PRAGUE, Czech Republic — The most noteworthy achievement to date for natural orifice transluminal endoscopy (NOTES) is to have shaken up the 20-year-old practice of minimally invasive surgery (MIS), setting off a new wave of innovation in both procedures and technology.
The theme of the 17th annual congress of the European Association for Endoscopic Surgery (EAES), held here last week, officially was new advances in onocological endoscopy, yet NOTES dominated the program and drew by far the greatest participation in scientific sessions dedicated to different aspects of the topic, especially the rapidly developing practice of single-port access (SPA).
Meanwhile, only two true, defined NOTES procedures have been performed in the nine years since the concept was introduced by Anthony Kalloo, MD, of Baltimore, EAES presenters said.
Instead, due to limitations of the current line of endoscopes and instruments, and more critically, concerns for patient safety, thousands of hybrid procedures grouped under the heading of NOTES have been performed.
In the two pure NOTES procedures, the only surgical access for creating a working space, dissecting tissue and removing the targeted organ is the patient's natural orifice, such as the mouth, the anus or the vagina, with the result that the intervention is truly minimally invasive leaving no scar from an external incision.
In the hybrid procedures, while much of the procedure is performed through the access orifice, a trocar is placed in the patient's abdomen to provide a view unobstructed by the working instruments, or else to aid in retracting organs adjacent to the organ targeted for removal.
As a result, the patient is left with a slight scar from the trocar, a significant reduction from the three to five trocars used in current laparoscopic and endoscopic procedures for appendectomy or cholecystectomy, but canceling out the intended promise of absolutely scarless surgery.
"It is not failure to place a trocar; it is about the patient's safety," said Alberto Arezzo, MD, of the department of surgery at the University of Genova (Genova, Italy).
Concensus among European surgeons is that NOTES is proving to be a high-risk technique that offers no clinical advantage over current minimally invasive procedures and only a cosmetic benefit for the patient.
The risks are the result of a reduced working space where surgeons physically struggle to properly cut, pinch, and grasp vital organs, a poor visualization of the surgical site, and the resulting potential for complications at the surgical site for leakage, bleeding or fistula, and ultimately, for the natural orifice with a potential for permanent damage to the esophagus or the vagina.
The procedures take more time, from 25% to 400% longer depending on the procedure, require a crew of five to support the surgeon, and require a close cooperation with anesthesiologists and surgeons with specific anatomical expertise for an endoscopic surgeon who typically works with one assistant and a scrub nurse for a 40 minute procedure.
And finally, NOTES procedures are not reimbursed.
"NOTES is a revolution, but a slow one, much slower than we have seen with MIS," said Nicola Di Lorenzo, MD, of the department of general surgery at the University of Rome, during a pre-conference workshop on emerging issues for NOTES and safety.
The head of the Technology Committee for EAES, Di Lorenzo said he is convinced that "the department of surgery at my hospital will not be a department in 10 or 15 years, but for the moment the magnitude of benefit for the patient with NOTES is not as great as conventional surgeries."
His conclusion was widely shared by surgeons speaking in sessions over the four day event: "NOTES is not ready yet."
Reopening a natural scar, the bellybutton
The move to scarless surgery inspired by Kalloo led to a further innovation in 2007 when Paul Curcillo, MD, of Drexel University College of Medicine (Philadelphia), presented results ofa cholecystectomy performed using a single access port through the belly button.
The director of robotic and minimally invasive surgery at Drexel, Curcillo used a new set of laparoscopic instruments engineered by Novare Surgical Systems (Cupertino, California) called RealHand that partially resolve the difficulties of in-line instrumentation.
Since his presentation in San Francisco in May 2007 at the Society of Laparoscopic Surgeons, the number of published papers on SPA has jumped from 12 to 70 so far this year on PubMed.
Within six months Novare reported 100 SPA surgeries and here in Prague, two years after the introduction of the technique, surgeons were told more than 5,000 SPA procedures have been performed in the U.S. alone, rapidly expanding from cholecystectomy to diverse applications for organ removal and bariatric treatment.
"As with any new surgical technique procedures start with the gall bladder, which is the gold standard for laparoscopic practice, then we each move to our own areas of interest," said R. Tacchino, MD, of the Catholic University of the Sacred Heart (Rome).
Yet SPA is far from established as a safe procedure.
Abe Fingerhut, MD, of the Centre Hôpitalière deSaint-Germain-en-Laye (Poissy, France), said, "We thought we could transfer NOTES to a single trocar resulting in better cosemetics, less pain, and fewer complications. Yet the disadvantages is that it is more complex with minimal triangulation for instruments, compromised visualization and higher costs."
Novare is no longer alone as a provider with both new ports and instruments introduced here at EAES by major companies, such as Olympus Europa GmbH (Hamburg, Germany), Karl Storz (Tuttlingen, Germany) and Covidien (Mansfield, Massachusetts).
While both surgeons and industry are aggressively pursuing this new access for MIS, the real demand for these procedures is coming from patients.
In other words, expressed in pure American during a presentation by Alexander Rosemurgy from the University of South Florida (Tampa), "It's all about the scar."
The conclusion for the dozens of presentations of clinical cases of SPA given here at EAES was consistently a photo of the patient's belly button showing no scar as a result of the intervention.
Joseph Mamazza, MD, head of general surgery at the University of Ottawa (Ottawa) told MDD he does not see how there could ever be a randomized clinical trial to compare SPA surgeries to conventional laparoscopic procedures, "because which patient is going to agree to be part of the control group knowing it means having four holes punched in their abdomen instead of a scarless procedure?"
Reinhard Zentner, executive director for Olympus Medical Systems (Tokyo), charged with relations with surgeons, told MDD, "Single-port access is going to run with this innovative spirit for another two to three years, and then medical evidence will begin to drive any further developments."
"Right now, it is true that this demand is coming from the patients even more than the doctors."