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

Cheryl Clark, for HealthLeaders Media, May 3, 2010

But in time, the trial may enroll patients for other NOTES® procedures, many of which are already being performed around the world, not just to remove organs, but to repair tissue and stage progression of disease. For example these NOTES® procedures have already been done:

  • Removal of the appendix through the vagina in women and through the mouth in men, performed at UCSD.
  • Sleeve gastrectomy, a type of bypass surgery for weight loss, through the vagina, done at UCSD.
  • Repair of achalasia, a disorder marked by difficulty in swallowing, through the mouth, performed at UCSD.
  • Removal of the kidney through the vagina, performed at Johns Hopkins Medical Center.
  • Removal of a portion of the colon through the vagina, performed at Hospital Clínic, University of Barcelona, Spain, and a colonic resection at Massachusetts General Hospital, Boston.
  • Removal of the spleen through the vagina, performed at Hospital de la Santa Creu I Sant Pau Barcelona, Spain.
  • Repair of hernia through the vagina at UCSD.
  • Staging of pancreatic cancer to see if tumor has spread elsewhere in the abdomen, performed at Ohio State University Medical Center.

Horgan's team at UCSD also is about to attempt the removal of an appendix and gall bladder through the rectum and colon.

Kochman, the Wilmott Family Professor of Medicine at the University of Pennsylvania, says he doesn't know what types of NOTES® procedures will be boilerplate offerings in U.S. hospitals in a few years. Use of the technique in areas where medical facilities are inadequate, such as Africa, or in military deployment areas where true operating rooms aren't available, are obvious options.

When NOTES® surgery came on the scene in the U.S. four years ago, some surgeons found it horrifying.

After the first NOTES® gallbladder removal through the vagina in 2007 at NewYork-Presbyterian Hospital/Columbia University Medical Center, Christine Ren, assistant professor at New York University's school of medicine, told the New York Times, "I just think it is crude, and there aren't many things that should be going in and out of the vagina . . . I don't think a gallbladder should be, or those instruments."

Horgan acknowledges that it has been difficult to convince some surgeons that this idea isn't just medical showboating. "My father was a surgeon who said 'the bigger the scar, the better the surgeon. Well that's not true anymore. We are making almost no incisions and the operations are better."

And he thinks many formerly skeptical providers are coming around because the field has evolved so dramatically. For starters, Horgan says, "we have much better equipment available and under development. We have devices that can suture for us through the endoscope."

Even though he has confidence that NOTES® works better, "today's standards for documenting the procedure with evidence are far more strict. We're being held to different standards than when we started performing laparoscopic surgeries. There's increased scrutiny."

But Horgan doesn't mind.

"What I tell my peers when I give lectures is that there are two kinds of surgeons—those who believe lap is the best you can do and that's it. Or those like me, who believe we can make it better, we can improve and change."


Cheryl Clark is senior quality editor and California correspondent for HealthLeaders Media. She is a member of the Association of Health Care Journalists.
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