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July 2010 Progress Report
CIMIT Strategic Initiative on NOTES

A transformational new diagnostic and therapeutic approach that utilizes the mouth, anus and vagina to enter the abdominal, pelvic and thoracic cavities, natural orifice surgery (NOTES) is becoming a viable option for minimally invasive procedures. 

The Boston-based, CIMIT-supported initiative is a multidisciplinary, multi-institutional collaboration of leading surgeons and endoscopists from Massachusetts General Hospital, Brigham and Women’s Hospital, Beth Israel Deaconess Medical Center, the Massachusetts Institute of Technology and Dartmouth Medical Center. David Rattner, MD, chief of the Division of General and Gastrointestinal Surgery at MGH, leads the CIMIT strategic initiative and is a founder of NOSCAR, the national coalition of doctors interested in this revolutionary approach to scarless surgery.

» VIDEO: What is the Boston-based NOTES Initiative?

What is the Boston-based NOTES Initiative?

CIMIT has been supporting NOTES research since 2003.  In 2008, it selected the NOTES team as the CIMIT Strategic Initiative and awarded a three-year $2.1 million grant. Its four key focus areas of the NOTES initiative are:

  • Refinement of NOTES technology to perform a gastrojejunal anastomosis
  • Refinement of the trans-rectal approach to the peritoneal cavity and performance of segmental colon resections using a Transanal Endoscopic Microsurgery (TEM)/NOTES approach
  • Development of trans-esophageal mediastinal and intrathoracic NOTES procedures
  • Development of platform devices to allow complex tissue manipulation that will facilitate NOTES procedures

A significant milestone of the NOTES Strategic Initiative was achieved in November 2009 when MGH Surgeon Patricia Sylla, MD travelled to Barcelona to perform the first-in-human transanal NOTES rectal cancer resection using TEM. In May of the same year Dr. Rattner led a surgical team at MGH in performing the New England region’s first NOTES procedure, entering the patient’s abdominal cavity through the vagina to remove her gall bladder. In the U.S., five centers have performed NOTES procedures in human patients.

Progress has also been made in each of the initiative’s four target areas. 

  • Researchers are currently working to refine their NOTES gastrojejunostomy technique to be able to perform it on patients with duodenal obstruction. 
  • The TEM approach is being expanded to perform formal colon resections as well as access upper abdominal organs. 
  • In an effort to consider alternative logical entrance points into the thoracic cavity, researchers have developed a method of transversing the esophageal wall to access the mediastinum and pleural cavity. They have demonstrated it to be safe when tested on animals, and work is currently planned to develop this methodology further for both diagnostic and therapeutic applications.
  • A small intestinal submucosal (surgiSISÒ) covered stent that could be deployed over the mucosectomy site and tunnel has been developed, and an investigation into the best closure method, stenting or suturing, of the transedophageal exit site created during NOTES procedures is currently underway. 

All of these steps should bring researchers closer to making NOTES procedures through all orifices ready for human trials.

Natural Orifice Translumenal Endoscopic Surgery (NOTES) offers many benefits over traditional abdominal surgery and could offer certain advantages to laparoscopic approaches.  Patients are the primary beneficiaries of NOTES procedures as it is likely to be much less painful, leave no scars and consequently lead to a much more rapid recovery than is seen in current surgical procedures. And with shorter recovery periods, employers will benefit because employees will be able to return to work sooner. 

Significant challenges remain before a NOTES alternative can be realized.  In order to prevent complications, a new stable working platform must be developed to provide a failsafe method to enter these cavities and close the access sites.  Also important will be methods to ensure sterility and enhance dexterity beyond what is currently possible using flexible endoscopes.

The national NOTES initiative is a global collaboration facilitated by leading endoscopists, surgeons and NOSCAR, the organization jointly created and supported by the American Society for Gastrointestinal Endoscopy (ASGE) and the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES). 

Natural Orifice Translumenal Endoscopic Surgery (NOTES)
is an approach to surgery that leaves no visible scars. During the procedure, entry to the abdominal cavity is gained through one of the body’s natural orifices – mouth, anus or vagina.


Videos

Q&A with David Rattner, MD:
» What is NOTES?
» NOTES vs. Endoscopy
» What is TEM?
» TEM Procedure and Collaboration
» What is the Boston-based NOTES Initiative?
» Is NOTES an Improvement over Traditional Laparoscopic Procedures
» What Procedures Might Benefit from the NOTES Approach?
» What is a Typical Minimally Invasive Thoracic Procedure?
» What is the Potential for NOTES?
» NOTES vs. Single-Port Surgery
» The Evolution of NOTES
» The Role of CIMIT
» When might Patients Benefit from NOTES?

» David Rattner, MD at Ideas Boston
» Transanal Endoscopic Microsurgery (TEM)


Benefits of NOTES
• Less painful
• Leaves no visible scars
• Reduces chance of infection
• More rapid recovery
• Potentially “transportable” to less acute settings, including out-patient or other more austere environments

 


Natural Orifice Translumenal Endoscopic Surgery™ (NOTES®) is a new type of surgical procedure currently being studied at research hospitals and facilities around the world. The idea of NOTES® was developed several years ago in response to the concepts that patients would 1) realize the benefits of less invasive surgery by reducing the recovery time, 2) experience less physical discomfort associated with traditional procedures and, 3) have virtually no visible scarring following this type of surgery. All of these advantages have spurred research and investigation forward, encouraging physicians and researchers to develop new equipment and techniques to use during NOTES® procedures.

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. Some operations might be done via the rectum, vagina, urethra or bladder as well.

Because NOTES® is so new, research generally has been confined to animals, mainly pigs. Recently, however, human studies have emerged that report the procedures to be highly successful. Further studies involving a variety of procedures, under close supervision by medical experts and review boards, are being performed.


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