Stomaphyx: Gastric bypass pouch repair

Stomaphyx a novel approach to fixing a gastric bypass pouch that has stretched

San Antonio, TX

Bariatric surgery has been a real boon for patients who need to lose massive amounts of weight. But sometimes, the small pouches created by gastric bypass procedures expand. Now, there’s a new procedure to help fix that problem.
Claudia Sisk, 51, of San Antonio lost more than 80 pounds after her original bypass surgery several years ago, but her pouch began to expand and she started regaining unwanted weight.

“Now I see myself eating a little more than usual so that’s why I went back and asked what else, was there a way they could tighten this pouch and make it smaller,” Sisk said.

“Previously, we would have to go in and operate and make incisions on the skin,” explained Dr. Mickey Seger, a bariatric surgeon. “It’s a very high risk operation. There’s over a 40% chance of having a problem or a complication with a re-do surgery like that.”

At Methodist Specialty and Transplant Hopsital, Sisk had a new procedure called Stompahyx. No cuts in the abdomen. The surgeon uses an endoscope to look down into the pouch, and a special tool to make it smaller.

Here’s how it works. The instrument is guided into the stomach. A vacuum sucks a small piece of tissue into the tube, and then the device injects a fastener into place, creating a fold in the stomach. A series of folds literally closes down the pouch, making it harder for the patient to overeat.

“It’ll dramatically reduce the amount of food she can take before being full,” Seger said. “Whereas now she can eat pretty much a regular-sized meal, we’ll be able to get her satisfied with less than a cup.”

The procedure takes less than an hour. There are no cuts and no scars. Sisk is hopeful this novel approach will be the help she needs to achieve her goal.

“Hopefully, I’ll get under 200,” Sisk stated. “I want to be, you know, 180 to 200.”

There is no big recovery with this procedure. Patients are out of the hospital within 24 hours and back to work almost immediately. The idea is that they’ll start losing weight once again.

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ASMBS: Laparoscopic adjustable gastric banding less effective than gastric bypass and sleeve gastrectomy

Dallas, TX

Patients who underwent laparoscopic adjustable gastric banding achieved less weight loss and less improvement in comorbid conditions than those who had gastric bypass or sleeve gastrectomy.

Slightly more than half of gastric banding patients lost more than 50% of excess weight after five years compared with more than 90% of patients who underwent laparoscopic Roux-en-Y gastric bypass, Diego Awruch, MD, reported at the American Society of Metabolic and Bariatric Surgery.

Surgical failure, defined as less than 50% excess weight loss, was almost six times more common with gastric banding.

"Laparoscopic adjustable gastric banding was associated with fewer complications, but the percent weight loss at one and five years was inferior to laparoscopic Roux-en-Y gastric bypass," said Dr. Awruch, of Pontificia Universidad Catolica in Santiago, Chile.

"Surgical failure occurred in more than 40% of patients who underwent gastric banding, and 16% of the patients required surgical revision of the initial procedure," he said.

Similar disparities in weight loss occurred in the comparison of gastric banding and sleeve gastrectomy.

Across the entire range of body mass index (BMI), laparoscopic sleeve gastrectomy led to greater weight loss, said David Schumacher, MD, of Wright State University in Kettering, Ohio.

Dr. Awruch reported outcomes for 91 patients treated with laparoscopic Roux-en-Y surgery and 62 who underwent gastric banding from 2001 to 2003.

Five-year follow-up was available for 73.6% of the gastric bypass patients and 91.5% of the gastric banding patients.

Comparison of baseline characteristics showed that bypass patients weighed significantly more (106.4 versus 97.6 kg, P<0.001) and had a significantly higher BMI (39 versus 35, P<0.001).

Gastric bypass was associated with a higher rate of early complications (14.2% versus 1.6%, P=0.009). In addition, nine bypass patients required reoperation or endoscopic dilatation compared with one patient in the banding group.

Late complications occurred in 37.3% of bypass patients compared with 27.4% of gastric banding patients, but the difference did not reach statistical significance. A higher proportion of gastric banding patients required reintervention (23 of 62 versus 20 of 91).

Percent weight loss at five years averaged 92.9% with gastric bypass compared with 59.1% with gastric banding (P<0.001).

Dyslipidemia, insulin resistance, hypertension, and type 2 diabetes improved or resolved in 80% to 100% of bypass patients compared with 20% to 40% of the gastric banding group.

At five years, 94% of bypass patients and 54.4% of gastric banding patients had maintained >50% excess weight loss.

Dr. Schumacher reported outcome data for 104 patients who underwent laparoscopic sleeve gastrectomy and 227 who had gastric banding from January 2006 through August 2008. Follow-up data were 99% as of January 2009.

Among patients followed for at least 18 months (about half of the total), weight loss averaged 133.82 lb in the sleeve group versus 58.93 lb in the banding group.

For the same time interval, excess weight loss averaged 55.54% with sleeve gastrectomy versus 38.65% with banding.

Stratification of patients by baseline BMI showed that sleeve patients had a greater excess weight loss in patients with BMI more than 50 (50% versus 33%), 40 to 49 (68% versus 40%), and less than 40 (90% versus 43%).

