What is StomaphyX?

StomaphyX is an incision-less trans-oral fastening device that creates plications—an angular or round shape made by folding—using polypropylene SerosaFuse fasteners (staples). StomaphyX has been approved by the Food and Drug Administration (FDA) for suturing tissue and blood vessels in the gastrointestinal (GI) tract and has been successfully used for the surgical joining of tubal structures.

When is StomaphyX appropriately utilized during a surgical procedure?

The StomaphyX device is utilized after complications have arisen during Bariatric revision surgery. Bariatric revision surgery, also known as weight loss surgery, refers to the various surgical procedures that are utilized to treat obesity by surgical modification of the GI tract in order to reduce the intake of food.

The Roux-en-Y gastric bypass (RYGB) is the most commonly performed bariatric procedure in the United States to treat obesity. Despite the favorable short-term outcomes of this bariatric surgical procedure, approximately 10-40% of patients do not achieve favorable long-term weight loss. The weight regain typically occurs within 2 to 7 years after the RYGB surgery.  This may be due to changes in the shape and function of the GI tract over time as well as the lifestyle habits of patients.

What type of complication may require the use of a StomaphyX device?

Gastric leaks represent the most serious complications of bariatric surgery. With the increase in the popularity of bariatric procedures, complications resulting from the procedure have also increased. StomaphyX is a non-surgical device that successfully sutures the area where the leak has occurred.  

Does StomaphyX have any other uses?

StomaphyX is not only effective for the use of repairing gastric leaks caused by Bariatric revision surgery, but the device is also utilized as a Gastric Bypass Revision (GBR) procedure for individuals who have undergone RYGB surgery and have regained weight due to a stretched stomach pouch or enlarged stomach outlet.

How is the StomaphyX Gastric Bypass Revision procedure performed?

A patient is placed under anesthesia, while a surgeon guides the StomaphyX device into the mouth, down the esophagus and into the stomach pouch. The device is inserted via a thin tube, equipped with an endoscope (a miniature camera and light source), once the StomaphyX device is in place within the stomach pouch, sections of the stomach tissue are suctioned into a small opening in the device, which creates folds of tissue that resemble a pleat. The folds are then stapled together resulting in a smaller stomach pouch.

How long does the StomaphyX procedure take?

The StomaphyX procedure takes approximately 20-60 minutes, depending on the patient and the amount of revision that is necessary.

How long is the post-procedure recovery period?

There is minimal recovery required post-procedure. Most patients are able to return to work as early as the following day. Because the procedure is non-surgical, there are no incisions, no visible scars and no limitations on lifting or exercise. However, the patient is typically placed on an all liquid diet until the pleats of tissue have had the opportunity to bond together ensuring a successful revision.

What are the benefits of the StomaphyX procedure?

The benefits of the StomaphyX procedure are:

  • Overall risk to the health of the patient is lower than traditional invasive surgery
  • Does not require surgical incisions, reducing the incidence of infection
  • There is no visible scarring
  • The procedure is adjustable and revisable
  • Preserves future treatment options

The benefits for each patient will vary and discussing these factors with a weight loss surgeon is recommended. 

What are the risks of the StomaphyX procedure?

All of the risks of the StomaphyX procedure have not been calculated because there have been no randomized controlled studies performed regarding this procedure. The primary risk, which is common to all Bariatric revision surgeries, is the potential for perforation of the stomach pouch tissue resulting in bleeding or leaking of GI fluids.

Who are the ideal candidates for the StomaphyX procedure?

The ideal candidates for the StomaphyX procedure can only be determined by a surgeon after a comprehensive medical examination. Typically, individuals who have not successfully achieved a satisfactory level of weight loss after Bariatric revision surgery are the targeted candidates for this procedure.

What is the cost of StomaphyX?

The cost of the StomaphyX procedure is variable depending on geography, the skill of the surgeon and the needs of the patient, but typically the procedure costs $9000-$11,000.

Disclaimer: This information is intended only as an introduction to this procedure. This information should not be used to determine whether you will have the procedure performed nor does it guarantee results of your elective surgery. Further details regarding surgical standards and procedures should be discussed with your physician.

By Staff
Updated: January 23, 2009

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