Minimally Invasive Surgery Matures, Strives to Reach Full Potential

Minimally Invasive Surgery Matures, Strives to Reach Full Potential

By Michelle Beaver

Minimally invasive surgery (MIS) is an easy sell to patients: less pain, shorter recovery time, less scarring, and a lower likelihood of complications.¹ Plus, MIS costs the healthcare system less than traditional procedures. One of few downsides: MIS can be a hefty investment for owners of ambulatory surgery centers (ASCs). Creating an MIS operating suite can cost $200,000 to $300,000 per room.²

In most cases, however, it’s an investment worth making as the demand for MIS is growing. The global MIS device and instrument market was worth about $12 billion in 2005 and is expected to reach $18.5 billion by 2011, according to the paper, “Trends in the noninvasive and minimally invasive medical device market.” That’s an annual growth rate of 7.5 percent between 2006 and 2011.¹ MIS may be profitable and is usually good for patients, but it’s not simple. It can be difficult for traditional surgeons to learn, and poses many more risks than minor surgery.

Even so, laparoscopic surgery is typically better than alternatives, says George Christoudias, MD, of Holy Name Hospital in Teaneck, N.J. Christoudias has performed spleenectomies, appendectomies, colectomies and lymph node biopsies since 1979.

“When it comes to patient comfort and speed of recovery and return to normal activity, there is no comparison, by any account, between the outcomes of laparoscopic versus conventional surgery,” Christoudias says.

He believes laparoscopic surgery has come a long way, but that it’s still in its infancy.

Through the Bellybutton?

Thanks to a single port access (SPA) surgery in July, medical staff members were able to remove a woman’s ovaries through a single incision in her bellybutton, which left the patient with a hidden scar at the entry point. According to medical staff, the 54-year-old female patient experienced only minimal discomfort. Traditional ovary removals typically require three or four incisions and leave obvious scars.

The technique for this SPA ovary removal was developed by Paul Curcillo, MD, of Drexel University College of Medicine, and was performed by Stephanie King, MD, an associate professor and chief of gynecologic oncology. Curcillo has preformed more than a dozen surgeries — including stomach, gallbladder and hernia — using the SPA technique.

For the gynecologic surgery, King used a new high-dexterity instrument called RealHand™, engineered by Novare Surgical Systems, Inc. of Cupertino, Calif. According to Novare representatives, when the surgeon’s hand moves in one direction, the tip of the instrument follows.

RealHand™ features seven degrees of movement and does not require additional hardware. The instrument is easy to manipulate whether it is positioned over, under, or around structures, product literature states.

“The benefit to our technique and the new high dexterity instrumentation is that it can be easily applied by all general laparoscopic surgeons and gynecologists with minimal additional training,” says Curcillo. “I believe this will truly revolutionize the way laparoscopic surgery is performed.”

Curcillo is going to run national training labs at Drexel to teach SPA techniques.

A Laparoscopic Hysterectomy

Another successful laparoscopic gynecological surgery that was preformed with RealHand™ also occurred in July. A hysterectomy was conducted laparoscopically on a 39-year-old woman and left no visible scar. The process is called a single port TLH, and was performed by Kate O’Hanlan, MD, a fellow of the American College of Obstetricians and Gynecologists, and the American College of Surgeons. Operative time was 65 minutes, which is shorter than conventional hysterectomies, surgery team members say.

When O’Hanlan performed the surgery, she removed the patient’s appendix, also through a SPA technique. Medical staff members report that the patient is delighted with her surgery.

Goodbye Gallstone, Hello NOTES

Another notable recent surgery is the first batch of trangastric gallbladder operations conducted through natural orifice transluminal endoscopic surgery (NOTES). Those involved call it an “entirely new way” to operate on the gallbladder.

One surgery was in June and was conducted by Lee Swanstrom, MD, of Portland, Ore., who performed two similar surgeries around the same time. Each of the patients recovered quickly and did not experience complications, the surgical team reports. The team removed the gallbladder without making incisions on the surface of the skin. The more nuanced method is supposed to cause less pain and infection risk than traditional methods.

This form of NOTES involves flexible surgical tools and a camera that surgical team members pass through the patient’s mouth en route to the abdominal cavity. Through this vantage point they make an incision in the stomach. Afterwards, the surgeon removes excess tissue through the patient’s mouth, then closes the hole in the stomach.

