NOSCAR Statement on Flexible Endoscopes used during NOTES Procedures
The Natural Orifice Surgery Consortium for Assessment and Research® (NOSCAR®), a joint initiativebetween the American Society for Gastrointestinal Endoscopy and the Society of American Gastrointestinal and Endoscopic Surgeons, was mandated by its parent societies to oversee the early investigation and clinical experience with natural orifice surgery.
In its initial summary, published in 2005, NOSCAR stated that Natural Orifice Translumenal Endoscopic Surgery® (NOTES®)could potentially represent a revolutionary advance in patient care, but more research was required to prove its safety and efficacy.
At the July 2012 NOSCAR meeting, the Joint Committee completed an extensive review of published endoscopic and surgical literature for sponsored research and clinical experience in NOTES. Based on this review, NOSCAR concluded that, while NOTES procedures are still considered experimental and require IRB approval, data regarding instrumentation are now sufficiently robust to make new recommendations.
Specifically, the use of a flexible endoscope to traverse the wall of the GI tract or vagina is acceptable during NOTES procedures and should not be considered experimental. Many decades of reports of both intentional and unintentional use of flexible endoscopesas a surgical instrument to traverse the lumen of the GI tract document minimal risk of infectious complicationsregardless of whether the scope has been processed using high level disinfection or gas sterilization. The accumulated evidence, thus far,also indicates that use of the flexible endoscope through transmural access points in NOTES surgery is well-tolerated and poses no extraordinary patient risk by reason of infection or instrument-related complications.
Therefore, NOSCAR urges stakeholders to view flexible endoscopes as acceptable instrumentation during IRB-approved NOTES procedures.
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