Fistula Plug Surgery: Device Repairs Intestinal Issue

Warning: The following story is icky. But the truth is that a lot of medical conditions do have an "ick" factor, and those are the things that most require a physician's help.

So if you're a trauma patient with an abdominal puncture wound, or if you have Crohn's Disease or other physical ailments related to serious and prolonged intestinal distress, your body may develop something called an enterocutaneous fistula, which sounds a lot nicer than it is.

Paul LoPresti, MD with fistula plug surgery device
Interventional radiologist David LoPresti, MD, holds a sample fistula plug and surgical application device.

"It's an abnormal opening between the lumen of the bowel and the external surface of the skin, usually the abdomen," explained interventional radiologist David LoPresti, MD, one of the few physicians in Phoenix trained to perform a new procedure to repair fistulas.

Think of the lumen of the bowel as the casing on a sausage. When it is punctured in trauma, or when it is weakened and abscessed by disease, fecal material can leak.

The only good news is that this does not happen spontaneously in healthy, uninjured people. It most often happens when people with a chronic condition (like Crohn's Disease) experience malabsorption of food and subsequent malnutrition, weakness and compromised immune system.

"Traditionally," Dr. LoPresti said, "fistulas have been treated with an ostomy bag. Attempts have been made to repair fistulas surgically, but it's hard to operate on inflamed tissue. Frequently, inflamed tissue does not heal quickly or correctly and the patient suffers."

New hope comes with a new device from Cook Medical that works like a plug, Dr. LoPresti said. But it's not for everyone.

"It's tricky, and it has a fairly high failure rate," he said. "About two-thirds of the devices we implant fail. However, this is a low-risk procedure, so if you have a fistula that leaks fecal material, you'll probably want to find out if you can make it into the lucky one-third whose devices work."

fistula plug surgery device
This cutaway medical diagram shows how the fistula plug blocks the hole in the bowel wall and the opening in the external surface of the skin. A tissue graft creates a scaffold for healing the abdominal wall between the two plugs.

The device has a flange attached to a collapsible disc attached to a graft of pig intestine, because porcine parts are most compatible with human tissue. The collapsible disc is inserted through the fistula into the bowel where the flange is deployed to block the hole. The porcine graft fills the linear track and acts as a scaffold for human tissue to grow to heal the fistula.

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"When it works, it is a tremendous service to the patient," Dr. LoPresti added. "There's no real downside to the patient, except time."

The procedure is done on an outpatient basis but requires three visits. First is an evaluation which includes a physical exam and a review of the patient's medical history to determine if the patient is an appropriate candidate for the procedure.

Next is a planning session which includes a medical test involving dye. This helps the physician define the magnitude of the fistula and the exact location of the intestinal abscess. Based on this information, specifics are sent to the device manufacturer and a custom-built device is produced specifically for the patient. The manufacturing process takes about three weeks.

Once the product is manufactured, a 30-minute outpatient procedure is scheduled. Post-procedural time is required for recovery from anesthesia, but an overnight hospital stay is not necessary.

During the next two weeks, while healing begins, the patient is required to be very careful. Bending, lifting and extreme activity are all forbidden. "We want to give the device the best chance possible to be successful," Dr. LoPresti said.

Within a month, however, successful patients can return to most normal activities of daily living, he said.

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