BB&T Contributing Writer

CHICAGO – With patients demanding a scarless surgery, surgeons are scrambling to learn the new technique whereby instead of 4 or 5 ports inserted into the abdomen to perform surgery, all instruments are slid through the belly button in order to hide the scar. Some say this is in response to NOTES (natural orifice translumenal endoscopic surgery) that results in no scar, but others insist it is the natural progression of twenty years of performing laparoscopic surgery. Regardless of the motivation, surgeons were swarming around exhibit booths and training sessions at the American College of Surgeons 95th Annual Clinical Congress held here in order to learn this new technique.

Patients are demanding “Belly Button Surgery“ in spite of the fact that there is no data demonstrating any improvement in clinical outcome, and the only obvious benefit is cosmetic. In fact, there are real concerns due to the differences in technique that single port requires and the incumbent new learning curve for the surgeons. Hospitals look at single port as a marketing tool to either keep their current patient flow or capture patients from competing hospitals that cannot boast of belly button surgery. Surgeons experienced in single port surgery can use their expertise as a bargaining chip for recruitment by hospitals. Unfortunately, the only one winning in this equation is the patient; and that is even questionable since other than cosmesis, there is no documented clinical upside. Intuitively, one would think the fewer the holes, the less pain and less chance of infection. But studies have not borne that out yet and surgeons are making no promises to that effect. To confound this situation even more, hospitals are reimbursed the same amount for a procedure whether it is performed the conventional laparoscopic way or through a single port. The problem is that single port surgery, at least initially, takes longer to perform, adding costly operating room minutes. On top of that, the instruments required (again, initially) add hundreds of dollars to the cost of the procedure without any means for the surgeon or hospital to re-coup those costs. Logically one might think it prudent for those patients who insist on single port for cosmetic reasons (since there are no other reasons) should pay the incremental cost. For instance, conventional laparoscopic cholecystectomy would be covered by insurance; but if the patient insists on single port surgery to perform the lap choley, then the patient could pay the additional $500 out of pocket, as one would do for any plastic surgery procedure. The problem with that business model is that in some states (like Massachusetts), it is illegal to have different pay scales for the same procedure; leaving the hospital faced with making the decision of whether marketing belly button surgery will bring in enough incremental patient volume to offset the additional costs. With this scenario as a backdrop, both small and large companies are hustling around the opportunity to enable surgeons to perform single port surgery: the new “scarless“ or invisible surgery. While NOTES or natural orifice transluminal endoscopic surgery still lingers in product and marketdevelopment, single port surgery — the previous ugly step sister — has become the Cinderella of today's ball. By performing standard laparoscopic surgery through the umbilicus (with maybe a small needle hole higher up in the abdomen), one can achieve seemingly “scarless“ surgery just like NOTES boasts. The belly button hides all scars created by the port and or trocars used for entry into the abdomen and if an extra little hole is needed, one can be made using a 2.3 mm needleoscopic instrument instead of a 5 mm trocar, leaving hardly visible punctures. A full 8 hour training session was dedicated to enabling laparoscopic surgeons to evolve into single port surgeons, along with an exhibit hall full of vendors showing a complete range of instruments and other enabling tools to support this new endeavor.

In this well-attended post graduate course “Single Port Laparoscopic Surgery“ experts focused on the theory, technique, safety and practice issues of reducing the typical 5 port laparoscopic procedures to a single port with 3 to 4 trocars within that port. Training was initially on lap choleys since over a million are performed annually in the U.S. and most laparoscopic surgeons are already performing them with the conventional 5 port technique. Paul Curcillo, MD, Vice Chairman, Department of Surgery Director, Drexel University College of Medicine (Philadelphia) introduced the audience to the evolution and concept of evolving from 5 ports to one by using a Dr. Seuss rhyme with real names and events substituted for the storybook Seuss characters. It was not only extremely entertaining, but it also told the story quite well of how surgery has evolved over the years and how the characters (surgeons) shaped it into the way we see it today. Dr. Curcillo continued his instruction by telling the audience “Single incision does not mean one 12 inch incision,“ but rather “reduced port surgery“ that he evolved into by reducing the number of ports “one port at a time.“ First he eliminated one port, having just 4. Then from 4 to 3, then from 3 to 2 etc. until he found himself comfortable enough to always use single port surgery. He cautioned, though, that even though he has performed hundreds of procedures using single port technique, he still does not promise the patient that there will only be one scar. Instead he tells them that he will do his best to reduce the number of ports.

Aurora Pryor, MD, Assistant Professor of Surgery, Duke University School of Medicine (Durham, NC) explained the requirements, at least to begin performing single port surgery, as being “accessibility, instrumentation, retraction, insufflation, and closure.“ She encouraged the attendees to “use the technique and products you are most comfortable with.“ She then described the ideal single port system (see Table 1) and continued with the pros and cons of the various options to entering the world of single port surgery (see Table 2).

