Introduction
Nearly a century ago, New Orleans gave birth to jazz, a new brand of music. The exciting notes and syncopated rhythms characteristic of this new music spread rapidly throughout the world; jazz continues to be popular today.
This year, at the 93rd annual conference of the American College of Surgeons, surgeons gathered in the same city to learn about music composed from another type of NOTES: Natural Orifice Transluminal Endoscopic Surgery. The session was moderated by David W. Rattner, MD, Chief, Division of General and Gastrointestinal Surgery, Massachusetts General Hospital, Boston, Massachusetts. A large audience listened carefully as a panel consisting of 3 surgeons and 1 gastroenterologist discussed the problems and potential for this new approach based upon incision-free surgery. The procedure has great appeal to patients who anticipate less pain and more rapid recovery from incision-free surgery. But the big question for surgeons and for patients is simply whether NOTES procedures will ever become as popular as endoscopic surgery, or will it die a quiet death, joining other abandoned procedures in a remote surgical graveyard?
Does NOTES Have a Future?
David Rattner stressed the rapid growth of NOTES with more than 2 dozen procedures performed on humans so far. Most cases have not yet been reported in the literature, but 1 of the first operations may have been performed in India when appendicitis developed in a severely burned patient. Rather than using an abdominal incision through potentially infected burned skin, the surgeons successfully removed the patient's appendix using a transgastric endoscopic approach. This case has yet to be reported in the medical literature.
Dr. Rattner pointed out that members of the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) and the American Society for Gastrointestinal Endoscopy (ASGE) are working together to monitor progress, provide training, foster research, and record results in a NOTES registry. The group's activities are available on the Internet at noscar.org.
Nathaniel J, Soper, MD, Professor and Chairman, Department of Surgery, Northwestern University Feinberg School of Medicine, Chicago, Illinois, the first panelist, outlined the possible benefits of NOTES but emphasized that we should anticipate pitfalls and problems. The hoped-for benefits include less pain, less trauma, no visible scar, less cardiovascular strain. These yet-to-be-proven benefits must be balanced against real obstacles, which include the need for new skills, new tools, and the potential catastrophic problem of a leak from the puncture wound in the stomach -- required for NOTES. Surgeons are not ordinarily trained in sophisticated endoscopic procedures and gastroenterologists are not prepared to perform intraoperative procedures. Some sort of cross-training in 2 currently separate disciplines will be required.
He cited an informal survey of about 200 patients who were asked a hypothetical question: would they prefer cholecystectomy performed by a NOTES or a laparoscopic procedure? Slightly more than half (56%) said they would prefer the NOTES approach; cosmesis did not seem to be the underlying reason. In contrast, in a survey of 357 surgeons only 25% favored a NOTES approach.
Dr. Soper asked several pointed questions: "Is removing the gallbladder via the stomach or vagina likely to be superior to laparoscopic cholecystectomy?" "Should we cater to the whim of the public?" "If we don't do it, will the gastroenterologists take over the field?" His final conclusion: "NOTES = NO WAY."
Robert H. Hawes, MD, Professor of Medicine, Medical University of South Carolina, Charleston, SC, a gastroenterologist, pointed out the need for cooperation between surgeons and gastroenterologists to stimulate the initial phases of growth, given the complementary skills of the 2 groups. The training issue is enormous -- short courses are unlikely to provide sufficient skills, nor will simulators substitute for real patient experience. If NOTES is to take off, Dr. Hawes suggested that we will need a new specialist who has both skill sets. Revenue sharing and practical scheduling issues make it unlikely that the NOTES procedures will be performed jointly by two different specialists. Nevertheless, there is a good model for a NOTES team approach: surgeons and anesthesiologists, who have entirely different skills, have worked together for years with minimal problems. It would, in fact, be impossible to carry out today's sophisticated surgical operations without close cooperation between surgeons and anesthesiologists.
Mark A Talamini, MD, Professor and Chairman of the Department of Surgery, University of California, San Diego, CA discussed a combined laparoscopic/NOTES procedure using a vaginal approach supplemented by a single umbilical port in 2 patients who underwent cholecystectomy . The combined approach afforded superior vision and instrumental control. Magnets can be used to apply traction to the gallbladder -- a technique that still awaits US Food and Drug Administration approval.
These procedures were performed with strict Institutional Review Board (IRB) approval -- an absolute necessity at this stage of the development of NOTES. Both patients were discharged on the day following surgery and the amount of pain medication they required was about the same or perhaps less than that required for traditional laparoscopic cholecystectomy.
Dr. Talamini stressed that the combined approach makes it safer, but it does require a single small umbilical incision, rather than the traditional 3 ports. Surgeons and patients will have to decide whether avoiding 2 small abdominal incisions justifies developing an entirely new surgical approach. Randomized trials of NOTES procedures must be performed to determine whether this new procedure is clearly superior to existing laparoscopic approaches.
The final presentation was from W. Scott Melvin, MD, Chief, Division of General and Gastrointestinal Surgery, Ohio State University, Columbus, Ohio, and he spoke on challenges of NOTES. He outlined three major areas that must be addressed if this technique is to become successful.
Technological issues.
