Medical Device Daily Contributing Writer

WASHINGTON — As was the case last year at the Digestive Disease Week meeting, NOTES (for Natural Orifice Translumenal Endoscopic Surgery) continued to take center stage at this year's DDW gathering last week, but in an even more dramatic, center-front fashion.

During a DDW combined specialty symposium that filled three huge adjacent ballrooms, Anthony Kalloo, MD, chief of gastroenterology of the Johns Hopkins University School of Medicine (Baltimore), introduced the program by saying, "The mere size of the audience is overwhelming, much less the number of research papers and poster presentations here at this meeting that reflect the large amount of interest in this area."

NOTES is an emerging platform that allows abdominal surgeries using flexible endoscoopes passed through a natural orifice such as the mouth or vagina, It has been coined "invisible healing" because, as this indicates, there is no visible scar left behind.

But the procedure hasn't developed an absolute consensus in the field because it has its share of critics. Opponents of NOTES, also present in the audience, were quick to quip, "There certainly is a scar, you just don't see it because it is in the stomach [or other orifice]," reminding us all that NOTES is an emerging and yet unproven new specialty.

Theoretically, because there is no abdominal wound with NOTES, there should be no infections, no surgical adhesions, less anesthesia, quicker healing, fewer post-op pain meds, and better access into the thorax and abdomen.

"However, all this is theory at this point," Kalloo said. "The research will continue. The corroboration of endoscopists and surgeons provides for powerful synergies."

And, he added: "It is ethical and essential to do all NOTES procedures with, and under the supervision of, an IRB [investigational review board]." While scientists are still attempting to get NOTES accepted as a legitimate and necessary tool to add to the armamentarium of surgeons and endoscopists, others feel as though it might end up being primarily patient-driven, much like laparoscopic cholecsystectomies in the 1980s. Many believe that patient behavior is such that "If you offer it, they will come."

To test that theory, Monika Hagen, MD, of Hopitaux Universitaires de Geneve (Switzerland) reported on "Cosmetic Issues of NOTES: A Rationale for Further Research and Investments."

She asked, "Why are we doing NOTES? And how important are scars in real surgery?"

She then surveyed 292 individuals (43% male) who previously had surgery and asked them how satisfied they were with their scars, how important it was to not have scars, and how much additional surgical risk would they accept to avoid scars.

She broke the 292 into three age groups: 15-29, 30-49 and over 50. Her results were statistically significant — and surprising — lending credence to the view that this surgical option may be largely patient driven.

Overall, patients were willing to accept a 21% increased surgical risk to have a scarless surgery, with no significant difference between men and women. Even more surprising was that the oldest group was willing to take on the highest increased risk (31%), while the youngest group wanted less risk. Paul Swain, MD, professor of gastrointestinal endoscopy of Imperial College, School of Medicine (London) presented "The Development and Testing of a Toolbox for NOTES," describing the key activities in performing NOTES procedures: access, closure, hemostasis, ligation and dissection.

He said, "The current device limitations are a broad barrier to improving the safety, efficacy and advancement of NOTES. For this field to move ahead safely and with broad adoption, technologic advances are needed."

He listed the 35 human NOTES cases that he was aware of — 14 appendectomy/tubal ligations, 10 cholycystectomies, five transvaginal cholycystectomies, and 10 diagnostic peritonoscopies — and said that if new endoscopic tools could provide manipulation in the absence of triangulation (as used in laparoscopic surgery), then a broad range of new procedures could be undertaken.

He concluded: "In this early stage of development it is difficult to forecast whether NOTES will become a clinical reality, [although] there are certain areas where it makes more sense. In the near future it is safe to conjecture that NOTES will be used in hybrid procedures, and the optimist would believe it capable of stand-alone procedures in the next few years." Following the panel's presentations, an audience member asked, "What do you think will be the first procedures commonly performed using NOTES?"

Panelists agreed that NOTES will probably evolve not by specific procedure but rather by first performing simple procedures that are currently done by laparoscopic techniques and then slowly evolve into more complex procedures as the necessary tools are developed to perform those operations.

But the very first use will probably be as an exploratory procedure, for instance, looking for dead gut. Another early application could be removal or organs.

An announcement was then made by Kalloo that "Our counterparts at the American Urological Association [AUA, Linthicum, Maryland], who are meeting right now in Anaheim, just reported that they have performed the first NOTES kidney removal; by morcellating and then extracting a kidney through the urethra."

He added with a chuckle: "The gauntlet has been dropped!" NOTES research represents an unprecedented collaboration between both surgical and endoscopic specialties, not seen before in any other technological breakthrough. While the procedure is trying to live down its reputation as a "technology in search of an application," there are viewpoints on both sides of the fence.

But those involved with the continuing research appear determined to do it in a safe, stepwise manner, as evidenced by the enthusiasm, and scrutiny of procedural details, at this meeting.