Editorial Natural orifices translumenal endoscopic surgery (NOTES)— Who should perform it? Emmanouil Zacharakis, MD, PhD, Sanjay Purkayastha, BSc, MBBS, MRCS, Julian Teare, MD, FRCP, Guang-Zhong Yang, PhD, and Ara Darzi, KBE, HonFREng, FMedSci, London, UK
From the Department of Biosurgery and Surgical Technology, Imperial College London, St Mary’s Hospital
THE CONCEPT of abdominal surgery via natural orifices without abdominal scars is very attractive. Indeed, it is difficult for a patient to choose to undergo a traditional ‘‘open’’ abdominal operation or even a laparoscopic one, given the option to have the same procedure without any abdominal incisions. At present, surgery is undoubtedly focused on the principle of minimally invasive access. The benefits of smaller incisions as well as associated decreased postoperative pain and recovery time are already well attested in many areas of surgical practice. Patient demand also has proven to be a powerful stimulus to these changes in surgical technique. In the United States and most of the world, Natural Orifices Endoscopic Surgery (NOTES) had been confined to the animal laboratory until the first report of a NOTES cholecystectomy in a human being by Marescaux et al.1 It is obvious that the opportunity provided by the development of these new techniques for leadership and creativity is exciting. It is also possible that many ÔsurgeonsÕ around the world might attempt to take advantage of the new situation by trying to perform NOTES on patients who may seek the less invasive, least painful, and ‘‘scarless’’ option. The question actually is who should perform these new techniques. The answer may be found in the recent history of surgery. The explosion of interest in minimally invasive surgery, after the first laparoscopic removal of Accepted for publication January 19, 2008. Reprint requests: Professor the Lord Darzi of Denham KBE, HonFREng, FmedSci, Professor of Surgery, Head of Department of Biosurgery and Surgical Technology, Imperial College London, 10th Floor, QEQM Wing, St Mary’s Campus, Praed Street, London W2 1NY, UK. E-mail:
[email protected]. Surgery 2008;144:1-2. 0039-6060/$ - see front matter Ó 2008 Mosby, Inc. All rights reserved. doi:10.1016/j.surg.2008.01.003
the gallbladder by Muhe in Germany in 1985, represented the most dramatic change in surgery since the introduction of anaesthesia. The proved advantages of laparoscopic cholecystectomy had put considerable pressure on the surgical community to learn the new technique. Reports of high complications rates, however, suggested that the training and evaluation of laparoscopic general surgeons needed urgent attention. As with any dextrous skill, while on the learning curve, the procedures took longer and there was an increased risk to the patient. A higher incidence of iatrogenic bile duct injuries (BDIs) was reported during the introduction of laparoscopic cholecystectomy. The Southern Surgeons Club documented a 2.2% incidence of BDIs for the first 13 cases performed by every surgeon, whereas for the subsequent patients, the incidence decreased to 0.1%.2 The Royal College of Surgeons of England made a useful early statement in 1990 as to how training should proceed and in North America, the Society of American Gastrointestinal Surgeons made a statement suggesting guidelines for ‘‘credentialing surgeons’’ in the performance of laparoscopic procedures.3,4 Today, the questions of training, learning curve and accreditation in NOTES need to be addressed urgently. The term ‘‘learning curve’’ was introduced to medicine in the 1980s after the advent of minimal access surgery and was labeled as a dangerous stage, with morbidity, mortality, and unproven outcomes. To avoid some of the misunderstandings, missteps, and complications that occurred with the introduction of laparoscopic surgery, responsible leaders in surgical laparoscopy and gastrointestinal endoscopy should address the major issues that confront NOTES intervention. One of the main lessons learned from the introduction of laparoscopic surgery is that these issues should be addressed before widespread introduction of a new technology. The learning curve of a new technique may depend SURGERY 1
