The results of a small surgical trial demonstrate that elective transvaginal cholecystectomies are safe and suggest that the evolution of natural orifice surgery is constrained only by the development of better instruments, public acceptance, surgeons' training, and anatomy.
Imagine a day when some surgeries no longer require incisions and patients recover faster, with less pain, lower risk of infection, and no ugly scars.
Steven Schwaitzberg, MD |
As of last weekend, that day seems much more possible, at least for elective gallbladder surgery in women. That's when doctors released results of a small, four-year, $1.7 million randomized trial in which surgical scissors, a tiny 5-mm camera, and diseased tissue were passed not through the abdomen, but through a small cut in the vaginal wall.
In the trial, nine surgeons at six hospitals used Natural Orifice Translumenal Endoscopic Surgery (NOTES) surgical procedure for cholecystectomy. The gallbladders of 39 women were removed through traditional laparoscopy, which involves four incisions near the belly button, sternum, and near the abdomen. The gallbladders of a matched cohort of 37 women were removed through the vagina.
With follow-up ranging from 30 to 180 days, the procedures were found to be equally safe.
Blood loss, length of stay, and need for post-operative medications were the same in both groups, and there were no bile duct injuries, necessity for reoperations, readmissions within 30 days, infections, or wound ruptures in either group. There was one relatively minor and avoidable event in the vaginal cohort: One woman's intrauterine device became dislodged.
'No Longer Experimental'
"We can now say that NOTES is no longer experimental," says Steven Schwaitzberg, MD, a surgeon with the Cambridge Health Alliance in Cambridge, MA who co-directed the gallbladder NOTES trial. Transvaginal NOTES cholecystectomies are just as safe as their more invasive alternatives, he adds.
Pain was slightly less in the NOTES cohort, although not statistically significant, and cosmetic skin appearance scores were superior, outcomes that will improve over time to be better than the alternatives, Schwaitzberg predicts.
The only difference between the traditional lap group and the NOTES group was that the NOTES group surgeries took about 90 minutes as opposed to 65 minutes. Schwaitzberg says that's not a big concern.
And because this was a trial, the surgeons made a tiny incision near the umbilical cord to insert a small camera. "It was not an absolute requirement. We now know these can be done safely without a camera incision," he says.
Optimistic surgeons say the NOTES procedure is constrained only by the evolution of smaller and more flexible instruments, public acceptance, surgeons' training, and of course, anatomy: Instruments and removed tissue can pass through the vagina, the rectum, and the mouth.
"We're still in an early stage of an evolutionary learning curve. We don't know what will happen after five years of practice. And if you remember, the first lap procedures took four or five hours," he says.
The Surgical Trial
Schwaitzberg says that organizing the device-agnostic trial was extremely difficult. About $1.7 million had to be raised to pay for procedures randomized to the transvaginal arm of the trial, money that came from five manufacturers of equipment that is used in all modes of cholecystectomies, Ethicon, Stryker, Olympus, Storz, and Covidien. The caveat was that surgeons could use whatever equipment they wanted to avoid biasing the results.
Participating hospitals included Yale-New Haven Hospital; Baystate Medical Center in Springfield, MA; Legacy Clinic in Portland, OR; Northwestern University in Evanston, IL; University of California San Diego Medical Center, and Ohio State University Wexner Medical Center.
Beyond demonstrating safety, Schwaitzberg says the trial also proved that two professional societies, the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES), and the American Society of Gastrointestinal Endoscopy (ASGE), could work together. The members of both groups had previously been at odds over issues of whether endoscopists should perform surgery. Now they support a joint initiative called Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR).
"SAGES was formed because surgeons were blocked from access to the endoscopy suite or even having endoscopic privileges at all," Schwaitzberg recalls. "We have come full circle today where we can work on common issues."
Santiago Horgan, MD, chief of minimally invasive surgery at UC San Diego Medical Center, who performed some of the gallbladder surgeries, agrees that the trial has provided the necessary evidence.
"We can now prove that we don't see a higher rate of complications," he says. "Once this news gets out, people will see that this operation works. We may need more numbers to prove there is less pain, but in my patients, they are experiencing much less pain."
Santiago Horgan, MD |
Still, there is the question of how long it will take for insurance companies and Medicare to agree that NOTES is no longer experimental and to approve payment. That will require peer review and publication of the trial results in a journal, which is coming soon, Schwaitzberg says.
Adoption of the technique also requires physicians and patients to get over any squeamishness they might have, which has reportedly been an issue in the past.
Schwaitzberg says that of the 750,000 elective gallbladder procedures performed each year in the U.S., between 500,000 and 600,000 are in women who may benefit from the NOTES approach.
Surgeons Taking Responsibility
Another lesson learned, he says, is that "professional medical societies can, and perhaps should, take on the responsibility of answering important clinical questions so that we move forward with data rather than advertising."
The NOTES approach, which began more than 10 years ago, does not begin and end with diseased gallbladders. Surgical advances have evolved to treat other conditions such as achalasia, a disorder that impairs the ability of the esophagus to move food to the stomach. Now, repair is done through a laparoscopic procedure called a Heller myotomy, but a trial called POEM, per oral endoscopic myotomy, uses an incision to cut the wall of the esophageal muscle, Schwaitzberg says.
Colon surgery through the rectum is another possibility. And surgeons are working on removal of the appendix through the vaginas of women and through the mouths of men.
I'm glad this trial proves NOTES wasn't just a glimmer in a few surgeons' eyes, especially for the infections they may avoid. The news is just in time for summer—and some bathing suits now won't have to hide surgical scars.