Readmission rates were 6% of sleeve gastrectomy patients and 1.3% with gastric banding. One patient (0.96%) in the sleeve group required reoperation compared with 19 (8.4%) gastric banding patients.

"Laparoscopic sleeve gastrectomy appears to allow greater weight loss in all BMI classifications over time with fewer reoperations," said Dr. Schumacher. "The most efficient weight loss occurred in the lowest BMI classification.

"Laparoscopic sleeve gastrectomy can be used effectively as a primary operation in any weight classification, achieving a greater than 50% excess weight loss in all BMI subsets."

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Help now available after failed gastric bypass surgery

San Diego, CA

A new procedure, called a ROSE procedure, is now available for patients who have had gastric bypass, lost weight and then slowly put weight back on again as their stomach pouch stretched. One of the problems with surgeries that reduce the size of the stomach for weight loss is that the pouch size may not be permanent. Over time, the pouch can enlarge to the point where meals of significant size can be eaten.

Rose, or Restorative Obesity Surgery, Endolumenal, is an outpatient procedure where the surgeon inserts a tiny camera and special tools into the stomach by introducing them into the mouth and down through the esophagus. Remarkably, no incisions are made to reduce the size of the stomach opening and the actual stomach. The surgeon essentially makes folds in the tissue of the stomach from the inside, similar to creating pleats, then uses stitches to hold the folds in place.

The procedure is currently available at the Center For The Treatment of Obesity at UC San Diego Medical Center.

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Stompaphyx gastric bypass revision

Miami Beach, FL

A quarter of a million obese Americans undergo gastric bypass surgery for weight loss every year, but 20 percent of those surgeries will fail with time, doctors said.

That's what happened to Darlene Dillard, who regained 30 pounds after losing 100.

"My gastric bypass started failing five to six years out of the surgery," she said. "Increased appetite, the urge to eat constantly."

So, Dillard became the first South Florida patient to have Stomaphyx, a natural orifice surgery performed without any incisions.

"There's a suction apparatus that sucks the inside of the pouch, then we fire this double T fastener," said Dr. Michel Gagner of Mount Sinai Medical Center.

The suction creates folds that reduce the stomach size. In Dillard's case, doctors said they had to use 18 T fasteners around her stomach.

"I do have some discomfort in the lower chest area," Dillard said. "Not pain, just discomfort."

Dillard's doctors said they worry about bleeding from inside from the fasteners.

"They can create a little amount of bleeding," Gagner said.

Dillard said 24 hours after the procedure she was ready to go home.

Stomaphyx is for patients who have regained weight after bariatric surgery.

"It's going to be more for the 100 pounds or less of weight loss," Gagner said. "Because it is a restrictive operation. It restricts the volume in the inside of the stomach."

Mount Sinai Medical Center is one of only two hospitals using Stomaphyx for gastric bypass revision.

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What to do when gastric bypass surgery obesity fails

Los Angeles, CA

The number of people getting obesity surgery has more than doubled in the past eight years. But the highly popular and risky procedure doesn't always work for everyone. So can these patients be helped? One local doctor offers a high-tech solution.

When 47-year-old Patricia Weiss gets on a scale these days, she smiles.

"I've lost about 35 pounds since I had it. It's been a year almost a year," said Patricia.

It's been a year since her second time around with an obesity procedure. The first time was in 2002 -- Patricia underwent a gastric bypass and lost 150 pounds. But then the weight started to creep back on.
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"I put on about 30 to 40 pounds, and I said, 'No, no, going the wrong way.' I didn't do all this to have this come back," said Patricia.

In 2007, there were about 160,000 to 200,000 gastric bypasses performed -- that's at least double the number performed in 2000. Of those surgeries, doctors say about 15 percent fail.

Often patients regain because they start to over eat again and stretch out their reconstructed pouch. Patricia went to see Dr. Jeremy Korman. He says standard x-rays and endoscopes don't give doctors the whole picture and this makes it difficult to proceed. He says he may be the only surgeon in the U.S. to use the 64 slice CT scan technology on obesity surgery patients.

"Now once we understand accurately the size of the pouch, we can plan what kind of operation would be appropriate, what size of revision operation is appropriate," said Dr. Korman.

Dr. Korman says he can either redo the original surgery, implant a LAP-BAND to restrict the pouch growth, or perform a new minimally invasive endoscopic procedure in which he sews up and shrinks the pouch from the inside.

Patricia opted for the LAP-BAND. 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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Despite risks, gastric-bypass surgeries soar

Orlando, FL

Gastric-bypass procedures can be effective -- but require a lifelong commitment.

Monica Ramos lost about 200 pounds the hard way.

In 2004, a doctor stapled her stomach and rerouted her intestines.

A year later, Ramos collapsed in her Orlando home and was rushed to the hospital, where she needed another operation to stop internal bleeding.

Her weight-loss surgery represents the gamble that legions of morbidly obese Americans are taking every year. For many, it is worth the risk.

