Natural Orifice Trials Begin, A Potential 'Game Changer' for Hospitals

Cheryl Clark, May 3, 2010

Two weeks ago, surgeons in Massachusetts and California enrolled the first three of 140 patients in a clinical trial to see if diseased organs can be removed through two of the body's natural orifices–the vagina and the mouth–as safely and effectively as standard laparoscopic methods.

They want to see if using tinier cuts for cameras and tools can reduce infection rates, patient's pain, and length of hospital stay more than the traditional way of making an incision to remove the organ through the abdomen. They think it can, because they are avoiding larger incisions now made to extract tissue through the abdomen.

The technique is called "NOTES®," or Natural Orifice Translumenal Endoscopic Surgery®, and so far about 2,000 patients have undergone such procedures worldwide, more than 120 in the U.S. and 70 of them in a clinical trial at the University of California Medical Center, San Diego.

"This will truly be game-changing for hospitals and for doctors," says Santiago Horgan, MD, a NOTES® pioneer at UCSD, which along with Baystate Medical Center in Springfield, MA have been approved for the prospective multi-center randomized trial. "We are really changing the way we operate."

These NOTES® surgeons hope they can prove their approach not only reduces readmission rates, but also decreases postoperative hernias compared with traditional lap procedures. Additionally, there would be almost no visible scarring, which would likely improve patient satisfaction.

The NOTES® multicenter U.S. human trials are lead by NOSCAR®, 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 a variety of endoscopic equipment manufacturers.

At first, NOSCAR®'s trial sites will enroll patients to compare removal of the gall bladder, a procedure called a cholecystectomy. Patients will be randomized to receive NOTES®–either through the vagina or the mouth – or traditional laparoscopic surgery in which removal is through an incision in the abdomen. While one million traditional lap procedures have been performed nationally, only about 1,000 have been done worldwide using NOTES.

Instead of four incisions in laparoscopies, NOTES® uses only one, to insert camera and tools, and the incision is smaller, two to five millimeters compared with three or five centimeters.

Northwestern Memorial Hospital in Chicago; Legacy Good Samaritan Medical Center in Portland, OR; Ohio State University Medical Center in Columbus; the Mayo Clinic in Rochester; and Massachusetts General Hospital are lining up human subject paperwork approvals to join in.

Will more hospitals be involved in NOTES® types of surgeries in a few years? Michael Kochman, NOSCAR®'s co-principal investigator, says that's very likely. "The key issues will be whether the facilities have the equipment and expertise for these kinds of advanced endoscopic procedures, and that we demonstrate safety and efficacy."

Kochman says that for hospitals, there would likely be overall cost savings "if surgeries could be performed in a modified endoscopy suite rather than with general anesthesia in a typical operating room."

But, says Horgan, "We need to prove this is not worse than laparoscopic procedures. We should have no fear about what we are doing." Concerns remain that without surgically opening a visual field, some operators will lack precision to perform the procedures safely and quickly. Additionally, design and subsequent federal approval of sufficiently flexible surgical tools is not yet at a point where some believe it can be.

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