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.
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."