StomaphyX: Incisionless Surgery To Correct Weight Gain After Bypass
As the number of obesity cases continues to soar in the United States, the number of bariatric surgeries performed annually for weight loss increases steadily. But surgeons are now beginning to see another wave of patients whose success with the surgery has started to wane.
At Ohio State University Medical Center, surgeons have performed the first incisionless procedure in the United States for weight gain following gastric bypass – which makes it possible to escape the high rate of complications associated with traditional revisional surgery.
The incisionless technique has been approved by the Food and Drug Administration, using principles of revisional surgery to help shrink the size of the stomach. But the technique, “endoluminal tissue approximation,” is accomplished totally with a tube passed through the mouth – and no surgical incisions.
Key advantages of the new device, known as the StomaphyX, include: no incisions or scars; less pain; a lower rate of complications compared to the traditional revisional bariatric surgery; and a much quicker recovery, making it an outpatient procedure, according to Dr. Dean Mikami, a general surgeon at OSU Medical Center. Mikami helped to develop the new device and is the first surgeon in the U.S. to perform the procedure.
A flexible endoscope is passed through the mouth and advanced to the stomach, carrying a fiber-optic camera and a tubular surgical tool. Then tissue of the stomach is pulled by suction into the tubular device. Approximately 12 to 20 “H-shaped staple-like” fasteners are placed strategically in the stomach, to create pleats in the tissue and reduce the size of the stomach’s pouch.
“The incisionless surgery helps to re-create the patient’s smaller stomach, causing early satiety and further weight loss,” said Mikami. “This is currently the only endoscopic or nonsurgical way to reduce the size of the stomach after gastric bypass surgery.” The procedure also results in a smaller opening of the stomach’s pouch; a decrease in the stretch of the stomach, so that it can’t hold as much food; and a slower emptying of the stomach.
A total of 22 “endoluminal revisional bariatric operations” have been performed at Ohio State’s Medical Center since April 2007. All patients are doing well, according to Mikami. The average weight loss has been about 10 pounds at one month; 15 pounds at two months; and 20 pounds at three months.
The first patient in the United States to receive the new procedure was referred to Ohio State and received the incisionless operation on April 12, 2007. She had gained approximately 50 pounds since her gastric bypass. Since the StomaphyX procedure was performed, she has lost 26 pounds, or 38 percent, of her excess body weight.
“It is estimated that over 1 million people in the last 15 years have undergone gastric bypass surgery. About 10 to 15 percent of that group two to 10 years out may need a revisional procedure to reduce the size of their gastric pouch for further weight loss or to treat a post-operative bariatric surgery syndrome such as dumping. You’re looking at close to 200,000 patients who may need this type of follow-up procedure in the U.S. alone,” said Mikami, who has helped to train all of the surgeons in the United States – approximately 25 physicians so far – who have learned the procedure.
“As a bariatric surgeon, I treat a growing number of clinical severe obese patients,” said Mikami. “I know the joys of those patients who are cured of their diabetes and hypertension – and no longer require medication. It’s like they receive a second life. Now, the new device has actually given them a third chance at life – in a much safer way than could be offered in the past.”
The patient population for StomaphyX can range in age from 18 to 70. Mikami describes good candidates as those who have undergone gastric bypass for obesity, have re-gained some of the weight they had lost, are compliant with their diet, continue to exercise regularly, and do not have early satiety during meals. The StomaphyX procedure can give patients a tool to help them achieve their weight-loss goal and keep their obesity-related problems away.
“Incisionless surgery, or natural orifice surgery, is currently at the forefront of surgical procedures,” said Mikami. “This could perhaps also lead to the development of new ways to adjust the stomach, even before weight gain occurs. We are definitely on the leading edge of surgical technology.” (Source)