The team used new technology called the EndoSurgical Operating System (EOS) from USGI Medical, Inc. Such technology will be useful in other types of surgeries too, Swanstrom says.

“These initial cholecystectomy procedures are an important first step in the development of methods and devices to enable the widespread adoption of incisionless NOTES surgery,” Swanstrom says. He is director for The Oregon Clinic’s Division of Gastrointestinal and Minimally Invasive Surgery and is director of MIS at Legacy Health System.

“In our first patients, we used two or three small laparoscopic ports to assess the safety of the procedure and to assist in the refinement of the technique,” he says. “As we continue to gain experience, our protocol allows us to begin to eliminate these external ports.”

Swanstrom is a founding member of Natural Orifice Surgery Consortium for Assessment and Research (NOSCAR), which formed in 2005. His three recent cholecystectomies were conducted after four years of laboratory research.

“I am happy to begin transitioning our research to direct patient care,” he says. “The success of this surgery will have very positive implications for patients…Even with laparoscopic or ‘keyhole’ surgery, patients stay off of work for several days, and have activity restrictions.

With NOTES they could potentially go back to work the next day.” Swanstrom says that most of the discomfort that patients feel with laparoscopic surgery is because of the incisions — albeit small — in the abdominal wall. With NOTES, the incision is made in the stomach where there are fewer nerve fibers and thereby less propensity for pain. The skin and muscle of the abdominal wall (which is punctured in some laparoscopic surgeries) register more pain, members of Swanstrom’s team say.

NOTES advocates are hopeful that NOTES procedures will improve in several ways, including that they may be able to be performed under sedation, not general anesthesia.

They are also confident that post-operative infections and hernias will be minimized through NOTES since so little cutting is done. There is, however, a risk of infection to the abdominal cavity from bacteria in the gastrointestinal tract, but Swanstrom’s team claims these instances are rare.

Indeed, many industry professionals are enthusiastic about the combination of talents that could stem from surgeons, gastrointestinal endoscopists and new technology, when teamed up for NOTES. Many procedures are well suited for a NOTES approach, such as endoscopic mucosal resection, small tumor excision, and access to the peritoneum.³

NOTES presents “powerful” approaches and could forever change the field, according to the author of “NOTES: a gastroenterologist’s perspective,” which ran in the Gastrointestinal Endoscopy Clinics of North America journal.

Innovative surgical endoscopists who have long tried to surpass the constraints of the gastrointestinal lumen by using a flexible endoscope, have slowly but surely met their goals, according to the authors of “A primer on natural orifice transluminal endoscopic surgery: building a new paradigm,” which ran in Surgical Innovations in June 2006.

“The future of surgical endoscopy may be the shared entity of NOTES, which further integrates endoscopy, gastroenterology, and minimally invasive and general surgery,” the authors state. “Although the promise of NOTES is electrifying to surgeons and endoscopists, several key issues need to be characterized prior to the incorporation of NOTES into routine practice.”

Some of these issues are quite serious, according to Kirby Vosburgh of Massachusetts General Hospital and Raul San Jose Estepar of Brigham and Women’s Hospital, who authored the paper, “(NOTES): An Opportunity for Augmented Reality Guidance.”

Concerns with NOTES include the fact the flexibility of the endoscope tip can be complicated, and effective navigation of the stomach and abdominal cavity requires two years of sub-specialty training.

“Several surgical targets lie in a retrograde position with respect to an incision in the stomach wall,” the authors say. “Efficient and safe access to the pancreas, gall bladder, or the kidneys requires detailed knowledge of the tip placement relative to adjacent anatomic structures.”

Other problems are that there is limited direct access to the abdomen, which means iatrogenic injuries (such as the accidental cutting of an artery) are more dangerous and difficult to manage in NOTES procedures, they continue.

Hope prevails, however, as the authors claim that concerns can be mitigated through augmented reality techniques that use pre-procedure CT or MRI imaging, real time tracking and reference image registration, and display to the operating physician.

“As an example, the utility of image registration techniques for orientation for the gastric access puncture is discussed in detail,” they say. “It is anticipated that such augmentation will make intra-cavitary interventional techniques easier to master and use in practice, and thus more likely to be widely adopted.”