When Ramos had her initial operation, she was on 17 medications for diabetes and other ailments. Today, she needs no prescriptions. Her diabetes is gone; she feels great.

But the soft-spoken nursing student warns that surgery is not a cure for obesity.

"This is a lifelong commitment, and there are going to be days when you're sorry you've made this commitment," said Ramos, 26, who runs a support group in Orlando for weight-loss-surgery pa- tients.

If current trends continue, she will be busy. More >>

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Another Complication For Gastric Bypass Patients

November 27, 2007

Obese patients who suffer complications after gastric bypass surgery may face further health risks because their weight exceeds the limits of diagnostic imaging equipment, according to a study presented November 27 at the annual meeting of the Radiological Society of North America. In the study, approximately 27 percent of patients weighing more than 450 pounds needed imaging to diagnose a problem after surgery and could not be accommodated because of their size.

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"When patients weigh more than 450 pounds, standard diagnostic imaging often cannot be used," said Raul N. Uppot, M.D., an assistant radiologist at Massachusetts General Hospital (MGH) and instructor of radiology at Harvard Medical School in Boston. "In these cases, physicians must resort to other means of diagnosis such as exploratory surgery or using less accurate or more invasive techniques."

According to the Centers for Disease Control and Prevention, obesity has grown dramatically in the last 20 years. Today, nearly one-third of the American population is obese. Along with the rise in obesity among American adults has come an increase in the number of gastric bypass procedures performed.

The American Society for Bariatric Surgery estimated approximately 140,000 gastric bypass procedures were performed in the United States in 2005. In a gastric bypass procedure, the stomach is surgically reduced, and part of the small intestine is bypassed. Like any surgical procedure, gastric bypass is not without risks. Most common complications include suture tears and leaks, pulmonary embolism, pneumonia and infection. Serious complications tend to be more prevalent among the severely overweight.

Dr. Uppot and colleagues conducted an eight-year retrospective study of all patients weighing more than 450 pounds who underwent a gastric bypass procedure at MGH between June 1999 and April 2007. Patient imaging usage and clinical course were tracked using electronic health records and evaluated to determine the outcomes of those who, based on their weight, were denied their physicians' first choice of imaging. The maximum weight limit for a computed tomography (CT) table is 450 pounds.

The researchers found that 12 (27 percent) of the 44 patients who weighed more than 450 pounds required postsurgical imaging because of a clinical condition, but were denied because they were above the weight restriction for the equipment. Four patients who could not be evaluated with imaging for suspected leaks were required to return for surgery.

Two additional patients with suspected lung blood clots could not undergo a chest CT. Of two patients who came in with nonspecific abdominal pain, one was evaluated with ultrasound and the other one had a barium swallow test. Because imaging was not an option, one patient who suffered trauma underwent exploratory surgery in lieu of noninvasive imaging. Another patient was denied a chest CT and received no further imaging evaluation.

"When obese patients cannot be diagnosed using standard-of-care imaging techniques, then other diagnostic measures have to be instituted," Dr. Uppot said. "Patient care may be ultimately affected due to a compromised diagnosis."

Dr. Uppot noted that the obesity trend cannot be ignored. "Unless major changes are made to the American diet or exercise habits, this is a problem that we will have to address," he said. "When an obese person is contemplating gastric bypass surgery, he or she should consider that they will need follow-up imaging but may not be able to get the appropriate tests."

Co-authors of the paper presented by Dr. Uppot are D.V. Sahani, M.D., D.A. Gervais, M.D., P.R. Mueller, M.D., P.F. Hahn, M.D., Ph.D., and S.I. Lee, M.D., Ph.D.

Adapted from materials provided by Radiological Society of North America.

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StomaphyX: Incisionless Gastric Bypass Surgery Revision

NEW YORK (Reuters Health) - When weight loss stalls or other problems arise years after gastric bypass, the surgery can be successfully revised with an incisionless, from-the-inside approach, researchers from Ohio State University in Columbus report.

The technique, involves the use of a device called StomaphyX, which has been approved by the US Food and Drug Administration. The device is inserted with an endoscope via the mouth into the stomach, where suction pulls the stomach walls against the device. Staple-like fasteners are then deployed to create pleats in the walls, effectively reducing the size of the stomach.

"The incisionless surgery helps to recreate the patient's smaller stomach, causing early satiety and further weight loss," Dr. Dean Mikami, a surgeon involved in the development of StomaphyX and the first to perform the operation in the US, said in a statement. "This is currently the only endoscopic or nonsurgical way to reduce the size of the stomach after gastric bypass surgery."

Since April, a total of 22 such gastric bypass revisions have been performed at OSU. On average, patients dropped 10 pounds after 1 month, 15 pounds after 2 months, and 20 pounds after 3 months.

According to Mikami, between 10 and 15 percent of patients who undergo gastric bypass surgery will require a revision 2 to 15 years later.

Good candidates for treatment with StomaphyX, Mikami said, include those who have regained some of their weight after gastric bypass surgery and are compliant with their diet, exercise regularly, and do not experience early satiety during meals.

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