NOTES human trial on transoral, transvaginal cholecystectomies

In recent years, rapidly emerging technologies and improved techniques have brought minimally invasive endoscopic surgery closer to a once-elusive goal: incisionless surgery. At the forefront of this trend, Columbia and Weill Cornell physicians at NewYork-Presbyterian Hospital have been developing NOTES^™ (natural orifice translumenal endoscopic surgery) in both research and clinical settings.

NOTES uses various body orifices as points of entry, including the vagina, rectum, and mouth, instead of initiating an operation from the skin. The hope is that NOTES which is being even less invasive than laparoscopic surgery, will be able to reduce or eliminate pain, leave no scars, and shorten recovery time. Possible applications include appendix operations and biopsies, as well as more significant operations such as removing parts of the stomach and intestine. The method challenges the basic paradigm of surgery: the idea that cutting across the lumen of an organ into the patient's abdominal cavity is to be avoided.

"Surgeons are always taught not to cross those walls unless they're operating on that specific organ," said Marc Bessler, MD. "The big issue we've addressed is how to close the organ you're going through, safely."

This Spring at NewYork-Presbyterian Hospital/Columbia University Medical Center, Dr. Bessler and his colleagues Dennis L. Fowler, MD, and Peter D. Stevens, MD, used NOTES techniques and laparoscopic assistance to complete the first flexible endoscopic transvaginal cholecystectomy in the United States. They inserted an endoscope through the patient's vaginal wall, then into her body cavity. Using that scope, they detached her gallbladder and removed it through the vagina, which they then sutured. To ensure that the technique was performed as safely as possible, the team used laparoscopic assistance. The first operation involved a few incisions. Soon afterward, the doctors conducted the same surgery on a second patient and made only 1 navel incision measuring 5 mm, which is just wide enough to insert the smallest available standard clip used in laparoscopy.

Marc Bessler, MD

Based on the successful outcomes of these 2 cases, NOTES seems promising, according to Dr. Bessler. The second patient went home the same day as her surgery and did not need pain medication. Although the idea of operating through a sexual organ might make some people feel uneasy, he explained, the procedure focuses on an area of the vaginal wall near the cervix that has minimal pain sensation and is not involved in sexual function. Dr. Bessler plans to evaluate outcomes after every 10 patients and hopes to soon move into a comparative trial that randomly assigns patients to gallbladder removal by either laparoscopy or NOTES.

At NewYork-Presbyterian Hospital/Weill Cornell Medical Center, colorectal surgeons are tailoring the NOTES approach to the large intestine, entering the patient's body via the rectum. "We're trying to develop means by which diseases of the large intestine can be entirely treated through the channels of the large intestine," said Jeffrey W. Milsom, MD. "We're doing hybrid endoscopic and laparoscopic procedures using 2 or 3 tiny incisions in the abdomen to augment this capability of removing lesions from inside the colon, which would otherwise require bowel resections."

The NewYork-Presbyterian/Weill Cornell team consists of Dr. Milsom along with Toyooki Sonoda, MD, Sang Lee, MD, and Alfons Pomp, MD. Together, they have carried out the hybrid procedure in nearly 40 patients. The group is also conducting lab research in animal and cadaver models to develop completely incisionless procedures, techniques that will eventually treat a variety of diseases including benign intestinal growths, rectal prolapse, strictures, infections that lie adjacent to the colon, and possibly even cancer.

Additionally, Dr. Milsom's team is collaborating with bioengineers at NewYork-Presbyterian/Weill Cornell to form Minimally-Invasive New Technologies (MINT), a project that explores how technology can expand minimally invasive surgery. For example, imaging modalities such as 3-dimensional CT scanning, ultrasound, and MRI might couple with endoscopy in the operating room, or newly designed scopes could have improved optics and give surgeons better access to insert necessary tools.

"NOTES is the next natural evolution of what we've been doing over the past 15-plus years," said Dr. Milsom, who bases his current work on the more than 3,000 laparoscopic colon resections he has completed during his career. "Surgery is becoming more and more minimized, as the optics and tools used to carry out surgical actions are all becoming more miniaturized. So, it's more evolutionary than revolutionary."

Editor's Note: On December 10 and 11, 2007, Columbia and Weill Cornell physicians will co-host the NewYork-Presbyterian Hospital First Annual International NOTES^™ Course. For more information, visit www.nypdigestive.org.