Pryor concluded by saying, “Single port surgery can be done by all surgeons and you can use anything from standard instruments to integrated platforms.“

Needleoscopic Surgery Reborn

Over a decade ago when laparoscopy was rapidly emerging, several instrument companies developed instruments that would fit through a 14-gauge IV catheter that was being used as a trocar and thus called “needleoscopy“. The purpose at that time was to use the umbilicus for all the surgical work while using an arrangement of minimal puncture holes for dissection and retraction at other sites that would not leave additional wound scars on the abdomen. This concept was not well adopted and most of the manufacturers of those early needleoscopic instruments no longer exist, mainly because as an additional light source, the 2 mm cameras were inadequate and the instruments by the sheer nature of their thin design, were too floppy and not robust enough to get the job done well. But a select group of skilled laparoscopic surgeons continued to perform needleoscopic procedures like Michel Gagne, MD who claimed “needleoscopic surgery never really went away; it just remained in the hands of a few.“ Gagner, Clinical Professor of Surgery, Florida International University (Miami Beach, Florida) shared his needleoscopic techniques and also compared needleoscopic (NC) vs. laparoscopic cholecystectomies (LC) in a meta-analysis where “the results demonstrated increased difficulty in performing the needleoscopic procedures and a higher skill set is needed.“ (see Table 3). He asked the audience, “Do the improved cosmetic and pain benefits outweigh the increased OR time?“ He ended his presentation with a slide showing that the result of the needles was invisible at one year, getting confused with an existing freckle or mole.

“Needleoscopic surgery puts triangulation back into the equation, which should translate into a margin of safety,“ Gagne stated. In a small study of 60 patients he compared needleoscopic to laparoscopic effects in cholecystectomies and found that there was a 20% increase in OR time but the use of analgesia was reduced by 70%. Currently Gagne performs needleoscopic procedures using the same amount of OR time as when done with conventional laparoscopic techniques, but with a significantly better scar.

Stryker (San Jose, California) was exhibiting their MiniLap line of instruments that are 2.3 mm ultra thin instruments to assist in the manipulation, retracting and grasping during single port surgery. Stryker is currently the only ones on the market with these small instruments, but Storz and Wolf offer 3 mm ones. It is possible that Covidien could resurrect the original 1990's version that was created by United States Surgical, but that is only circumspect. When using needleoscopic instruments, only a steri-strip is used to “close“ the wound, if you can even call it that—no suture is required.

“Safety is the big issue in new technologies,“ claimed Nathaniel J. Soper, MD, Chair, Department of Surgery, Northwestern University (Chicago). “In single port surgery, retraction is different and operating in line with the microscope is not as easy to judge as with regular laparoscopy. The techniques for single port are different and harder to manage than with standard laparoscopy, and we all know that “Classical anatomy only presents in less than half the time“ so it is harder to see anomalies with single port (See Table 4).

Following Soper's advice on safety, Morris Franklin, Jr., MD, Director, Texas Endosurgery Institute (San Antonio) discussed “Energy Devices and Thermal Injury“ with more cautions on the safety of adopting single port surgery. He said that “the close proximity of instruments set the stage for electrical injuries, and in single port surgery it is difficult to see everywhere and if the instruments are touching, especially when they are outside your field of vision.“ He warned that there are three things that can happen when using electricity in single port surgery:

• You can have direct coupling, which is usually pilot error

• You can have insulation failure which is often found when using reposable instrument

• You can get capacitive coupling when a second instrument is electrified if it is within a milimeter of the first instrument. It can even happen when using bipolar electricity.

Franklin continued by stating that bipolar energy has fewer safety problems than monopolar but it doesn't work as well in surgery; while ultrasonic cutting is safer electrically but heats up to 240 degrees and takes 9 seconds to cool. When asked by an audience member what to do about electrical injury prevention, he said “Convert to a different energy source (than monopolar) or fix the one you are using; it is not a matter of IF but WHEN it will happen.“

The first integrated platform for single port surgery was launched here by TransEnterix (Durham, North Carolina). It offers surgeons triangulation through two dynamic flexible channels as well as active channels that provide full rotation at the distal ends, allowing them an intuitive-based learning curve. This disposable multi-channel single port SPIDER (Single Port Instrument Delivery Extended Reach) system is expected to be marketed first quarter 2010. To offset the increase in cost of the procedure using the SPIDER, only a single operator need be in the room.

Given that the patient demand is not apt to disappear soon, the issue becomes one of safety versus cost and surgeons are learning both at a rapid rate. Regarding the cost factor, Paul Curcillo, MD has perfected his technique of bypassing the use of a port and instead doing a simple Hassan dissection to the fascia and then inserting 3 small low cost trocars from Apple Medical Corporation (Marlborough, Massachusetts), claiming that he actually saves money performing single port surgery in this manner. Curcillo told the audience: “Manufacturers beware: In a cost conscious society, doctors are becoming increasingly creative.“ In regards to the safety factors, he claimed, “Using an extra port is not a failure, it is smart. Single port surgery is not for every patient and not for every surgeon. 'Reduced port' should be the commonly used term to remind surgeons (and patients) that the goal is to minimize scars while maintaining safety and effective procedures.“