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on the manual dexterity of the individual surgeon and the background knowledge of surgical anatomy. The type of training the surgeon has received is also very important as training on inanimate trainers and animal tissue has been shown to facilitate the process of learning.5 The slope of the curve depends on the nature of the procedure and frequency of procedures performed in specific time period. Another important factor that affects the learning curve is the supporting surgical team. However, many dilemmas exist and many questions will be asked while NOTES is in its infancy: Who bears the burden of the learning curve? Are the patients aware of the risks? Many reports validate the impression that a patient operated upon during the early part of the learning curve takes greater risks and incurs more adverse circumstances than the patient operated upon later. The issue needs to be addressed of how informed the consent should be. Is the integrity and conscience of a surgeon measurable? Should the market forces be curtailed or regulated? NOTES is a new technology in surgery which may eventually streamline surgical processes in gastrointestinal surgery or other procedures. As with any new technology, the introduction of new hardware is not without problems. Such changes may cause issues initially until the teething problems are ironed out and successful initiatives become common place. This is known as the effect of emerging technology. Once established, change then takes time to diffuse from the innovator to others, initially to those interested in change, and then to other groups when change is a necessity and is forced upon them. The technology that will result in further success of NOTES procedures may arise from many different thought processes. One possibility is the utilization of robotic endolumenal technology in conjunction with natural orifice access for surgery. This requires the development of fully articulated devices, which may facilitate safe application of NOTES, transferring the advantages of the human-robotic interface into this emerging field.6 The international research effort will try to address and diminish these problems; until it has done so, however, NOTES presents a far greater potential for causing harm than conventional procedures and so must be introduced with care. Initial training of surgeons and endoscopists in natural orifice interventions must involve laboratory and animal models. Training should involve a team approach that takes advantage of the unique skills of endoscopists and laparoscopic surgeons. Appropriate laboratory experience and establishing supportive data are important to gain Ethics Committee/Institutional Review Board (EC/IRB)
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approval for NOTES intervention in human subjects. After a team has learned and taught one another fundamental skill sets, it is imperative that EC/IRB oversight be obtained before interventions in human subjects are attempted. Having supportive laboratory data should be an essential step prior to approval for performing initial NOTES in humans. Once the basic skills of NOTES have been attained and the means are available for supervised practice on animal training models, training courses are important and should also be available to all surgeons during their training process. A few courses on NOTES are available today, varying in both content and quality. We hope that the future establishment of national and international NOTES training units may go some way to solving the problem of providing standardized training. NOTES is here to stay and its success will be determined by how quickly, effectively, and, most importantly, safely we learn, and also by the right instruments that will be developed in future years that will facilitate its safe practice. However, certain measures may be taken to lessen some of the adverse effects of the learning curve. Current guidelines in many countries are vague if they exist. The need for training is well documented. The message for individual surgeons is to identify their deficiencies, and chart a way forward for their personal graph of progress in a laboratory setting initially. The message for the surgical community and the scientific journals is to discourage the application of NOTES to humans by surgical teams without recognized previous experimental efforts, laboratory based training, and recognized ethical approval, while public information on the potential risks should be a must. Evaluation and monitoring in a systematic scientific manner will benefit the surgeons with a satisfactory learning curve that will ensure that patient welfare is not compromised. REFERENCES 1. 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: 823-6; discussion 826-7. 2. The Southern Surgeons Club. A prospective analysis of 1518 laparoscopic cholecystectomies. New Engl J Med 1991;324:1073-8. 3. Royal College of Surgeons of England. Minimal access surgery. London: RCS; 1990. 4. Society of American Gastrointestinal Endoscopic Surgeons. Granting of privileges for laparoscopic general surgery. Am J Surg 1991;161:324-5. 5. Aggarwal R, Moorthy K, Darzi A. Laparoscopic skills training and assessment. Br J Surg 2004;91:1549-58. 6. Jha A. £2m to develop i-Snake robot for keyhole surgery. The Guardian on Line: December 29, 2007. Available from: http:// www.guardian.co.uk/science/2007/dec/29/medicalresearch
