about 50 of them in the Bay Area, and study them for five years.

It is a blind study - all volunteers will have the device implanted, but it will be turned on in only two-thirds of them, and neither researchers nor patients will know whether it is on or off. After the first year, the device will be turned on in all patients. More >>

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The Realize Band a new alternative to Lap Band and gastric bypass surgery

Birmingham, AL

Dr. Lee A. Schmitt, a surgeon at St. Vincent's East, last week began using the Realize Band, a new medical device that offers patients another option for weight-loss surgery.

The Realize Band was approved in December by the FDA as an alternative to the popular Lap-Band.

Both stomach bands have been shown to be effective in helping patients lose weight. They are wrapped around the stomach and squeeze down its size, thus restricting food intake. The devices can be adjusted for tightness by pumping fluid through a port.
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Another type of weight-loss operation, commonly called a gastric bypass, requires more extensive surgical remodeling of the stomach and intestine.

Schmitt is one of Alabama's busiest weight-loss surgeons and puts about 100 stomach bands a year in patients. He said the new Realize Band is slightly different from the Lap-Band, and had three patients scheduled last week for the new band.

"I don't know which band is going to be better," he said. "I think it's like a pickup truck. What's better, a Ford or a Chevy? Both of them have little differences. Both of them carry you from A to B, and you can carry a ton of stuff in the back."

The new band is wider, which could keep it from slipping out of place. Slippage occurs in only about 2 percent of his cases, said Schmitt.

The most common complication with a stomach band involves the port that is just under the skin's surface and attached to the abdominal wall. Doctors use a needle to pump a saline solution into this port, which adjusts the stomach band.

Schmitt said sometimes the port comes loose, flips around and can't be accessed. The Realize Band has a different way of attaching the port. It's quicker to put in, and may secure enough to prevent complications, Schmitt said.

The Realize Band also exerts a slightly lower pressure on the stomach, which may reduce a rare complication called erosion. This occurs when the band erodes into the stomach.

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Laproscopic gastric bypass surgery gives new life to Milwaukee hairdresser

Milwaukee, WI

At age 37, local hairdresser Ann Marie Heim learned that if she didn't do something to improve her health, she would die by age 40. Heim suffered from morbid obesity for nearly 15 years and after undergoing laparoscopic gastric bypass surgery in 2002 has lost a remarkable 225 pounds. Thanks to the surgery, last month Heim turned 40 and feels better than she ever imagined.

An adopted child, Heim believes her biological mother was obese but concedes that despite healthy offerings from her parents, she ate whatever she wanted and constantly craved sugar. In her adult life, Heim suffered from severe weight induced diabetes for nearly 10 years. She constantly felt sick with physical aches and pains and had difficulty carrying her nearly 418 pounds around every day.

"My doctor said, 'I have nothing vested in you, you have nothing vested in me, but you should know that you are going to die.' He was cut and dry. He said, 'You need to take hold of your weight,'" Heim admits.

It was this honesty that Heim needed to begin looking into the options to save her life. Dr. Manfred Chiang at the Bariatric Institute of Wisconsin required Heim to complete months of clinically monitored exercise and diet before undergoing the surgery. More >>

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Philadelphia woman found it took more than a gastric bypass procedure to maintain her weight loss

Philadelphia, PA

IN THE PAST few years, bariatric surgery, otherwise known as gastric bypass or gastric banding, has become all the rage.

With 65 percent of Americans either overweight or obese, according to the federal Centers for Disease Control, it's not surprising that many people are electing to have this procedure done.

After all, post-procedure weight losses range from 60 to 80 percent of excess body weight in patients with a body mass index of 35 to 60, over the first two years. That could roughly equal a loss of 80 to 150 pounds, depending on your original weight.

Undoubtedly, weight-loss surgery guarantees permanent weight loss, right?

Well, perhaps . . .

Melissa Blanco, 32, once carried a whopping 274 pounds on her 5-foot-4-inch frame. But the Philly native shed 130 pounds after having the gastric bypass procedure.

"I did Weight Watchers, Jenny Craig, and the weight-loss program at the University of Pennsylvania, and had some success to some degree, but could not maintain it. I started feeling tired and wobbly. I knew something had to change," Blanco said.

So, in the winter of 2005, after doing some research, she decided to have gastric bypass surgery that reduced her stomach to the size of an egg. More >>

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Settlement sought in mini-gastric bypass lawsuit

Greensboro, NC

A national surgical group being sued by High Point Regional Hospital and Cornerstone Health Care hopes to reach a settlement later this month.

The hospital and physicians practice sued Feb. 5 in the Middle District of North Carolina, claiming the American College of Surgeons is trying to shut them out of the lucrative bariatric surgery practice by denying accreditation of their mini-gastric bypass operation for obese patients.

Without accreditation, Medicare and most major insurance companies will not pay for bariatric procedures, a field that generated about $5.1 billion for hospitals nationally last year.

Forsyth Medical Center, Wake Forest University Baptist Medical Center and Moses Cone Health System are accredited to perform a more widely accepted version of the surgery.

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Virginia woman dies, contracted human variant of mad cow after gastric bypass surgery

Portsmouth, VA

A 22-year-old Virginia woman suspected of having the human variant of mad cow disease died at 5:30 p.m. Wednesday, The Virginian-Pilot reports.

Doctors suspect Aretha Vinson contracted Creutzfeldt-Jakob Disease shortly after she had gastric bypass surgery three months ago. The disease, which affects roughly one-in-a-million people, is a degenerative and fatal brain disorder linked to tainted medical instruments and certain medical procedures, as well as to contaminated beef.

