Introduction to NOTES White Paper

Excerpt

We are nearing the 20-year anniversary of the first laparoscopic cholecystectomy, a procedure that was initially viewed with skepticism but ultimately changed the way surgery is practiced. Perhaps less appreciated by many surgeons are the tremendous advances in interventional flexible endoscopic devices and capabilities that have also occurred. Recent laboratory studies have demonstrated the feasibility of performing intraperitoneal surgery via a transgastric route using flexible gastroscopes and reports are circulating throughout the world of first in human transgastric procedures. In this setting, the leaders of SAGES and ASGE convened a working group to address the potential barriers to development and safe introduction of natural orifice transluminal endoscopic surgery (NOTES). The deliberations of the working group are summarized in the White Paper appearing in this issue. Although no one is yet sure where this exciting new approach will take us, there is consensus that the initial transluminal procedures should be performed under the auspices of institutional review boards (IRB) both to ensure patient safety and to be certain that results are carefully tracked and reported. To that end, the working group established the foundation for a larger and more inclusive group called the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR). It is the hope of the working group that by publishing this White Paper, NOTES research can be focused on solving critical barriers to adoption and that when procedures are ready for clinical evaluation, the procedures are performed by qualified teams that report their results—whether favorable or unfavorable—to the rest of the surgical and gastroenterological community. Although NOTES holds great promise for patients by minimizing pain and disability, public scrutiny of medical procedures is at an all-time high and a few false starts could lead to regulatory intervention that would shut down NOTES surgery before it had a fair trial. If the reader takes away only one message from the White Paper, it should be the importance of strict adherence to IRB guidelines and the team skill set concept. The working group members see great promise for the NOTES approach to many conditions, and if we proceed in a thoughtful and ethical manner, it is likely that this promise will be realized in the next 5 years. …