Physicians at Ohio State first in U.S. to use stomach reduction technique

Specialists in the Department of Surgery at Ohio State University Medical Center in August were the first in the United States to use a new minimally invasive stomach revision technique designed for patients who have had gastric bypass surgery and lost weight but are now regaining it.

Using an endolumenal fastener-and-delivery device called the StomaphyX, the procedure enables the surgeon to reduce the size of the stomach pouch to help the patient lose weight again, but without making external or internal incisions. The result is a faster recovery and lower complication rate than is found in either open or laparoscopic revisional surgery, both of which require incisions.

“We were the first center in the United States to perform a case,” says Dr. Dean J. Mikami, assistant professor of surgery in the Division of General and Gastrointestinal Surgery and the U.S. trainer for the StomaphyX device. “We have used the procedure with 22 patients at Ohio State, and they showed an 18- to 20-pound weight loss, without a single major complication. Open and laparoscopic revisional surgery have a major complication rate 8 to 10 times higher.”

Dr. Dean J. Mikami

Some patients had minor complications, such as sore throat and epigastric pain.

In the procedure, the surgeon uses a flexible endoscope to insert the StomaphyX device through the mouth into the stomach. Stomach tissue is suctioned into a port at the end of the device, and then a fastener is inserted into the tissue to create a pleat in the stomach. Creating a series of pleats pulls the side wall of the stomach inward to reduce the stomach pouch.

Mikami worked with engineers at Endogastric Solutions, of Seattle, Wash., for two years to develop a prototype of the StomaphyX into an endolumenal revisional bariatric procedure device. Following initial studies conducted this year in Belgium, which demonstrated its safety, he wrote the protocol for the device. The Food and Drug Administration has cleared the StomaphyX for endolumenal revisional bariatric surgery.

He is submitting to the Institutional Review Board a proposal for a clinical study of weight loss following the procedure.

Mikami emphasizes the need for revisional surgery. “On average, 10 to 20 percent of patients will regain some weight 5 to 10 years after gastric bypass,” he says. “This means that each year, 10,000 to 20,000 patients in the United States will need a revision procedure.”

Dr. W. Scott Melvin

Patients who have gained roughly 10 percent more than their lowest weight after gastric bypass are eligible for the procedure.

Mikami and Dr. W. Scott Melvin, professor of surgery, chief of the Division of General and Gastrointestinal Surgery, director of the Center for Minimally Invasive Surgery, and scientific advisor for Endogastric Solutions, are currently the only surgeons at Ohio State performing the procedure.

Mikami says the device has the potential to be used for other endolumenal surgical procedures. “We’re looking at using the device to reduce reflux in patients after gastric bypass procedures,” he says. “What we have found is very significant. The StomaphyX procedure actually reduces something called ‘late dumping syndrome,’ in which patients have postprandial diarrhea. Three of our patients had total resolution of their diarrhea, because the procedure slows down gastric emptying.”

Asked if endolumenal procedures will one day replace laparoscopic procedures, Mikami says, “Minimally invasive surgery is moving toward natural orifice surgeries, in which we don’t have to make incisions. I think endolumenal procedures are going to be another tool in our arsenal. They won’t completely replace laparoscopic surgery, but they will definitely aid it and make it even less invasive.”

Originally printed in Surgery Today Newsletter, November 2007.