NOTES: of caution

Abstract

Not since the introduction of laparoscopic cholecystectomy has the development of a new surgical technique generated as much excitement and enthusiasm as the concept of natural orifice translumenal endoscopic surgery (NOTES). First described by Kalloo et al. [2], the idea of performing surgery in a body cavity through a natural orifice has rapidly expanded from simple transgastric peritoneoscopy to interventions performed through the rectum, vagina, and bladder. The initial work, performed with porcine models, sought to describe the technique, its feasibility, and its limits. Further studies, most supported by generous grants from industry, helped to define the physiologic, infectious, and immunologic implications of the method [5, 6]. New instrumentation specifically addressing the needs and unique problems of natural orifice surgery has been emerging, offering promise for this technique as well as for traditional endolumenal therapy. With the enthusiastic reception of NOTES came the vision for an entirely new approach to human surgical therapy offering improved cosmetic results and potentially less pain. The video demonstration of a NOTES appendectomy, performed in India, has electrified the surgical world and offered great promise. Human NOTES procedures have been anecdotally reported at meetings, in the media, and by word of mouth. Performed in the United States and other parts of the world, NOTES procedures have included peritoneoscopy, cholecystectomy, tubal ligation, and percutaneous endoscopic gastrostomy ‘‘rescue’’ [1, 3, 4]. Recognizing the great excitement surrounding NOTES and the potential for errant development of procedures, members of the Society of American Gastrointestinal and Endoscopic Surgeons and the American Society for Gastrointestinal Endoscopy met for the Natural Orifice Consortium for Assessment and Research (NOSCAR). The NOSCAR meeting provided a forum for discussing areas of research and clinical practice with regard to NOTES and issued a paper outlining the perceived areas for research and practice of the method [7]. An overriding principle established early on was the protection of patients by the assurance that all initial procedures would be performed under the auspices of institutional review board (IRB) oversight. Most of the NOTES procedures in the United States have been performed under IRB protocol. In other parts of the world, IRB protocols also are used to ensure patient protection and safety. Unfortunately, some cases are being performed off protocol, and reports of patient injury and even death have surfaced, but in unpublished form. In our zeal to develop this new area of surgery, we must ensure that patient safety is at all times paramount and that results are honestly and clearly presented. Work presented in journals or at meetings should represent only the results of IRB-approved protocols, and videos or reports of non-IRB approved work should be avoided. This exciting new area offers much potential for the future and must not be discredited by misadventures with patients unaware of the procedure’s potential risks. J. L. Ponsky (&) M. J. Rosen B. K. Poulose Department of Surgery, University Hospitals Case Medical Center, Lakeside 7th Floor, Mailstop 5047, Cleveland, OH 44106, USA e-mail: jponsky@yahoo.com