Making a surgical incision to reach areas with the abdomen has always been the most practical method of entry or at least the most common.
But more and more surgeons are using alternatives to this conventional method, primarily using the body's natural openings as passageways that may be less problematic for the patient and providing quicker recovery. D no observable scars.
And in this era where speed is weighted almost as equally as quality, surgeons have struck gold using the mouth as a primary entry point.
Steven Gorcey, MD, division chief of gastroenterology at Monmouth Medical Center (Long Branch, New Jersey) and Frank Borao, MD, chief of minimally invasive surgery and medical director of Monmouth's bariatric surgery program, recently used this pathway to do a procedure that helps patients lose the weight they've regained after gastric bypass.
The incision-free procedure, which surgeons have dubbed "ROSE" (restorative obesity surgery, endolumenal), reduces the size of the stomach pouch and stoma to the original post-gastric bypass proportions to help the patient lose the regained weight.
"The benefit [of going through the mouth] is a quicker recovery time," Borao told Medical Device Daily. "Patients go home immediately. The only thing they suffer from is a mild sore throat and that's it."
It is estimated that about 44% of patients who undergo gastric bypass regain weight and the dangerous co-morbidities associated with that weight a few years after their initial operation.
Studies indicate that post-gastric bypass weight is regained sometimes because the stomach pouch and the opening to the small intestine (the stoma) slowly stretch out, enabling the patient to eat more without feeling full.
Invasive procedures to restore the anatomy to the original post-surgery proportions have been too complicated and dangerous for most patients, leaving them without feasible treatment options, but with much of the weight they thought they had lost.
To perform the procedure, Borao used a small flexible endoscope and a new EndoSurgical Operating System (EOS) developed by USGI Medical (San Clemente, California), a company focused on these types of procedures, inserted through the mouth into the stomach pouch. Tissue anchors are used to create multiple, circumferential tissue folds around the stoma to reduce its diameter. The surgeon then uses the same technique to place anchors in the stomach pouch to reduce its volume capacity.
Hooks and graspers such as these are characteristic of these instruments and they are being combined with robotic manipulation to become even more sophisticated in what they can do.
"The idea is that a device should be able to operate like an endoscope," Chris Magee, director of marketing for USGI, told MDD. "EOS is a four-channel device, with one channel reserved for visualization and the other three for channels holding tools."
EOS received FDA approval in September 2007, he said, adding that the company is currently seeking the CE mark.
Magee added that the device is actually being marketed as a platform system that could be used to perform other procedures.
The procedure is part of a growing trend in the use of medical devices, called natural-orifice translumenal surgeries, or NOTES, that uses the natural passageways of the body to avoid external incisions, and, it is hoped , to reduce the chance of infection.
Other reported NOTES procedures have included removal of gall bladders and cancerous tumors.
On the horizon are more complex procedures, such as resections of fallopian tubes, bypass procedures and the draining of coronary arteries. These are being performed primarily in preclinical trials.
As this research work moves forward, it is producing a wealth of patent filngs.
But the field is not without controversy. While NOTES proponents tend to call it incision-less, the procedure usually requires incisions inside the body.
Controversy or not, the strategy is sure to grow as more procedures of this type are performed and word spreads among patients hungry for procedures billed as "minimally invasive."
Last month, surgeons at UC San Diego Medical Center reported performing what they said they believe is the country's first removal of a diseased appendix through the mouth. This clinical trial procedure received approval for a limited number of patients by UC San Diego's Institutional Review Board (IRB) which oversees clinical research.
"The purpose of this clinical trial is to test more patient-focused' techniques for minimally invasive surgery," Mark Talamini, MD, professor and chair of the department of surgery at UC San Diego Medical Center, said in a statement. "[We are] testing groundbreaking ways in which to perform surgery with fewer incisions, less pain and more rapid recoveries."
Santiago Horgan, MD, professor and director of UC San Diego's Center for the Future of Surgery, and Talamini, president-elect of the Society of American Gastrointestinal and Endoscopic Surgeons, performed the surgery on a 42-year-old man. The center said it is first U.S. hospital to perform the procedure, with India being the only other country to report such an operation.
"Only one small incision to insert a small camera in the bellybutton was required to complete the surgery, vs. three incisions required for a laparoscopic procedure," said Horgan. "The patient was discharged 20 hours after surgery and is now reporting minimal pain, which is a goal for all of our patients."
Magee, who was aware of the USGI procedure, said the center is at the beginning of a wave of an emerging market. "There is no shortage of interest in this procedure," he said. "We're seeing patients and surgeons genuinely interested in this."