StomaphyX is a new and innovative revision procedure for individuals who have had Roux-en-Y gastric bypass surgery and have regained weight due to a stretched stomach pouch or enlarged stomach outlet. Approved by the US FDA in 2007, the StomaphyX procedure reduces the stomach pouch and stomach outlet (stoma) to the original gastric bypass size without traditional surgery or incisions and with minimal recovery time. It is not performed as a primary method of weight loss surgery, but as a type of revisional bariatric surgery for gastric bypass patients.


Why is the StomaphyX procedure performed?


Although gastric bypass surgery is successful in achieving an average of 60 to 80% excess weight loss, some patients start to regain weight a few years after surgery. The stomach pouch and stoma can gradually stretch over time as the body’s digestive system becomes accustomed to the changes and the patient returns to unhealthy eating patterns. The StomaphyX procedure reduces the stomach pouch and stoma to a size similar to the original gastric bypass surgery, once again limiting food intake and slowing the emptying of the stomach into the small intestine. This results in earlier satiety (feeling of fullness) and more weight loss. Without having to undergo additional traditional surgery, StomaphyX helps gastric bypass patients eat less and lose more weight.


How do I know if my stomach pouch or stoma has stretched?


If you and your doctor suspect that your stomach pouch or stoma may have stretched, there is a simple procedure known as an upper endoscopy that can be performed to find out for certain. This quick and easy procedure is performed by a Gastroenterologist (scope doctor) who uses a small scope with a video camera to measure the stomach pouch and stoma. For the procedure you will be lightly sedated, then the doctor will guide the scope down through the mouth and into the stomach pouch to take measurements. Before undergoing the endoscopy procedure, it is important for the Gastroenterologist to talk to your Bariatric Surgeon and find out exactly what measurements need to be taken.


How is the StomaphyX procedure performed?


First, the patient is put under anesthesia. Then, the bariatric surgeon gently guides the StomaphyX device through the mouth and into the stomach pouch inside a long, thin tube and performs the procedure using endoscopic visualization (miniature light source and camera). Once inside the stomach pouch, sections of stomach tissue are suctioned into a small opening in the StomaphyX device which creates folds of tissue that resemble a pleat. The folds of tissue are then fastened together with little blue staples to hold them in place, making the pouch smaller. The amount of folds required depends on a patient's anatomy, but usually a patient needs multiple folds. Then the opening between the stomach pouch and small intestine is sutured together to return it to the appropriate size.


The StomaphyX procedure takes approximately 20-60 minutes, depending on the size of the stomach pouch and how much revision needs to be done. Most time the procedure is performed on an outpatient basis.


How long is the recovery period?


The recovery period is very minimal following the StomaphyX procedure. Most patients can return to work as early as the next day. As the procedure is done through the mouth, there are no incisions and no visible scars. In order to allow the pleats to bond to each other, patients are put on a liquid diet for two weeks.


Benefits of the StomaphyX procedure include:


Overall risks are much lower than with traditional surgery
Does not require abdominal or internal surgical incisions
Since there are no visible incisions, there are no visible scars
Reduces risk of infection from surgical incisions
Reduces size of stomach pouch, which limits food intake
Reduces enlarged stoma, which slows passage of food into the small intestine and causes earlier satiety
Can usually be performed on an outpatient basis
Quick recovery (1 day vs. two to eight weeks for revision surgery)
Virtually painless
Adjustable and/or revisable
Preserves future treatment options
Adaptable to different anatomies
Lower mortality rate (1 in 10,000) than with gastric bypass revision (1 in 100)
Risks of StomaphyX procedure include:


No long-term studies because the procedure is new, but bariatric surgeons say it poses little to no risk to patients, as long as the surgeon is properly trained in using the device
Two main risks are bleeding and perforation, which should be minimal if the procedure is performed by an experienced surgeon who knows how to do endoscopy and how to use the device.


Other Surgical Options for Failed Roux-en-Y Gastric Bypass


Revision surgery to restore the original gastric bypass anatomy
Conversion to Vertical Sleeve Gastrectomy (Gastric Sleeve)
Conversion to Duodenal Switch
Conversion to Bilio-Pancreatic Diversion (Scopinaro-type)
Adjustable Gastric Banding (LAP-BAND or REALIZE Band)
Gastric bypass revision with the ROSE Procedure
Patient Criteria for StomaphyX


The StomaphyX procedure is designed for gastric bypass patients who never achieved adequate weight loss or regained weight after their initial weight loss.


Eventually the StomaphyX procedure will become available for individuals with "virgin" stomachs. Although it is not yet possible to perform StomaphyX as a primary method of weight loss surgery, it is only a matter of time before the medical community develops an instrument that can reach the curves of a normal stomach.


StomaphyX Results


The StomaphyX procedure offers gastric bypass patients a safer alternative than previously available for gastric bypass revision. Without having to undergo another traditional surgical procedure, gastric bypass patients can have their stretched stomach pouch or stoma reduced to an appropriate size. The overall results of StomaphyX are earlier satiety and increased weight loss.