Natural Orifice Translumenal Endoscopic Surgery (NOTES) Fact Sheet

What it is: Natural Orifice Translumenal Endoscopic Surgery (NOTES) is a novel approach to performing surgical procedures without making incisions on the surface of the body or leaving scars. NOTES utilizes flexible endoscopes through the mouth, anus or vagina to enter the abdominal, pelvic and thoracic cavities. The idea of NOTES was developed several years ago in response to the concept that patients would realize the benefits of less invasive surgery by reducing the recovery time, experience less physical discomfort associated with traditional procedures, and have virtually no scarring following this type of surgery. As an example, in natural orifice surgery the gallbladder might be removed through the mouth. The doctor would insert a tube down the esophagus, make a small incision in the stomach or digestive tract to gain access to the abdominal cavity and take the organ out by the same route. A range of procedures might be performed this way, such as gastric bypass, fallopian tubal ligation, removal of the ovaries and diagnostic work. To date, the NOTES technique has been used primarily for diagnostic and therapeutic procedures on animal models, including transgastric organ removal. However, some human studies have emerged that report the procedures to be highly successful.

Significance: The development of minimally invasive surgical techniques in the 1990s revolutionized the treatment of many common conditions. Nonetheless, many minimally invasive surgical procedures require 1-3 weeks for patients to return to their baseline functional status. NOTES is a novel approach with the potential to hasten recovery because the abdominal and chest wall, which are the source of the most post-operative pain, are not violated. Initially, applications of NOTES techniques could conceivably replace procedures that are associated with significant post-operative pain. If the potential promise of NOTES is fulfilled, many current surgical procedures would become no more disabling than a dental extraction, allowing patients to return to work within 48 hours of a procedure. If the techniques necessary to operate on organs solely through natural orifices can be developed, the impact on health care could rival that of the minimally invasive surgical revolution of the 1990s.

Context – worldwide collaboration: NOTES represents an innovative approach to surgery that is being investigated by doctors in medical centers throughout the U.S. and the world. Part of the reason it is developing rapidly is that leading researchers are sharing information, and working together to accelerate understanding.

CIMIT support of NOTES innovation: CIMIT was a very early supporter of this revolutionary approach to minimally invasive surgery. Through new concept grants, career development awards and working group grants, CIMIT provided critical financial support in the nascent days of NOTES. This early financial support of science projects has enabled this Boston-based, multi-disciplinary, multi-institutional team to take a leadership role in the early formation of the national NOTES collaboration. At its founding, CIMIT was focused primarily in the area of minimally invasive surgery. One of CIMIT’s original founders, David Rattner, MD, continues to lead the MIS program and was an early advocate for CIMIT’s support of NOTES. Five years ago, CIMIT began providing support to a series of projects and working groups within the MIS program. Leading the Boston-based effort of the national NOTES initiative are Dr. Rattner, a general surgeon at Massachusetts General Hospital, who was joined by Christopher Thompson, MD, MS, an endoscopist at Brigham and Women’s Hospital.

Melding medical skills: NOTES relies on a multidisciplinary approach: the collaboration of physicians having the skills of both an advanced therapeutic endoscopist and a laparoscopic surgeon. Many doctors have shown an interest in NOTES, because it is an evolution of laparoscopy, the minimally invasive technique that has gained popularity since the ‘80s.

Disruptive technology, workable platform: NOTES has the potential of being the next breakthrough in minimally invasive surgery, providing patients with scarless, relatively painless procedures while cutting costs at the medical center. It can emerge as a new “stable working platform” that will be a disruptive technology while helping patients, employers and hospitals.

Patients and society will benefit: Patients will benefit because NOTES leaves no scars on the body and creates less pain. There is also less chance of infection. Employers will benefit, because their workers will return to the job more quickly and their health plans won’t have to cover as many days in the hospital. Those in developing countries could benefit, because NOTES systems would be transportable, with little post-operative care required.

Issues surrounding NOTES: In order to prevent complications, a fail-safe method to enter these cavities and then close the access site is needed. Safety will remain an issue until more tests are completed. Also, the lack of small, supple instruments is a major challenge facing NOTES. Doctors are working with medical-device companies to develop new technology that will make endoscopes more flexible and effective. Efficiency and safety must be demonstrated.

Commercial potential: The emergence of NOTES will require new tools and medical devices. Numerous device makers have shown an interest in the procedure and are providing financial support through research grants, sponsorships of medical conferences and other means. Corporate supporters of the national NOTES initiative have included Covidien, Ethicon Endo-Surgery, a Johnson & Johnson company, Olympus, Power Medical Interventions, Boston Scientific, Storz Endoscopy, Stryker, Cook Medical, Davol, Intuitive Surgical, Pentax and USGI Richard Wolf.

Support of professional societies: In July 2005, leaders of the American Society of Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) formed a working group called the Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR), proof that leading institutions in the field support further exploration of this promising procedure.

CIMIT’s NOTES team: Medical experts from four institutions and three disciplines – medicine, surgery and engineering – make up CIMIT’s NOTES team. Key investigators are, from Massachusetts General Hospital, David W. Rattner, MD, William R. Brugge, MD, Field Willingham, MD, Denise Gee, MD, and Patricia Sylla, MD; from Brigham and Women’s Hospital, Christopher C. Thompson, MD, MS, and Marvin Ryou, MD; from Dartmouth Medical Center, Richard Rothstein, MD; and from MIT, Jeffrey Lang, PhD.

NOTES – the CIMIT Strategic Initiative: The primary goal of the CIMIT-supported NOTES Strategic Initiative is to develop key devices and techniques to make NOTES procedures ready for human trials. The NOTES initiative proposes a focus on areas where NOTES would appear to have a distinct advantage over laparoscopic and thoracoscopic approaches. It is likely that NOTES could emerge as a niche application. NOTES would not replace all laparoscopic or open surgeries but rather be used in those specific procedures that are associated with significant post-operative pain, such as those invading the abdominal and chest wall.