Editorial Message: Where’s the IRB for SILS?

| November 17, 2009

Dear Collegues:
I just returned from the American College of Surgeons 95th Annual Clinical Congress in Chicago, and, as is always the case, I was impressed with the mathematical organization and size of the meeting. There were thousands of surgeons present, buses going back and forth, and the never-ending walk through the Moscone center.

The highlight of the meeting for me was the amount of marketing, driven mainly by members of industry and a group of surgeons, for single-incision laparoscopic surgery (SILS) or single-port surgery. I cannot hide my discontent at seeing the large amount of dollars and energy spent on what I believe is, at this point, a dangerous approach. Let me share with you my thoughts and reasons on why I say that.

First, I believe this approach takes away the surgeon’s ability to triangulate and to exercise traction and counter traction on tissue when dissecting planes, and, more importantly, by moving instruments and scope along the same pathway, it takes away visibility. Can you call a procedure done under these circumstances safe?

Second, the procedures are carried out with significantly longer operating times, exposing patients to more anesthesia and its associated risks, as documented in the literature for decades. While I was practicing in Germany, a mentor of mine used to say, “In the operating room, be fast without hurrying up.” I cannot renounce the expression of my concern when significantly longer operating times are spent at the expense of temporary cosmetic advantage.

Third, surgeons are hiding the expression single incision under the term laparoscopy because the approach is conducted under pneumoperitoneum. The latter allows them to perform this new and experimental type of surgery without an institutional review board (IRB) protocol approval and proper consent. Surgeons performing the procedure often tell patients, “I will start with one trocar and increase the number of trocars as necessary.” While this is not the full content of what this approach entails, I believe this is a fair statement. Why? Every time you see one of these cases being performed live, more than one trocar is utilized, and yet they still call it “single” or “mono” port.

Fourth, to resolve the above-mentioned issues, some industry partners are producing an array of new trocars, instruments, and scopes costing us lots of unnecessary dollars. It is no surprise that healthcare costs are going through the roof and we surgeons have nothing to say when it comes to reform.

Why should we if we cannot exercise cost control with a situation as simple as this one in our own operating theatres?

Fifth, (and probably the most upsetting about this new trend) there is no clear advantage to the patient, the institution, or the surgeon by using this approach. If one were to write an IRB protocol for this technique, what would be the working hypothesis? What are we trying to prove? Those who are trying to find benefits from this new method say “cosmesis.” I challenge them! We all know that 5-mm trocar incisions will heal in months, and, in the majority of the cases, they do not cause pain and will not even leave a scar. So, when it gets right down to it, whether employing four-, five-, or forty-incision laparoscopic surgery (what I like to call “FILS”), there are going to be just as many scars (or lack thereof) compared to SILS. In reality, SILS has only a  “temporary cosmetic benefit.” Proponents of this procedure are taking advantage of patients’ lack of knowledge and understanding of what is really going on. Twenty years after laparoscopic cholecystectomy was introduced into our practices, we still see patients who come through the emergency room and are pleasantly surprised to hear that we can conduct surgery without having to “cut them open.” They do not know why this is better, they just trust us.

Finally, many claim that laparoscopic cholecystectomy started in a similar way to SILS: taking a longer time in the operating room, costing millions of dollars on new equipment, and, in some cases, putting our patients at risk. If we indeed started the laparoscopic era “wrongly,” why repeat the same mistakes? We still have, in published series, a significantly higher incidence of common bile duct injuries today. But the end point, the hypothesis for employing laparoscopic cholecystectomy, was that we were reducing pain, decreasing the complication rates of large incisions, and enabling our patients to recover early and resume their normal activities more quickly compared to open procedures. Cosmesis? Of course it was and still is important, but it is last, not first, on our list of potential benefits. I cannot wait to read the first prospective, randomized trial comparing any surgical procedure using one trocar versus multiple ones.

I am not against progress; in fact, I am privileged to conduct a number of new studies and participate in numerous United States Food and Drug Administration (FDA) trials. But every single one of those studies has an IRB protocol in place to protect our patients, the trial centers, and the trial investigators. Bernard Shaw once said, “Progress depends on the unreasonable man.” The problem with this statement when applied to surgery is that we are not dealing with airplanes, scopes, machines, or objects, but with human lives.

On a happy note, I congratulate United Healthcare for taking the initiative to approve sleeve gastrectomy as a valid treatment option for morbid obesity. This is a great move for a safe and efficacious procedure.

Finally, I would like to recommend to our readers this issue’s exit interview with my dear friend Dr. Scott Shikora after a wonderful year as president of American Society for Metabolic and Bariatric Surgery (ASMBS) (See “Dr. Shikora Has Left the Building,”). I am sure he will enjoy weekends back at home with his family. Great job, Scott! Congratulations on a job well done.

Sincerely,

Raul J. Rosenthal, MD, FACS
Editor, Bariatric Times

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