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Fifteen years ago, laparoscopic surgery revolutionized the operating room. Instead of making large incisions in the body, surgeons could perform many operations with special, slender instruments and a video camera lens inserted through several small holes in the skin.
Now, a new approach that goes beyond laparoscopy is on the horizon, eliminating the need for any external incisions. Known popularly as “scar-free” or “scarless” surgery, the technique utilizes natural orifices to reach deep within the body with instruments and perform surgical procedures.
“The new approach eliminates the need for any external incisions.”
“The new approach eliminates the need for any external incisions.”
The technical name for the procedure is natural orifice transenteric surgery, or NOTES. It combines endoscopic and laparoscopic techniques to access the abdominal cavity through the mouth, anus, vagina or bladder. To date, few NOTES procedures in humans have been reported and research has focused mainly on animal models. Surgeries performed in animals include removal of the gall bladder, appendix, fallopian tubes, ovaries and adrenal glands.
Doctors in Strasbourg, France, recently announced that they removed a woman’s gall bladder through her vagina without abdominal incisions. Their report is published in the September 2007 issue of the Archives of Surgery. At New York Presbyterian Hospital/Columbia University Medical Center doctors performed a modified version of the surgery, making two tiny incisions in the patient’s abdomen to insert laparoscopic instruments. Another procedure was reported in India where a patient’s appendix was removed through the mouth.
Interest in NOTES has been building since 2004 when results of the first successful experiments in pigs were published. Two years ago a consortium of surgeons and gastroenterologists formed the Natural Orifice Surgery Consortium for Assessment and Research, or NOSCAR. They recommended that NOTES in humans be introduced gradually, starting with diagnostic procedures to ensure patient safety.
A group of researchers at Ohio State University Medical Center in Columbus initiated a pilot study in humans, using laparoscopic instruments inserted through the mouth to examine the abdominal cavity. They compared the results of this procedure in 10 patients with a pancreatic mass to traditional laparoscopic examination with incisions into the abdominal wall in the same group of patients.
Using a gastroscope passed through the esophagus into the stomach, surgeons made an incision in the wall of the stomach to allow passage of laparoscopic instruments into the abdominal cavity. They concluded that the non-traditional procedure was safe and effective, although a number of technical issues needed to be resolved. Their findings were published in Surgical Endoscopy in June 2007.
The French group concluded that the NOTES approach to gall bladder removal enhanced all the advantages of laparoscopy—minimal postoperative pain and scarring and quick recovery. However, although transvaginal access to the abdominal cavity has been used for years, they caution that transgastric access still has challenging issues, such as the risk of infection and leakage and a safe means of closing the incision in the stomach wall.
Additionally, they said NOTES is more time consuming and technically difficult. An editorial accompanying their study states that the “benefits are not earthshaking and the risks are real. The only clear benefit is the absence of visible scars.”
A Sept. 2007 article in Current Opinion in Gastroenterology suggests that NOTES might be especially beneficial to morbidly obese patients and others who can’t tolerate general anesthesia. It might also spare some children a lifetime risk of complications from an incision as well as issues resulting from scars.
A related technique is being perfected in neurosurgery — endoscopic transnasal brain surgery. Surgical access through the nose has proven to be a successful in removing pituitary tumors for years. Now, some surgeons are using this route to reach into the brain and remove tumors at the base of the skull.
Doctors in Chicago, Pittsburgh and India have reported excellent results with this transnasal approach. Rather than the more debilitating, disfiguring method of cutting through the face and the skull, they use narrow scopes and miniature surgical tools inserted through the nose. They have found that the procedure is simpler and faster, with fewer complications and less pain and scarring for the patient. The chief risk is cerebral fluid leakage.
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NOTES (natural orifice transenteric surgery) is absolutely the latest development in minimally invasive surgery (MIS). I really feel it represents the next wave of MIS and may be a paradigm shift. Two years ago at an international MIS meeting, it was greeted with skepticism. Today, the reaction among surgeons is, “How do we make this happen?”
“If NOTES concepts prove valid, this procedure can further quicken recovery, lessen pain and be less traumatizing to tissue.”
With the advent of laparoscopy and thoracoscopy (minimally invasive chest surgery), the surgeon’s hands are no longer in the body cavity, and we can operate successfully via video cameras and small instruments. Laparoscopy started with gall bladder removal. Now we perform some very complex surgeries — including pancreatic resections, liver resections and antireflux procedures, as well as the removal of adrenal tumors and colon cancers and gastric bypass surgery — via laparoscopy.
With NOTES, the need for tiny incisions in the skin is eliminated and openings through the mouth, rectum, anus, urinary tract or vagina are used. In the case of neurosurgery, the nose is the natural orifice.
In terms of patient recovery, we made a huge leap forward when we went from open surgery to MIS. There is less pain, less bleeding and quicker recovery. If NOTES concepts prove valid, this procedure can further quicken recovery, lessen pain and be less traumatizing to tissue.
However, we are still trying to figure out how we want to proceed with this latest development of MIS. With very few exceptions, we haven’t taken it to patients yet. It’s still in the animal and equipment developmental stages.
“It may take another decade before we find the right technology.”
Our ability to do NOTES isn’t limited by our desire. It’s limited by our technology. That was also the case 15 years ago with laparoscopic surgery. Initially, we didn’t have the skills or the equipment, but we caught up.
At the UK Center for Minimally Invasive Surgery, we are beginning to research NOTES on animal models. The porcine model is used because the intra-abdominal anatomy of a pig is similar to a human’s and the abdomen is large enough that we can get in and work.
Flexible endoscopy needs to advance for NOTES so that we can move our instruments in multiple directions as we can in laparoscopy. Right now, it’s difficult to close the incisions made internally during NOTES with the equipment we have. Surgeons who have performed NOTES are using off-the-shelf instruments. One of the goals of animal research is to develop ways to use the equipment we now have.
Companies that supply MIS equipment are working feverishly to develop new instruments. At UK we are trying to partner with the industry to develop the best endoscopes and suturing devices. But it may be another decade before we find the right technology. In the UK Center for Minimally Invasive Surgery we hope to move forward into human clinical trials validating NOTES techniques and procedures as we progress with successful animal developmental studies.
Thus far, all that NOTES research has proven is that we can do the procedure successfully on animals with some off-the-shelf technology. Further research may show that NOTES is less effective and has a higher infection rate. But the chance to improve patient care is too great, so we must continue our research.
Dr. Gagliardi is director of the UK Center for Minimally Invasive Surgery and associate professor of surgery at the UK College of Medicine.
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