X-Stop Surgery

Any sane patient would rather take part in a surgery that is unobtrusive as opposed to one that practically turns them inside out — especially in regard to the spine. A relatively new technique called interspinous process decompression system (extension stop, or XStop ®, for short) is making waves in the treatment of lumbar spinal stenosis. The Food and Drug Administration approved the X-Stop® process in 2005.

Lumbar spinal stenosis restricts movement and commonly afflicts elderly patients as a natural part of the aging process. X-Stop® requires a small incision in the back for placement of a small titanium device. The procedure has been performed on about 5,000 patients.

The theory behind the process is that it is best to maintain the affected spinal segment in a slightly flexed position (which also prevents extension). This supposedly allows the patient to resume normal posture rather than having to flex the entire spine.

In southern Florida, an institute devoted to this very practice opened at the end of summer 2007. The South Palm OrthoSpine Institute is run by Stewart Eidelson, an orthopedic surgeon. He has performed more than 3,000 spinal surgeries and is a champion of minimally invasive procedures such as the X-Stop®. The practice features several doctors, as well as a state-of-the-art research center for clinical studies.

Eidelson says he founded the OrthoSpine Institute in an effort to make minimally invasive and technologically advanced surgeries available to more patients. With the X-Stop®, he claims patients often have a 100 percent return to their normal activity levels.

“After undergoing the X-Stop®, my patients are usually back at home the next day and returning to their normal activities within two weeks,” Eidelson says.

The procedure is performed under local anesthesia and can be completed in less than one hour. Surgeons place a titanium spacer between the spinous process of the vertebrae in the lumbar spine. It’s designed to stay in place without being attached to bone or ligaments. If completed effectively, the patient can resume an active life, complete with participation in sports such as golf and tennis.

The X-Stop could be an alternative to more invasive procedures such as laminectomy and fusion. According to representatives of the Spinal Stenosis Foundation, most X-Stop® patients see immediate improvements in back, buttock and leg pain and can become moderately active within two weeks of the procedure. It doesn’t require postoperative bracing, sutures are removed within seven days and only minor medication is necessary.

Seeing the Future

Minimally invasive surgery requires additional visualization since the surgeon has decreased exposure. Technology for minimally invasive surgery will need to provide this missing information, either through endoscopic visualization techniques, intraoperative imaging, or surgical navigation, says Marc Mackey, director of business development for BrainLAB, Inc.

“The key challenge is to combine all this information in a sensible way so that it can be used and interpreted during surgery,” Mackey says. “Computer-assisted surgery will play a central role in the evolution of MIS by combining the different sources of this information into a single, comprehensive, and simplified intraoperative view that guides the surgeon. In the end, surgeons will have real-time access to more information with a computer-assisted MIS procedure than with a conventional open procedure, so that you will see new surgical treatments evolve that were previously not possible without this additional information.”

Such technology is vital for orthopedic surgery, and has proved especially useful in femoral acetabular impingement, according to Paul Beaulé, MD, FRCSC, of the Ottawa Hospital, in Ottawa, Canada.

“Over the last few years, hip arthroscopy has emerged as a surgical technique offering patients suffering from tears of the hip cartilage (labrum) a quicker recovery and less surgical morbidity,” Beaulé says.

“This has been especially true in the treatment of hip impingement deformities which are a cause of hip arthritis. …Companies like BrainLAB have been working in close collaboration with orthopedic surgeons to improve surgical accuracy through computer-assisted navigation,” he adds. “Needless to say, having the capacity to use computer assisted navigation in combination with hip arthroscopy for the surgical correction of hip impingement will not only ensure optimal patient outcome but also minimize the risk of suboptimal correction of the deformity.”

No one knows the details of how MIS will revolutionize the surgery injury, but all can agree that MIS will be prominent and that patients will continue to welcome the change.

1. Trends in the noninvasive and minimally invasive medical device market. BCC Research. June 2006.

2. Cook N. Future trends in minimally invasive surgery. AORN Journal. December 2005.

3. Alverdy JC. NOTES: A Surgeon’s Perspective. Gastrointestal Endoscopy Clinics of North America. July 2007.

4. Pasricha PJ. NOTES: A Gastroenterologist’s Perspective. Gastrointestinal Endoscopy Clinics of North America. July 2007.