We will need new flexible instruments. The current rigid laparoscopic instruments are not designed to effectively remove an organ such as the gallbladder through a gastric incision;
Adequate lighting of the entire abdominal cavity is more difficult using a NOTES approach than with laparoscopy;
Sterility is likely to be more of a challenge for NOTES than for traditional operations, in which bactericidal agents effectively provide antisepsis. (Of some reassurance, we do know that vaginal operations such as vaginal hysterectomy are commonly performed without any excess risk of infection);
Closing the hole in the stomach is a weak point in the procedure. Both morbidity and mortality will increase in patients who develop peritonitis from a gastric leak; and
A final technical issue concerns spatial orientation, which is more difficult with NOTES.
Ethical issues. Currently, NOTES procedures are experimental and therefore should be performed with strict IRB approval. But even with such approval, ethical issues still exist:
Should we perform a procedure that could be more dangerous than currently available operations?
Is the avoidance of a few tiny scars sufficient reason to offer NOTES as an option to our patients?
Conceptual issues.
What about insurance? Is it likely that insurance companies will pay for NOTES procedures without clear evidence that it is cost effective? Unlike laparoscopic cholecystectomy, which dramatically shortened hospital stay and eliminated a major source of pain, what benefits can we expect from NOTES?
Is the basic driving force for NOTES corporate profit?
These tough questions require careful thought and clear answers. Along with the other speakers, Dr Melvin believes that for NOTES to become successful, surgeons and gastroenterologists will have to cooperate, at least during the developmental stages.
Following the formal presentations, the panelists answered several questions:
"Is pain less without any abdominal incisions?" "We're not sure" was the response from all the panelists. "Too few patients have been operated [on]."
"How do you close the incision in the stomach or other organ?" "For the vaginal approach there's no problem because the opening can be closed under direct vision. New methods for safely closing the gastric incision still need to be developed." Dr. Melvin mentioned that in operations on dogs, leaving the gastrotomy wound open did not lead to any complications.
"How long does it take to prepare for a NOTES procedure?" As with any new procedure, the setup time is longer than it will be when surgeons become more familiar with the technique.
"Are randomized trials planned and are they feasible?" Currently only a registry of human cases is planned, but eventually after the procedure has been developed, randomized trials must be performed to validate the procedure against standard techniques.
"Is there likely to be any beneficial spin-off from NOTES." Yes, similar to side benefits from the space program, NOTES is likely to move the entire field of surgery forward because of the development of new, more flexible instruments.
"Can conventional laparoscopic instruments be used transvaginally?" No, because they won't be long enough, but it should be easy to design similar instruments with longer shafts.
Key Points and Summary
NOTES is currently still in the early developmental stage. We now know that NOTES procedures can be performed. Yet to be established is whether or not these procedures should be performed.
Conceptual issues such as insurance payment for these procedures must be worked out along with the solution to technical issues.
Training issues are likely to be a major impediment. Will there be a new type of specialist that can do both advanced endoscopy and surgery, or is a team approach superior?
New flexible instruments must be designed if NOTES is to achieve its full potential.
Combining NOTES with laparoscopy might be safer than a completely transluminal route.
Take home message. Only after the completion of carefully designed clinical trials will we know if NOTES offers any advantage over existing surgical procedures. Until then, NOTES procedures in patients should be regarded as experimental, requiring IRB approval. At present NOTES is only a prelude, needing further development if it is ever to become a full symphony.[1]
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References | Additional Reading
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References
Rattner DW, NOTES Forum: Frontier for Intervention or Just Another Pathway to Mischief? American College of Surgeons 93rd Annual Clinical Congress.
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Additional Reading
Bardaro SJ, Swanstrom L. Development of advanced endoscopes for Natural Orifice Transluminal Endoscopic Surgery (NOTES). Minim Invasive Ther Allied Technol. 2006;15:378-383.
de la Fuente SG, Demaria EJ, Reynolds JD, Portenier DD, Pryor AD. New developments in surgery: Natural Orifice Transluminal Endoscopic Surgery (NOTES). Arch Surg. 2007;142:295-297. (Review)
Gettman MT, Blute ML. Transvesical peritoneoscopy: initial clinical evaluation of the bladder as a portal for natural orifice translumenal endoscopic surgery. Mayo Clin Proc. 2007;82:843-845.
Kalloo AN, Singh VK, Jagannath SB, et al. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc. 2004;60:114-117.
Marescaux J, Dallemagne B, Perretta S, Wattiez A, Mutter D, Coumaros D. Surgery without scars: report of transluminal cholecystectomy in a human being. Arch Surg. 2007;142:823-826; discussion 826-827.
Wagh MS, Thompson CC. Surgery insight: natural orifice transluminal endoscopic surgery -- an analysis of work to date. Nat Clin Pract Gastroenterol Hepatol. 2007;4:386-392. (Review.)
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Author(s)
Albert B Lowenfels, MD
Albert Lowenfels, MD, Professor of Surgery, New York Medical College, Valhalla, New York; Emeritus Surgeon, Department of Surgery, Westchester Medical Center, Valhalla, New York
Disclosure: Albert B. Lowenfels, MD, has served as an advisor to Solvay Pharmaceuticals.
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CME Information
CME Released: 01/02/2008; Valid for credit through 01/02/2009
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Diagnosis DCIS using best current approaches
Use radiation therapy and adjuvant therapy appropriately for DCIS
Discuss obstacles and benefits of NOTES
Use evidence to determine the efficacy of current common perioperative practices
Prevent surgical site infections
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