Vinson’s health began to deteriorate just after she had the surgery. The Portsmouth, Va., resident's motor skills and memory had faded and she became unconscious and died at the Bon Secours Maryview Medical Center.

There is no treatment or cure for the disease.

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Vagotomy: Gastric bypass surgery alternative?

Orlando, FL

Weight loss surgery is becoming a more popular choice for obese Americans. There were nearly 10 times as many weight loss procedures performed in 2005 as 1998. Gastric bypass surgery is a real option for patients, but it also comes with real risks. Nutritional deficiencies occur in more than 30 percent of patients and nausea and vomiting after eating occurs in up to 15 percent of patients. Other major risks include ulcers, hernias and even death.

SAFER APPROACH: A procedure that was once commonly used to treat ulcers, called a vagotomy, is now being tested as a safe weight loss surgery. Robert Lustig, M.D., from the University of California, San Francisco Medical Center, says, "[Vagotomy] was actually the most common procedure done in this country between 1944 and 1978." But the way the procedure was performed back then for ulcers caused lot of undesirable side effects. Even so, doctors noticed that people who had the procedure for ulcers also lost weight. Because it was invasive and had bad side effects, the procedure fell to the wayside, especially as newer drugs and treatments for ulcers emerged and, of course, so did gastric bypass surgery for obesity. Doctors are now revisiting vagotomies as a way to lose weight. They have modified the procedure so that it is safe and side effects are minimal -- and they've also made it a laparoscopic procedure. For weight loss, the procedure can be done non-invasively with five small incisions in about 20 minutes.

WHAT IS IT? During a laparoscopic vagotomy, doctors actually go in and cut the vagus nerve in the esophagus. Dr. Lustig says, "The vagus nerve is the energy storage nerve. That's its job. That's part of why you get hunger is the vagus nerve from the stomach to the brain tells you, the stomach is empty, you need to eat." By cutting the nerve, Dr. Lustig can eliminate the severe hunger that many obese patients report. Their hunger just simply goes away. Dr. Lustig says, "The majority of the weight loss that's achieved is primarily in the first six months, nine months and then it definitely slows down. But they're not regaining it. They are actually keeping their weight down." More >>

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StomaphyX: New procedure for gastric bypass surgery patients

Los Angeles, CA

A new procedure could help gastric bypass surgery patients who may need a second surgery.

The device is called stomaphyx and only a handful of surgeons are trained to use it.

It's inserted through the mouth to do corrective surgery in order to shrink the stomach again.

The good news, doctors don't have to cut the patient open, but there's a catch.

"We can fix the stomach, but if they don't fix their lifestyle and if they don't get involved in the support groups and follow ups with the surgeon then the stomach won't work the way they want it to work," said Dr. Julie Ellner, Alvardo Surgical Weight Loss Director.

Doctors recommend repeated follow-up visits, and a committment to exercise and nutritional programs.

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Obesity epidemic leading to rise in gastric bypass surgery

Kansas City, MO

For many obese or overweight Americans, shedding weight has led them to lifestyle changes, such as a healthier diet and a new exercise regimen. Many others go the surgical route, as 177,000 Americans opted for weight loss surgery in 2006 alone. The vast majority of those surgeries were Roux-en-Y gastric bypass
surgery. While gastric bypass can seem like a quick fix that enables patients to shed weight almost overnight, the surgery and its ramifications are in fact quite complicated, and should never be looked at as an easy way to drop weight.

What is gastric bypass?

Roughly 80 percent of the weight loss surgeries performed in America this year will be gastric bypass procedures. This is a two-part procedure.

• Stomach pouch: The creation of a stomach pouch is the portion of the procedure many people refer to as “stomach stapling.” During this part of the surgery, the stomach is divided unequally, with one large pouch and one much smaller pouch. After this division, the smaller pouch is sewn or stapled. That pouch can only hold a very small amount of food (roughly one cup). Such a small holding capacity is designed to make people feel full faster, which in turn will make them eat less.

• Bypass: In the second stage the surgeon will employ the Roux-en-Y technique, in which the smaller pouch is disconnected from the first part of the small intestine (the duodenum). The surgeon will then reconnect the stomach to a lower portion of the intestine (the jejunum). Once that has occurred, any food consumed will pass directly from the stomach into this lower portion, where fewer calories and nutrients are absorbed.

What happens after the surgery?

While patients can expect to lose weight after gastric bypass surgery, there are negative consequences as well. Though not all patients will experience such consequences, and death is extremely rare (especially when surgery is performed by an experienced gastric bypass surgeon), some of the following might occur after surgery:

• Wound infections

• Problems with digestion

• Bleeding

• Ulcers

Those are some of the more common complications after surgery. Some of the less common, though extremely serious and potentially life-threatening, complications include the following.

• Pulmonary embolism (blood clot)

• Serious infection and persistent bleeding

• Heart attack

• Leakage in the surgical connections in the intestines

Because of the nature of the surgery, in which food is re-routed into the jejunum where FEWER nutrients are absorbed, certain health problems can arise as a result. For example, the human body needs a certain amount of iron and calcium to remain healthy. However, the jejunum does not absorb these nutrients well, and conditions such as anemia and osteoporosis can arise as a result. Iron and calcium supplements, as well as routine blood tests, can lower the risk of developing such conditions.

Although there can be complications, many gastric bypass patients experience positive results. Weight loss is often dramatic, especially for patients who were considerably overweight.

Another benefit of gastric bypass is that patients who have obesity-related health problems often see improvements in those conditions after surgery. Such conditions include diabetes, sleep apnea and high blood pressure.
While the benefits of gastric bypass surgery are numerous and have helped many a public figure, it’s important to recognize the surgery is not a one-size-fits-all solution, and each case needs to be examined on an individual basis.

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