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Pioneering surgery study underway at Baystate Medical Center

May 11, 2010

Surgeons at Baystate Medical Center have enrolled the first patient in a national multi-center study of the potential for a new surgical technique to be as effective and safe as traditional approaches while at the same time reducing recovery time, infection rates, postsurgical scarring and perhaps even health costs.

Baystate is a leading hospital in developing and practicing NOTES—Natural Orifice Translumenal Endoscopic Surgery—which uses tiny cuts, or no external cuts at all, to remove diseased tissue from the body’s internal cavity. With NOTES, surgeons extract tissue through the patient’s natural body openings, usually the mouth or vagina, using tiny cameras and surgical tools manipulated with extreme precision.

By minimizing incisions and decreasing the body cavity’s exposure to external bacteria, NOTES has the potential to revolutionize modern surgery, as shorter hospital stays and lower complication rates would significantly improve patient satisfaction and help control health costs, too.

But first, doctors need to be sure the new technique is just as safe as current approaches, and so Baystate and other academic medical centers across the country are enrolling 140 patients in a rigorous test of NOTES’ effectiveness.

“We know from our experience that NOTES can be very effective for procedures like cholecystectomy [surgical removal of the gallbladder],” said Dr. John Romanelli, director of Bariatric Surgery and Robotic Surgery at Baystate Medical Center and a pioneer in the field of minimally invasive surgery. “This multi-center clinical trial is an extremely important step in determining whether NOTES can be safe and effective for an exponentially greater number of patients, and we’re proud to be at the forefront of this study.”

In June 2007, Dr. Romanelli and Dr. David Desilets, chief of gastroenterology at Baystate Medical Center, performed the world’s first stapled NOTES cyst-gastrostomy, passing an endoscope and surgical stapler through their patient’s mouth and down into his digestive tract to puncture and drain an infected pancreatic pseudocyst, and resolve the patient’s life-threatening condition.  

“Even since that operation, we have come a long way in terms of what we can do to minimize the impact of surgery on the patient’s body,” said Dr. Romanelli. “I believe that minimally invasive approaches like NOTES will in the not-too-distant future become the norm for some types of surgery.”

The NOTES study is an initiative of NOSCAR, the Natural Orifice Surgery Consortium for Assessment and Research, a joint venture between the American Society for Gastrointestinal Endoscopy and the Society of American Gastrointestinal and Endoscopic Surgeons. NOSCAR is financially supported by ASGE, SAGES, and endoscopic equipment manufacturers.

At first, trial sites will enroll patients to compare removal of the gall bladder. Patients will be randomized to receive NOTES–either through the vagina or the mouth – or traditional laparoscopic surgery in which removal occurs via cuts in the abdomen. While one million traditional laparoscopic procedures have been done nationally, less than 1,000 have been done worldwide using NOTES.

There are opportunities for additional patients to participate in the trial at Baystate, as long as they are appropriate candidates, said Romanelli.

Baystate Medical Center to date has won six Beacon Awards for Critical Care Excellence, is designated a Magnet Hospital for nursing excellence, and operates the state’s second-busiest emergency room, serving the most seriously ill and injured patients from across western Massachusetts and critical trauma patients from across the Northeast. Baystate is one of Leapfrog Group’s top 45 hospitals in the U.S. for quality and efficiency, a Thomson Reuters Top 100 Cardiovascular Hospital, and a U.S. News Best Hospital for endocrine and diabetes care.